2009.06.19 – Cephalon Cancer Drug Shows No Increase In Survival Rate
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Cephalon Cancer Drug Shows No Increase In Survival Rate
Friday June 19th, 2009
DOW JONES NEWSWIRES Biopharmaceutical company Cephalon Inc. (CEPH) said a trial of its treatment for acute myeloid leukemia when used with chemotherapy didn’t show any improvement for patients with a specific gene mutation compared with chemotherapy alone.
Cephalon Chief Medical Officer Lesley Russell said, “We are disappointed that this study with lestaurtinib did not demonstrate a benefit for this patient population, but we remained committed to oncology clinical research.”
Cephalon’s shares were recently down 0.9% at $57 in premarket trading. While the stock is down 25% this year, the company has weathered the recession fairly well, increasing sales with the launches of new products. Cephalon has also been pressing to expand.
Myeloid leukemia affects bone marrow. Chief Executive Frank Baldino said last month that if the study was positive, Cephalon would submit data to the Food and Drug Administration later this year for a potential product launch in 2010.
The FDA granted orphan drug designation to lestaurtinib for the treatment of acute myeloid leukemia in 2006, providing seven years of marketing exclusivity. The agency can designate a medication as an orphan drug if the product is intended to treat a rare disease or condition affecting fewer than 200,000 Americans a year.
In leukemic cells, the drug inhibits certain enzymes and induces cell death. In some disorders, mutations in JAK2, an enzyme the drug inhibits, may allow large numbers of abnormal blood cells or platelets to grow and spread. Based on its potential to inhibit that activity, the drug is in studies for the treatment of such disorders, known as “myeloproliferative.”
The company said the results of the study wouldn’t have an impact on its previously issued financial outlook for this year.
-By Kerry E. Grace, Dow Jones Newswires; 201-938-5089; kerry.grace@dowjones.com
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Friday June 19th, 2009 / 15h18 Source : Dowjones Business News