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Replies to post #193972 on Biotech Values
09/29/15 7:48 PM
OXiGENE's advancement plans include two phase 2/3 clinical trials evaluating whether CA4P improves the current standard-of-care in patients who have failed to respond to initial treatment. Both trials planned by the company are designed as two stage, phase 2/3 studies. The first stage of each trial would be a randomized, investigator-blinded, placebo-controlled study with up to 80 patients. The second stage of each trial would be a large, double-blind, placebo-controlled, confirmatory phase 3 study, the start of which would be triggered by a demonstration of efficacy in the first stage.
…The first clinical trial OXiGENE plans to initiate will be in platinum-resistant ovarian cancer, with the goal of determining whether the addition of CA4P to the standard-of-care (chemotherapy plus Avastin (bevacizumab)) improves patient outcomes. Patients would be randomized on a 1:1 basis to receive either the current standard-of-care or the current standard-of-care plus CA4P. The primary endpoint will be progression-free survival (PFS). The company expects to initiate the trial in the first half of 2016.
…The second phase 2/3 clinical trial OXiGENE plans to initiate will be in glioblastoma multiforme (GBM) patients who have failed first-line chemotherapy treatment, with the goal of determining whether CA4P improves upon the current standard of care, which is treatment with Avastin(R) alone. Patients will be randomized on a 1:1 basis to receive either Avastin(R) or Avastin plus CA4P. The primary endpoint will be PFS. The company expects to initiate the trial in the second half of 2016.
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