Soligenix Announces Formation of Oral Mucositis Medical Advisory Board

Princeton, NJ – February 4, 2013 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development-stage biopharmaceutical company, announced today the formation of a Medical Advisory Board (MAB) to provide medical/clinical strategic guidance to the Company as it advances the development of SGX942 for the treatment of oral mucositis, a common complication of cancer treatments.

Comprised of cancer supportive care thought leaders with extensive experience in oral mucositis, the MAB will play an important advisory role in the design and conduct of the upcoming Phase 2 clinical study as well as in the design of subsequent clinical studies and associated regulatory interactions with health authorities. The MAB will provide feedback, input and guidance on clinical strategies and their implementation as well as on other critical issues, such as health economics and reimbursement to assist Soligenix in meeting the needs of the oral mucositis patient population.

“Oral mucositis is a significant unmet medical need which ultimately impacts the tolerability of radiation and chemotherapy and therefore the survivability of cancer” stated Stephen T Sonis, DMD, DMSc, Clinical Professor of Oral Medicine at Harvard School of Dental Medicine.  “The lack of an effective treatment has frustrated healthcare providers and caused misery for innumerable patients. I’m delighted to be helping to develop SGX942 as I believe it holds significant promise as a mucositis intervention. As an innate defense regulator (IDR), SGX942 directly targets a fundamental biological mechanism which leads to mucosal injury caused by radiation and chemotherapy.”

“We are pleased to be able to attract such esteemed and enthusiastic professionals to participate as members of our Medical Advisory Board,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “The initiation of an oral mucositis program marks the first step in the development of our IDR technology platform.  We look forward to working with the MAB and initiating a clinical program in 2013.”

The MAB Members

Stephen T. Sonis, DMD, DMSc

Dr. Sonis currently serves as Clinical Professor of Oral Medicine at Harvard School of Dental Medicine and Senior Surgeon and Chief, Divisions of Oral Medicine at Brigham and Women’s Hospital and the Dana-Farber Cancer Institute, and as Chief Scientific Officer, Biomodels, LLC.  He also serves as a consultant to a number of biotechnology and pharmaceutical companies, advising directly on the conduct of clinical trials of oral mucositis.  Throughout his career, Dr. Sonis has focused on the biology and clinical significance of cancer regimen-related mucosal toxicities.  In particular, Dr. Sonis was pivotal in identifying the crucial role of innate immunity in the generation of severe oral mucositis. The results of his studies have provided treatment targets for biological and pharmaceutical development. Dr. Sonis and his collaborators have identified specific pathways that are critical in toxicity development and have used these to form the basis for models of gene-based risk prediction. Dr. Sonis has published and lectured extensively on the clinical, biological, and health economic aspects of cancer and complications associated with its treatment. He serves on a number of editorial boards, and is a founding member of the International Society of Oral Oncology and the International Academy of Oral Oncology. Dr. Sonis received his Doctor of Dental Medicine (DMD) from Tufts University, his Doctor of Medical Science (DMSc) from Harvard University and was a Knox Fellow at Oxford University.

Dorothy Keefe, MD, FRACP, FRCP 

Professor Keefe is Service Director, SA Cancer Services, Professor of Cancer Medicine at the University of Adelaide and a Senior Medical Oncologist at Royal Adelaide Hospital Cancer Centre.  She is Head of the Mucositis Research Group in the Hanson Institute, and Immediate Past-President of the Multi-national Association of Supportive Care in Cancer (MASCC).  Professor Keefe’s research interests include mucositis in its broadest sense, covering patho-biology, epidemiology, prevention and treatment. She has been highly involved in leading the development of evidence-based guidelines for the management of mucositis through MASCC, as well as co-chairing an international, multi-centre study investigating burden of illness and cost of care for patients with mucositis. Professor Keefe graduated in Medicine (Bachelor of Medicine, Bachelor of Surgery; MBBS) from the University of London. She migrated to Australia, where she undertook her Physician Training in General Medicine and Medical Oncology at the Queen Elizabeth Hospital in South Australia. She became a Fellow of the Royal Australasian College of Physicians (FRACP) and later a Fellow of the Royal College of Physicians in London (FRCP). She received her Doctorate of Medicine from the University of Adelaide.

