Antigenics says Oncophage looks promising
United Press International
WASHINGTON, Oct 10, 2005 (UPI via COMTEX) -- Antigenics said preliminary phase III results indicate its personalized cancer vaccine Oncophage may extend median survival by eight months in patients with advanced melanoma, compared with aggressive treatment with conventional options.
The company said the difference in survival time is not statistically significant, but noted this is the first cancer vaccine to show a potential survival benefit in this category of patients in a phase III trial.
Antigenics expects to have a final analysis completed in the first quarter of 2006, and plans to initiate another phase III trial next year, with the aim of filing for Food and Drug Administration approval sometime in 2007, spokesman Sonny Uberoi told United Press International.
"These findings further validate our technology platform and our ability to create personalized cancer vaccines in a real-life setting," Garo Armen, chairman and chief executive officer of Antigenics, which is located in New York City, said in a statement. "We look forward to discussing our results with the FDA and developing a strategy for registration."
The category of patients that showed a potential survival benefit consisted of those with stage IV melanoma, meaning the cancer had spread to subcutaneous tissue or distant lymph nodes, but not to their vital organs.
Dr. John Kirkwood, who was involved in the trial and is director of the Melanoma Center at the University of Pittsburgh Cancer Institute, told UPI that cancer specialists are "enthusiastic" about Oncophage, because the current treatment options for metastatic melanoma generally are ineffective and some can be quite toxic to the patient.
"Patients with this disease face a desperate situation for which we really lack any promising approaches," Kirkwood said, noting about 60,000 people develop melanoma each year in the United States, and approximately 8,000 die from it.
Oncophage is made from a patient's tumor. By customizing the vaccine to each patient, the hope is it will spur the body's immune system to recognize only cancer cells and spare healthy tissues, thereby avoiding some of the serious side effects of chemotherapy and radiation.
In the study, which Antigenics said is not intended for registration, 133 patients received Oncophage and 107 received physician's choice, which included interleukin 2, dacarbazine and temozolomide, and complete tumor resection.
Those receiving Oncophage had a median survival time of 20.9 months, compared with 12.8 months in the physician's choice arm, an improvement of 50 percent.
Antigenics also is developing Oncophage technology to treat renal-cell carcinoma and plans to file for FDA approval in 2006 for that indication, Uberoi said. The FDA has granted the vaccine both fast track and orphan drug status for both melanoma and renal-cell carcinoma.
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Key(s): Antigenics Interleukin
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