ViRexx says enrollment complete for one of two phase 3 OvaRex MAb trials for ovarian cancer

By E. Janene Geiss

Philadelphia, Dec. 14 - ViRexx Medical Corp. said Wednesday that enrollment has been completed for the first of two identical phase 3 trials for OvaRex MAb.

The Impact I phase 3 trial reached its target enrollment of 177 patients with stage III/IV advanced ovarian cancer who have successfully completed front-line therapy, according to a company news release.

"OvaRex MAb represents a potential new standard of care for ovarian cancer patients who endure a five-year survival rate of only 31%. There have been no recent innovations in the treatment of ovarian cancer. Completing enrollment in the first of two phase 3 trials is a major milestone toward the commercialization of this important product," Lorne Tyrrell, chief executive officer, said in the release.

The OvaRex MAb trials are being conducted and funded by ViRexx's licensing partner, Unither Pharmaceuticals, Inc., a subsidiary of United Therapeutics, officials said.

The two phase 3 double-blind placebo controlled trials are being conducted at more than 60 sites across the United States.

Unither said that the Impact II trial continues to enroll patients. The enrollment target for each trial is 177 patients, randomized 2:1 OvaRex MAb versus placebo.

The primary endpoint for each trial is time-to-relapse comparing OvaRex MAb and placebo with relapse as the endpoint, officials said.

OvaRex MAb-B43.13 (oregovomab) is a monoclonal antibody developed by ViRexx that has a high degree of specificity to a tumor associated antigen (CA125) that is over-expressed by the majority of late-stage ovarian cancer patients.

OvaRex MAb has received both orphan drug designation and fast track status by the Food and Drug Administration. Each year about 22,000 new cases are diagnosed and about 16,000 women die from ovarian cancer in the United States, according to estimates from the American Cancer Society.

Although most patients initially respond to surgery and chemotherapy, the relapse rate is estimated to be about 85%. Once relapse occurs there is no known curative therapy.

ViRexx is an Edmonton, Alta., biotechnology company focused on the development of novel therapeutic products for the treatment of certain cancers and specified chronic viral infections.

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