Soligenix Inc (OTCBB:SNGX) has announced that it will be partnering with National Organization for Rare Disorders and the Foundation for Cutaneous Lymphoma, in order to advance phase-3 of its clinical trials. Through this partnership, the company aims to educate and enroll patients to its phase-3 clinical trials for its cutaneous T-cell lymphoma drug. The drug already holds the orphan drug and fast track designations from the FDA. CTCL is a rare disease, with unmet medical needs and effects the white blood cells in the immune system.
Soligenix is a biopharmaceutical company, which focuses on areas of oncology, inflammation and bio-defense, to identify areas of unmet medical needs. Its new partner NORD is an NPO, which provides assistance to patients in identification and treatment of rare diseases. Similarly CLF works to support patients and increase awareness about cutaneous lymphoma. The two organizations would work to increase the awareness of the trial amongst CTCL patients and enroll them for the phase-3 trials.
The drug is applied externally on lesions, where it is then activated by visible light. This approach avoids the risks of secondary developments. In its phase-1 trials the drug demonstrated safety amongst volunteers and in phase-2 the drug came out to be well tolerated, up to 58.3%, amongst CTCL patients. For its phase-3 trials the company hopes to enroll 120 patients. There will be three treatment cycles, with each one extending up to 8-weeks, with the drug being administered twice a week.
The follow-up is planned to be carried on for the next 6-months. Soligenix plans to start the trials in 2Q2015, with initial reports by second half of 2016. Apart from the current drug, the company is also busy developing a toxin vaccine, Rivax, an anthrax vaccine, VeloThrax and a GI acute radiation syndrome therapy, OrbeShield. Most of these vaccines make use of the company’s proprietary heat stabilization technology, ThermoVax.
Soligenix Inc (OTCBB:SNGX) closed trading on June 6 at a share price of $1.94, after reporting a decline of 15.65% and trading 375,651 shares during the session.