Specialized BioTherapeutics
Reference literature for our Specialized BioTherapeutics pipeline programs.
HyBryte™
- Kim EJ, Mangold AR, DeSimone JA, et al. Efficacy and Safety of Topical Hypericin Photodynamic Therapy for Early-Stage Cutaneous T-Cell Lymphoma (Mycosis Fungoides): The FLASH Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2022;158(9):1031–1039. doi:10.1001/jamadermatol.2022.2749
- Rook, A.H., et al., A phase II placebo-controlled study of photodynamic therapy with topical hypericin and visible light irradiation in the treatment of cutaneous T-cell lymphoma and psoriasis. J Am Acad Dermatol, 2010. 63(6): p. 984-90.
- Fox, F.E., et al., Photoactivated hypericin is an anti-proliferative agent that induces a high rate of apoptotic death of normal, transformed, and malignant T lymphocytes: implications for the treatment of cutaneous lymphoproliferative and inflammatory disorders. J Invest Dermatol, 1998. 111(2): p. 327-32.
- Degar, S., et al., Inactivation of the human immunodeficiency virus by hypericin: evidence for photochemical alterations of p24 and a block in uncoating. AIDS Res Hum Retroviruses, 1992. 8 (11): p. 1929-36.
- Criscione, V.D. and M.A. Weinstock, Incidence of cutaneous T-cell lymphoma in the United States, 1973-2002. Arch Dermatol, 2007. 143(7): p. 854-9.
- Blank, M., et al., Enhanced ubiquitinylation of heat shock protein 90 as a potential mechanism for mitotic cell death in cancer cells induced with hypericin. Cancer Res, 2003. 63(23): p. 8241-7.
- Lenard, J., A. Rabson, and R. Vanderoef, Photodynamic inactivation of infectivity of human immunodeficiency virus and other enveloped viruses using hypericin and rose bengal: inhibition of fusion and syncytia formation. Proc Natl Acad Sci U S A, 1993. 90(1): p. 158-62.
- Meruelo, D., G. Lavie, and D. Lavie, Therapeutic agents with dramatic antiretroviral activity and little toxicity at effective doses: aromatic polycyclic diones hypericin and pseudohypericin. Proc Natl Acad Sci U S A, 1988. 85(14): p. 5230-4.
- Duran, N. and P.S. Song, Hypericin and its photodynamic action. Photochem Photobiol, 1986. 43 (6): p. 677-80.
Paper
SGX942
- Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Scott Z, Elder J, Sonis ST, Straube R, Donini O. Dusquetide: Reduction in oral mucositis associated with enduring ancillary benefits in tumor resolution and decreased mortality in head and neck cancer patients. Biotech Reports. 2017; 15:24-26.
- Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Elder J, Sonis S, Straube S, Donini O. Dusquetide: A novel innate defense regulator demonstrating a significant and consistent reduction in the duration of oral mucositis in preclinical data and a randomized, placebo-controlled phase 2a clinical study. J Biotech 2016; 239: 115-125.
- North JR, Takenaka S, Rozek A, Kielczewska A, Opal S, Morici L, Finlay BB, Schaber CJ, Straube R, Donini O. A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy. J Biotech 2016; 226: 24-34.
- Yu HB, Kielczewska A, Rozek A, Takenaka S, Li Y, Thorson L, et al. Sequestosome-1/p62 is the key intracellular target of innate defense regulator peptide. J Biol Chem. 2009;284,36007-11.
- Moscat J, Diaz-Meco MT. p62 at the crossroads of autophagy, apoptosis, and cancer. Cell 2009; 137(6),1001-4.
- Sonis ST, Schwartzbert LS, Walker MS, Weidner S, Alterovitz G. 2013. Predicting risk of chemotherapy-induced side effects in patients with colon cancer with single-nucleotide polymorphism (SNP) Bayesian networks. J Clin Oncol 2013;31 (4_suppl): Abstract 344.
