FDA grants orphan drug status to Oxigene's CA4P for treatment of ovarian cancer

By Lisa Kerner

Erie, Pa., May 15 - The Office of Orphan Products Development of the Food and Drug Administration has granted orphan drug designation to Oxigene, Inc.'s lead vascular disrupting agent, Combretastatin A4P (CA4P), for the treatment of ovarian cancer, the fourth most common cancer in women and the deadliest of the gynecologic cancers.

Preclinical research has shown that CA4P's complementary mechanisms block the flow of blood to a tumor and deprive it of oxygen and nutrients essential to its survival, according to a company news release.

The orphan drug designation provides economic incentives to stimulate the development of products designed to treat diseases that typically affect fewer than 200,000 individuals in the United States.

Additionally, the designation provides Oxigene with a guarantee of seven years of market exclusivity if the company is the first to obtain market approval for CA4P to treat patients with platinum resistant ovarian cancer.

Oxigene received orphan drug indication in 2003 for CA4P for the treatment of anaplastic thyroid cancer, as well as medullary, stage 4 papillary and stage 4 follicular thyroid cancers. The European Agency for the Evaluation of Medicinal Products awarded Oxigene the orphan medicinal product designation for CA4P as a treatment for anaplastic thyroid cancer.

Oxigene said CA4P is being evaluated in a phase 2 clinical trial in combination with the chemotherapy regimen, carboplatin and paclitaxel, for the treatment of platinum resistant ovarian cancer. The company said a previous phase 1b clinical trial demonstrated a 67% response rate to the combined CA4P-chemotherapy treatment in women with advanced ovarian cancer who failed previous cancer therapy.

Located in Waltham, Mass., Oxigene is an emerging pharmaceutical company developing novel small-molecule therapeutics to treat cancer and eye diseases.

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