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Friday, 11 January 2013
Soligenix gets green light from FDA for clinical development of radiation drug, OrbeShield
Development stage biopharmaceutical company Soligenix Inc. (OTCQB:SNGX) Friday said that the FDA has cleared the way for further development of its radiation therapy, OrbeShield.
The company said that the FDA has 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 Soligenix can now initiate its development program which will include safety and efficacy evaluations conducted in “appropriate preclinical models” 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.
“We are very excited to advance the development of OrbeShield which we believe has the potential to be a safe and effective medical countermeasure in the event of a nuclear attack or radiation accident," said senior VP and chief medical officer Kevin Horgan.
"We believe our proprietary two-tablet system has the pharmacological, clinical and manufacturing attributes necessary to potentially provide a substantial contribution to our national defense response systems so that we are optimally prepared in the event of a public health emergency such as nuclear accident or terrorist attack."
OrbeShield is being developed for the treatment of gastrointestinal acute radiation syndrome, 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.
Earlier this week, Soligenix announced that the FDA has granted orphan drug designation OrbeShield which will give 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.
There is no established treatment or preventive measure for the gastrointestinal damage that occurs after high-dose radiation, andSoligenix has said there is an “urgent need” to develop specific medical countermeasures against the effects of radiation-induced gastrointestinal injury.
The company noted that BDP has been marketed in the U.S. and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma.
Soligenix said that oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation such as Crohn's disease and radiation enteritis.
Last week, the company regained the North American and European commercial rights to its oral BDP.
Soligenix is currently developing oral formulations of the drug, including its two-tablet system specifically designed for delivery of BDP throughout the small bowel and the colon.
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.