Monday, 14 January 2013

UPDATE: Soligenix shares surge on news of potential multi-million dollar contract for OrbeShield

***updated with latest share price data***
Soligenix's (OTCQB:SNGX) shares soared this afternoon after it said earlier today that it will submit a proposal for a potential multi-million dollar contract to develop its radiation therapy, OrbeShield.
Its stock rose almost 13 per cent to trade at 80 cents just after 2pm ET on Monday. 
The Biomedical Advanced Research and Development Authority (BARDA) has called on the company to submit a full proposal for a potential multi-year, multi-million dollar contract to develop OrbeShield.
The development stage biopharmaceutical company said it submitted its white paper to BARDA in response to a Broad Agency Announcement for advanced research and development of medical countermeasures for chemical, biological, radiological and nuclear threats.
Following a review of the report, BARDA invited Soligenix to supply a proposal to develop OrbeShield from its current level of technical readiness to FDA approval.
OrbeShield is being developed for the treatment of gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.
The main ingredient in OrbeShield is oral BDP - a topically active corticosteroid that has a local effect on inflamed tissue. 
"We are very excited by BARDA's invitation to submit a full proposal for development of OrbeShield as a medical countermeasure against GI ARS," said president and CEO Christopher J Schaber. 
"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.”
Soligenix will continue to develop OrbeShield following a recent $600,000 Small Business Innovation Research grant to support further GI ARS canine studies.
In a canine model of GI ARS, the company said that OrbeShield showed a “statistically significant survival advantage” in animals that received the therapy up to 24 hours following exposure to lethal doses of total body irradiation when compared with placebo control animals.
Median survival post exposure in the control group was eight days, compared to 87 days in the OrbeShield treated group.  
Soligenix last week announced that the FDA had completed and cleared its review of an investigational new drug (IND) application for OrbeShield “for the mitigation of morbidity and mortality associated with the gastrointestinal acute radiation syndrome (GI-ARS)”.
Clearance of the IND means that the company can now initiate its development program, which will include preclinical safety and efficacy evaluations and a phase 1/2 study of OrbeShield in healthy adolescents and young adults.
The program will provide the needed data to inform dose extrapolation from the animal studies to the appropriate dose in humans, the company noted.
Earlier in the week, the FDA granted orphan drug designation OrbeShield, which Soligenix said gives the company a seven year term of market exclusivity for the drug upon final approval, and leverage to a wide range of financial and regulatory benefits.
Last month, it also acquired SGX94 - a drug technology that regulates the immune system. Soligenix is planning to develop the drug technology in both of its key units, namely cancer supportive care in its biotherapeutics segment, and infectious diseases under its vaccines/biodefense division. 
Meanwhile, through its biodefense division, the company is developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.

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