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Soligenix Announces Formation of Oral Mucositis Medical Advisory Board

Posted by Z Dental Group - February 4th, 2013



PRINCETON, N.J., Feb. 4, 2013 /PRNewswire/ — Soligenix, Inc. (OTCQB: SNGX) (Soligenix or a Company), a development-stage biopharmaceutical company, announced now a arrangement of a Medical Advisory Board (MAB) to yield medical/clinical vital superintendence to a Company as it advances a expansion of SGX942 for a diagnosis of oral mucositis, a common snarl of cancer treatments.

Comprised of cancer understanding caring suspicion leaders with endless knowledge in oral mucositis, a MAB will play an vicious advisory purpose in a pattern and control of a arriving Phase 2 clinical investigate as good as in a pattern of successive clinical studies and compared regulatory interactions with health authorities. The MAB will yield feedback, submit and superintendence on clinical strategies and their doing as good as on other vicious issues, such as health economics and payment to support Soligenix in assembly a needs of a oral mucositis studious population.

“Oral mucositis is a poignant unmet medical need that eventually impacts a tolerability of deviation and chemotherapy and therefore a survivability of cancer,” settled Stephen T Sonis, DMD, DMSc, Clinical Professor of Oral Medicine during Harvard School of Dental Medicine.  ”The miss of an effective diagnosis has undone medical providers and caused wretchedness for countless patients. I’m gay to be assisting to rise SGX942 as we trust it binds poignant guarantee as a mucositis intervention. As an inherited invulnerability regulator (IDR), SGX942 directly targets a elemental biological resource that leads to mucosal repairs caused by deviation and chemotherapy.”

“We are gratified to be means to attract such venerable and eager professionals to attend as members of a Medical Advisory Board,” settled Christopher J. Schaber , PhD, President and Chief Executive Officer of Soligenix. “The arising of an oral mucositis module outlines a initial step in a expansion of a IDR record platform.  We demeanour brazen to operative with a MAB and initiating a clinical module in 2013.”

The MAB Members

Stephen T. Sonis , DMD, DMSc 

Dr. Sonis now serves as Clinical Professor of Oral Medicine during Harvard School of Dental Medicine and Senior Surgeon and Chief, Divisions of Oral Medicine during Brigham and Women’s Hospital and a Dana-Farber Cancer Institute, and as Chief Scientific Officer, Biomodels, LLC.  He also serves as a consultant to a series of biotechnology and curative companies, advising directly on a control of clinical trials of oral mucositis.  Throughout his career, Dr. Sonis has focused on a biology and clinical stress of cancer regimen-related mucosal toxicities.  In particular, Dr. Sonis was pivotal in identifying a essential purpose of inherited shield in a era of critical oral mucositis. The formula of his studies have supposing diagnosis targets for biological and curative development. Dr. Sonis and his collaborators have identified specific pathways that are vicious in toxicity expansion and have used these to form a basement for models of gene-based risk prediction. Dr. Sonis has published and lectured extensively on a clinical, biological, and health mercantile aspects of cancer and complications compared with a treatment. He serves on a series of editorial boards, and is a first member of a International Society of Oral Oncology and a International Academy of Oral Oncology. Dr. Sonis perceived his Doctor of Dental Medicine (DMD) from Tufts University, his Doctor of Medical Science (DMSc) from Harvard University and was a Knox Fellow during Oxford University.

Dorothy Keefe , MD, FRACP, FRCP

Professor Keefe is Service Director, SA Cancer Services, Professor of Cancer Medicine during a University of Adelaide and a Senior Medical Oncologist during Royal Adelaide Hospital Cancer Centre.  She is Head of a Mucositis Research Group in a Hanson Institute, and Immediate Past-President of a Multi-national Association of Supportive Care in Cancer (MASCC).  Professor Keefe’s investigate interests embody mucositis in a broadest sense, covering patho-biology, epidemiology, impediment and treatment. She has been rarely concerned in heading a expansion of evidence-based discipline for a supervision of mucositis by MASCC, as good as co-chairing an international, multi-centre investigate questioning weight of illness and cost of caring for patients with mucositis. Professor Keefe graduated in Medicine (Bachelor of Medicine, Bachelor of Surgery; MBBS) from a University of London. She migrated to Australia, where she undertook her Physician Training in General Medicine and Medical Oncology during a Queen Elizabeth Hospital in South Australia. She became a Fellow of a Royal Australasian College of Physicians (FRACP) and after a Fellow of a Royal College of Physicians in London (FRCP). She perceived her Doctorate of Medicine from a University of Adelaide.

Mark Schubert , DDS, MSD

Dr. Schubert is a Professor in a Department of Oral Medicine, School of Dentistry during a University of Washington and is a Director of Oral Medicine with a Seattle Cancer Care Alliance as good as a Member in a Clinical Research Division during a Fred Hutchinson Cancer Research Center. Dr. Schubert’s investigate interests have focused on a oral complications of cancer and cancer therapy, generally as they describe to hematopoietic dungeon transplantation.  A primary area of seductiveness has been a supervision of oral mucositis compared with cancer therapy. Research in oral mucositis supervision has focused on accepted anti-infectives (defensins), expansion factors and cytokines (KGFs and IL-11), cytoprotective agents (benzydamine, amifostine), and low turn lasers therapy. Additional investigate interests embody simple investigate and supervision strategies for other oral complications of cancer therapy including salivary gland dysfunction, oral graft-versus-host illness in allogeneic hematopoietic dungeon transplant recipients, and dental expansion and expansion problems following hematopoietic dungeon transplant. Additionally, Dr. Schubert has been concerned with investigate compared to oral changes and infections in HIV-infected patients.  Dr. Schubert perceived his Doctor of Dental Surgery from a University of Washington, where he finished a residency in Hospital Dentistry, and after perceived his Masters of Dental Sciences grade from a University of Washington.

