RXi Pharmaceuticals Corporation completed enrollment in its Phase 2 clinical trial, RXI-SCP-1502, with Samcyprone™for the clearance of cutaneous warts.
Samcyprone™ is a proprietary topical formulation of the small molecule diphenylcyclopropenone (DPCP). This topical immunomodulator works by initiating a T-cell response. DPCP has been used for several decades by physicians and is supported in publications for its use as an immunomodulator for the treatment of warts, alopecia areata and cutaneous metastases of malignant melanoma.
It has never been reviewed or approved by a regulatory authority as a drug; however, DPCP is a new chemical entity under a U.S. Investigational New Drug Application (IND). The Company's proprietary topical formulation of DPCP, Samcyprone™, is expected to achieve market exclusivity post approval. In March 2015, the Company was granted Orphan Drug Designation for Samcyprone™ by the U.S. Food and Drug Administration for the treatment of malignant melanoma stage IIb to IV.
RXi Pharmaceuticals Corporation completed an exclusive global license to Samcyprone™ from Hapten Pharmaceuticals, LLC. After the transfer of the IND to RXi, the Company completed a process to optimize the topical formulation followed by the initiation of its Phase 2 study, RXI-SCP-1502.
This study is a multi-center, multi-dose trial conducted in subjects with at least one cutaneous, plantar or periungual wart present for at least four weeks. In this Phase 2 trial, subjects are first treated with a sensitization dose on the inner arm and one or more preselected wart lesion(s). Once the sensitization response is confirmed, subjects continue with weekly treatments for 10 weeks. Wart clearance will be evaluated based on Investigator's Global Assessment Score (IGAS) and wart measurements over time during the treatment period.