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Myriad Genetics Announces Topline Results of Phase 1 Trial of Vivecon for HIV
Trial Indicates Favorable Safety and Pharmacokinetics Profiles
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updated 6:30 a.m. ET, Wed., Sept. 17, 2008
SALT LAKE CITY, UT - Myriad Genetics, Inc. (NASDAQ: MYGN) (www.myriad.com) announced today that it has successfully completed dose escalation in the Phase 1 human clinical trial of Vivecon(TM), its HIV viral maturation inhibitor, in healthy volunteers. The trial demonstrated a favorable safety profile with Vivecon in 55 subjects enrolled across 9 cohorts.
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-naive 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).
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