Allos Therapeutics Completes Patient Enrollment in Pivotal Phase 2 PROPEL Trial of PDX in Patients with Peripheral T-cell Lymphoma
Tuesday April 22, 8:00 am ET
WESTMINSTER, Colo.--(BUSINESS WIRE)--Allos Therapeutics, Inc. (NASDAQ: ALTH - News) today announced that it has completed patient enrollment in PROPEL, the Company’s pivotal Phase 2 trial of PDX (pralatrexate) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
“The completion of enrollment in our pivotal PROPEL trial, a quarter ahead of schedule, is an important milestone for PDX and Allos,” said Pablo J. Cagnoni, M.D., Chief Medical Officer of Allos. “We gratefully acknowledge the investigators and patients for participating in the study and for their important role in helping to evaluate the safety and efficacy of PDX for the treatment of relapsed or refractory peripheral T-cell lymphoma, a disease for which there are currently no approved treatments. We believe that PDX has the potential to offer a new treatment option for patients with this challenging disease and look forward to reporting top line results of the trial later this year.”
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 enrolled patients with relapsed or refractory PTCL who 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 treatment regimen also includes vitamin B12 and folic acid supplementation. 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.
The PROPEL trial was initiated in August 2006. In accordance with the PROPEL trial protocol, the Company conducted three pre-planned interim analyses of safety data and one pre-planned interim analysis of response data. In January, September and December 2007, the Company announced that an independent data monitoring committee (DMC) completed interim analyses of safety data from the first 10, 35 and 65 evaluable patients who completed at least one cycle of treatment with PDX, respectively, and recommended that the trial continue per the protocol at each analysis. No major safety concerns were identified by the DMC. In September 2007, the Company announced that 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.
The PROPEL trial is being conducted under an agreement reached 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 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 and fast track designation to PDX for the treatment of patients with T-cell lymphoma in July 2006 and September 2006, respectively. 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 Peripheral T-cell Lymphoma
Peripheral T-cell lymphomas, or PTCLs, are a biologically diverse group of blood cancers that account for approximately 10% to 15% of all cases of non-Hodgkin's lymphoma in the United States. There are currently no pharmaceutical agents approved for use in the treatment of either first-line or relapsed or refractory PTCL. PTCL patients are often treated with multi-agent chemotherapy regimens. However, a significant number of these patients relapse or become refractory after treatment with first-line therapy. A study that included patients with aggressive PTCL found that the average five-year survival for those patients was approximately 25%.
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 other related DHFR inhibitors. The Company believes PDX has the potential to be delivered as a single agent or in combination therapy regimens. |
