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news.Antigenics, a biotechnology company, has reported that FDA has granted the orphan drug status for Oncophage for the treatment of glioma.
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Orphan drug designation entitles Antigenics to seven years of market exclusivity for Oncophage in the treatment of glioma patients in the event of market approval for this indication.
According to Antigenics, final data from a Phase I investigator-sponsored trial showed that Oncophage vaccination following brain cancer surgery increased overall median survival to approximately 10.5 months, with four patients surviving beyond 12 months and one patient surviving almost 2.5 years. This is compared to a historical median survival of only 6.5 months postsurgery.
Oncophage has been studied in Phase III clinical trials for the treatment of kidney cancer and metastatic melanoma and is currently being investigated in a Phase II trial in recurrent glioma. Phase II results are expected to be presented later in 2009.
Andrew Parsa, lead investigator of a Phase II trial evaluating Oncophage in glioma, said: “Given the poor survival rates, the medical community needs new treatment options, and I am hopeful of the potential for Oncophage to significantly improve clinical outcomes in this patient population.”