Mark Schubert, DDS, MSD

Dr. Schubert is a Professor in the Department of Oral Medicine, School of Dentistry at the University of Washington and is the Director of Oral Medicine with the Seattle Cancer Care Alliance as well as a Member in the Clinical Research Division at the Fred Hutchinson Cancer Research Center. Dr. Schubert’s research interests have focused on the oral complications of cancer and cancer therapy, especially as they relate to hematopoietic cell transplantation.  A primary area of interest has been the management of oral mucositis associated with cancer therapy. Research in oral mucositis management has focused on topical anti-infectives (defensins), growth factors and cytokines (KGFs and IL-11), cytoprotective agents (benzydamine, amifostine), and low level lasers therapy. Additional research interests include basic research and management strategies for other oral complications of cancer therapy including salivary gland dysfunction, oral graft-versus-host disease in allogeneic hematopoietic cell transplant recipients, and dental growth and development problems following hematopoietic cell transplant. Additionally, Dr. Schubert has been involved with research related to oral changes and infections in HIV-infected patients.  Dr. Schubert received his Doctor of Dental Surgery from the University of Washington, where he completed a residency in Hospital Dentistry, and later received his Masters of Dental Sciences degree from the University of Washington.

About SGX942

SGX94 is an IDR, a new class of short, synthetic peptides that has a novel mechanism of action in that it has simultaneous anti-inflammatory and anti-infective activity. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation-therapy.  SGX94 has demonstrated safety in a Phase 1 clinical study in healthy human volunteers and efficacy in numerous animal disease models including mucositis, colitis, skin infection and other bacterial infections.  SGX94 is the subject of an open Investigational New Drug (IND). SGX94 was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada and approximately $40 million has been put towards its development inclusive of government grants.

About Oral Mucositis 

Mucositis is the clinical term for damage done to the mucosa by anticancer therapies (e.g., radiation or chemotherapy).  It can occur in any mucosal region, but is most commonly associated with the mouth (i.e., oral mucositis), followed by the small intestine. Mucositis affects 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy.  Mucositis almost always occurs in patients with head and neck cancer treated with radiation therapy (>80% incidence of severe mucositis) and is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of mucositis depends greatly on the nature of the conditioning regimen used.  Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia.  The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes. Direct and indirect consequences of mucositis have been estimated to add ~$18K per patient to cancer treatment costs.

The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral Mucositis.

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government’s Strategic National Stockpile. Soligenix’s lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix’s new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.

For further information regarding Soligenix, Inc., please visit the Company’s Website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes,” “intends,” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

FDA Grants Soligenix Fast Track Designation for OrbeShield™ for the Reduction of Mortality Associated with Gastrointestinal Acute Radiation Syndrome (GI ARS)

Princeton, NJ – January 29, 2013 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that its OrbeShield™ (oral beclomethasone 17,21-dipropionate or oral BDP) development program for the treatment of GI ARS has received “Fast Track” designation from the U.S. Food and Drug Administration (FDA). Soligenix has also previously received Orphan Drug designation from the FDA for oral BDP for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for OrbeShield™ on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission.  Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of six months.

“There are no FDA approved therapies for the treatment of GI ARS,” stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix. “The FDA’s action in granting fast track designation is a validation of BDP’s potential to address this life-threatening, unmet medical need.  We look forward to working closely with the FDA, as well as with the National Institute of Allergy and Infectious Disease (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) to potentially expedite the OrbeShield™ development program.”

About GI ARS

ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow the GI tract and later the lungs.   In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gy are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death in 5-15 days.  The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI.  Although the hematopoietic syndrome has the potential to be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that results from high-dose radiation exposure. Therefore, there is an urgent need to develop specific medical countermeasures against the lethal pathophysiological manifestations of radiation-induced GI injury.

About OrbeShield™

OrbeShield™ contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. OrbeShield™ is formulated for oral administration in GI ARS patients as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract and the other tablet is intended to release BDP in the distal portions of the GI tract.  BDP has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. Oral BDP may also have application in treating other GI disorders characterized by severe inflammation such as Crohn’s disease and radiation enteritis.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral Mucositis.

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government’s Strategic National Stockpile. Soligenix’s lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix’s new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.

For further information regarding Soligenix, Inc., please visit the Company’s Website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes,” “intends,” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

BARDA Invites Soligenix to Submit Contract Proposal for Development of OrbeShield™ in GI ARS

Princeton, NJ – January 7, 2013 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that pursuant to review of the Company’s white paper on development of OrbeShield™ as a countermeasure for the gastrointestinal effects of acute radiation syndrome (GI ARS), the Biomedical Advanced Research and Development Authority (BARDA), Division of Chemical, Biological, Radiological and Nuclear (CBRN) Medical Countermeasures has informed the Company that after careful analysis and consideration, it is inviting Soligenix to submit a full proposal for a potential multi-year, multi-million dollar contract to develop OrbeShield™ from its current level of technical readiness to FDA approval.

