Soligenix (OTCQB:SNGX), a clinical stage biopharmaceutical company, has received fast track designation from U.S. regulatory authorities for its lead compound, for which it is aiming to start phase 2 trials in the second half of this year.
The company was granted the status from the U.S. FDA for its development program of SGX942 for the treatment of oral mucositis as a result of radiation and/or chemo in head and neck cancer patients.
The designation, which expedites the review of new drugs, is reserved for a drug intended to treat a serious or life-threatening condition, and shows the potential to address an unmet medical need.
Under the status, Soligenix would be eligible to submit a new drug application for SGX942 on a rolling basis, allowing the FDA to review sections of the application before receiving the complete submission.
The applications are also typically eligible for priority review under fast track designation, which usually means a shortened review period of approximately six months.
"Oral mucositis is a significant unmet medical need which ultimately impacts the tolerability of radiation and chemotherapy and therefore the survivability of cancer," said Dr. Stephen T. Sonis, a clinical professor of oral medicine at Harvard, and a member of theSoligenix Oral Mucositis Medical Advisory Board.
"The lack of an effective treatment has frustrated healthcare providers and caused misery for innumerable patients. As an innate defense regulator (IDR), SGX942 directly targets a fundamental biological mechanism which leads to mucosal injury caused by radiation and chemotherapy."
There are currently no FDA-approved drugs for the treatment of oral mucositis in head and neck cancer patients.
The company is slated to start a phase 2 randomized, double blind, placebo-controlled study of SGX942 in the second half of this year. In phase 1 trials, it was shown to reduce the severity and duration of oral mucositis and induce anti-inflammatory activity.
"We believe that the FDA's action in granting fast track designation is a validation of the potential of SGX942 to address this life-threatening, unmet medical need," said Soligenix's president and chief executive, Christopher J. Schaber.
Shares of Soligenix have been rising steadily in the past months, as the company progresses its pipeline of developing drugs. Its stock extended year-to-date gains in late May after the biopharmaceutical company announced that it was granted a U.S. patent for its Thermovax vaccine thermostabilization technology.
The company, which is focused on developing products to treat inflammatory diseases and biodefense countermeasures, says the patent claims encompass composition of matter and methods for the technology, which is exclusively licensed to Soligenix by the University of Colorado. According to Soligenix, for vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the use of ThermoVax, which has been tested in combination with the company's RiVax and VeloThrax vaccines, can lead to easier storage and the distribution of strategic national stockpile vaccines in emergency situations.
The drug company also in May took a step toward advancing one of its other drugs, saying it had started the first clinical study for the development of SGX203, its treatment for pediatric Crohn's disease.
Soligenix's stock gained more than 12 per cent on Friday to close at $1.46, with its shares more than doubling since the start of the year, to rise from a level of 62 cents on January 2.
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