Soligenix, a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced that its SGX301 (synthetic hypericin) development programme for the first-line treatment of cutaneous T-cell lymphoma (CTCL) has received “Fast Track” designation from the US Food and Drug Administration (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, president and chief executive officer of Soligenix.  “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.”

Cutaneous T-cell lymphoma (CTCL) is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system.  Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin.  These skin-trafficking malignant T-cells migrate to the skin, causing various lesions to appear that may change shape as the disease progresses, typically beginning as a rash and eventually forming plaques and tumours.  Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced.  There is currently no cure for CTCL.

CTCL constitutes a rare group of NHLs, occurring in about 4 per cent of the approximate 500,000 individuals living with the disease.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL, that it affects over 20,000 individuals in the US, with approximately 2,800 new cases seen annually.

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 2 clinical study in CTCL, patients experienced a statistically significant (p = 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective: 58.3 per cent compared to 8.3 per cent, respectively. SGX301 has received orphan drug designation from the FDA.