Myriad Genetics, Inc.'s HIV Drug Shows Favorable Safety Profile
The Phase 1 trial was designed as a single ascending dose study to assess the safety, tolerability and pharmacokinetic parameters of the compound in healthy volunteers. The overall safety profile was favorable with no serious adverse events or clinically significant changes in laboratory values or ECG. The observed pharmacokinetic profile supports continued development. Vivecon has good oral bioavailability and the study demonstrated enhanced absorption of Vivecon when taken with food. This is an additional positive for the drug candidate since that is the preferred option to dosing on an empty stomach.
Based on these results, Myriad is proceeding to a Phase 2a study, a multiple ascending dose trial in treatment-naïve HIV-infected individuals. The Phase 2a trial will further evaluate the safety, pharmacokinetic parameters and Vivecon's ability to inhibit viral replication. This clinical development plan may allow a relatively rapid overall development timeline and accelerated initiation of pivotal studies.
"Our anti-HIV program is proceeding well, led by Vivecon as a viral maturation inhibitor," said Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "The Phase 1 data indicates a well-tolerated drug candidate with excellent characteristics for use in the potential treatment of HIV infection."
Vivecon has been tested extensively for anti-viral activity and safety with both in-vitro and in-vivo models, in preclinical studies. It demonstrated anti-viral activity of less than 10 nanomolar IC50 against the HIV virus, with at least a 1,000-fold therapeutic safety index. Vivecon was also shown to be active against viral strains that are resistant to currently marketed anti-HIV drugs, including nucleoside reverse transcriptase inhibitors such as AZT(TM), non-nucleoside reverse transcriptase inhibitors such as Efavirenz(TM) and protease inhibitors such as Ritonavir(TM).
About HIV/AIDS
According to the U.S. Centers for Disease Control and Prevention (CDC), there are approximately 1.1 million persons in the United States living with HIV/AIDS. In 2005, the estimated number of new diagnoses of AIDS in the United States and dependent areas was 41,897 per year. The estimated number of deaths in 2005 of persons with AIDS in the United States and dependent areas was 17,011.
According to the United Nations UNAIDS program, over 33 million people throughout the world are living with HIV/AIDS, and over 22 million people have died from the disease. Some 2.5 million people were newly infected with the virus in 2007, or 6,800 new infections every day.
While the widespread availability of antiretroviral and other drugs in North America has helped the number of AIDS-related deaths there to remain relatively low, the challenge has become managing these patients, due to the increase in viral resistance to the current classes of drugs. There is a strong need for drugs that can stop the resistant virus from spreading.
Myriad Genetics, Inc. is a healthcare company focused on the development and marketing of novel therapeutic and molecular diagnostic products. Myriad's news and other information are available on the Company's Web site at www.myriad.com.
Vivecon is a trademark of Myriad Genetics, Inc. in the United States and other countries. MYGN-G
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the progress of our anti-HIV program; the indication from our Phase 1 data that Vivecon is well-tolerated with excellent characteristics for use in the potential treatment of HIV infection; the continued development of Vivecon, including the Phase 2a study, a multiple ascending dose trial in treatment-naïve HIV-infected individuals; the ability of the Phase 2a study to allow us to further evaluate the safety, pharmacokinetic parameters and Vivecon's ability to inhibit viral replication; and the ability of our clinical development plan to allow a relatively rapid overall development timeline and accelerated initiation of pivotal studies for Vivecon. These forward looking statements are based on management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to, our inability to further identify, develop and achieve commercial success for new products and technologies; our ability to discover drugs that are safer and more efficacious than our competitors; 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; our ability to protect our proprietary technologies; 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 Item 1A in our Annual Report on Form 10-K for the year ended June 30, 2008, 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 undertakes no duty to update this information unless required by law.
Contact: William A. Hockett Exec. VP, Corporate Communications (801) 584-3600
Source: Myriad Genetics