RXi Pharmaceuticals Corporation has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation of its second clinical candidate, Samcyprone™, for the treatment of Malignant Melanoma Stage IIb to IV. A number of patients with Stage IIb to IV malignant melanoma develop cutaneous metastases. Samcyprone™ is being developed for treatment of these metastases.
Samcyprone is a topical formulation of Diphenylcylcopropenone (DPCP) in clinical development for the treatment of warts, alopecia areata and cutaneous metastases of melanoma. The mechanism of action for treatment cutaneous metastases of melanoma involves elicitation of an immune response in the skin that subsequently causes destruction of the cutaneous tumor.
Melanomas, cancers that arise from melanocytes, are the most aggressive form of skin cancer. Once melanoma has spread beyond the localized area of the primary lesion, the survival rate decreases and melanoma becomes increasingly more difficult to treat successfully. Management of metastatic melanoma, including cutaneous metastases, is challenging and represents an area of great unmet need.
"This is an important step for patients suffering from this devastating disease," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He further added, "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."