Interim Safety Analysis Supports Continuation Of Allos Therapeutics' Pivotal Phase 2 PROPEL Trial Of PDX In Patients With Peripheral T-cell Lymphoma
"The DMC recommendation represents another important milestone in the development of a potential new treatment option for patients with relapsed or refractory peripheral T-cell lymphoma, a patient population for which there are currently no approved agents," said Pablo J. Cagnoni, M.D., Senior Vice President and Chief Medical Officer of Allos. "We remain pleased with the progress of the PROPEL trial and look forward to continuing to drive our PDX product development and commercialization plans in 2008."
PROPEL (Pralatrexate in Patients with Relapsed Or Refractory PEripheral T-cell Lymphoma) is a pivotal Phase 2, international, multi-center, open-label, single-arm study that will seek to enroll a minimum of 100 evaluable patients with relapsed or refractory PTCL who have progressed after at least one prior treatment. Patients receive 30 mg/m2 of PDX once every week for six weeks followed by one week of rest per cycle of treatment. The primary efficacy endpoint of the study is objective response rate (complete and partial response). Secondary efficacy endpoints include duration of response, progression-free survival and overall survival.
Owen A. O'Connor, MD, PhD, Director, Lymphoid Development & Malignancy Program and Chief, Lymphoma Service, Columbia University, Herbert Irving Comprehensive Cancer Center, New York, is the international study chair.
In accordance with the PROPEL study design, in January 2007, the DMC completed an interim analysis of safety data based on the first 10 patients enrolled to the study who completed at least one cycle of treatment with PDX, and recommended that the trial continue per the protocol. Also in accordance with the study design, in September 2007, an interim analysis of patient response and safety data was conducted based on the first 35 patients enrolled to the study who completed at least one cycle of treatment with PDX. The results of the interim analysis of patient response data exceeded the pre-specified threshold for continuation of the trial, which required a minimum of four responses (complete or partial) out of the first 35 evaluable patients, as determined by independent oncology review. In addition, the DMC identified no major safety concerns and recommended that the trial continue per the protocol.
The PROPEL trial is being conducted under an agreement with the United States Food and Drug Administration (FDA) under its special protocol assessment (SPA) process. The SPA process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of an NDA, and provides an agreement that the study design, including trial size, clinical endpoints and/or data analyses are acceptable to the FDA. The FDA granted orphan drug designation to PDX for the treatment of T-cell lymphoma in July 2006 and granted fast track designation to PDX for the treatment of patients with T-cell lymphoma in September 2006. In April 2007, the Commission of the European Communities, with a favorable opinion of the Committee for Orphan Medicinal Products of the European Medicines Agency, or EMEA, granted orphan medicinal product designation to PDX for the treatment of patients with PTCL
About the Data Monitoring Committee (DMC)
The DMC is comprised of independent medical experts and was established by Allos as part of the Company's compliance with good clinical practice guidelines. The DMC is responsible for monitoring the on-going safety of patients participating in the PROPEL trial and for conducting formal interim safety assessments of trial results.
About Peripheral T-cell Lymphoma
Peripheral T-cell lymphomas, or PTCLs, are a biologically diverse and uncommon group of blood cancers that account for approximately 10% to 15% of all cases of non-Hodgkin's lymphoma, or about 7,100 patients annually. The average five-year survival rate for PTCL patients is approximately 25%. There are currently no pharmaceutical agents approved for use in the treatment of either first-line or relapsed or refractory PTCL.
About PDX (pralatrexate)
PDX is a novel, small molecule chemotherapeutic agent that inhibits dihydrofolate reductase, or DHFR, a folic acid (folate)-dependent enzyme involved in the building of nucleic acid, or DNA, and other processes. PDX was rationally designed for efficient transport into tumor cells via the reduced folate carrier, or RFC-1, and effective intracellular drug retention. The Company believes these biochemical features, together with preclinical and clinical data in a variety of tumors, suggest that PDX may have a favorable safety and efficacy profile relative to methotrexate and certain other DHFR inhibitors.
About Allos Therapeutics, Inc.
Allos Therapeutics is a biopharmaceutical company focused on the development and commercialization of small molecule therapeutics for the treatment of cancer. The Company's lead product candidate, PDX (pralatrexate), is a novel antifolate currently under evaluation in a pivotal Phase 2 (PROPEL) trial in patients with relapsed or refractory peripheral T-cell lymphoma. The PROPEL trial is being conducted under an agreement reached with the U.S. Food and Drug Administration under its special protocol assessment, or SPA process. The Company is also investigating PDX in patients with non-small cell lung cancer and a range of lymphoma sub-types. The Company's other product candidate is RH1, a targeted chemotherapeutic agent currently being evaluated in a Phase 1 trial in patients with advanced solid tumors or non-Hodgkins Lymphoma (NHL). For additional information, please visit the Company's website at http://www.allos.com.
Safe Harbor Statement
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements relating to the potential safety and efficacy profile of PDX relative to methotrexate and certain other DHFR inhibitors, the potential safety and efficacy of PDX for the treatment of PTCL or any other type of cancer; the Company's projected timeline for completing enrollment in the PROPEL trial; and other statements that are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others: that the Company may experience delays in the conduct or completion of the PROPEL trial, whether caused by competition, adverse events, patient enrollment rates, regulatory issues or other factors; that clinical trials may not demonstrate that PDX is both safe and effective for the treatment of patients with PTCL or any other type of cancer; that data from preclinical studies and clinical trials may not be indicative of future clinical trial results; that the safety and/or efficacy results of the PROPEL trial may not support an application for marketing approval in the United States or any other country; that an application for marketing approval may not be accepted for priority review or at all by the FDA or any other regulatory authority; and that the Company may lack the financial resources and access to capital to fund future clinical trials for PDX or any of its other product candidates. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2006 and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this presentation, except as required by law.
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Allos Therapeutics, Inc.
http://www.allos.com
Interimare de siguranþã Analiza sprijinã Continuarea Allos terapeutice "pivot Faza 2 propulsa proces al PDX periferice la pacienþii cu T-cell Lymphoma - Interim Safety Analysis Supports Continuation Of Allos Therapeutics' Pivotal Phase 2 PROPEL Trial Of PDX In Patients With Peripheral T-cell Lymphoma - articole medicale engleza - startsanatate