Princeton, NJ – October 17, 2013 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense medical countermeasures where there remains an unmet medical need, announced today the formation of an international melioidosis Scientific Advisory Board (SAB).
Comprised of clinicians and researchers from Australia, Thailand, Lao and The Netherlands with extensive experience in melioidosis, the SAB will play an important advisory role in the design and conduct of the research and development to advance SGX943 and SGX101 for the treatment of melioidosis. The SAB will provide feedback, input and guidance to both Soligenix and its collaborative partner, Intrexon Corporation (NYSE: XON), on research strategies and their implementation as well as on other critical issues, such as clinical strategy and health economics.
“Melioidosis is a significant unmet medical need in endemic regions in Thailand and surrounding areas, including Australia. The incidence of endemic melioidosis is expected to increase world-wide in parallel with the increasing incidence of diabetes,” stated Direk Limmathurotsakul, MD, Head of Microbiology, Mahidol-Oxford Tropical Medicine Research Unit. “The mortality rate associated with this infection highlights the need for more effective strategies and the risk posed by this commonly misidentified organism.”
“We are pleased to be able to attract such esteemed and enthusiastic professionals to participate as members of our Scientific Advisory Board,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “The development of both SGX943 and SGX101, in collaboration with our partner Intrexon, as potential treatments for melioidosis represent what we believe to be unique approaches to offering life-saving therapy in endemic regions and in response to the potential biothreat posed by Burkholderia pseudomallei. Both therapies are designed to address the fundamental pathophysiology of the disease in a manner complementary to the current insufficient antibiotic therapies. With the increasing endemic incidence of the disease and the increased interest from a biodefense perspective, we feel this is an opportune time to accelerate these programs.”
The SAB Members
Bart Currie, FRACP – Australia. Dr. Currie currently serves as Professor, Menzies School of Health Research and Head of the Royal Darwin Hospital Infectious Diseases Department, Darwin, Northern Territory, Australia. Dr. Currie runs the Darwin Prospective Melioidosis Study, now in its 25th year. Since 2000 he has been Professor in Medicine at the Northern Territory Medical Program, Flinders University and he is Adjunct Professorial Fellow, Charles Darwin University. Dr. Currie’s passion is in coordinating links between clinicians, public health colleagues and other service providers, laboratory scientists and community. The research Dr. Currie has been involved in has targeted improving prevention and treatment of specific illnesses usually through a better understanding of the underlying disease processes, including an emphasis on melioidosis. Dr. Currie received his Diploma of Tropical Medicine and Hygiene from the London School of Tropical Medicine and Hygiene
David AB Dance, MB, ChB, MSc, FRCPath – Lao People’s Democratic Republic (PDR). Dr. Dance serves as Consultant Microbiologist for the Lao-Oxford-Mahosot-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, UK, and Public Health England. Dr. Dance currently works on bacterial infections of importance to public health in Laos. He has had a particular interest in all aspects of melioidosis (Burkholderia pseudomallei infection) dating back to 1986 when he helped to initiate prospective studies of the disease in Ubon Ratchathani, north east Thailand, especially gaining a greater understanding of the global distribution of the disease and the environmental factors that underpin its distribution. Dr. Dance received his medical degree from the University of Bristol, UK and his MSc in clinical microbiology from the London School of Hygiene and Tropical Medicine.
Direk Limmathurotsakul, MD, PhD – Thailand. Dr. Limmathurotsatokal currently serves as Assistant Professor, Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Thailand; Mahidol-Oxford Tropical Medicine Research Unit (MORU), Bangkok, Thailand. Dr. Limmathurotsatokal’s primary clinical area of expertise is in melioidosis, leptospirosis and ricketsiosis with a specific emphasis on research methodology, epidemiology and statistics, including Bayesian data analysis. He was a key committee member of the World Melioidosis Congress of 2013 and one of the foremost authorities on endemic melioidosis. Dr. Limmathurotsakul received his MD from Chulalongkorn University, Thailand and his PhD from Open University, UK.
W. Joost Wiersinga, MD, PhD – The Netherlands. Dr. Wiersinga serves as a post-doctoral researcher at the Center for Infection and Immunity (CINIMA) and the Center for Experimental Molecular Medicine (CEMM) and as consultant at the Department of Internal Medicine, Division of Infectious Diseases, Department of Internal Medicine, Center for Experimental Molecular Medicine, Academic Medical Center, University of Amsterdam, the Netherlands. In addition to his infectious disease practice, Dr. Wiersinga’s research interests are in host-pathogen interactions and innate immune responses in infectious diseases, including sepsis. His PhD and ongoing work is particularly focused on Burkholderia pseudomallei. Dr. Wiersinga received his MD from the University of Amsterdam and his PhD from the University of Amsterdam.
SGX943 is the drug product designation for the active ingredient SGX94 in the treatment of melioidosis. SGX94 is an innate defense regulator (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.
SGX101 is the designation for a novel therapeutic product for melioidosis to be developed in collaboration with Intrexon Corporation, under an Exclusive Channel Collaboration between Soligenix and Intrexon. SGX101 is intended as a human monoclonal antibody therapy directed at host cells infected with Burkholderia pseudomallei. SGX101 may also be utilized in conjunction with available antibiotic therapy.
Melioidosis is a potentially fatal infection caused by the Gram-negative bacillus, Burkholderia pseudomallei (Bp). There is no effective immunotherapy or vaccine on the horizon for prevention or treatment of melioidosis. Highly resistant to many antibiotics, Bp can cause an acute disease characterized by a fulminant pneumonia and a chronic condition that can recrudesce. Therefore, there is a significant medical need for improved prevention and therapy.
Bp infection (melioidosis) is a major public health concern in the endemic regions of Southeast Asia and Northern Australia. Moreover, the organism has a worldwide distribution and the full extent of global spread is likely underestimated. Bp activity is seen in Southeast Asia, South America, Africa, the Middle East, India, and Northern Australia. The highest pockets of disease activity occur in Northern Australia and Northeast Thailand, Burma and Vietnam, and is likely under-reported in China. In Northeast Thailand, the mortality rate associated with Bp infection is over 40%, making it the 3rd most common cause of death from infectious disease in that region after HIV/AIDS and TB. Beyond their public health significance, Bp and the closely-related B. mallei (Bm) are considered potential biological warfare agents by the U.S. Department of Health and Human Services (DHHS). Bp is classified as a Tier 1 biothreat and a category B priority pathogen by the National Institute of Allergy and Infectious Diseases (NIAID) and is a top 5 priority in the 2012 Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Strategy document.
About Intrexon Corporation
Intrexon Corporation (NYSE: XON) is a leader in synthetic biology focused on collaborating with companies in Health, Food, Energy and the Environment to create biologically-based products that improve the quality of life and the health of the planet. Through the Company’s proprietary UltraVector® platform, Intrexon provides its partners with industrial-scale design and development of complex biological systems. The UltraVector® platform delivers unprecedented control over the quality, function, and performance of living cells. We call our synthetic biology approach and integrated technologies Better DNA®, and we invite you to discover more at http://www.dna.com.
About Soligenix, Inc.
Soligenix is a clinical 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 BARDA and NIAID contract awards valued up to $26.3 million and $6.4 million, respectively. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID. Recently, Soligenix announced a worldwide exclusive collaboration with Intrexon Corporation that will focus on the joint development of a treatment for melioidosis, a high priority biothreat and an area of unmet medical need.
For further information regarding Soligenix, Inc., please visit the Company’s Website at https://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, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as “anticipates,” “estimates,” “believes,” “intends,” “potential,” 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, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, 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 funding to support product development and commercialization efforts, including 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, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, 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.