HIV :: Human genome sciences reports positive results of ccr5 mab in hiv-1

Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that the results of a Phase 1 clinical trial of HGS004 (CCR5 mAb) demonstrate that it was well tolerated and exhibited antiviral activity in patients who are infected with HIV-1, the retrovirus that causes acquired immunodeficiency syndrome (AIDS). The results were reported in San Francisco in an oral presentation at the American Society for Microbiology’s 46th Annual Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

“The availability of the newer classes of antiretroviral agents has produced considerably improved outcomes in the treatment of AIDS and HIV-1 infection, but there is a significant need for novel classes of safe and effective agents that have additive or synergistic activity and a low risk of cross-resistance,” said Jacob P. Lalezari, M.D., Director, Quest Clinical Research, Assistant Clinical Professor of Medicine, UCSF/Mount Zion Hospital, San Francisco, and lead investigator for the Phase 1 trial of HGS004. “The results of the Phase 1 study of HGS004, along with preclinical data, warrant additional study of HGS004 and other therapeutic candidates in the HGS CCR5 antibody program.”

“The Phase 1 results presented at ICAAC demonstrate proof of concept for the HGS CCR5 antibody program,” said William W. Freimuth, M.D., Ph.D., Vice President, Clinical Research, Immunology, Rheumatology and Infectious Disease, HGS. “The study demonstrates that HGS004 was well tolerated and exhibited significant dose-related antiviral activity that correlates well with pharmacokinetic data and with the sensitivity of specific HIV-1 viral strains. We note that data from in vitro studies suggest that HGS101, an alternate CCR5 mAb candidate, is likely to have approximately 5.5-fold greater potency and a broader range of activity against HIV-1 viral strains than HGS004. The other attributes of HGS101 are similar to those of HGS004, including favorable pharmacokinetics, strong in vitro evidence of anti-viral activity that is additive or synergistic in combination with other therapeutic agents, and a low likelihood of the development of resistance. In the coming months, we will determine the best path forward for the HGS CCR5 mAb program.”

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