Oxigene given U.K. approval for phase 3 trial of Combretastatin A4P

New York, Dec. 12 - Oxigene, Inc. said it received regulatory approval from the U.K. Medicines and Healthcare Products Regulatory Agency for the first phase 3 trial of its lead product candidate Combretastatin A4P.

The Waltham, Mass., developer of biopharmaceutical compounds will evaluate Combretastatin A4P in combination with radiotherapy and chemotherapy for the treatment of unresectable Stage IIIb/IV non-small cell lung cancer.

"We believe that this notice of acceptance to commence a phase 3 trial represents an important step forward for Oxigene's clinical program as it represents the achievement of another significant clinical landmark for the company in 2005," said Frederick Driscoll, president and chief executive officer, in a news release.

"Oxigene's clinical progress this year, which includes the initiation of this phase 3 trial, as well as the initiation of a phase 2 clinical trial in platinum-resistant ovarian cancer and the commencement of a phase 1b trial evaluating CA4P in combination with Avastin, demonstrates our clinical focus on oncology and reflects our roadmap for our intended clinical development path."

The trial of Combretastatin A4P is expected to enroll approximately 370 patients who have not had prior treatment for non-small cell lung cancer and who will be randomized into either a control group or a treatment group.

The primary objective is to compare median survival time of patients in the treatment group versus the control group.

Non-small cell lung cancer accounts for 75% of all lung cancer, Oxigene said.

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