Massachusetts, USA-headquartered Oxigene says it will conduct a domestic Phase II clinical study of its lead product candidate, Combretastatin (CA4P) as a treatment for stage IIIa/IIIb non-small cell lung cancer.
Initially, the trial will enroll 12 patients who will receive the drug intravenously, in order to establish its tolerability and to determine the most effective dose. The second stage of the study, which will enroll a further 66 patients, will be randomized, open-label and designed to evaluate the compound when given in combination with chemoradiotherapy. The overall aim of the study will be to determine the survival benefit after one year of treatment.
The upcoming trial follows clearance from the UK's Medicines and Healthcare Regulatory Agency to begin Phase III clinical trials of the drug in patients with inoperable stage IIIb/IV NSCLC.
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