Soligenix’s Cutaneous T-Cell Lymphoma Treatment Receives ‘Fast Track’ Designation

Soligenix Inc. (OTCQB:SNGX) announced that the US Food and Drug Administration (FDA) has given its SGX301 development program a “fast track” designation. The program is used for first-line treatment of cutaneous T-cell lymphoma.

As quoted in the press release:

Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition.  Fast track designation is designed to facilitate the development and expedite the review of new drugs.  For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for SGX301 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.

Christopher J. Schaber, president and CEO of Soligenix, commented:

We are very pleased to have been granted fast track designation from the FDA to go along with the orphan drug designation previously received.  We believe that the FDA’s action in granting fast track designation validates the unmet medical need that currently exists for first-line treatment in CTCL and for the potential key role SGX301 can serve as a first-line therapy in this rare, life-threatening disease. With the pivotal Phase 3 protocol now cleared through the FDA and completion of the recent targeted financing, we look forward to working closely with our esteemed Medical Advisory Board to initiate the clinical study in the first half of 2015.

Click here to read the full Soligenix Inc. (OTCQB:SNGX) press release.