Soligenix, Inc. (OTCBB: SNGX) said Tuesday morning that the Food and Drug Administration has granted a “Fast Track” designation for OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP), the company’s treatment in development for the reduction of mortality associated with Gastrointestinal Acute Radiation Syndrome, or GI ARS.
The FDA grants Fast Track designations to expedite development of drugs or therapies that may address a significant area of unmet medical need.
There are not FDA approved therapies for the treatment of GI ARS, a condition occurring after toxic radiation exposure that affects several organ systems, explained Dr. Christopher Schaber, president and chief executive of Soligenix in a corporate statement.
“We look forward to working closely with the FDA, as well as with the National Institute of Allergy and Infectious Disease (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) to potentially expedite the OrbeShield development program,” said Schaber.
High levels of radiation exposure, such as that in a nuclear disaster, can cause severe damage to the gastrointestinal system and result in death in 5 to 15 days, according to the Princeton, New Jersey-based company.
Earlier this month, Soligenix received Orphan Drug designation from the FDA for OrbeShield for a treatment after exposure to a radiological disaster. Orphan drug designations are given to support and encourage the development of drugs or therapies focused on rare diseases or disorders.
Shares of SNGX have been on a strong climb over the past six months, rising from 23 cents in the last days of June to Monday’s closing price of $1.46 for gains in excess of 530 percent. Shares are currently at the highest level since early in September 2011 when share value plummeted 85 percent on news that an independent Data Safety Monitoring Board recommended the cessation of a phase III clinical trial for acute gastrointestinal graft-versus-host disease.
Soligenix Inc. (SNGX) Stock Quote and News:
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