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Ludwig Institute for Cancer Research and Polaris Group Form Collaboration to Expand Development of Polaris' Novel Cancer Drug, ADI-PEG 20

NEW YORK and SAN DIEGO, May 18, 2011 /PRNewswire/ -- Ludwig Institute for Cancer Research LTD (LICR) and Polaris Group (Polaris) today announced the formation of a collaboration to expand development of Polaris' novel cancer drug, pegylated arginine deiminase (ADI-PEG 20). ADI-PEG 20 kills tumor cells by depletion of the amino acid arginine.

As part of the collaboration, LICR and Polaris will explore further the potential of ADI-PEG 20 as a cancer therapy and aim to identify other amino acid-degrading enzymes with anti-tumor activity.  The collaboration builds on an existing relationship under which LICR and Polaris have studied ADI-PEG 20 in melanoma and are currently conducting a Phase 2 clinical trial in small cell lung cancer (SCLC) that was initiated in December 2010.  LICR is the sponsor of the SCLC clinical trial, and LICR and Polaris are sharing expenses and resources to conduct this trial.

"We are delighted to have this agreement with Polaris," said Andrew Simpson, Ph.D., Scientific Director of LICR. "This collaboration builds on the work of Lloyd Old, M.D. of LICR and his seminal work on amino acid-degrading enzymes, including asparaginase and arginine deiminase, as anti-cancer treatments. We look forward to continuing our close working relationship with Polaris."

Bor-Wen Wu, Ph.D., Chief Executive Officer of Polaris, said, "This agreement is the fruit of many years of collaboration between LICR and Polaris, and is an opportunity to leverage the strengths of both organizations to attempt to bring ADI-PEG 20 to patients. In particular, I would like to thank Dr. Old for his vision, guidance and dedication to this project, and to his mentoring as we have moved ADI-PEG 20 from pre-clinical studies into human clinical trials."

Dr. Old commented: "The actions of antibodies and enzymes are remarkable for their high degree of specificity, and it is this property that makes them so attractive as potential anti-cancer agents.  Although antibodies have now found broad use in cancer treatment, enzyme therapy has lagged far behind, with the one exception being the success of asparaginase in the treatment of childhood leukemia. For 10 years, LICR and Polaris have worked together to identify enzymes with anti-tumor activity, and an outcome of this collaboration is the identification of ADI, an arginine-degrading enzyme, as a highly promising therapeutic enzyme.  The anti-cancer specificity comes from the fact that arginine, a non-essential amino acid for normal cells, becomes essential for certain cancers because they lack arginine-synthesizing enzymes.  Initial clinical testing has shown that ADI has an excellent safety profile, is highly effective in eliminating arginine from the blood for extended periods, and has demonstrable anti-tumor activity in hepatocellular cancer and melanoma."  

"The current trial of ADI in patients with SCLC is particularly exciting because of the strong preclinical anti-tumor activity in SCLC models, the high frequency of arginine-dependence in SCLC, and the initial striking sensitivity of SCLC to cytotoxic agents," added Dr. Old.  "Because arginine dependence appears to be a characteristic of many tumor types, LICR and Polaris have decided to establish a formal partnership to explore the full potential of ADI in human cancer therapy and to use our joint strengths to identify other amino acid-degrading enzymes with anti-tumor activity. With the rapidly expanding base of information about metabolic pathways in cancer coming from deep sequencing, we look forward to finding a large number of other metabolic targets for enzyme therapy."

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. Phase 2 clinical trials have yielded positive results in patients with hepatocellular carcinoma or metastatic melanoma, and Phase 2 trials for small cell lung cancer and mesothelioma are currently ongoing. Polaris also plans to initiate clinical studies in prostate cancer, pancreatic cancer, leukemia, lymphoma and sarcoma this year.

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 advancing into 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, prostate cancer, 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.

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About the Ludwig Institute for Cancer Research

The Ludwig Institute for Cancer Research is a global non-profit organization committed to improving the understanding and control of cancer through integrated laboratory and clinical discovery employing over 800 scientists in Branches throughout North and South America, Europe and Australia. Leveraging its worldwide network of investigators and the ability to sponsor and conduct its own clinical trials, LICR is actively engaged in translating its discoveries into applications for human benefit.

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