Soligenix submitted its white paper entitled “OrbeShield™, oral beclomethasone 17,21-dipropionate  (BDP), a candidate broad spectrum therapeutic countermeasure for GI ARS,” to BARDA in response to a Broad Agency Announcement (BARDA-BAA-12-100-SOL-00011) for advanced research and development of medical countermeasures for chemical, biological, radiological and nuclear threats. BARDA is interested in the advanced development and eventual licensure/approval of effective medical countermeasures that mitigate, treat, affect, delay, or interrupt the progression of injuries resulting from an acute exposure to radiation from a radiological/nuclear accident or attack, particularly injuries associated with ARS.

In a canine model of GI ARS, OrbeShield™ demonstrated a statistically significant survival advantage in animals that received OrbeShield™ therapy up to 24 hours following exposure to lethal doses of total body irradiation (TBI) when compared with placebo control animals (p=0.04).  Median survival post TBI exposure in the control group was 8 days, compared to 87 days in the OrbeShield™ treated group.  A subsequent study to replicate and expand upon the observations made in the canine model is being initiated and, like the previous study, is supported by a recent National Institute of Allergy and Infectious Diseases (NIAID) Small Business Innovation Research (SBIR) grant award.

“We are very excited by BARDA’s invitation to submit a full proposal for development of OrbeShield™ as a medical countermeasure against GI ARS,” stated Christopher J Schaber, PhD, President & Chief Executive Officer of Soligenix. “Although there are no guarantees, we believe that we are well-positioned to receive BARDA support for this indication and that the full proposal will allow us to further demonstrate the growing body of compelling scientific evidence supporting OrbeShield™’s potential as a countermeasure for GI ARS. We intend to submit our proposal to BARDA in February 2013 and look forward to their response. Meanwhile, we continue to develop OrbeShield™ pursuant to our recent $600,000 SBIR grant supporting further GI ARS canine studies.”

The invitation to submit a proposal is non-binding and the selection of Soligenix’s white paper for submission of a full proposal is not a guarantee of a BARDA contract.  A contract award will require a favorable technical and scientific review by BARDA followed by negotiation of fair and reasonable contract terms.

About GI ARS

ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow the GI tract and later the lungs.   In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gy are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death in 5-15 days.  The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI.  Although the hematopoietic syndrome can be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that occurs after high-dose radiation. Therefore, there is an urgent need to develop specific medical countermeasures against the lethal pathophysiological manifestations of radiation-induced GI injury.

About OrbeShield™

OrbeShield™ is formulated for oral administration in GI ARS patients as a single product consisting of two tablets; one tablet releases BDP in the proximal portions of the GI tract and the other tablet releases BDP in the distal portions of the GI tract.  BDP has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. Oral BDP may also have application in treating other GI disorders characterized by severe inflammation such as Crohn’s disease and radiation enteritis.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat serious gastrointestinal diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17.21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as SGX942 for the treatment of oral mucositis.

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government’s Strategic National Stockpile. Soligenix’s lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix’s new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.

For further information regarding Soligenix, Inc., please visit the Company’s Website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes,” “intends,” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

Soligenix Receives IND Clearance from FDA to Initiate Program Evaluating OrbeShield™ as a Therapy for Gastrointestinal Acute Radiation Syndrome

Princeton, NJ – January 4, 2013 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that the Food and Drug Administration (FDA) has completed its review and cleared the Investigational New Drug (IND) application for OrbeShield™ (oral beclomethasone 17,21-dipropionate or oral BDP) for the mitigation of morbidity and mortality associated with the gastrointestinal acute radiation syndrome (GI-ARS). Soligenix has previously received Orphan Drug Designation for oral BDP for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

Clearance of the IND allows Soligenix to initiate the development program which will include safety and efficacy evaluations conducted in appropriate preclinical models as well as a Phase 1/2 pharmacokinetic (PK)/pharmacodynamic (PD) study of OrbeShield™ in healthy adolescents and young adults.  The PK/PD data from the Phase 1/2 study will provide the needed data to inform dose extrapolation from the animal studies to the appropriate dose in humans.

“We are very excited to advance the development of OrbeShield™ which we believe has the potential to be a safe and effective medical countermeasure in the event of a nuclear attack or radiation accident,” stated Kevin Horgan, MD, Senior Vice President & Chief Medical Officer of Soligenix.  “We believe our proprietary two-tablet system has the pharmacological, clinical and manufacturing attributes necessary to potentially provide a substantial contribution to our national defense response systems so that we are optimally prepared in the event of a public health emergency such as nuclear accident or terrorist attack.”

About GI-ARS

ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow the GI tract and later the lungs.   In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gy are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death in 5-15 days.  The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI.  Although the hematopoietic syndrome can be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that results from high-dose radiation exposure. Therefore, there is an urgent need to develop specific medical countermeasures against the lethal pathophysiological manifestations of radiation-induced GI injury.

