Agensys Announces IND Submission for Monoclonal Antibody AGS-PSCA for Cancers of Prostate, Pancreas, Bladder
SANTA MONICA, Calif.--(BUSINESS WIRE)--June 30, 2005--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) to initiate a Phase 1 clinical trial with AGS-PSCA. AGS-PSCA is a fully human monoclonal antibody (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.
AGS-PSCA is a high affinity, human IgG1k MAb directed to Agensys' proprietary target Prostate Stem Cell Antigen (PSCA). 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. "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 mouse models, AGS-PSCA has consistently demonstrated significant inhibition of both tumor growth and metastases.
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 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. 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. |
