Interim Response and Safety Analyses Support Continuation of Allos Therapeutics' Pivotal Phase 2 PROPEL Trial of PDX in Patients with Peripheral T-Cell Lymphoma
PROPEL Enrollment Ahead of Schedule with Completion Expected Q2 2008
WESTMINSTER, Colo., Sept. 24 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced the completion of pre-planned interim analyses of patient response and safety data from the Company's pivotal Phase 2 PROPEL trial of PDX (pralatrexate) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). 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, an independent Data Monitoring Committee (DMC) completed an interim analysis of the safety data from the first 35 evaluable patients and recommended that the trial continue per the protocol. No major safety concerns were identified by the DMC.
In accordance with the trial protocol, the DMC will conduct another interim analysis of safety data from the first 65 evaluable patients. The Company expects to report the outcome of the 65-patient safety analysis by the end of 2007. Additionally, the Company now expects to complete enrollment in the PROPEL trial in the second quarter of 2008.
"The outcomes of these interim analyses represent continued progress toward the completion of the PROPEL trial and an important milestone in the development of a potential new treatment option for patients with relapsed or refractory peripheral T-cell lymphoma," said Pablo J. Cagnoni, M.D., Chief Medical Officer of Allos. "We are pleased with the progress of the PROPEL trial and look forward to completing enrollment in the second quarter of 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 endpoint of the study is objective response rate (complete and partial response). Secondary endpoints include duration of response, progression-free survival and overall survival. Owen O'Connor, M.D., Ph.D., Director of the Lymphoid Development and Malignancy Program in Columbia University Medical Center's Herbert Irving Comprehensive Cancer Center and Chief of the Lymphoma Service at NewYork-Presbyterian Hospital, is the international study chair. In July 2006, the Company reached agreement with the United States Food and Drug Administration (FDA) under its special protocol assessment (SPA) process on the design of this Phase 2 trial. 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 a New Drug Application (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 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 drug designation to PDX for the treatment of patients with PTCL.
Information regarding this study is available at www.allos.com or the U.S. government's clinical trials database at clinicaltrials.gov. |
