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RXi Pharma gets FDA orphan drug status for melanoma drug samcyprone

RXi Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for its second clinical candidate, Samcyprone, to treat malignant melanoma stage IIb to IV.

Several patients with stage IIb to IV malignant melanoma develop cutaneous metastases and samcyprone is being developed to treat these metastases.

Samcyprone is a topical formulation of Diphenylcylcopropenone (DPCP), an immunomodulating agent that works by eliciting a T-cell response.

The drug is currently being developed to treat warts, alopecia areata and cutaneous metastases of melanoma.

The mechanism of action to treat cutaneous metastases of melanoma involves elicitation of an immune response in the skin that subsequently causes destruction of the cutaneous tumor.

RXi Pharmaceuticals president and CEO Dr Geert Cauwenbergh said: "This orphan designation underscores the value of expanding our clinical pipeline through the acquisition of Samcyprone.

"It provides the company with access to cost-saving benefits and incentives to aid in the development of this drug, and establishes a link to one of our other preclinical research programs with our sd-rxRNA platform focused on tyrosinase, a key enzyme in the synthesis of melanin."

The company is currently conducting an investigator sponsored clinical trial in cutaneous metastases of melanoma, as well as a new investigator sponsored clinical trial in alopecia areata.

Additionally, the company intends to start a Phase IIa clinical trial in warts for samcyprone by the end of 2015.