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Fw: NATAP: Albuferon Starts Phase III in Naives

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  • alleypat
    NATAP http://natap.org/ ... Human Genome Sciences Initiates Phase 3 Clinical Trial of Albuferon(R) With Ribavirin in Treatment-Naive Patients With Chronic
    Message 1 of 1 , Mar 1, 2007
      NATAP http://natap.org/


      Human Genome Sciences Initiates Phase 3 Clinical Trial of Albuferon(R) With Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C Genotypes 2 and 3

      Enrollment of both Phase 3 trials of Albuferon to be completed in 2007

      Press release from HGS

      ROCKVILLE, Md., Feb. 27 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (NASDAQ: HGSI) today announced that it has initiated dosing in ACHIEVE 2/3, a Phase 3 clinical trial of Albuferon(R) (albinterferon alfa-2b) in combination with ribavirin in treatment-naive patients with chronic hepatitis C genotypes 2 and 3. ACHIEVE 2/3 is the second of two pivotal Phase 3 trials of Albuferon that HGS is conducting, with the goal of filing global marketing applications in 2009. Albuferon is being developed by HGS and Novartis under an exclusive worldwide development and commercialization agreement entered into in June 2006.

      "We believe that Albuferon could become the interferon of choice in treatment regimens for chronic hepatitis C, and we are pleased to announce that both Phase 3 trials of this potentially important compound are now underway," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "These trials, assuming that they are successful, will provide the pivotal data to support global marketing applications for Albuferon in 2009."

      Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. It is estimated that as many as 170 million people worldwide are infected with hepatitis C virus. This includes nearly four million people in the United States.

      "Chronic hepatitis C represents a significant unmet medical need," said David Nelson, M.D., lead investigator of the ACHIEVE 2/3 trial, and Associate Professor of Medicine, Medical Director of Liver Transplantation, and Chief of the Hepatobiliary Disease Section, University of Florida. "Albuferon requires half as many injections, and clinical results to date suggest it may offer efficacy at least comparable to pegylated interferon, with the potential for less impairment of health-related quality of life. We look forward to continuing the evaluation of Albuferon in larger populations in Phase 3 trials."

      About the Albuferon Phase 3 Development Program

      The Albuferon Phase 3 clinical development program includes two randomized, open-label, active-controlled, multi-center, non-inferiority trials to evaluate the efficacy, safety and impact on health-related quality of life of Albuferon in combination with ribavirin, versus PEGASYS (peginterferon alfa-2a) in combination with ribavirin. In December 2006, HGS initiated dosing in ACHIEVE 1, a Phase 3 trial of Albuferon in treatment-naive patients with chronic hepatitis C genotype 1. ACHIEVE 2/3 will be conducted in treatment-naive patients with chronic hepatitis C genotype 2 or 3.

      "HGS designed ACHIEVE 1 and ACHIEVE 2/3 working closely with our development and commercialization partner, Novartis, and with leading international experts in the field of hepatitis C," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "We also reviewed the pivotal trial designs with U.S. and key European regulatory authorities and received their positive feedback. Based on the response we have had from the clinical research community, we fully expect to attain our goal of completing the enrollment of both of our Phase 3 trials of Albuferon by the end of 2007."

      Higher doses of Albuferon administered every 4 weeks, in combination with ribavirin, will be explored in a separate Phase 2b trial to be conducted by Novartis, beginning in 2007.

      About Albuferon

      Albuferon is a novel, long-acting form of interferon alpha, which was created by HGS using the Company's proprietary albumin fusion technology. Albuferon results from the genetic fusion of human albumin and interferon alpha. Human albumin is the most prevalent naturally occurring blood protein in the human circulatory system, persisting in circulation in the body for over twenty days. Research has shown that genetic fusion of therapeutic proteins to human albumin decreases clearance and prolongs the half-life of the proteins. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers.

      About the Collaboration with Novartis

      Under an exclusive worldwide development and commercialization agreement entered into in June 2006, HGS and Novartis will co-commercialize Albuferon in the United States, and will share clinical development costs, U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization in the rest of the world and will pay HGS a royalty on those sales. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including a $45 million upfront payment and $47.5 million received in January 2007 following dosing of the first patient in a Phase 3 trial.

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