- Schwartzberg LS, Sonis ST, Walker MS, Weidner SM, Alterovitz G. Single Nucleotide Polymorphism (SNP) Bayesian networks (BNs) Predict Risk of Chemotherapy-Induced Side Effects in Patients with Breast Cancer Receiving Dose Dense (DD) Doxorubicin/Cyclophosphamide Plus Paclitaxel (AC+T). Cancer Res. 2012;72 (24 Suppl): Abstract nr P1-15-12.
- Sonis S, Antin J, Tedaldi M, Alterovitz G, SNP-based Bayesian networks can predict oral mucositis risk in autologous stem cell transplant recipients. Oral Dis. 19(7):721-7.
- Alterovitz G, Tuthill C, Rios I, Modelska K, Sonis S. 2011. Personalized medicine for mucositis: Bayesian networks identify unique gene clusters, which predict the response to gamma-D-glutamyl-L-tryptophan (SCV-07) for the attenuation of chemoradiation-induced OM. Oral Oncol. 2011;47:951-5.
- Peterson DE, Bensadoun RJ, Roila F. Management of oral and gastrointestinal mucositis: ESMO clinical practice guidelines. Annals of Oncology 22. 2011; Supplement 6: vi78–vi84.
- Sonis ST. New thoughts on the initiation of mucositis. Oral Dis. 2010;16,597-600.
- Into T, Inomata M, Niida S, Murakami Y, Shibata K. Regulation of MyD88 Aggregation and the MyD88-dependent Signaling Pathway by Sequestosome-1 and Histone Deacetylase 6. J Biol Chem. 2010;285(46),35759-35769
- Rosenfeldt, M.T. and K. M. Ryan. The role of autophagy in tumour development and cancer therapy. Exp Rev Mol Med 2009,11: e36.
- Zheng YT, Shahnazari S, Brech A, Lamark T, Johansen T, Brumell JH. The adaptor protein p62/SQSTM1 targets invading bacteria to the autophagy pathway. J Immunol. 2009; 183,5909-16.
- Yoshikawa Y, Ogawa M, Hain T, Yoshida M, Fukumatsu M, Kim M, et al. Listeria monocytogenes ActA-mediated escape from autophagic recognition. Nat Cell Biol. 2009;11,1233-40
- Dupont N, Lacas-Gervais S, Bertout J, Paz I, Freche B, Van Nhieu GT, et al. Shigella phagocytic vacuolar membrane remnants participate in the cellular response to pathogen invasion and are regulated by autophagy. Cell Host Microbe. 2009;6,137-49
- Kim JY, Ozato K. The sequestosome 1/p62 attenuates cytokine gene expression in activated macrophages by inhibiting IFN regulatory factor 8 and TNF receptor-associated factor 6/NF-kappaB activity. J Immunol. 2009;182,2131-40
- Elting L et al. 2008 Patient-reported measurements of oral mucositis in head and neck cancer patients treated with radiotherapy with or without chemotherapy: demonstration of increased frequency, severity, resistance to palliation, and impact on quality of life. Cancer, 2008;113(10), 2704-13.
- Nonzee NJ, Dandade NA, Markossian T, Argiris A, Patel JD, Kern RC, Munshi HG, Calhoun EA, Bennett CL. Evaluating the supportive care costs of severe radiochemotherapy-induced mucositis and pharyngitis. Cancer. 2008;113:1446–52.
- Foster SL, Hargreaves DC, Medzhitov R. Gene-specific control of inflammation by TLR-induced chromatin modifications. Nature. 2007;447,972-8
- Scott MG, Dullaghan E, Mookherjee N, Glavas N, Waldbrook M, Thompson A, Wang A, Lee K, Doria S, Hamill P, Yu JJ, Li Y, Donini O, Guarna MM, Finlay BF, North JR, Hancock REW. An anti-infective peptide that selectively modulates the innate immune response. Nat Biotechnol 2007;25: 465-72.
