MTD in NSCLC Identified; Phase 2 Study Planned
WESTMINSTER, Colo., Oct. 25 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. (Nasdaq: ALTH), a biopharmaceutical company focused on the development and commercialization of small molecule therapeutics for the treatment of cancer, today announced that results from three PDX studies were presented as posters during the 2007 AACR-NCI-EORTC conference held October 22-26, 2007 in San Francisco, California. The posters described the effects of PDX (pralatrexate) in patients with non-small cell lung cancer (NSCLC), in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) and Hodgkin's disease, and in human cancer models in vivo and in vitro.
PDX in NSCLC (Phase 1)
The poster entitled "Phase 1 study of the antifolate pralatrexate when given with vitamin B12 and folic acid supplementation in patients with advanced non-small cell lung cancer (NSCLC)" presented results of this Phase 1 dose ranging study. In the study, a total of 22 patients with relapsed or refractory NSCLC were treated at doses of 150 to 325 mg/m2 of PDX. The maximum tolerated dose (MTD) was determined to be 270 mg/m2, which is twice that observed in a previous Phase 1 study in which PDX was administered without vitamin supplementation. Clinically significant radiologic responses were observed. Greater than 50% of patients (13/22) received two or more prior treatment regimens. Based on PDX clinical experience to date, the Company plans to initiate a randomized Phase 2 study of PDX in patients with NSCLC.
PDX in NHL (Phase 1/2)
The poster entitled "A Phase '2-1-2' Study of Two Different Doses and
Schedules of Pralatrexate, A High Affinity Substrate for the Redu
|SOURCE Allos Therapeutics, Inc.|
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