Allos Therapeutics Receives Special Protocol Assessment for Pivotal Phase 2 Study of the Company`s Novel Antifolate PDX in Patients with Peripheral T-cell Lymphoma
August 02, 2006 07:31:14 (ET)
WESTMINSTER, Colo., Aug 02, 2006 /PRNewswire-FirstCall via COMTEX/ -- Allos Therapeutics, Inc. (ALTH, Trade) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment process (SPA) on the design of a pivotal Phase 2 trial of the company's novel, next generation antifolate PDX (pralatrexate) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). 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, and provides a binding agreement that the study design, including trial size, clinical endpoints and/or data analyses are acceptable to the FDA.
"We're pleased to have reached agreement with the FDA on the design of this important clinical trial as it provides a well defined pathway for pursuit of marketing approval of PDX," said Paul L. Berns, President and Chief Executive Officer. "We expect to move forward as planned with the initiation of enrollment in this trial by the end of the third quarter."
The Phase 2, non-randomized, open-label trial will look to establish the safety and efficacy of PDX with concurrent vitamin B12 and folic acid supplementation in patients with relapsed or refractory PTCL. Patients will receive PDX at 30 mg/m2 once every week for six weeks followed by one week of rest per cycle of treatment. The Company currently plans to enroll 100 evaluable patients at approximately 35 leading cancer centers in the U.S., Canada and Europe. The study protocol includes interim assessments of safety and response. Owen A. O'Connor, M.D., Ph.D., Head of the Laboratory of Experimental Therapeutics for Lymphoproliferative Malignancies, Lymphoma and Development Chemotherapy Services, Memorial Sloan-Kettering Cancer Center, will serve as the international study chair.
Interim results from a Phase 1/2 study of PDX in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) and Hodgkin's disease, which is currently on-going at Memorial Sloan-Kettering Cancer Center, demonstrated preliminary evidence of activity in patients with various subtypes of aggressive and chemotherapy resistant T-cell lymphoma. As reported at the 2005 American Society of Hematology Annual Meeting, four of seven evaluable patients with T-cell lymphoma achieved a complete response following treatment with PDX, despite having failed multiple prior therapies. The addition of vitamins to the treatment regimen appeared to successfully mitigate the previously established dose limiting toxicity of stomatitis.
"To date pralatrexate has achieved a high complete response rate that has proven very durable among PTCL patients with a historically very poor prognosis," said Dr. O'Connor. "These results suggest that pralatrexate may offer a new therapeutic option for patients with PTCL -- a disease desperately in need of new effective treatments."
About PDX (pralatrexate)
PDX is a small molecule chemotherapeutic agent that inhibits dihdrofolate reductase, or DHFR, a folic acid (folate) dependent enzyme involved in the building of DNA and other processes. PDX was rationally designed for improved transport into tumor cells via the reduced folate carrier (RFC-1), and greater intracellular drug retention. These biochemical features, together with preclinical data in a variety of tumors, suggest that PDX has an enhanced potency and toxicity profile relative to methotrexate and other related DHFR inhibitors.
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 NHL, or about 6,700 patients. The average five year survival rate for PTCL patients is approximately 25%. There are currently no pharmaceutical agents approved for the treatment of relapsed or refractory PTCLs.
About Allos Therapeutics, Inc.
Allos Therapeutics, Inc. (ALTH, Trade) is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. The Company's lead product candidate, EFAPROXYN(TM) (efaproxiral), is a synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, tumor tissue during radiation therapy. EFAPROXYN is currently being evaluated as an adjunct to whole brain radiation therapy in a pivotal Phase 3 trial in women with brain metastases originating from breast cancer. The Company's other product candidates are: PDX (pralatrexate), a small molecule chemotherapeutic agent (DHFR inhibitor) currently under investigation in patients with non-small cell lung cancer and Non-Hodgkin's lymphoma; and RH1, a small molecule chemotherapeutic agent bioactivated by the enzyme DT-diaphorase currently under evaluation in patients with advanced solid tumors. For more information, please visit the Company's web site at: www.allos.com.
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