Cambridge Antibody reports recent progress in licensed product candidates.Cambridge Antibody Technology (Cambridge, England) recognized reports this week by Human Genome Sciences Human Genome Sciences NASDAQ: HGSI is a biopharmaceutical corporation founded in 1992. Its stated purpose is to "discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs. , Inc. and Abbott Laboratories relating to LymphoStat-B, ABthrax and HUMIRA. LymphoStat-B (belimumab) is a fully human anti-BLyS monoclonal antibody licensed by CAT to HGSI. HGSI is developing LymphoStat-B as a potential treatment for systemic lupus erythematosus Systemic Lupus Erythematosus Definition Systemic lupus erythematosus (also called lupus or SLE) is a disease where a person's immune system attacks and injures the body's own organs and tissues. Almost every system of the body can be affected by SLE. (SLE SLE systemic lupus erythematosus. SLE abbr. systemic lupus erythematosus Systemic lupus erythematosus (SLE) ) and rheumatoid arthritis (RA). In an announcement dated October 5, 2005, HGSI said the results of a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II demonstrated that LymphoStat-B was safe, well tolerated, and showed signs of clinical effect in patients with SLE, although the drug did not meet the overall primary efficacy endpoints of reducing the signs and symptoms of SLE at Week 24 as measured by SELENA SLEDAI, or increasing the time to first SLE flare over 52 weeks. LymphoStat-B reduced the signs and symptoms of SLE at Week 52 at a level of statistical significance in seropositive patients, a subgroup that represented 75% of the study's patient population, as measured by both SELENA SLEDAI (p=0.021) and the Physician's Global Disease Assessment (p=0.016). Trends to greater reduction in prednisone therapy also were observed across the active study population. Based on these results, HGSI stated that it now has a path forward to Phase III for LymphoStat-B in SLE. ABthrax is a fully human monoclonal antibody licensed by CAT to HGSI. HGSI is developing ABthrax for use in the treatment of anthrax disease. In an announcement dated October 3, 2005, HGSI announced that it has been awarded a two-phase contract to supply ABthrax, a human monoclonal antibody developed for use in the treatment of anthrax disease, to the US Government. Under the first phase of the contract, Human Genome Sciences will supply ten grams of ABthrax to the US Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Health and Human Services, HHS (HHS HHS Department of Health and Human Services. ) for comparative in vitro and in vivo testing. Under the second phase of the contract, under the Project BioShield Act The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for the donation of over $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. of 2004, the US Government has the option to place an order within one year for up to 100,000 doses of ABthrax for the Strategic National Stockpile The Strategic National Stockpile (SNS) of the U.S. Centers for Disease Control is a national repository of antibiotics, chemical antidotes, antitoxins, life-support medications, IV administration, airway maintenance supplies, and medical/surgical items. , for use in the treatment of anthrax disease. The HHS comparative testing results, along with HGSI's own preclinical and clinical study results, will form the basis of the US Government's decision process for exercising its option for additional product for the Strategic National Stockpile. HUMIRA (adalimumab) is a fully human anti-TNF-alpha monoclonal antibody, isolated and optimised by CAT in collaboration with Abbott and now approved for marketing as a treatment for RA. In an announcement dated October 4, 2005, Abbott Laboratories announced it has simultaneously submitted a supplemental Biologics License Application with the US 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. ) and a Type II Variation to the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. (EMEA) seeking approval to market HUMIRA as a treatment for ankylosing spondylitis, an inflammatory disease of the spine and spinal joints. Additionally, on October 4, 2005, Abbott announced that the FDA approved HUMIRA as a first-line treatment of recent onset moderate to severe RA. The EMEA granted similar approval in August 2005. Cambridge Antibody Technology +44-0-1223-471-471 www.cambridgeantibody.com Human Genome Sciences, Inc. www.hgsi.com Abbott Laboratories www.abbott.com |
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