WESTMINSTER, Colo., Sept. 24 Allos Therapeutics,Inc. (Nasdaq: ALTH) today announced the completion of pre-planned interimanalyses of patient response and safety data from the Company's pivotal Phase2 PROPEL trial of PDX (pralatrexate) in patients with relapsed or refractoryperipheral T-cell lymphoma (PTCL). Results of the interim analysis of patientresponse data exceeded the pre-specified threshold for continuation of thetrial, which required a minimum of four responses (complete or partial) out ofthe first 35 evaluable patients, as determined by independent oncology review.In addition, an independent Data Monitoring Committee (DMC) completed aninterim analysis of the safety data from the first 35 evaluable patients andrecommended that the trial continue per the protocol. No major safetyconcerns were identified by the DMC.
In accordance with the trial protocol, the DMC will conduct anotherinterim analysis of safety data from the first 65 evaluable patients. TheCompany expects to report the outcome of the 65-patient safety analysis by theend of 2007. Additionally, the Company now expects to complete enrollment inthe PROPEL trial in the second quarter of 2008.
"The outcomes of these interim analyses represent continued progresstoward the completion of the PROPEL trial and an important milestone in thedevelopment of a potential new treatment option for patients with relapsed orrefractory peripheral T-cell lymphoma," said Pablo J. Cagnoni, M.D., ChiefMedical Officer of Allos. "We are pleased with the progress of the PROPELtrial and look forward to completing enrollment in the second quarter of2008."
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 patientswith relapsed or refractory PTCL who have progressed after at least one priortreatment. Patients receive 30 mg/m2 of PDX once every week for six weeksfollowed by one week of rest per cycle of treatment. The primary endpoint ofthe study is objective response rate (complete and partial response).Secondary endpoints include duration of response, progression-free survivaland overall survival. Owen O'Connor, M.D., Ph.D., Director of the LymphoidDevelopment and Malignancy Program in Columbia University Medical Center'sHerbert Irving Comprehensive Cancer Center and Chief of the Lymphoma Serviceat NewYork-Presbyterian Hospital, is the international study chair. In July2006, the Company reached agreement with the United States Food and DrugAdministration (FDA) under its special protocol assessment (SPA) process onthe design of this Phase 2 trial. The SPA process allows for FDA evaluationof a clinical trial protocol intended to form the primary basis of an efficacyclaim in support of a New Drug Application (NDA), and provides an agreementthat the study design, including trial size, clinical endpoints and/or dataanalyses are acceptable to the FDA. The FDA granted orphan drug designation toPDX for treatment of T-cell lymphoma in July 2006 and granted fast trackdesignation to PDX for the treatment of patients with T-cell lymphoma inSeptember 2006. In April 2007, the Commission of the European Communities,with a favorable opinion of the Committee for Orphan Medicinal Products of theEuropean Medicines Agency, or EMEA, granted orphan drug designation to PDX forthe 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 http://www.clinicaltrials.gov.
About the Data Monitoring Committee (DMC)
The DMC is comprised of independent medical experts and was established byAllos as part of the Company's compliance with good clinical practiceguidelines. The DMC is responsible for monitoring the on-going safety ofpatients participatin