Oncophage, a vaccine to treat brain cancer has been granted Orphan Drug status – a special designation given to drugs which could provide significant benefit to patients suffering from life-threatening diseases -in Europe.
Oncophage contains vitespen. Vitespen has already been approved for the treatment of renal cell carcinoma or kidney cancer by the European Medicines Agency (EMEA).
EMEA’s orphan drug designation provides Oncophage’s maker Antigenics Inc 10 years of potential market exclusivity if the product is approved for marketing in the European Union (EU).
Oncophage is derived from each individual’s tumour. So Oncophage contains the ‘antigenic fingerprint’ of the patient’s particular cancer and is designed to reprogramme the body’s immune system to target only cancer cells bearing this fingerprint. Oncophage is intended to leave healthy tissue unaffected and limit the debilitating side effects typically associated with traditional cancer treatments such as chemotherapy and radiation therapy. Oncophage has been studied in Phase 3 clinical trials for the treatment of kidney cancer and metastatic melanoma and is currently being investigated in a Phase 1/2 trial in recurrent glioma, a from of brain cancer.
Glioma is the second indication for which the EMEA has granted orphan drug status to Oncophage. Oncophage received orphan drug designation in the European Union for the treatment of renal cell carcinoma (kidney cancer) in April 2005.
Later on, Antigenics submitted a Marketing Authorization Application (MAA) to the EMEA in October 2008 requesting approval for Oncophage in earlier-stage, localized renal cell carcinoma.
“We are committed to supporting the evaluation of Oncophage in patients diagnosed with glioma, as this remains a life-threatening disease with limited treatment options,” stated Garo Armen, PhD, chairman and CEO of Antigenics. “Furthermore, orphan drug status has the potential to accelerate the development of Oncophage in this patient population, which is critical given the poor survival rates.”
In addition to potential 10-year EU market exclusivity, orphan drug status provides regulatory assistance, reduced regulatory fees associated with applying for marketing approval, and protocol assistance.
Oncophage was approved in Russia for the adjuvant treatment of kidney cancer patients at intermediate-risk for disease recurrence, in April 2008.
Oncophage has also received fast track and orphan drug designations from the U.S. Food and Drug Administration for both kidney cancer and metastatic melanoma.
Glioma is the most common type of brain tumor. Glioma is currently a fatal disease impairing areas such as thinking, personality and movement. The National Cancer Institute estimates that about 19,000 cases are diagnosed every year in the US and according to historical estimates, the median survival of patients with previously treated glioma is typically three to six months.
Antigenics is a biotechnology company working to develop treatments for cancers and infectious diseases.