About OrbeShield™

OrbeShield™ contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. OrbeShield™ is formulated for oral administration in GI-ARS patients as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract and the other tablet is intended to release BDP in the distal portions of the GI tract.  BDP has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. Oral BDP may also have application in treating other GI disorders characterized by severe inflammation such as Crohn’s disease and radiation enteritis.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17.21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as SGX942 for the treatment of oral mucositis.

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government’s Strategic National Stockpile. Soligenix’s lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix’s new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.

For further information regarding Soligenix, Inc., please visit the Company’s Website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes,” “intends,” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

FDA Grants Soligenix Orphan Drug Designation for OrbeShieldTM for Treatment after Exposure to a Radiological Disaster

Princeton, NJ – January 2, 2013 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted orphan drug designation to OrbeShield™ (oral beclomethasone 17,21-dipropionate or oral BDP) for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders.  In addition to providing a seven year term of market exclusivity for oral BDP upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application for oral BDP, and certain tax credits.

Oral BDP is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP is the active ingredient in OrbeShield™, currently being developed for the treatment of gastrointestinal acute radiation syndrome (GI ARS), the driving component in early mortality following high doses of total body irradiation (TBI).

“The FDA’s decision to grant oral BDP orphan drug designation signifies an important step for Soligenix as we continue to expand our oral BDP pipeline,” stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix.  “The marketing exclusivity that orphan drug designation imparts adds significantly to the existing patent estate surrounding OrbeShield™. We believe that OrbeShield™ has the potential to be a significant advancement in the preparation necessary for this nation to manage a public health emergency like a nuclear attack.”

About GI ARS

ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow the GI tract and later the lungs.   In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gy are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death in 5-15 days.  The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI.  Although the hematopoietic syndrome can be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that occurs after high-dose radiation. Therefore, there is an urgent need to develop specific medical countermeasures against the lethal pathophysiological manifestations of radiation-induced GI injury.

About OrbeShieldTM

OrbeShield™ is formulated for oral administration in GI ARS patients as a single product consisting of two tablets; one tablet  releases BDP in the proximal portions of the GI tract and the other tablet releases BDP in the distal portions of the GI tract.  BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. Oral BDP may also have application in treating other GI disorders characterized by severe inflammation such as Crohn’s disease and radiation enteritis.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17.21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as SGX942 for the treatment of oral mucositis.

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government’s Strategic National Stockpile. Soligenix’s lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix’s new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.

For further information regarding Soligenix, Inc., please visit the Company’s Website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes,” “intends,” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

Soligenix Regains North American and European Commercial Rights to Oral BDP

Princeton, NJ – December 27, 2012 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, today announced that it has regained the North American and European commercial rights to oral BDP (beclomethasone 17.21-dipropionate) through an amendment of its Collaboration and Supply Agreement with Sigma-Tau Pharmaceuticals, Inc. Soligenix is now free to commercialize or enter into commercialization agreements for its oral BDP suite of products with other parties without limitation.

BDP a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhaler for the treatment of patients with allergic rhinitis and asthma. Oral BDP is the subject of several issued and pending US and worldwide patents held by or exclusively licensed to Soligenix.  Oral BDP is also the subject of four orphan drug designations in the US including pediatric Crohn’s Disease. Orphan drug designations provide for 7 years of market exclusivity upon approval in the US.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17.21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as SGX942 for the treatment of oral mucositis.

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government’s Strategic National Stockpile. Soligenix’s lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix’s new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShieldTM has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.

For further information regarding Soligenix, Inc., please visit the Company’s Website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes,” “intends,” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

Soligenix Expands Pipeline with Acquisition of Novel Innate Defense Regulator Clinical Program

Newly Acquired SGX94 Technology Strengthens Both BioTherapeutics and Vaccines/BioDefense Business Segments

Princeton, NJ – December 18, 2012 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today the acquisition of a novel drug technology, known as SGX94, representing a unique approach to modulation of the innate immune system.  SGX94 is an innate defense regulator (IDR) that regulates the innate immune system to reduce inflammation, eliminate infection and enhance tissue healing by binding to the pivotal regulatory protein p62, also known as sequestosome-1.  As part of the acquisition, Soligenix acquired all rights, including composition of matter patents, preclinical and Phase 1 clinical study datasets for SGX94, which is poised to enter Phase 2 clinical testing in humans and is highly synergistic with the company’s existing development pipeline.

