SALT LAKE CITY, Sept. 14, 2009 (GLOBE NEWSWIRE) -- Myriad Pharmaceuticals Inc. (Nasdaq:MYRX) today announced the presentation of two abstracts detailing positive data for MPC-4326, its novel maturation inhibitor for the treatment of HIV infection.
The two abstracts, which were presented today at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Annual Meeting, demonstrated that the 50 and 100 mg tablet formulations of MPC-4326 were safe and well tolerated, and that 200 mg and 300 mg twice a day dosing maintained concentrations needed to achieve viral load reduction.
A companion diagnostic based on the genetic sequence of an individual's virus has been developed to identify patients that respond to MPC-4326. Using this algorithm in a retrospective analysis, the predicted defined responder patient population treated with 300 mg MPC-4326 twice a day had significantly greater viral load reduction than predicted responder patients treated with 200 mg twice a day. The companion diagnostic will be validated during the course of subsequent clinical studies.
"I am very excited that the new 100mg tablet formulation of MPC-4326 has performed so well," said Dr Adrian Hobden, President and CEO of Myriad Pharmaceuticals. "Coupled with the potential companion diagnostic and the significant viral load reductions seen in these two studies, we believe that we have a clear clinical path forward."
As previously announced, the poster and oral presentation are available as PDFs on the Myriad Pharmaceuticals' website at www.myriadpharma.com.
About MPC-4326
MPC-4326 (bevirimat dimeglumine) is Myriad Pharmaceuticals' drug candidate being developed as an oral treatment of human immunodeficiency virus 1 (HIV-1) infection. MPC-4326 is a potent small-molecule that acts as a viral maturation inhibitor and is a first-in-class drug candidate with a novel mechanism of action. New drugs with novel mechanisms of action are needed to combat the evolution of HIV drug resistance to the currently available therapies. Importantly, pre-clinical studies have demonstrated that MPC-4326 exhibits potent activity against a broad range of HIV strains, including isolates that are resistant to currently approved HIV therapies. MPC-4326 therefore has the potential to strengthen the portfolio of approved drugs being used in combination to treat patients with HIV.
Clinical studies in over 675 subjects to date have shown MPC-4326 to be well tolerated and to have demonstrated significant and clinically relevant reductions in viral load in patients representing approximately 60% of all HIV patients, who can be readily identified with a simple and proprietary genotyping assay. MPC-4326 has been granted Fast Track designation by the U.S. Food and Drug Administration. Myriad Pharmaceuticals plans to initiate a two-arm, 24 week Phase 2b randomized study in HIV treatment-experienced patients to assess the novel 100 mg tablet formulation of MPC-4326 while utilizing the diagnostic genotyping algorithm to prospectively identify the responder patient population by the end of the calendar year.
About Myriad Pharmaceuticals, Inc.
Myriad Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing novel small molecule drugs that address severe medical conditions, including cancer and HIV infection. Our pipeline includes clinical and pre-clinical product candidates with distinct mechanisms of action and novel chemical structures that have the potential to be first-in-class and/or best-in-class therapeutics. For more information visit www.myriadpharma.com.
The Myriad Pharmaceuticals, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6327
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential efficacy and timing of development of MPC-4326, such as the Company's plans to initiate a two-arm, 24 week Phase 2b randomized study of MPC-4326 in HIV treatment-experienced patients. These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that we may be unable to further identify, develop and achieve commercial success for new products and technologies; the risk that we may be unable to discover drugs that are safer and more efficacious than our competitors; the risk that we may be unable to develop and maintain manufacturing capabilities for our products; the possibility of delays in the research and development necessary to select drug development candidates and delays in clinical trials; the risk that clinical trials may not result in marketable products; the risk that we may be unable to successfully finance and secure regulatory approval of and market our drug candidates, or that clinical trials will not be completed on the timelines we have estimated; uncertainties about our ability to obtain new corporate collaborations and acquire new technologies on satisfactory terms, if at all; the development of competing products and services; the risk that we may be unable to protect our proprietary technologies; the risk of patent-infringement claims; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in our Form 10 which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad Pharmaceuticals undertakes no duty to update this information unless required by law.