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Polaris Group Doses First Patient in Phase 1 Clinical Trial of Lead Therapeutic Candidate ADI-PEG 20 in Pediatric Patients with Emphasis on Leukemia, Lymphoma and Sarcoma
Date:2/29/2012

SAN DIEGO, Feb. 29, 2012 /PRNewswire/ -- Polaris Group (Polaris) today announced that it has dosed the first patient in a Phase 1 clinical trial evaluating its lead cancer therapeutic, pegylated arginine deiminase (ADI-PEG 20), in pediatric patients with emphasis on leukemia, lymphoma and sarcoma cancers. These three cancers represent approximately 50% of all cancers that occur in the pediatric population.

Patients with advanced cancers who have failed current therapy will be eligible to be treated with ADI-PEG 20. In addition, a tumor specimen from these potentially eligible patients must be deficient in expression of the enzyme argininosuccinate synthetase, the rate limiting step in formation of arginine. Patients will be enrolled into cohorts of increased doses of ADI-PEG 20, and will receive weekly intramuscular injections of ADI-PEG 20 until disease progression.  The primary endpoints of the study are safety and efficacy, and secondary endpoints will include finding the maximum tolerated dose of ADI-PEG 20 in a pediatric tumor population.

The rationale for the use of ADI-PEG 20 in these cancers was previously reported by Polaris collaborators, using both cell based assays and xenograft mouse models. In addition, they found a high percentage of these cancer tissue specimens require arginine. This Phase 1 clinical study is being conducted at MD Anderson Cancer Center, Houston, Texas.

"We are delighted to begin this first study of ADI-PEG 20 in pediatric patients," said John Bomalaski, M.D., Executive Vice President, Medical Affairs, of Polaris. "We believe ADI-PEG 20 is a promising cancer therapeutic for these cancers, and we plan to initiate Phase 2 studies in adults with these cancers. ADI-PEG 20 as monotherapy is already in a Phase 3 global trial for patients with hepatocellular carcinoma, and in Phase 2 trials for patients with small cell lung carcinoma and mesothelioma. In addition, a Phase 1 trial in prostate cancer
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