Due to its novel mechanism acting on the regulatory molecule p62, SGX94 is simultaneously anti-inflammatory and anti-infective.  SGX94 is active in a wide range of disease models including life-threatening bacterial infections as well as the severe side-effects of chemo- and/or radiation-therapy.  Moreover, since SGX94 targets the host and not the bacteria, it evades antibiotic resistance mechanisms and has potential as both an alternative and/or an adjunct to antibiotic therapy.  SGX94 has demonstrated safety in a Phase 1 clinical study in healthy human volunteers and is the subject of an open Investigational New Drug (IND) application which has been cleared by the US Food and Drug Administration.  SGX94 is being developed pursuant to discoveries made by Professors B. Brett Finlay and Robert Hancock of the University of British Columbia, Canada with approximately $40 million having been put towards its development to date, inclusive of government grants.

In addition to SGX94, the acquired technology package includes other analogs and crystal structures of SGX94 with its protein target p62, opening the possibility for a pipeline of additional products to be developed.  Soligenix intends to continue development of SGX94 in both of its key business segments, namely, cancer supportive care applications, such as oral mucositis under its BioTherapeutics business segment, and infectious disease applications such as melioidosis under its Vaccines/BioDefense business segment.

Dr. Finlay commented, “I look forward to working with Soligenix to continue to develop SGX94, which has the potential to be a ground-breaking technology for the treatment of infectious diseases and related innate immune disorders. I am confident that Soligenix has the drug development expertise to successfully develop SGX94 so that new treatments can be made available to these patients.”

“We are very excited by the acquisition of this cutting edge science which represents a new paradigm for the treatment of tissue injury and infection,” stated Christopher J Schaber, PhD, President & Chief Executive Officer of Soligenix. “With SGX94 we will be able to leverage our experience in clinical development of cancer supportive care and biodefense products.  We also anticipate the potential for a number of grant funding opportunities for SGX94 across both segments of our business.”

About Innate Immunity

The immune system is constantly exposed to pathogenic microorganisms (bacteria, virus, fungi, and parasites) but has evolved a powerful response to deal with these threats to our health. This response has been divided into two general types of reactions: reactions of innate immunity and reactions of adaptive immunity. Innate immunity is the “first responder” component of the immune system that is immediately activated to destroy invading microorganisms and trigger inflammation that contributes to blocking their assault.  If microorganisms breach the innate immune system, adaptive immunity is activated. Adaptive immunity uses T and B cells to produce antibodies and killer cells to destroy infected cells. The two components of the immune system provide excellent protection against infections but they also pose a risk. If the activation threshold of either component is too low, or if activation is excessive, inflammatory disease may follow.

The innate immune system is a highly integrated system of cells involving both circulating blood cells and cells in tissues protecting us from pathogens at all body surfaces that interface with the external environment: skin, mouth, gastro-intestinal tract and lung. Innate immunity is dependent on rapidly sensing infection or damage and responding quickly with both inflammation and host repair or anti-infective functions. When excessive activation of innate immunity causes inflammation, modulation of the activated innate immune system can re-direct the system to decrease inflammatory responses and increase the anti-infection or healing responses.  The innate immune system responds quickly by sensing non-specific molecules released by the process of infection and damage through its Toll-like receptors and associated receptors. The p62 molecule integrates and regulates the signals sensed by these receptors and can re-direct the response of the innate immune system in a benign way without perturbing the function of the adaptive immune system.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat serious gastrointestinal diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17.21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®).

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government’s Strategic National Stockpile. Soligenix’s lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix’s new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.

For further information regarding Soligenix, Inc., please visit the Company’s Website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes,” “intends,” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

Soligenix Reports Third Quarter 2012 Financial Results and Highlights Recent Accomplishments

Princeton, NJ – November 14, 2012 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today its financial results for the third quarter ended September 30, 2012.

Soligenix’s revenues for the quarter ended September 30, 2012 were $931,627 as compared to $5,795,862 for the third quarter of 2011. Revenues for the third quarter of 2011 included grant revenues of $795,862 and license revenue of $5,000,000 from Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau) for rights to orBec® (oral beclomethasone 17,21-dipropionate or BDP) in the European territory.  Grant revenue increased by $135,765 and was primarily related to increased reimbursable costs from the Company’s ThermoVax™, Thermostability Technology Grant focused on a novel method of rendering aluminum salt adjuvanted vaccines stable at elevated temperatures.

Soligenix’s net (loss) for the quarter ended September 30, 2012 was $758,966 or $(0.07) per share, as compared to a net income of $2,204,874 or $0.20 per share for the quarter ended September 30, 2011, representing an increased loss of $2,963,840. The increased loss is primarily related to the execution of the license with Sigma-Tau for rights to the European territory in the third quarter of 2011.

Research and development expenses for the quarter ended September 30, 2012 were $371,338 as compared to $2,342,253 for the quarter ended September 30, 2011. The significant decrease of $1,970,915 is attributable to payment of approximately $1,000,000 in the  form of cash and company stock in connection with the Sigma-Tau European territory license agreement and decreased spending associated with the discontinuation of the confirmatory Phase 3 clinical trial of orBec® for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD).  General and administrative expenses for the quarter ended September 30, 2012 decreased by $36,144 to $558,877, compared to $595,021 for the quarter ended September 30, 2011.