- Sonis S, Haddad R, Posner M, Watkins B, Fey E, Morgan TV, Mookanamparambil L, Ramoni M. Gene expression changes in peripheral blood cells provide insight into the biological mechanisms associated with regimen-related toxicities in patients being treated for head and neck cancers. Oral Oncol. 2007;43:289-300.
- Moscat J, Diaz-Meco MT, Wooten MW. Signal integration and diversification through the p62 scaffold protein. Trends Biochem Sci. 2007;32,95-100.
- Seibenhener ML, Geetha T, Wooten MW. Sequestosome 1/p62--more than just a scaffold. FEBS Lett. 2007;581,175-9
- Doyle SL, O'Neill LA. Toll-like receptors: from the discovery of NFkappaB to new insights into transcriptional regulations in innate immunity. Biochem Pharmacol. 2006;72,1102-13.
- Tosi MF. Innate immune responses to infection. J Allergy Clin Immunol. 2005;116,241-9; quiz 50
- Finlay BB, Hancock RE. Can innate immunity be enhanced to treat microbial infections? Nat Rev Microbiol 2004;2: 497-504.
- Athman R, Philpott D. Innate immunity via Toll-like receptors and Nod proteins. Curr Opin Microbiol. 2004;7,25-32.
- Beutler B. Innate immunity: an overview. Mol Immunol. 2004;40,845-59.
- Sonis ST. A Biological Approach to Mucositis. J Supp Onc. 2004; 2(1), 21-36.
- Beutler B, Hoebe K, Du X, Ulevitch RJ. How we detect microbes and respond to them: the Toll-like receptors and their transducers. J Leukoc Biol. 2003;74,479-85.
- Janeway CA, Jr., Medzhitov R. Innate immune recognition. Annu Rev Immunol. 2002;20,197-216.
- Matzinger, P. The Danger Model : A renewed sense of self. Science. 2002; 296(5566), 301-305
- Aita V et al. Cloning and genomic organization of Beclin-1, a candidate tumor suppressor gene on chromosome 17q21. Genomics. 1999. 59:59-65.
Paper
- Donini O, Straube R. Host-Directed Innate Defense Regulators (IDRs) – Agnostic Therapy to Treat Bacterial Infections and Fight Resistance. Poster presentated at the 2018 ESCMID/ASM Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. 2018.
- Donini O, Behrens E, Haulenbeek A, Pullion C, Schaber C. An Innate Defense Regulator for the Treatment of Macrophage Activation Syndrome: Preclinical Studies in an Orphan Indication. Poster Presentated at the National Organization for Rare Diseases (NORD) Rare Diseases and Orphan Products Breakthrough Summit. 2016.
- Donini O, Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Elder J. SGX942 Reduces the Duration of Severe Oral Mucositis. Poster presented at the 25th Multinational Association of Supportive Care in Cancer. 2016.
- Kielczewska A, Yu HB, Rozek A, Takenaka S, Li Y, Guarna MM, North JR, Foster LJ, Finlay BB, Donini O. Sequestosome-1 / p62 is the key intracellular target of innate defense regulator peptide. Poster presentation at Keystone Symposium on The Macrophage: The intersection of Pathogenic & Protective Inflammation. 2010.
- Donini O, Watkins BA, Palardy J, Opal S, Sonis S, Abrams MJ, North JR. Reduced Infection and Mucositis in Chemotherapy-Treated Animals Following Innate Defense Modulation Using a Novel Drug Candidate. 2010. Blood (ASH Annual Meeting Abstracts) 2010; 116:3781
- Takenaka S, Rozek A, Kielczewska A, Thorson L, North JR, Finlay BB, Donini O. Innate Defense Regulators are a novel macrophage-mediated therapy to treat infectious and inflammatory diseases. Poster presentation at Keystone Symposium on The Macrophage: The intersection of Pathogenic & Protective Inflammation. 2010.
