Cancer Therapy Center

CHICAGO, Oct 17 (Reuters) - Genta Inc. said on Tuesday its lead cancer drug Genasense received orphan drug designation from regulators in Australia allowing for its use to treat patients with late-stage malignant melanoma, a deadly form of skin cancer.

Genta said the designation was granted for the use of Genasense as treatment for patients with Stage IV malignant melanoma. Orphan drug designation is intended to facilitate the development of drugs that address significant unmet medical needs.

It provides seven years of market exclusivity after approval, grants and tax credits for research and development, and reduced filing fees for marketing applications.

TheStreet.com writes that the Food and Drug Administration completed a special protocol assessment of the proposed trial, which will enroll patients with symptomatic chronic lymphocytic leukemia who have not previously received chemotherapy. Last month, an FDA oncology drug advisory committee voted against approving a new drug application for Genasense. Although the FDA isn’t required to follow the advice of its advisory committee, it often does. A decision from the FDA is expected Oct. 29.

“We are pleased that the FDA had no outstanding issues regarding the design or analysis of this trial, and also with the agency’s agreement that there were no safety issues that precluded the use of Genasense in previously untreated patients,” said Genta’s CEO Dr. Raymond Warrell.

Shares of Genta surged more than 20% after the cancer-drug developer said regulators agreed to the design of a proposed trial for its experimental leukemia treatment. The stock gained 20.1% to 96 cents in premarket trading Friday. More recently, shares were trading up 7 cents, or 9.4%, at 88 cents.