FRAZER, Pa., Dec. 8 /PRNewswire/ -- Cephalon, Inc. announced today that new science highlighting the use of its anti-cancer therapeutics in a variety of hematologic cancers will be presented at the 47th meeting of the American Society of Hematology (ASH). Two platform presentations on leading investigational compounds and more than 60 other abstracts and posters will introduce data about the Cephalon Oncology portfolio to a broad audience of hematology specialists.
“The scope of basic and clinical science relating to our compounds that will be discussed at ASH demonstrates the value of our decisions to build a fully integrated oncology business,” said Dr. Paul Blake, Executive Vice President, Worldwide Medical and Regulatory Operations at Cephalon. “Our oncology products are well positioned for further clinical development in challenging cancers with significant unmet need.”
The ASH platform presentations provide the latest data from company- sponsored Phase 2 multi-center registration studies on two Cephalon Oncology investigational compounds, TREANDA(R) (bendamustine HCL) and CEP-701 (lestaurtinib). At ASH, researchers also will report data from investigator- sponsored studies of TRISENOX(R) (arsenic trioxide) injection, the company’s marketed anti-cancer therapeutic.
TREANDA:
TREANDA is a novel alkylating-benzimidazole hybrid cytotoxic in which a molecular ring common to traditional alkylators is altered. Preclinical research provides evidence that TREANDA induces efficient and durable cell damage. Multiple Phase 2 clinical trials suggest potential efficacy in indolent non-Hodgkin’s lymphoma (NHL) refractory or relapsed from both traditional alkylators and the monoclonal antibody rituximab (Rituxan(R)). Cephalon Oncology is conducting a pivotal Phase 3 clinical trial at sites in the United States and Canada to evaluate the safety and efficacy of TREANDA as a single agent in patients with rituximab-refractory indolent, or slow growing NHL. Bendamustine has been available in Germany for more than three decades for several indications, including NHL, chronic lymphocytic leukemia, multiple myeloma, and several solid tumors. At an ASH platform presentation, researchers will report Phase 2 multi-center data on TREANDA in NHL:
-- Bendamustine HCl (TREANDA(R)) Treatment Results in High Rates of Objective Response in Patients with Rituximab-Refractory and Alkylator- Refractory Indolent B-Cell Non-Hodgkin’s Lymphoma (NHL): Results from a Phase II Multicenter Single-Agent Study (SDX-105-01). Friedberg, et.al., Abstract 229, Monday, December 12, 7:30 a.m. EST. Location: B405-B407 CEP-701:
CEP-701 (lestaurtinib) is an orally-active small molecule tyrosine kinase inhibitor discovered by Cephalon scientists. This investigational compound is in Phase 2 clinical trials as a targeted, single agent against acute myelogenous leukemia (AML) in patients with identifiable genetic alterations known as FLT3 mutations. Pre-clinical findings demonstrate that one of the mechanisms of CEP-701 blocks the signaling ability of mutant FLT3. Researchers at ASH will report details at a platform presentation of the ongoing randomized, open-label Phase 2 study of CEP-701 in FLT3-mutated AML:
-- A Randomized, Open-Label Study of Lestaurtinib (CEP-701), an Oral FLT3 Inhibitor, Administered in Sequence with Chemotherapy in Patients with Relapsed AML Harboring FLT3 Activating Mutations: Clinical Response Correlates with Successful FLT3 Inhibition. Levis, et.al., Abstract 403, Monday, December 12, 1:30 p.m. EST. Location: Thomas Murphy 4 TRISENOX:
TRISENOX is a targeted therapy indicated for the treatment of patients with relapsed or refractory acute promyelocytic leukemia (APL). Considered a standard of care in this life-threatening disease, TRISENOX was approved in Europe in 2000 and in the United States in 2002, and is now marketed by Cephalon Oncology. In clinical trials, TRISENOX has been shown to provide high complete response rates (70-75 percent) and a high molecular remission rate (82 percent) in patients with relapsed disease. Preclinical data suggest that TRISENOX has multiple mechanisms of action, including induction of programmed cell death (apoptosis) and damage and degradation of a fusion protein called PML/RAR. A number of investigator-sponsored studies at ASH will provide data on the use of TRISENOX, alone and in combination therapy, in several hematologic cancers.
Cephalon Oncology Portfolio
The Cephalon Oncology portfolio includes three lead compounds to treat patients with hematologic cancers: TRISENOX, an intravenous arsenic-based targeted therapy; TREANDA, a multi-functional hybrid cytotoxic; and CEP-701, an oral small molecule tyrosine kinase inhibitor.
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 http://www.trisenox.com. TRISENOX is not presently indicated or approved by the Food and Drug Administration (FDA) for use in any other disease or related cancer.
TREANDA and CEP-701 are investigational agents under active clinical development for relapsed indolent non-Hodgkin’s lymphoma and acute myelogenous leukemia associated with mutations in the kinase FLT3, respectively. Neither compound is presently indicated or approved by the FDA for these or any other diseases.
For more information about Cephalon Oncology, visit http://www.cephalononcology.com.
Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products to treat sleep and neurological disorders, cancer and pain. Cephalon currently employs approximately 2,500 people in the United States and Europe. U.S. sites include the company’s headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon’s European headquarters are located in Maisons-Alfort, France, and other European offices are located in Maisons-Alfort, Guildford, England, and Martinsried, Germany.
The company currently markets four proprietary products in the United States: PROVIGIL(R) (modafinil) [C-IV], GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II] and TRISENOX, and more than 20 products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
Rituxan(R) is a registered trademark of Genentech, Inc.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, including TREANDA and CEP-701, interpretation of clinical results, prospects for regulatory approval of our product candidates, manufacturing development and capabilities, market prospects for its products, including prospects deriving from Cephalon’s commercial presence in the oncology market or otherwise as a result of building a fully integrated oncology business, sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Cephalon’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
Cephalon, Inc.
CONTACT: Media: Stacey Beckhardt, +1-610-738-6198, or Mobile:+1-610-247-0212, sbeckhar@cephalon.com, or Investors: Robert (Chip)Merritt, +1-610-738-6376, cmerritt@cephalon.com, both of Cephalon, Inc.
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