- Yu H, Kielczewska A, Rozek A, Takenaka S, Li Y, Guarna M, Thorson L, Hancock R, North J, Foster L, Donini O, Finlay B. SQSTM-1/p62: A Novel Therapeutic Target in Infectious and Inflammatory Disease. Poster Presentation at 49th Interscience Conference on Antimicrobial Agents and Chemotherapy. 2009.
Poster
SGX203
- Díez-Campelo M, Sánchez-Guijo FM, Pérez Simón JA. Beclometasone dipropionate: a topically active corticosteroid for the treatment of gastrointestinal graft-versus-host disease. Expert Opin Investig Drugs. 2008;17(9); 1389-1401.
- Hockenbery DM, Cruickshank S, Rodell TC et al. A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Blood. 2007;109:4557-4563
- Rizello F, Gionchetti P, D’Arienzo A et al. Oral beclomethasone dipropionate in the treatment of active ulcerative colitis: a double blind placebo controlled study. Aliment Pharmacol Ther. 2002;16:1109-1116.
- Campieri M, Cottone M, Miglio F et al. Beclomethasone dipropionate enemas versus prednisolone sodium phosphate enemas in the treatment of distal ulcerative colitis. Aliment Pharmacol Ther. 1998;12: 361-366.
- Burggraaf J, van Haarst AD, Fockens P et al. The gastrointestinal passage and release of beclomethasone dipropionate from oral delivery systems in ileostomy volunteers. Br J Clin Pharmacol. 1998;46: 207-214.
- Martin LE, Tanner RJN, Clark TJH et al. Absorption and metabolism of orally administered beclomethasone dipropionate. Clin Pharmacol Ther. 1974;15:267-275.
- CCFA.org. 2012. “What is Crohn’s disease.” Retrieved September 10, 2012, from http://www.ccfa.org/what-are-crohns-and-colitis/what-is-crohns-disease/
- Crocco S, Martelossi S, Giurici N, Villanacci V, Ventura A. 2012. Upper gastrointestinal involvement in paediatric onset Crohn's disease: prevalence and clinical implications. J Crohns Colitis. 6(1):51-5.
- Prantera C, Rizzi M, Cottone M, et al. Beclomethasone dipropionate in Crohn’s ileitis: A randomised, double-blind trial. Digestive and Liver Disease. 2011; 43:459-464.
- Villanueva FN, Perez-Simon JA, Silva FF et al. Oral Beclomethasone Dipropionate for the Treatment of Gastrointestinal Chronic Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2009;15:1331-1336.
- Kappelman MD, Rifas-Shiman SL, Kleinman K, Ollendorf D, Bousvaros A, Grand RJ, Finkelstein JA. 2007. The prevalence and geographic distribution of Crohn's disease and ulcerative colitis in the United States. Clin Gastroenterol Hepatol. 5(12):1424-9.
- McDonald GB. Oral beclomethasone dipropionate: a topically active corticosteroid for the treatment of gastrointestinal graft-versus-host disease following allogeneic hematopoietic cell transplantation. Expert Opin Investig Drugs. 2007;16(10):1709-24.
- Barnes NC. The properties of inhaled corticosteroids: similarities and differeneces. Prim Care Respir J. 2007;16:149-154.
- Issar M, Sahasranaman S, Buchwald P et al. Differences in the glucocorticoid to progesterone receptor selectivity of inhaled glucocorticoids. Eur Respir J. 2006;27:511-516.
- Tursi A, Giorgetti GM, Brandimarte G, et al. Beclomethasone dipropionate for the treatment of mild-to-moderate crohn’s disease: An open-label, budesonide-controlled, randomized study. Med Sci Monit. 2006; 12(6): PI29-32.
- Filipovich AH, Weisdorf D, Pavletic S et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. Diagnosis and Staging Working Group Report. Biol Blood Marrow Transplant. 2005;11:945-955.
- Iyer RV, Hahn T, Roy HN et al. Long-term use of oral beclomethasone dipropionate for the treatment of gastrointestinal graft-versus-host disease. Biol Blood Marrow Transplant. 2005;11:587-592.
