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FDA grants orphan drug designation to Samcyprone for malignant stage IIb to IV melanoma
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RXi Pharmaceuticals announced it has received orphan drug designation from the FDA for Samcyprone, its clinical candidate for treating malignant melanoma stage IIb to IV.
Samcyprone, a proprietary topical formulation of diphenylcylcopropenone (DPCP), is being developed for the treatment of warts, alopecia areata and cutaneous metastases of melanoma, according to a press release from RXi.
DPCP works by eliciting a T-cell response that that subsequently causes destruction of the cutaneous tumor, the release stated. Samcyprone’s mechanism of action is linked to DPCP’s ability to alter multiple gene expression and miRNAs involved in the immune response.
The FDA grants orphan drug status for novel drugs or biologics to treat rare medical diseases or conditions that affect fewer than 200,000 people in the United States, according to the release. Incentives included with the designation include 7 years of market exclusivity after the drug’s approval, tax credits for clinical research costs and application fee reductions, the release stated.
Investigator-sponsored clinical trials of Samcyprone in cutaneous misstates of melanoma and alopecia areata are ongoing, according to the release. The company also plans to launch a phase 2a clinical trial of Samcyprone for treating warts by the end of the year.
Reference: www.rxipharma.com.