Renal Cell Carcinoma is the most common type of kidney cancer. According to the International Agency for Research on Cancer, renal cell carcinoma accounts for nearly 90 percent of all kidney tumors. Approximately 60,511 new cases of kidney cancer were diagnosed in 2004, 29,453 of those individuals diagnosed died from the disease.
Antigenics Inc.’s (Nasdaq: AGEN) Oncophage contains an “antigenic fingerprint” of a patient’s particular cancer. It was designed to reprogram the body’s immune system to target only the cancer cells with this specific fingerprint.
In April, 2008, Oncophage was approved in Russia for the treatment of kidney cancer patients; however, there are currently no European Medicines Agency (EMEA)-approved drug therapies in the European Union. To change this, Antigenics today announced it has submitted a Marketing Authorization Application (MAA) to the EMEA. The application is a request of approval for Antigenics’ Oncophage drug therapy for early-stage kidney cancer.
“The creation of the EMEA’s conditional approval regulation provides an important mechanism for allowing patients and physicians potentially earlier access to products that fulfill an unmet medical need for serious or life-threatening diseases,” Garo H. Armen, Ph.D, chairman and CEO of Antigenics stated in the press release. “This application represents a major achievement in the development of Oncophage, and if approved, will be the first therapeutic cancer vaccine to receive a marketing license from the European agency.”
In 2005 Oncophage received European orphan drug status, allowing the possibility for 10 years of exclusive marketing that would allow for the use of Oncophage in all 27 EU member states and non-member states.
In previous meetings, associated parties discussed results for Oncophage’s phase III kidney cancer trail, as well as Antigenics’ plans to fine for under conditional approval provision. The EMEA, paired with UK authorities, will coordinate the review of the application.
According to the press release, Antigenics is confidant the results from the phase 3 study will support the need for Oncophage to treat patients with kidney cancer in the EU, but will still need to conduct further clinical studies of Oncophage.
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