Posts tagged ‘C’
Stocks to trade
Human Genome Sciences, Inc. (Nasdaq: HGSI) The following is a list of products pending. Keep an eye on this volitile stock and profit.
BENLYSTA™ (belimumab, formerly LymphoStat-B®)
BENLYSTA is an investigational human monoclonal antibody drug that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS®, which was discovered by HGS in 1997. In lupus, rheumatoid arthritis and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body’s own healthy tissues. BENLYSTA has successfully met its primary endpoint in BLISS-52, the first of two Phase 3 trials in systemic lupus. Results of BLISS-76, the second BENLYSTA Phase 3 trial, are expected in November 2009. The design of the two trials is similar, except for the duration of therapy, which will be 52 weeks in BLISS-52 and 76 weeks in BLISS-76. Assuming the second Phase 3 trial is also successful, HGS believes that BENLYSTA has the potential to become the first new approved drug for people living with lupus in more than 50 years. BENLYSTA is being developed by HGS and GlaxoSmithKline (GSK) under a co-development and commercialization agreement entered into in August 2006.
ZALBIN™ (albinterferon alfa-2b, formerly Albuferon®)
ZALBIN is a long-acting investigational treatment for chronic hepatitis C, and is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006. ZALBIN has met its primary endpoint of non-inferiority to Pegasys (peginterferon alfa-2a) in two pivotal Phase 3 clinical trials in chronic hepatitis C. The results of both Phase 3 trials demonstrate that, with half the injections, 900-mcg Albuferon achieved efficacy comparable to peginterferon alfa-2a, with a positive safety profile. The filing of global marketing applications for Albuferon is planned for fall 2009. Assuming licensure by the FDA and other regulatory agencies, HGS believes that Albuferon could become a market-leading treatment for chronic hepatitis C..
Raxibacumab (ABthrax™)
Raxibacumab is a human monoclonal antibody drug that HGS discovered and developed for the treatment of inhalation anthrax. Raxibacumab represents a new way to address the anthrax threat. While antibiotics can kill the anthrax bacteria, they are not effective against the deadly toxins that the bacteria produce. Raxibacumab is a first-in-class treatment that targets anthrax toxins after they are released by the bacteria into the blood and tissues. In an inhalation anthrax attack, people may not know they are infected with anthrax until the toxins already are circulating in their blood, and it may be too late for antibiotics alone to be effective. In April 2009, HGS completed the delivery of 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile. In July 2009, HGS received a second order for 45.000 doses of raxibacumab from the U.S. Government, to be delivered over a period of three years, beginning near the end of 2009.
TRAIL Receptor Antibodies
HGS has pioneered the development of highly targeted antibody therapies for cancer based on the TRAIL receptor apoptotic pathway. The Company’s TRAIL receptor antibodies specifically bind to TRAIL receptors 1 or 2, and directly induce the death of cancer cells through apoptosis, or controlled cell death.
HGS-ETR1 (mapatumumab), an antibody to TRAIL receptor 1, is the most advanced of any product in development that targets the TRAIL apoptotic pathway. HGS is currently conducting two randomized Phase 2 clinical trials of HGS-ETR1 – a trial of HGS-ETR1 in combination with bortezomib (Velcade) in patients with advanced multiple myeloma, and a trial of HGS-ETR1 in combination with paclitaxel and carboplatin as first-line therapy in patients with non-small cell lung cancer.
The results of an open-label, dose-escalation Phase 1b trial in patients with advanced solid tumors have demonstrated that HGS-ETR2 (lexatumumab), an antibody to TRAIL receptor 2, was generally safe and well tolerated in combination with four different standard chemotherapy regimens.
HGS believes that the TRAIL pathway offers therapeutic opportunities across a broad range of cancers. In December 2007, the Company acquired exclusive rights from Aegera Therapeutics to develop and commercialize a novel class of small molecules that also enhance apoptosis in cancer cells. These small molecules, known as IAP inhibitors, target a family of proteins that help cancer cells resist apoptosis and start growing again. HGS1029, the lead IAP inhibitor, is expected to enter clinical development early in 2008.
(SOURCE HGSI)
HGSI Up $7.00 at ther open Trade of the day
Human Genome news on Phase III
Human Genome Sciences (HGSI) anounced that BENLYSTA met the primary endpoint in BLISS-52, the first of two Phase 3 trials. In the placebo-controlled BLISS-52 study, the results showed that BENLYSTA response rate at Week 52, compared with standard of care alone. Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups.
SocialVibe