SAN DIEGO, CA, USA I February 3, 2015 I Polaris Group announced today that the first patient has been dosed in its Phase 1 trial of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) for the treatment of advanced gastrointestinal malignancies. In addition to a global Phase 3 study in hepatocellular carcinoma (HCC) featuring ADI-PEG 20 as a monotherapy, Polaris Group is currently conducting clinical trials on ADI-PEG 20 in combination with cisplatin in melanoma and ovarian cancer, in combination with sorafenib in HCC, in combination with doxorubicin in HER2 negative breast cancer, in combination with nab-paclitaxel and gemcitabine in pancreatic cancer and in combination with cisplatin and pemetrexed in malignant pleural mesothelioma and non-small cell lung carcinoma.
“FOLFOX is used in the treatment of many gastrointestinal cancers, and the combination of ADI-PEG 20 to this well-established regimen is based on numerous lines of preclinical data,” said John Bomalaski, M.D., Executive Vice President of Medical Affairs at Polaris. “We are pleased to start another trial of ADI-PEG 20 in combination with multi-agent current first line therapy, and hope that the addition of ADI-PEG 20, which has a different mechanism of action than these standard chemotherapies, will result in both safety and added efficacy.”
About ADI-PEG 20
ADI-PEG 20 is a biologic being developed by Polaris Group to treat cancers, especially those carrying a major metabolic defect that renders such cancer cells, unlike normal cells, unable to internally synthesize arginine. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, it is believed these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 is designed to deplete the external supply of arginine, which causes arginine-dependent cancer cells to die while leaving the patient’s 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 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 Group is also investigating ADI-PEG 20 as a treatment for other cancers, such as leukemia, lymphoma, melanoma, mesothelioma, non-small cell lung cancers, sarcoma, breast, ovarian, and pancreatic cancer. In addition to the ADI-PEG 20 program, Polaris Group is researching and developing other biotherapeutic agents and is advancing 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.
SOURCE: Polaris Group
Post Views: 31
SAN DIEGO, CA, USA I February 3, 2015 I Polaris Group announced today that the first patient has been dosed in its Phase 1 trial of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) for the treatment of advanced gastrointestinal malignancies. In addition to a global Phase 3 study in hepatocellular carcinoma (HCC) featuring ADI-PEG 20 as a monotherapy, Polaris Group is currently conducting clinical trials on ADI-PEG 20 in combination with cisplatin in melanoma and ovarian cancer, in combination with sorafenib in HCC, in combination with doxorubicin in HER2 negative breast cancer, in combination with nab-paclitaxel and gemcitabine in pancreatic cancer and in combination with cisplatin and pemetrexed in malignant pleural mesothelioma and non-small cell lung carcinoma.
“FOLFOX is used in the treatment of many gastrointestinal cancers, and the combination of ADI-PEG 20 to this well-established regimen is based on numerous lines of preclinical data,” said John Bomalaski, M.D., Executive Vice President of Medical Affairs at Polaris. “We are pleased to start another trial of ADI-PEG 20 in combination with multi-agent current first line therapy, and hope that the addition of ADI-PEG 20, which has a different mechanism of action than these standard chemotherapies, will result in both safety and added efficacy.”
About ADI-PEG 20
ADI-PEG 20 is a biologic being developed by Polaris Group to treat cancers, especially those carrying a major metabolic defect that renders such cancer cells, unlike normal cells, unable to internally synthesize arginine. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, it is believed these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 is designed to deplete the external supply of arginine, which causes arginine-dependent cancer cells to die while leaving the patient’s 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 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 Group is also investigating ADI-PEG 20 as a treatment for other cancers, such as leukemia, lymphoma, melanoma, mesothelioma, non-small cell lung cancers, sarcoma, breast, ovarian, and pancreatic cancer. In addition to the ADI-PEG 20 program, Polaris Group is researching and developing other biotherapeutic agents and is advancing 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.
SOURCE: Polaris Group
Post Views: 31