- Buttgereit F, Burmester G-R, Lipworth BJ. Optimised glucocorticoid therapy: the sharpening of an old spear. Lancet. 2005;365:801-803.
- Adams NP, Bestall JB, Malouf R et al. Inhaled beclomethasone versus placebo for chronic asthma. Cochrane Review. In: The Cochrane Library. 2005;1. Chichester, UK: John Wiley & Sons, Ltd.
- Fukuda T, Boeckh M, Carter RA et al. Risks and outcomes of invasive fungal infections in recipients of allogeneic hematopoietic stem cell transplants after nonmyeloablative conditioning. Blood. 2003;102:827-833.
- Hakki M, Riddell SR, Storek J et al. Immune reconstitution to cytomegalovirus after allogeneic hematopoietic stem cell transplantation: impact of host factors, drug therapy, and subclinical reactivation. Blood. 2003;102:3060-3067.
- Cohen RD. 2002. The quality of life in patients with Crohn’s disease. Aliment Pharmacol Ther; 16: 1603–1609.
- Marr KA, Carter RA, Boeckh M et al. Invasive aspergillosis in allogeneic stem cell transplant recipients: changes in epidemiology and risk factors. Blood. 2002;100:4358-4366.
- Nichols WG, Corey L, Gooley T at al. Rising pp65 antigenemia during preemptive anticytomegalovirus therapy after allogeneic hematopoietic stem cell transplantation: risk factors, correlation with DNA load, and outcomes. Blood. 2001;97:867-874.
- Daley-Yates PT, Price AC, Sisson JR et al. Beclomethasone dipropionate: absolute bioavailability, pharmacokinetics and metabolism following intravenous, oral, intranasal and inhaled administration in man. Br J of Clin Pharmacol. 2001;51:400-409.
- Lipworth BJ. Systemic adverse events of inhaled coriticosteroids. Arch Int Med. 1999;159:941-955.
- McDonald GB, Bouvier M, Hockenbery DM et al. Oral beclomethasone dipropionate for treatment of intestinal graft-versus-host disease: a randomized, controlled trial. Gastroenterology. 1998;115:28-35.
- McDonald GB, Bouvier M, Hockenbery DM, et al. Oral beclomethasone dipropionate for treatment of intestinal graft-versus-host disease: a randomized controlled trial. Gastroenterology. 1998;115:28-35.
- Elkon KB, Siier R, Saftel HC. Immunological studies of eosinophilic gastro-interitis and treatment with disodium cromoglycate and beclomethasone dipropionate. S Afr Med J. 1977;52:838-841.
- Lofberg R, Rutgeerts P, Malchow H et al. Budesonide prolongs time to relapse in ileal and ileocaecal Crohn's disease. A placebo controlled one year study. Gut. 1996;39:82-86.
- Baehr P, Levine D, Bouvier M, Hockenbery D, Gooley T, Stern J, Martin P, and McDonald G. 1995. Oral beclomethasone dipropionate for treatment of human intestinal graft-versus-host disease. Transplantation 60:1231-8.
- Lofberg R, Ostergaard Thomsen O, Langholz E et al. Budesonide versus prednisolone retention enemas in active distal ulcerative colitis. Aliment Pharmacol Ther. 1994;8:623-629.
- Rutgeerts P, Lofberg R, Malchow H et al. A comparison of budesonide with prednisolone for active Crohn's disease. N Engl J Med. 1994;331:842-845.
- Steed KP, Hooper G, Ventura P et al. The in vivo behaviour of a colonic delivery system: A pilot study in man. Int J Pharm. 1994;112:199-206
- Levine, DS. Immune modulating therapies for idiopathic inflammatory bowel disease. Adv Pharmacol. 1994;25:171-234.
- Mulder CJ, Endert E, van der HH et al. Comparison of beclomethasone dipropionate (2 and 3 mg) and prednisolone sodium phosphate enemas (30 mg) in the treatment of ulcerative proctitis. An adrenocortical approach. Neth J Med. 1989;35:18-24.