As of September 30, 2012, the Company’s cash position was approximately $3,700,000 with working capital of approximately $3,100,000.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, “In the third quarter of 2012 we continued to make steady progress in advancing a number of our programs utilizing oral BDP, in both our BioTherapeutics and Vaccine/BioDefense business segments. We were pleased to receive Investigational New Drug (IND) clearance and Fast Track designation for SGX203 from the U.S. Food and Drug Administration (FDA). We remain committed to enhancing our development pipeline through internal efforts and external strategic alliances. We look forward to reporting on further progress on all programs during the remainder of this year.”

Soligenix’s Recent Highlight: 

  • On November 8, 2012, the Company announced that its SGX203 program in pediatric Crohn’s disease received “Fast Track” designation from the FDA. The Company has also previously received Orphan Drug Designation from the FDA for oral BDP as a treatment for pediatric Crohn’s Disease.
  • On October 3, 2012, the Company announced the formation of a Scientific Advisory Board (SAB) to provide strategic guidance to the Company as it relates to the development of OrbeShield™ (oral BDP) for the treatment of gastrointestinal acute radiation syndrome (GI-ARS).
  • On September 28, 2012, the Company announced that results of a study in a canine model of OrbeShield™ was being presented at a poster session entitled, “Post-exposure oral BDP improves survival in a canine GI ARS model.” The presentation was made during the 58th Annual Meeting of the Radiation Research Society held in San Juan, Puerto Rico on September 30 through October 3, 2012.
  • On September 13, 2012, the Company announced that the U.S. Patent Office granted patent 8,263,582 entitled “Method of Treating Inflammatory Disorders of the Gastrointestinal Tract using Topically Active Corticosteroids.” The new patent’s main claims cover the use of BDP in orally administered dosage forms that act concurrently in both the upper and lower gastrointestinal tract. These dosage forms include the Company’s oral formulation of BDP currently in development for pediatric Crohn’s disease, acute radiation enteritis, and GI GVHD.
  • On September 6, 2012, the Company announced that the FDA had completed its review and cleared the IND application for SGX203 for the induction treatment of pediatric Crohn’s disease. Clearance of the IND allows Soligenix to initiate a Phase 1/2 pharmacokinetic /pharmacodynamic study of SGX203 in healthy adolescents and young adults.
  • On September 4, 2012, the Company announced that the National Cancer Institute (NCI) awarded Soligenix a Small Business Innovation Research (SBIR) grant to support the conduct of a Phase 2 clinical trial with  orBec®  in the treatment chronic GI GVHD. The award provides Soligenix with approximately $300,000 over a two-year period.
  • On August 30, 2012, the Company announced the results of a Phase 1B clinical trial of an aluminum hydroxide (Alum) adjuvanted formulation of RiVax™, designed to improve the immunogenicity of the vaccine. The results of the Phase 1B study indicate that Alum adjuvanted RiVax™ is safe and well tolerated, and induces greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax™.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat serious gastrointestinal diseases where there remains an unmet medical need, as well a developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®) .

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government’s Strategic National Stockpile. Soligenix’s lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix’s new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the National Institutes of Health.

For further information regarding Soligenix, Inc., please visit the Company’s Website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes,” “intends,” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

FDA Grants Soligenix Fast Track Designation for SGX203 for the Treatment of Pediatric Crohn’s Disease

Princeton, NJ – November 8, 2012 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that its program for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the induction treatment of mild-to-moderate pediatric Crohn’s disease has received “Fast Track” designation from the U.S. Food and Drug Administration (FDA). Soligenix has also previously received Orphan Drug Designation from the FDA for oral BDP as a treatment for pediatric Crohn’s Disease.

Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life- threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for SGX203 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission.  Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which implies an abbreviated review time of six months.

“There are no FDA approved corticosteroid therapies for the induction treatment of Crohn’s disease in the pediatric population,” stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix. “The FDA’s action in granting fast track designation is an indication of SGX203’s potential to address this debilitating, unmet medical need.  We look forward to working closely with the FDA to potentially expedite the development and NDA review process.”

About Pediatric Crohn’s Disease 

Crohn’s disease is an ongoing disorder that causes inflammation of the gastrointestinal (GI) tract. Crohn’s disease can affect any area of the GI tract, from the mouth to the anus, but it most commonly affects the lower part of the small intestine, called the ileum. The swelling caused by the disease extends deep into the lining of the affected organ. The swelling can induce pain and can make the intestines empty frequently, resulting in diarrhea. Because the symptoms of Crohn’s disease are similar to other intestinal disorders, such as irritable bowel syndrome and ulcerative colitis, it can be difficult to diagnose. People of Ashkenazy Jewish heritage have an increased risk of developing Crohn’s disease.