About SGX942

SGX94 is an IDR, a new category of short, fake peptides that has a novel resource of movement in that it has coexisting anti-inflammatory and anti-infective activity. IDRs have no approach antibiotic activity though allay horde responses, augmenting presence after infections with a extended operation of bacterial Gram-negative and Gram-positive pathogens, as good as accelerating fortitude of hankie repairs following bearing to a accumulation of agents including bacterial pathogens, mishap and chemo- and/or radiation-therapy.  SGX94 has demonstrated reserve in a Phase 1 clinical investigate in healthy tellurian volunteers and efficiency in countless animal illness models including mucositis, colitis, skin infection and other bacterial infections.  SGX94 is a theme of an open Investigational New Drug (IND). SGX94 was grown pursuant to discoveries finished by Professors B. Brett Finlay , PhD and Robert Hancock , PhD of a University of British Columbia, Canada and approximately $40 million has been put towards a expansion thorough of supervision grants. 

About Oral Mucositis

Mucositis is a clinical tenure for repairs finished to a mucosa by anticancer therapies (e.g., deviation or chemotherapy).  It can start in any mucosal region, though is many ordinarily compared with a mouth (i.e., oral mucositis), followed by a tiny intestine. Mucositis affects 500,000 people in a US per year and occurs in 40% of patients receiving chemotherapy.  Mucositis roughly always occurs in patients with conduct and neck cancer treated with deviation therapy (80% occurrence of critical mucositis) and is common (40-100% incidence) in patients undergoing high sip chemotherapy and hematopoietic dungeon transplantation, where a occurrence and astringency of mucositis depends exceedingly on a inlet of a conditioning fast used.  Mucositis can be exceedingly debilitating and can lead to infection, sepsis, a need for parenteral nourishment and analgesic analgesia.  The gastrointestinal repairs causes critical diarrhea. These symptoms can extent a doses and generation of cancer treatment, heading to sub-optimal diagnosis outcomes. Direct and surreptitious consequences of mucositis have been estimated to supplement ~$18,000 per studious to cancer diagnosis costs.

The mechanisms of mucositis have been extensively complicated and have been recently related to a communication of chemotherapy and/or deviation therapy with a inherited invulnerability system. Bacterial infection of a ulcerative lesions is now regarded as a delegate effect of dysregulated internal inflammation triggered by therapy-induced dungeon death, rather than as a primary means of a lesions.

About Soligenix, Inc.

Soligenix is a expansion theatre biopharmaceutical association building products to yield critical inflammatory diseases where there stays an unmet medical need, as good as building several biodefense vaccines and therapeutics. Soligenix is building exclusive formulations of oral BDP (beclomethasone 17,21-dipropionate) for a prevention/treatment of gastrointestinal disorders characterized by critical inflammation, including pediatric Crohn’s illness (SGX203), strident deviation enteritis (SGX201) and ongoing Graft-versus-Host illness (orBec®), as good as building a novel inherited invulnerability regulator (IDR) record SGX942 for a diagnosis of oral Mucositis.  

Through a BioDefense Division, Soligenix is building countermeasures pursuant to a Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in a US government’s Strategic National Stockpile. Soligenix’s lead biodefense products in expansion are a recombinant subunit vaccine called RiVax™, that is designed to strengthen opposite a fatal effects of bearing to ricin venom and VeloThrax™, a vaccine opposite anthrax exposure. RiVax™ has been shown to be good tolerated and immunogenic in dual Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are now a theme of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) extend ancillary expansion of Soligenix’s new vaccine feverishness stabilization record famous as ThermoVax™. Soligenix is also building OrbeShield™ for a diagnosis of gastrointestinal strident deviation syndrome (GI ARS) underneath a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShieldTM has formerly demonstrated statistically poignant preclinical presence formula in dual apart dog GI ARS studies saved by a NIH.

For serve information per Soligenix, Inc., greatfully revisit a Company’s website during www.soligenix.com.

This press recover contains forward-looking statements that simulate Soligenix, Inc.’s stream expectations about a destiny results, performance, prospects and opportunities. Statements that are not chronological facts, such as “anticipates,” “believes,” “intends,” or identical expressions, are forward-looking statements. These statements are theme to a series of risks, uncertainties and other factors that could means tangible events or formula in destiny durations to differ materially from what is voiced in, or pragmatic by, these statements. Soligenix can't assure we that it will be means to successfully rise or commercialize products formed on a technology, quite in light of a poignant doubt fundamental in building vaccines opposite bioterror threats, production and conducting preclinical and clinical trials of vaccines, and receiving regulatory approvals, that product expansion and commercialization efforts will not be reduced or dropped due to problems or delays in clinical trials or due to miss of swell or certain formula from investigate and expansion efforts, that it will be means to successfully obtain any serve grants and awards, say a existent grants that are theme to performance, enter into any biodefense buying contracts with a US Government or other countries, or that a US Congress might not pass any legislation that would yield additional appropriation for a Project BioShield program. These and other risk factors are described from time to time in filings with a Securities and Exchange Commission, including, though not singular to, Soligenix’s reports on Forms 10-Q and 10-K. Unless compulsory by law, Soligenix assumes no requirement to refurbish or correct any forward-looking statements as a outcome of new information or destiny events.

SOURCE Soligenix, Inc.

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