- van der Heide H, van den Brandt-Gradel V, Tytgat GNJ et al. Comparison of beclomethasone dipropionate and prednisolone 21-phosphate enemas in the treatment of ulcerative proctitis. J Clin Gastroenterol. 1988;10:169-172.
- Levine DS, Raisys VA, Ainardi V. Coating of oral beclomethasone dipropionate capsules with cellulose acetate phthalate enhances delivery of topically active anti-inflammatory drug to the terminal ileum. Gastroenterology. 1987;92:1037-1044.
- Levine DS, Raisys VA, Ainardi V. Coating of oral beclomethasone dipropionate capsules with cellulose acetate phthalate enhances delivery of topically active antiinflammatory drug to the terminal ileum. Gastroenterology. 1987;92(4):1037-44.
- Levine DS, Rubin CE. Topical beclomethasone dipropionate enemas improve distal ulcerative colitis and idiopathic proctitis without systemic toxicity. Gastroenterology. 1985;88:1473.
- Andersson P, Ryrfeldt A. Biotransformation of the topical glucocorticoids budesonide and beclomethasone 17 alpha,21 dipropionate in human liver and lung homogenate. J Pharm Pharmacol 1984;36:763-765.
- Brogden RN, Heel RC, Speight TM et al. Beclomethasone dipropionate. A reappraisal of its pharmacodynamic properties and therapeutic efficacy after a decade of use in asthma and rhinitis. Drugs. 1984;29: 99-126.
- Johansson SA, Andersson KE, Brattsand R et al. Topical and systemic glucocorticoid potencies of budesonide and beclomethasone dipropionate in man. Eur J Respir Dis Suppl. 1982;22:523-529.
- Kumana CR, Seaton T, Meghji M et al. Beclomethasone dipropionate enemas for treating inflammatory bowel disease without producing Cushing's syndrome or hypothalamic pituitary adrenal suppression. Lancet. 1982;1:579-583.
- Oishi T, Deguchi T, Marumo H. Metabolism of beclomethasone 17,21-dipropionate. Appl Pharmacol. 1981;22:717-727.
- Oishi T, T Deguchi, H Marumo Metabolic fate of beclomethasone 17, 21-dipropionate in the rat. Pharmacometrics. 1981;22:717-27
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- Brogden RN, Pinder RM, Sawyer PR et al. Beclomethasone dipropionate inhaler: A review of its pharmacology, therapeutic value and adverse effects I: Asthma. Drugs. 1975a;10:166-210.
- Harris DM. Some properties of beclomethasone dipropionate and related steroids in man. Postgrad Med J. 1975;51:20-25.
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Paper
SGX302
- Rook AH, Wood GS, Duvic M, Vonderheid EC, Tobia A, Cabana B. A phase II placebo-controlled study of photodynamic therapy with topical hypericin and visible light irradiation in the treatment of cutaneous T-cell lymphoma and psoriasis. J Am Acad Dermatol. 2010;63(6):984-90.
- Stern RS, Nichols KT, Vakeva LH. Malignant melanoma in patients treated for psoriasis with methoxsalen (psoralen) and ultraviolet A radiation (PUVA). The PUVA Follow-Up Study. N Engl J Med. 1997;336(15):1041-5.
- Feldman S. Treatment of psoriasis in adults. UpToDate. 2021.
- Parisi R, Iskandar IYK, Kontopantelis E, Augustin M, Griffiths CEM, Ashcroft DM, et al. National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study. BMJ. 2020;369:m1590.
- Le Roux E, Frow H. Diagnosis and management of mild to moderate psoriasis. prescribercouk. 2020:9-17.
- Stern RS, Nijsten T, Feldman SR, Margolis DJ, Rolstad T. Psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction. J Investig Dermatol Symp Proc. 2004;9(2):136-9.
- Griffiths CE, Barker JN. Pathogenesis and clinical features of psoriasis. Lancet. 2007;370(9583):263-71.