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news.The FDA has granted orphan drug designation to Oxigene's vascular disrupting agent, combretastatin A4P, for the treatment of ovarian cancer.
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The designation provides Oxigene with several potential benefits for combretastatin A4P (CA4P), including a guarantee of seven years of market exclusivity upon approval in the ovarian cancer indication. It also provides tax credits to defray the cost of research, funding to support clinical trials and assistance in designing research studies.
CA4P is being evaluated in a phase II clinical trial in combination with the widely used chemotherapy regimen, carboplatin and paclitaxel, for the treatment of platinum resistant ovarian cancer. Results from a phase Ib clinical trial showed a 67% response rate to the combined CA4P-chemotherapy treatment among women with advanced ovarian cancer who failed previous cancer therapy.
“US Orphan Drug designation for ovarian cancer is a significant achievement for Oxigene; a milestone that we believe may provide a market advantage as we advance CA4P as a treatment under development in this key indication,” commented Frederick Driscoll, president and CEO of Oxigene.