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Polaris Group and The Ludwig Institute for Cancer Research Ltd Initiate Phase 2 Trial of Amino-Acid Degrading Enzyme, ADI-PEG 20, in Patients with Small Cell Lung Cancer
Date:2/14/2011

NEW YORK and SAN DIEGO, Feb. 14, 2011 /PRNewswire/ -- Polaris Group (Polaris) and The Ludwig Institute for Cancer Research (LICR) today announced the enrollment of the first patient in a Phase 2 clinical trial evaluating ADI-PEG 20 in the treatment of small cell lung cancer (SCLC).  The trial, sponsored by LICR, is enrolling patients at Memorial Sloan-Kettering Cancer Center and Duke University Medical Center and will soon commence at St. Bartholomew's Hospital in London.

This study will evaluate the effectiveness of ADI-PEG 20 in patients with relapsed or refractory SCLC. Patients will be enrolled in two cohorts, each of which will have the sample size determined through a Simon two-stage design. SCLC is the fastest growing and most aggressive form of lung cancer and accounts for approximately 15 percent of all cases. Once diagnosed, few patients survive more than two years with current treatment.

ADI is a microbial enzyme, arginine deiminase, that degrades the amino acid arginine. ADI-PEG 20 is ADI conjugated with polyethylene glycol (PEG).  Since arginine can be internally synthesized in normal cells via the urea cycle, but not in certain cancer cells if they lack the necessary enzyme(s) to make arginine, deprivation of arginine caused by ADI-PEG 20 can selectively kill cancer cells without affecting the growth of normal cells. In preclinical models, ADI-PEG 20 eliminated arginine from the blood and showed substantial anti-tumor activity for arginine-dependent tumors.  In clinical trials, ADI-PEG 20 was also found to safely and efficiently eliminate arginine from the blood, and tumor responses as well as extension in overall survival have been observed in hepatocellular carcinoma and melanoma patients treated with ADI-PEG 20.

Amino acid deprivation is an established approach in the treatment of cancer and is exemplified by asparaginase, a widely used treatment for childhood leukemia. Lloyd J. Old, M.D., Director of the New
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