Soligenix shares more than doubled since the start of the year

Shares in Soligenix (OTC:SNGX) have been flying higher so far this year, up more than 12% today alone, with its stock more than doubling since the start of 2013 as investors await the outcome of its recent proposal for a potential multi-million dollar contract to develop its radiation therapy, OrbeShield. 

The company’ stock gained 15 cents on Friday alone, to $1.35. So far this year, its shares have risen 125% and are up over 69% in past 12 months. 

Earlier in January, the development stage biopharmaceutical company announced that the Biomedical Advanced Research and Development Authority (BARDA) had called on Soligenixto submit the potential multi-year, multi-million dollar contract proposal to develop OrbeShield.

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. Aside from acute radiation, the company is also developing oral BDP for pediatric Crohn's disease and gastrointestinal Graft-versus-Host disease (GVHD).

In pre-clinical studies, 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.  

Earlier this month, Soligenix said 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 could initiate its development program, which includes 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.

In December, 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. 

At the end of the year, Soligenix had increased its cash position to about $3.3 million after receiving funding from a tax transfer program.