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

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 in combination with docetaxel is ongoing. Thus ADI-PEG 20 has potential for therapeutic benefit in a number of cancers, and we look forward to continuing clinical development."

Additional information about the trial can be found online at
http://clinicaltrials.gov/ct2/show/NCT01528384?term=arginine+deiminase&rank=4.

About Pediatric Leukemia, Lymphoma and Sarcoma

Leukemia, lymphoma and sarcoma account for approximately 50% of childhood cancers. Leukemias are cancers of the blood, and account for approximately one-third of all cancers in the pediatric population. The major types are acute lymphocytic leukemia and acute myeloid leukemia. Lymphomas are cancers of the lymph nodes and related tissues. They account for approximately 10% of pediatric cancers. The major types are Hodgkin and non-Hodgkin lymphoma. Sarcomas and bone cancers attack either the soft tissues around the bone or the bone itself. They account for approximately 8 % of childhood cancers. The most common are rhabdomyosarcoma, osteosarcoma and Ewing sarcoma.

About ADI-PEG 20

ADI-PEG 20 is a biologic being developed by Polaris to treat cancers carrying a major metabolic defect that renders them, unlike normal cells, unable to make arginine internally. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 works by systemically depleting the external supply of arginine, which causes these arginine-dependent cancer cells to die while leaving the normal cells unharmed.

Multiple cancers have been reported to have a high degree of arginine-dependency.

About Polaris Group

Polaris Group is a privately held multinational biopharmaceutical company that specializes in the research and development of protein drugs to treat cancer and other debilitating diseases. The company's lead therapeutic, ADI-PEG 20, is currently being evaluated in a pivotal Phase 3 trial for hepatocellular carcinoma. Polaris is also investigating ADI-PEG 20 as a treatment for other arginine-dependent cancers, such as melanoma, leukemia, lymphoma, sarcoma and pancreatic cancer. In addition to the ADI-PEG 20 project, Polaris is researching and developing other biotherapeutic agents and has a small molecule drug program that utilizes a rational structure-based approach to design novel compounds that inhibit the biological function of cancer-related protein targets.

For additional information please visit www.polarispharma.com.

SOURCE Polaris Group

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