Monday, 14 January 2013

Soligenix gains further after potential multi-million contract announcement

Soligenix stock was on the rise again Tuesday, a day after it gained more than 14 per cent when it said it will submit a proposal for a potential multi-million dollar contract to develop its radiation therapy, OrbeShield.
Its stock closed at 80 cents on Monday, and was lately up by more than 11 per cent, changing hands at around 89 cents as of 1:25pm ET. 
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.
This was in response to a Broad Agency Announcement for advanced research and development of medical countermeasures for chemical, biological, radiological and nuclear threats.
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. 
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 also 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.
This news came after the FDA granted orphan drug designation for 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.
Through its biodefense division, the company is also developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.
Last month, the company acquired SGX94 - a drug technology that regulates the immune system, and which Soligenix is planning to develop in both of its key units - namely cancer supportive care in its biotherapeutics segment, and infectious diseases under its vaccines/biodefense division.

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