Agensys Initiates Phase I Clinical Trial in Prostate Cancer with Monoclonal Antibody AGS-PSCA.SANTA MONICA, Calif. -- Agensys, Inc. announced today the initiation of investigational human use of AGS-PSCA in the first Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I in 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 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 directed to Agensys' proprietary target Prostate Stem Cell stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. 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) ), an antigen expressed at significant levels on tumor cells from the majority of patients with all stages of prostate, pancreatic and bladder cancers. Last month Agensys and Merck announced the formation of a global alliance to jointly develop and commercialize AGS-PSCA. The Phase I, open-label, dose-escalation clinical trial is being conducted at both Memorial Sloan-Kettering Cancer Center The Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City is a cancer treatment and research institution founded in 1884 as the New York Cancer Hospital. The main campus is located at 1275 York Avenue, between 67th and 68th Streets, with other locations in New and Johns Hopkins Kimmel Cancer Center. The trial is designed to evaluate the safety and pharmacokinetic profile of a multiple-dose regimen of AGS-PSCA. Up to 24 patients with hormone refractory prostate cancer will be enrolled. "Commencing clinical trials with AGS-PSCA is an important milestone for Agensys. This is the first antibody product to be developed by the company for its portfolio of proprietary targets in cancer. It demonstrates our in-house capabilities to bring product candidates from discovery to the clinic," 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. of Agensys. "We have assembled an experienced clinical development team, and, together with Merck, we are pleased to engage these leading clinical centers in our trials." "Based on pre-clinical efficacy and safety results, AGS-PSCA has the potential to provide a much-needed targeted therapy for patients with prostate, pancreatic and bladder cancers," said Aya Jakobovits, Ph.D., Senior Vice President, Technology and Corporate Development and Chief Scientific Officer. "Under the alliance with Merck, we will explore the clinical development and therapeutic application of AGS-PSCA as monotherapy and potentially in combination with relevant chemotherapeutic drugs in these cancer indications." About AGS-PSCA AGS-PSCA is a high affinity, fully human IgG1k MAb directed to PSCA, generated using XenoMouse(R) technology. PSCA is expressed at significant levels on tumor cells from a majority of patients with all stages of prostate, pancreatic and bladder cancers. Pre-clinical 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 have consistently demonstrated that AGS-PSCA significantly inhibits 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 . Pre-clinical animal toxicology and pharmacokinetic studies have indicated that all administered doses of AGS-PSCA were well tolerated and demonstrated a long serum half-life. 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 and move into clinical trials antibody products and, through a partnership with Abgenix, has access to the XenoMouse(R) technology to generate fully human antibodies to multiple targets. Agensys is progressing a pipeline of preclinical MAb candidates with potential as naked or payload-conjugated therapeutic products, directed at a variety of cancer indications, including prostate, kidney, bladder, pancreas, lung, colon, ovary ovary, ductless gland of the female in which the ova (female reproductive cells) are produced. In vertebrate animals the ovary also secretes the sex hormones estrogen and progesterone, which control the development of the sexual organs and the secondary sexual , breast and skin. Agensys has initiated clinical trials with AGS-PSCA, a fully human MAb to Prostate Stem Cell Antigen (PSCA), a novel target which is expressed in the majority of prostate, pancreatic and bladder cancers. AGS-PSCA has demonstrated significant in vivo efficacy in a variety of human xenograft models and a benign safety profile in pre-clinical toxicology studies. In parallel to developing certain antibody products, Agensys has established partnerships to develop and commercialize selected antibody products and other product applications for its proprietary targets. The Company's laboratories, GMP GMP (guanosine monophosphate): see guanine. manufacturing facility and offices are located in Santa Monica, Calif. For further information about Agensys, please visit http://www.agensys.com. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion