ATLANTA, Dec. 12 /PRNewswire-FirstCall/ -- In a Phase 2 study of patients with advanced indolent non-Hodgkin’s lymphoma (NHL) who were previously exposed to multiple courses of therapy, 74 percent responded to TREANDA(R) (bendamustine HCl), including 35 percent with a complete response. All study participants had progressive disease after prior treatment with the antibody therapy rituximab (Rituxan(R)); a subgroup also had not responded to traditional alkylating agents. Rituximab and alkylators are commonly prescribed to treat NHL. The data from this international multi-center clinical trial sponsored by Cephalon Oncology were reported today in a platform presentation at the 47th Annual Meeting of the American Society of Hematology (ASH).
TREANDA, an investigational therapeutic under development by Cephalon, Inc. , is a novel hybrid cytotoxic alkylating agent that differs from conventional compounds in its apparent multi-functional mechanism of action. In addition to killing cells by damaging their DNA and triggering a self-destruct signal known as apoptosis - which is typical of alkylating agents - researchers demonstrated that TREANDA also causes mitotic catastrophe, or the disruption of cell division. Preclinical data suggest that TREANDA’s multi-functional mechanism of action may derive from its chemical structure in which one molecular ring common to traditional alkylators is altered.
“It’s unusual to see this kind of response in patients so far along in the course of the disease, especially since they previously did not respond to other alkylators and were relapsed from rituximab,” commented principal investigator Jonathan W. Friedberg, M.D., Associate Director of Lymphoma Clinical Research at the University of Rochester Wilmot Cancer Center in Rochester, New York. “None of the available therapies for NHL are curative, so every patient will eventually require new therapeutic interventions. These data suggest bendamustine might prove to be such an alternative.”
NHL, which according to the National Cancer Institute is the sixth most prevalent cancer in the United States, occurs when lymphatic cells divide too much and too fast. Growth control is lost, and the lymphatic cells may overcrowd, invade, and destroy lymphoid tissues and spread to other organs. There are two broad subtypes of NHL - indolent, also referred to as slow growing or low-grade, and aggressive. Indolent disease may “transform” into a more aggressive condition.
According to the study results, of the objective responses produced by TREANDA in 74 percent of the 77 study participants, 35 percent had complete response; 39 percent partial response; 7 percent stable disease; and 16 percent disease progression. Among a subgroup of 28 patients whose condition was both refractory to rituximab and unresponsive to previous exposure to conventional alkylating agents, 64 percent responded to TREANDA. All assessments were based on standard International Working Group criteria.
Hematologic side effects were expected, manageable, and reversible. Grade 3 or 4 hematologic toxicities included leukopenia (50 percent), neutropenia (47 percent), thrombocytopenia (24 percent), anemia (9 percent), and febrile neutropenia (7 percent). The most frequent non-hematologic adverse events were nausea (72 percent), fatigue (47 percent), vomiting (39 percent), fever (28 percent), diarrhea (25 percent), and constipation (24 percent). In addition, very low rates of hair loss were observed, occurring in only 5 percent of patients - and when observed it was mild (grade 1).
In addition to the platform session, a poster presentation at ASH also reported positive results from a second Cephalon Oncology-sponsored Phase 2 multi-center trial of the compound. In this study, TREANDA in combination with rituximab in patients with refractory and relapsed NHL produced a high overall response rate (87 percent) with minimal toxicity and no hair loss.
“Over the natural course of their disease, patients with indolent NHL will experience multiple relapses. The data presented today add clinical evidence to support our view that TREANDA has the potential to become an important therapeutic option for patients whose cancer has become resistant to current treatments for indolent NHL,” said Dr. Lesley Russell, Cephalon’s Senior Vice President, Worldwide Clinical Research.
A Phase 3 trial of TREANDA (bendamustine HCl) in indolent NHL refractory to rituximab is ongoing at sites in the United States and Canada. More information about this study is available at http://www.clinicaltrials.gov.
Cephalon Oncology-Sponsored Studies of TREANDA at 2005 ASH Meeting - 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, Oral Platform Presentation, Monday, December 12, 2005, 7:30 a.m. EST. Location: B405-B407 - Bendamustine HCl (TREANDA(R)) Treatment in Combination with Rituximab Results in Objective Responses in Patients with Refractory/Relapsed Indolent B-Cell and Mantle Cell Non-Hodgkin’s Lymphoma: Results from Phase II Multicenter Study (SDX-105-02). Robinson, et.al., Abstract 923, Poster Presentation, Monday, December 12, 2005, 9:15 a.m. - 7:30 p.m. EST. Location: Thomas Murphy 4 Cephalon Oncology Portfolio
The Cephalon Oncology portfolio includes three lead compounds to treat patients with hematologic cancers: from TRISENOX(R) (arsenic trioxide) injection, an intravenous arsenic-based targeted therapy; TREANDA, a multi- functional hybrid cytotoxic; and CEP-701 (lestaurtinib), an oral small molecule tyrosine kinase inhibitor.
TRISENOX is indicated for the induction of remission and consolidation in patients with acute promyelocytic leukemia (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 or 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 on 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 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, or sbeckhar@cephalon.com, or Investors, Robert (Chip)Merritt, +1-610-738-6376, or cmerritt@cephalon.com, both of Cephalon, Inc.
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