RandyW Posted February 3, 2006 Share Posted February 3, 2006 -- Combretastatin A4P (CA4P) will be Evaluated with Concurrent Chemoradiotherapy, a Widely-Accepted Treatment Regimen in the United States-- -- Trial Endpoint Targets a One-Year Survival Benefit in Patients with All Histological Types of Unresectable, Stage IIIa/IIIb NSCLC-- -- Distinct Clinical Trials in the US and Europe Could Maximize the Market Opportunity for CA4P in Key Oncology Indication-- OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), a leading developer of biopharmaceutical compounds designed to treat cancer and certain ophthalmologic diseases, today announced that it plans to commence a Phase II clinical trial in the United States for the treatment of Stage IIIa/IIIb Non Small Cell Lung Cancer (NSCLC). The Company will evaluate its lead clinical candidate, Combretastatin A4P (CA4P), in combination with concurrent chemoradiotherapy, a widely accepted standard in the United States for the treatment of patients with all histological types of unresectable Stage IIIa/IIIb NSCLC. The trial will be conducted under OXiGENE's Investigational New Drug (IND) application on file with the United States Food and Drug Administration. The Phase II clinical trial will commence by enrolling approximately 12 patients to assess the tolerability of the protocol and to establish the recommended dose of intravenously administered CA4P. This trial will be the first in which CA4P is administered to patients in combination with concurrent chemoradiotherapy. In other ongoing clinical trials, CA4P has been paired with chemotherapy or radiation therapy with no observed side effects beyond those typically experienced with either treatment. The Phase II clinical trial will then proceed as a randomized, open label, multi-center trial that will compare two cohorts of patients -- an investigational group and an active control group. Approximately 66 patients who have not had prior treatment for NSCLC will be randomized 2:1 into the two groups. Patients enrolled 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 Phase II clinical 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 (RECIST). The announcement of this randomized Phase II clinical trial with CA4P in the United States follows OXiGENE's recent announcement of receipt of regulatory clearance from the Medicines and Healthcare Products Regulatory Agency (MHRA) to commence a Phase III clinical trial of CA4P in the United Kingdom in patients with inoperable Stage IIIb/IV NSCLC, a subset of patients not deemed suitable for curative treatment with concurrent radiotherapy. "We believe this Phase II clinical trial to be a key stepping stone in the path towards potential commercialization of CA4P for the treatment of NSCLC," commented Frederick Driscoll, President and CEO of OXiGENE. "We expect that the commencement of this trial in the United States, combined with the Phase III clinical trial which we plan to commence in Europe for the treatment of patients with Stage IIIb/IV NSCLC, may provide a springboard for OXiGENE to maximize its registrational opportunities in a key oncology indication, and with standards of therapy most often selected by oncologists for each subset of patients. Strategically, this is a key clinical achievement Quote Link to comment Share on other sites More sharing options...
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