Last month, cancer vaccine developer, Antigenics, Inc. (Nasdaq: AGEN) announced that its personalized cancer treatment, Oncophage(R) was granted a positive recommendation by the Committee for Orphan Medical Products (COMP) of the Europen Medicines Agency (EMEA) for orphan drug designation for the treatment of giloma, a life-threatening cancer that starts in the brain or spine.
Results from a Phase 1, 12 patient investigator-sponsored study, showed that the overall median survival was approximately ten and a half months, with four patients surviving beyond 12 months and one patient surviving almost two and a half years.
This compares with survival based on historical experiences in a similar patient population, which is in the range of six and a half months. The company is currently enrolling patients for the Phase 2 portion of the study, which is ongoing and has enrolled about two-third of its target patients, according to Antigenics’ chairman and CEO, Garo Armen, PhD.
Oncophage is already approved as an adjuvant treatment for early stage kidney cancer in Russia, where the company is still seeking commercial partners and government reimbursement. Russia has only recently launched proprietary products from western companies, and there are additional uncertainties including the company securing the necessary partnerships and government funds to successfully launch the product.
Antigenics’ bread and butter is its licensing revenue from QS-21, an adjuvant that’s used in various vaccines. Antigenics’ licensees include GlaxoSmithKline and Elan. There are currently 16 vaccines that cover a number of indications including non-smal cell lung cancer, malaria, HIV, melanoma, and influenza that use QS-21. GSK’s malaria vaccine, which uses the adjuvant, should enter a phase 3 study across Africa in the “very near term,” according to Armen.
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