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April 19, 2015

RXi’s samcyprone receives FDA orphan drug designation to treat malignant melanoma

RXi Pharmaceuticals has received 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.

By Ranjith Dharma

Rxi

RXi Pharmaceuticals has received 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.

Cutaneous metastases will be developed in most of the patient with stage IIb to IV malignant melanoma. The drug is being developed to treat these metastases.

Samcyprone is a topical formulation of diphenylcylcopropenone (DPCP) in clinical development to treat warts, alopecia areata and cutaneous metastases of melanoma.

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 programmes with our sd-rxRNA platform focused on tyrosinase, a key enzyme in the synthesis of melanin."

DPCP is an immunomodulating agent that works by eliciting a T-cell response, which has been used for decades.

"It provides 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 programmes with our sd-rxRNA platform focused on tyrosinas."

Samcyprone’s mechanism of action is linked to DPCP’s ability to alter the expression of multiple genes and miRNAs involved in the immune response.

At present, an investigator sponsored clinical trial in cutaneous metastases of melanoma and a new investigator sponsored clinical trial in alopecia areata are ongoing, according to the company.

The firm intends to start a Phase IIa clinical trial in warts for samcyprone by the end of this year.

Samcyprone’s mechanism of action is linked to DPCP’s ability to alter the expression of multiple genes and miRNAs involved in the immune response.

RXi said that its sd-rxRNA platform helps in the rapid identification of lead compounds for multiple targets in different therapeutic areas and work with Samcyprone will allow discovering specific targets and developing new sd-rxRNAs to treat immunological disorders that are relevant to the skin and various systemic diseases.


Image: Lymph node with almost complete replacement by metastatic melanoma. Photo: courtesy of Gabriel Caponetti.

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