Crohn’s disease can appear at any age, but it is most often diagnosed in adults in their 20s and 30s. However, approximately 30% of people with Crohn’s disease develop symptoms before 20 years of age. Pediatric Crohn’s disease is a subpopulation of approximately 80,000 patients 0-19 years of age in the United States.  Crohn’s disease tends to be both severe and extensive in the pediatric population and a relatively high proportion (25-40%) of pediatric Crohn’s patients have involvement of their upper gastrointestinal tract.

Crohn’s disease presents special challenges for children and teens. In addition to bothersome and often painful symptoms, the disease can stunt growth, delay puberty, and weaken bones. Crohn’s disease symptoms may sometimes prevent a child from participating in enjoyable activities. The emotional and psychological issues of living with a chronic disease such as Crohn’s can be especially difficult for young people.

About SGX203

SGX203 contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. SGX203 is a two tablet delivery system (i.e., immediate and delayed release) of BDP specifically designed for oral use that allows for delivery of BDP throughout the small bowel and the colon. The FDA has previously awarded SGX203 Orphan Drug Designation for the treatment of pediatric Crohn’s disease.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat serious gastrointestinal diseases where there remains an unmet medical need, as well a developing several biodefense vaccines and therapeutics.. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17.21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease. SGX201 is the subject of a recently completed National Cancer Institute (NCI)-supported Phase 1/2 clinical trial.

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government’s Strategic National Stockpile. Soligenix’s lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix’s new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.

For further information regarding Soligenix, Inc., please visit the Company’s Website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes,” “intends,” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

Soligenix Announces Formation of Acute Radiation Syndrome Scientific Advisory Board

Princeton, NJ – October 3, 2012 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today the formation of a Scientific Advisory Board (SAB) to provide strategic guidance to the Company as it relates to the development of OrbeShield™ (oral beclomethasone dipropionate, or oral BDP) for the treatment of gastrointestinal acute radiation syndrome (GI-ARS).

Comprised predominantly of radiation biology and gastroenterology thought leaders, the SAB will play an important advisory role in the design and conduct of the OrbeShieldTM development program and associated interactions with government agencies such as the Biomedical Advanced Research and Development Authority (BARDA), National Institutes of Health (NIH) and the Food and Drug Administration (FDA). The SAB will routinely provide feedback, input and guidance on development strategies and their implementation as well as on other critical issues.

The continued development of OrbeShield™ as a mitigator of acute GI-ARS is based on results obtained from studies conducted in a canine model of GI-ARS.  The studies were performed by George E. Georges, MD, at the Fred Hutchinson Cancer Research Center in Seattle, WA as part of a NIH funded study.  The results indicated a statistically significant survival advantage in canines that received OrbeShield™ therapy starting both 2 and 24 hours following exposure to total-body irradiation (TBI) when compared with placebo control. Untreated canines succumbed to the GI-ARS at a median time of 8 days when exposed to high dose radiation of 10-12 Gray (Gy) even if the canines were given intensive supportive care such as antibiotics, intravenous fluids and anti-emetics.  A subsequent study to replicate and expand upon the observations made in Dr. George’s study is in the process of being initiated and, like the previous study, is also supported by a recent NIH Small Business Innovation Research (SBIR) grant award.

“We are pleased to be able to attract such knowledgeable and enthusiastic individuals to participate as members of this critical advisory board,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “The formation of this SAB will provide us with essential scientific guidance necessary to build this important development program with the goal of obtaining approval via the FDA Animal Rule. We look forward to working with the SAB and building upon the work of Dr. Georges and his team in Seattle.”

The SAB Members

George E. Georges, MD, is an Associate Professor of Medicine at the University of Washington and Associate Member, Fred Hutchinson Cancer Research Center, is recognized internationally as an expert in ARS, with a specific focus on bone marrow and GI components. Dr. Georges’ research focus is on development of radiation counter-measures in the dog model with the goal of translating the findings to the clinical care of patients. He is the Principal Investigator of several NIH sponsored grants including development of radiation mitigators for acute radiation syndrome associated neutropenia and thrombocytopenia, as well as the gastrointestinal syndrome. This research includes canine studies with new cytokines for improving hematopoietic recovery and immune reconstitution after radiation.  In addition, he has developed the canine model of GI-ARS to study novel agents to mitigate the effects of radiation injury in the gut. He has more than 70 peer-reviewed publications.

