Agensys Announces IND Submission for Monoclonal Antibody AGS-PSCA for Cancers of Prostate, Pancreas, Bladder.SANTA MONICA, Calif. -- Agensys, Inc. (www.agensys.com) announced today the submission of an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to initiate a Phase 1 clinical trial phase 1 clinical trial Phase 1 study. See Phase study. with AGS-PSCA. AGS-PSCA is a fully human monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing (MAb) with therapeutic potential in patients with prostate, pancreatic, and bladder cancers. Agensys plans to focus the initial Phase 1 clinical trial on patients with advanced prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . AGS-PSCA is a high affinity, human IgG1k MAb directed to Agensys' proprietary target Prostate Stem Cell Antigen (PSCA PSCA Profit Sharing/401(K) Council of America PSCA Philippine School of Culinary Arts PSCA Protein Sequence Comparative Analysis PSCA Parts Stress Count Analysis (British Telecom) ). It was generated using XenoMouse(R) technology through a licensing agreement with Abgenix (Nasdaq: ABGX). "The submission of our first IND is a significant milestone for Agensys," said Donald B. Rice, Chairman, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "Generation, development and manufacturing of AGS-PSCA were carried out at Agensys, demonstrating the breadth of our capabilities for successful development of therapeutic antibodies. We are establishing a pipeline of human MAb products, targeted to our portfolio of proprietary cancer targets and we plan to file additional INDs as our programs continue to progress," Dr. Rice added. PSCA is expressed at significant levels on tumor cells from the majority of patients with all stages of prostate, pancreatic and bladder cancers. These cancers, particularly in advanced stages, represent significant unmet medical needs. In a series of efficacy studies utilizing human specimens of these tumors in xenograft xenograft /xeno·graft/ (zen´o-graft) a graft of tissue transplanted between animals of different species; it may be concordant, mouse models, AGS-PSCA has consistently demonstrated significant inhibition of both tumor growth and metastases Metastasis (plural, metastases) A tumor growth or deposit that has spread via lymph or blood to an area of the body remote from the primary tumor. Mentioned in: Malignant Melanoma . Toxicology and pharmacokinetic studies of AGS-PSCA in animals indicated that all administered antibody doses were well tolerated and demonstrated a long serum half-life. "AGS-PSCA appears to affect both tumor cell growth and migration leading to a significant impact on all clinically relevant end points in xenograft models: tumor growth, metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases 1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to formation, overall health, and prolongation of survival," said Aya Jakobovits, Ph.D., Senior Vice President, Technology and Corporate Development and Chief Scientific Officer. "In addition to AGS-PSCA's significant efficacy when administrated as monotherapy, enhanced activity is observed when it is combined with chemotherapeutic drugs. We are excited by AGS-PSCA's preclinical efficacy and safety profile, which support its therapeutic potential in the treatment of prostate, bladder and pancreatic cancers." Agensys holds an exclusive license to PSCA, which was discovered by scientists at UCLA UCLA University of California at Los Angeles UCLA University Center for Learning Assistance (Illinois State University) UCLA University of Carrollton, TX and Lower Addison, TX . Agensys has conducted extensive research on PSCA and the development of PSCA-specific therapeutic antibodies. PSCA and related methods of use, together with AGS-PSCA and other antibodies, are protected by a large patent portfolio, including 18 issued and allowed patents. About prostate, pancreatic and bladder cancers In 2005 an estimated 232,000 men in the United States will be diagnosed with prostate cancer and more than 30,000 will die. These statistics make prostate cancer second only to lung cancer as a leading cause of cancer related deaths in men. An estimated 32,000 people in the United States will be diagnosed with pancreatic cancer in 2005 and more than 31,000 are expected to die. Deaths from bladder cancer in 2005 are expected to exceed 13,000, with more than 63,000 new cases diagnosed. Taken together these three cancers present over 327,000 new cases and account for more than 75,000 deaths each year. About Agensys Agensys, Inc. is a privately held biotechnology company that is developing a pipeline of therapeutic monoclonal antibodies to treat solid tumor cancers. These antibodies, many of which are fully human, are being generated to a diverse portfolio of proprietary, clinically relevant cancer targets that encompass 14 types of solid tumors. The Company has the capabilities to generate, develop and manufacture antibody products and, through a partnership with Abgenix, has access to the XenoMouse(R) technologies required to generate fully human antibodies. The Company has also established clinical development capabilities which will move its antibody products forward into clinical trials. In parallel to developing certain antibody products, Agensys aims to establish partnerships to develop and commercialize selected antibody products, and to exploit small molecule, vaccine, and diagnostic applications to its proprietary cancer targets. The Company's laboratories, GMP GMP (guanosine monophosphate): see guanine. manufacturing facility and offices are located in Santa Monica, California For other uses, see Santa Monica (disambiguation). Santa Monica is a coastal city in western Los Angeles County, California, USA. Situated on Santa Monica Bay of the Pacific Ocean, it is surrounded by the City of Los Angeles — Pacific Palisades and Brentwood on the north, . For further information about Agensys, please visit http://www.agensys.com. |
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