FDA Grants Soligenix Fast Track Designation for SGX301 for First-Line Treatment of Cutaneous T-Cell Lymphoma

Soligenix, Inc.’s SGX301 (synthetic hypericin) development program for the first-line treatment of cutaneous T-cell lymphoma (CTCL) received "fast track" designation from the FDA. 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.

"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," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With the pivotal Phase III 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."

SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer, which is topically applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase II clinical study in CTCL, patients experienced a statistically significant (p < 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective:  58.3 percent compared to 8.3 percent, respectively.  SGX301 has received orphan drug designation from the FDA.