Cambridge Antibody Technology Reports Recent Progress In Licensed Product Candidates
Cambridge, UK - Cambridge Antibody Technology acknowledges the announcements this week by Human Genome Sciences, Inc (HGSI) 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 (SLE) and rheumatoid arthritis (RA). In an announcement dated 5 October 2005, HGSI announced that the results of a Phase II clinical trial 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 3 October 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 (HHS) for comparative in vitro and in vivo testing. Under the second phase of the contract, under the Project BioShield Act 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, 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-TNFa 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 4 October 2005, Abbott Laboratories announced it has simultaneously submitted a supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA as a treatment for ankylosing spondylitis, an inflammatory disease of the spine and spinal joints.
SOURCE: Cambridge Antibody Technology