AGEN catching a bid for starting a trial in an indication with a small market. I think it'll fade. Short and strong:
>>NEW YORK--(BUSINESS WIRE)--April 9, 2003--Antigenics Inc. (NASDAQ: AGEN - News):
Trial to Be Conducted at Leading Medical Centers Worldwide
Antigenics Inc. (NASDAQ: AGEN - News) announced today that it has begun a Phase II study evaluating AG-858 personalized cancer vaccine in combination with Gleevec(TM) (imatinib mesylate, Novartis) for treatment of chronic myelogenous leukemia (CML), a cancer characterized by the proliferation of abnormal white blood cells.
The international clinical trial will evaluate the safety and efficacy of the combination treatment in up to 120 patients with chronic phase CML who are currently receiving Gleevec treatment but have not achieved complete clinical response.
"We are highly encouraged by the responses seen in our earlier clinical trial of CML patients receiving AG-858, and are pleased to be initiating a Phase II development program that can be used in support of a biologicals license application filing," said Jonathan J. Lewis, MD, PhD, chief medical officer of Antigenics. "We feel confident that enrollment for the trial can be completed quickly, given the positive findings from the first study and the enthusiasm expressed by CML patients and leading experts alike."
The launch of the Phase II study is based on earlier clinical data that demonstrated objective clinical responses associated with combination AG-858 and Gleevec treatment in five out of five patients tested, four of whom were unresponsive to treatment with Gleevec alone. Two of the five patients experienced complete molecular responses - a result achieved by fewer than 10 percent of patients treated with Gleevec alone, according to published reports. Updated findings from the earlier study will be announced in an oral presentation at this year's annual meeting of the American Society of Clinical Oncology in June.
Like Antigenics' lead product Oncophage® (HSPPC-96), AG-858 is a personalized cancer vaccine based on the company's proprietary heat shock protein technology. Derived from each patient's blood cells, the vaccine is designed to capture the 'antigenic fingerprint' of the patient's particular cancer to reprogram the body's immune system to target and destroy only the cancerous cells bearing this fingerprint.
About Chronic Myelogenous Leukemia
Chronic myelogenous leukemia is a cancer of the blood and bone marrow characterized by overproduction of white blood cells. The disease is caused by a genetic mutation that produces an abnormal enzyme (Bcr-Abl tyrosine kinase). Approved in 2001 for CML, Gleevec specifically blocks the action of this abnormal enzyme.
The American Cancer Society estimates that there will be about 4,400 new cases of chronic myelogenous leukemia in the United States this year. CML mainly affects adults and is slightly more common in men than women. <<
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Cheers, Tuck |
