biz.yahoo.com
Cephalon Comments on Study of its Leukemia Treatment Led by National Cancer Institute Cooperative Group
Wednesday January 24, 4:10 pm ET
-- CALGB and NCI Report Improved Survival in Newly Diagnosed Adult Patients with Acute Promyelocytic Leukemia (APL) in Study Using TRISENOX --
FRAZER, Pa., Jan. 24 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH - News) commented on the announcement today by the National Cancer Institute (NCI) and one of its Cooperative Clinical Trials Groups, the Cancer and Leukemia Group B (CALGB), regarding event-free and overall survival results from a clinical trial using TRISENOX® (arsenic trioxide) injection in newly diagnosed patients with acute promyelocytic leukemia (APL). After reviewing the results from more than 500 patients in the study, a data safety monitoring board notified the investigators and the NCI of the positive results and the findings are being released based on their impact on the treatment of APL. A complete scientific presentation of these study results is planned for the annual meeting of the American Society of Clinical Oncology (ASCO) in June 2007.
ADVERTISEMENT
A press release announcing some of the study results can be found at cancer.gov, the NCI Web site, as well as on the CALGB Web site, at calgb.org.
Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations, Cephalon, said, "The results of this study showing a survival benefit associated with the use of TRISENOX in patients with APL are an important development for physicians and patients, as demonstrated by the urgency to disseminate the results to clinicians in an expedited manner. We are encouraged by the oncology community's continued interest in the potential of TRISENOX, and these study results reinforce Cephalon's commitment to build a fully integrated oncology business."
TRISENOX is indicated for the induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation of PML/RAR-alpha gene expression. Full prescribing information, including boxed warning, is available at trisenox.com. While Cephalon is evaluating these study results as well as other areas of interest to consider future development of TRISENOX, the product is not presently indicated or approved by the U.S. Food and Drug Administration (FDA) for use in any other disease or related cancer beyond its labeled indications.
In addition to TRISENOX, the Cephalon Oncology therapeutic portfolio in the United States includes two other compounds in late-stage clinical development: TREANDA® (bendamustine HCl), a bi-functional cytotoxic in phase 3 development for chronic lymphocytic leukemia (CLL) and non-Hodgkins lymphoma (NHL), and CEP-701 (lestaurtinib), an oral small molecule inhibitor of tyrosine kinases including FLT-3, TRK and JAK-2, in phase 3 development for acute myeloid leukemia (AML). Neither compound is presently indicated or approved by the FDA for these or any other diseases. |
