WESTMINSTER, Colo., Aug. 15 Allos Therapeutics,Inc. (Nasdaq: ALTH) today announced the initiation of patient enrollment in aPhase 1, open-label, multi-center study of the Company's novel antifolate PDX(pralatrexate) with vitamin B12 and folic acid supplementation in patientswith relapsed or refractory cutaneous T-cell lymphoma (CTCL).
"Based on our experience with PDX in patients with peripheral T-celllymphoma, we're excited to initiate this study in patients with cutaneous T-cell lymphoma and view this effort as a natural progression of our PDXdevelopment program in hematologic malignancies," said Pablo J. Cagnoni, M.D.,Chief Medical Officer of Allos. "Therapies currently used to treat cutaneousT-cell lymphoma fail to produce durable remissions in the majority of patientswith advanced disease."
In this study, patients with either relapsed or refractory cutaneous T-cell lymphoma will receive PDX as part of a weekly schedule for two or threeweeks followed by one week of rest. Patients will receive starting doses ofPDX at 30 mg/m2, with dose reduction in subsequent cohorts based on toxicity.Up to 56 evaluable patients will be enrolled in the study with the objectiveof determining the optimal dose and safety profile of PDX in this population.A total of 20 of these patients will be enrolled at what is determined to bethe optimal dose and schedule. Steven Horwitz, M.D., Assistant AttendingPhysician, Lymphoma Service, Memorial Sloan-Kettering Cancer Center, willserve as the study chair.
"Given the evidence of activity observed to date with PDX in patients withaggressive T-cell lymphomas, coupled with the common cell lineage between PTCLand CTCL, there is a strong clinical rationale to pursue development of PDX inthis setting," said Dr. Horwitz.
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 Cutaneous T-cell Lymphoma
The cutaneous T-cells lymphomas are comprised of a number of non-HodgkinsT-cell lymphomas, including mycosis fungoides and Sezary syndrome, which havetheir primary manifestations in the skin. According to the Lymphoma ResearchFoundation, CTCL comprises about 2% to 3% of the estimated 63,000 new cases ofnon-Hodgkin's lymphoma diagnosed annually.
About PDX (pralatrexate)
PDX is a novel, small molecule chemotherapeutic agent that inhibitsdihydrofolate reductase, or DHFR, a folic acid (folate)-dependent enzymeinvolved in the building of nucleic acid, or DNA, and other processes. PDX wasrationally designed for efficient transport into tumor cells via the reducedfolate carrier, or RFC-1, and effective intracellular drug retention. Webelieve these biochemical features, together with preclinical and clinicaldata in a variety of tumors, suggest that PDX may have a favorable safety andefficacy profile relative to methotrexate and certain other DHFR inhibitors.
About Allos Therapeutics, Inc.
Allos Therapeutics is a biopharmaceutical company focused on thedevelopment and commercialization of small molecule therapeutics for thetreatment of cancer. The company's lead product candidate, PDX (pralatrexate),is a novel antifolate currently under evaluation in a pivotal Phase 2 trial inpatients with relapsed or refractory peripheral T-cell lymphoma. The companyis also investigating PDX in patients with non-small cell lung cancer and arange of other lymphoma sub-types. The Company's other product candidate isRH1, a targeted chemotherapeutic agent, for which the company expects toinitiate a Phase 1 trial in patients with advanced solid tumors in the secondhalf of 2007. For additional information, please visit the Company's websiteat www.allos.com.
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