Allos Therapeutics Initiates Phase 1 PDX Study in Patients With Non-Small Cell Lung Cancer
WESTMINSTER, Colo., Jan. 20 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. today announced the initiation of a Phase 1 dose escalation study of its investigational drug PDX (pralatrexate) with vitamin B12 and folic acid supplementation in patients with previously-treated (Stage IIIB-IV) advanced non-small cell lung cancer (NSCLC). This open-label, non-randomized study will seek to enroll one to six patients per treatment level cohort who have received one prior chemotherapy regimen and may or may not have received an EGFR Kinase inhibitor to test the safety, tolerability and pharmacokinetics (PK) of escalating doses of PDX.
To determine the maximum tolerated dose of PDX when administered with concurrent vitamin B12 and folic acid supplementation, patients will receive a starting dose of 150 mg/m2. Subsequent cohorts will receive doses of PDX increasing in 40 mg/m2 increments until protocol-defined dose limiting toxicities (DLTs) occur. Patients will receive their specific PDX dose intravenously twice during a 4 to 6 week period. Vitamin supplementation will be consistent for all patients regardless of PDX dose. Safety endpoints for the study include DLTs, treatment-related adverse events (AEs), PK/AE correlation and laboratory values.
"The results of clinical trials to date for PDX as both a single and combination agent have been encouraging and we look forward to further exploring the potential of this therapy in patients with NSCLC," said Dr. Michael Saunders, Vice President, Clinical Development of Allos. "We expect to begin a multi-center Phase 2 trial of PDX in patients with NSCLC once appropriate dosing has been determined."
Results of an earlier Phase 2 trial published in the June 2003 issue of Clinical Cancer Research demonstrated improved response rate and symptomatic benefits in patients with Stage IIIB or IV NSCLC who received PDX therapy. Median survival time of patients enrolled in the study was 13.5 months, with 1 and 2-year survival rates of 56% and 36%, respectively. Ten percent (10%) of PDX-treated patients had confirmed durable responses and 31% had stable disease.
About PDX
PDX (pralatrexate) is an injectable small molecule chemotherapeutic agent that has an enhanced potency and toxicity profile relative to methotrexate and other related dihydrofolate reductase, or DHFR, inhibitors. Drugs that inhibit DHFR, such as methotrexate, were among the first chemotherapeutic agents discovered. Methotrexate remains one of the most widely applied chemotherapy drugs and has been used to treat breast, bladder and head and neck cancers, leukemias and other cancers.
About Non-Small Cell Lung Cancer
Lung cancer is the most common cause of cancer death in the United States. According to the American Cancer Society, an estimated 171,900 new cases of lung cancer will be diagnosed this year, which account for about 14% of all cancer diagnoses. Non-small cell lung cancer is the most common type of lung cancer, accounting for almost 80% of lung cancer cases. More people die of lung cancer than of breast, prostate and colorectal cancers combined
*** POSTED JANUARY 20, 2005 ***