Thomas MacVittie, MS, PhD, is a Professor of Radiation Oncology and Pathology at the University of Maryland School of Medicine and is recognized internationally as an expert on the effects of radiation on the hematopoietic and gastrointestinal systems in non-human primates and their treatment. His early work demonstrated the efficacy of medical management (supportive care) and hematopoietic growth factors on increasing survival in lethally irradiated large animal models. The MacVittie group’s database demonstrating the effect of cytokines on enhancing survival and recovery of hematopoiesis serves as the focal point for current efforts to design the first pivotal trials under the FDA’s animal rule to determine the treatment efficacy of candidate drugs/biologics for final FDA approval.

Dr. MacVittie has served as an advisor to the World Health Organization (WHO) Collaborating Centers in Radiation Emergency Medical Preparedness and Assistance and the International Council on Radiation Protection and as a member of North Atlantic Treaty Organization (NATO) Radiation Research Study Groups. He is a member of the Centers for Disease Control and Prevention (CDC) Strategic National Stockpile Radiation Working Group, the International Association of Radiopathology, the American Society of Hematology, the International Society of Experimental Hematology, Radiation Research and the International Society of Cellular Therapy. Dr. MacVittie is a member of the editorial board of the journal Stem Cells and serves as an ad hoc reviewer for numerous journals and NIH/National Institute of Allergy and Infectious Diseases (NIAID) and Department of Defense (DoD) grants and contracts. He was also a consultant for the International Atomic Energy Agency (IAEA) and Canadian Defense Research Establishment and also served on the first National Biodefense Science Board Federal Advisory Committee at the invitation of the Secretary, U.S. Department of Health and Human Services.  He has more than 150 peer-reviewed publications.

George B. McDonald, MD, is a Professor of Medicine at the University of Washington School of Medicine and a Member at the Fred Hutchinson Cancer Research Center, in the Gastroenterology/Hepatology Section. His overall research goals have been the reduction of morbidity from cancer treatment, improved survival, and prevention of late sequelae of cancer treatment. Dr. McDonald is recognized internationally as an expert in the field of gastroenterology.  His research is focused on gastrointestinal and hepatobiliary complications of hematopoietic cell transplantation, specifically problems involving the toxicity of high-dose radiation/chemotherapy regimens that are used to prepare patients for transplantation and acute and chronic Graft-versus-Host disease (GVHD) involving the gastrointestinal tract and liver. He has recently developed and validated a new method of assessing the severity of acute GVHD, called the acute GVHD Activity Index, an accurate predictor of transplant-related mortality. He was the lead investigator on the clinical trials that pioneered the use of topical corticosteroid therapy with oral beclomethasone dipropionate for GI GVHD.  He is also collaborating with Dr. George Georges on evaluating the effects of radiation injury on the GI tract in the canine model of GI-ARS.  He has more than 200 peer-reviewed publications.

George A. Parker, DVM, PhD, is currently Vice President, Pathology at WIL Research.  Dr. Parker is a graduate of Auburn University College of Veterinary Medicine.  He completed a residency program in veterinary pathology at the Armed Forces Institute of Pathology and a PhD program in molecular and cellular immunology at the University of Medicine and Dentistry of New Jersey.  He is certified as a pathologist by the American College of Veterinary Pathology, as a toxicologist by the American Board of Toxicology, and is a Fellow of the International Academy of Toxicologic Pathologists. He has been continuously involved in toxicologic pathology since 1978.  Dr. Parker has served as study pathologist on over 1000 good laboratory practice (GLP) and non-GLP toxicology studies, and has served as primary reviewer for more than 1400 GLP pathology reports.  He currently directs a pathology department that includes 13 pathologists and approximately 70 technical or clerical staff members.  He has more than 60 peer-reviewed publications.

About GI ARS

ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow the GI tract and later the lungs.   In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gy are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death in 5-15 days.  The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI.  Although the hematopoietic syndrome can be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that occurs after high-dose radiation. Therefore, there is an urgent need to develop specific medical countermeasures against the lethal pathophysiological manifestations of radiation-induced GI injury.

About OrbeShield™

OrbeShield™ contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. OrbeShield™ is formulated for oral administration in GI-ARS patients as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract and the other tablet is intended to release BDP in the distal portions of the GI tract.  BDP has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. Oral BDP may also have application in treating other GI disorders characterized by severe inflammation such as Crohn’s disease and radiation enteritis.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. Soligenix’s lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid that has been initially developed for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation. Soligenix is also developing proprietary formulations of oral BDP for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201), which is the subject of a recently completed National Cancer Institute (NCI)-supported Phase 1/2 clinical trial.

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government’s Strategic National Stockpile. Soligenix’s lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix’s new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI-ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.

For further information regarding Soligenix, Inc., please visit the Company’s Website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes,” “intends,” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.