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Oxigene to evaluate CA4P for lung cancer
By Lisa Kerner
Erie, Pa., Feb. 3 - Oxigene, Inc. said it plans to begin a phase 2 clinical trial in the United States for the treatment of stage 3a/3b non-small cell lung cancer.
The company will evaluate its lead clinical candidate, Combretastatin A4P (CA4P), in combination with concurrent chemoradiotherapy. CA4P is a vascular disrupting agent that works to block blood flow to tumors, according to a company news release.
Oxigene said the trial will be conducted under Oxigene's Investigational New Drug application filed with the Food and Drug Administration.
The phase 2 clinical trial is designed to assess the tolerability of the protocol and to establish the recommended dose of intravenously administered CA4P.
The randomized, open label, multi-center trial will be the first in which CA4P is administered in combination with concurrent chemoradiotherapy, the company said.
About 66 patients who have not had prior treatment for non-small cell lung cancer will be randomized 2:1 into the two groups. Those in the investigational group will be treated with radiotherapy and seven cycles of chemotherapy plus CA4P, followed by maintenance chemotherapy plus CA4P.
The objective of the trial is to evaluate the survival benefit in patients achieved at one year. The response rate will be evaluated according to Response Evaluation Criteria in Solid Tumors.
Oxigene said it recently received regulatory clearance from the Medicines and Healthcare Products Regulatory Agency to begin a phase 3 clinical trial of CA4P in the United Kingdom in patients with inoperable stage 3b/4 non-small cell lung cancer.
Non-small cell lung cancer accounts for 75% of all lung cancer with about 350,000 cases diagnosed globally each year.
Oxigene, based in Waltham, Mass., is an emerging pharmaceutical company developing novel small-molecule therapeutics to treat cancer and eye diseases.
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