Phase III trials set to begin--better late than never.
Trimeris and Roche to Start T-20 Phase
III Clinical Trials -- Important Advance for First of a New Class Of HIV/AIDS Drugs, Fusion Inhibitors --
DURHAM, N.C. & NUTLEY, N.J.--(BW HealthWire)--Oct. 3, 2000-- Trimeris Inc. and Hoffmann-La Roche Inc. announced today that T-20 is entering Phase III clinical trials. The companies plan to initiate two pivotal studies, one in North, Central and South America and a second in Europe and Australia in the next several weeks.
T-20 is the first member of a new>anti-HIV compounds known as fusion inhibitors. Unlike existing AIDS drugs that work inside the cell and target viral enzymes involved in the replication of the virus, T-20 inhibits fusion of HIV with host cells before the virus enters the cell and begins its replication process. T-20 has received fast-track designation by the FDA for the treatment of HIV-infected individuals. Fast-track is granted to expedite the development of products that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease. The investigational drug T-20 is being developed through a collaboration between Trimeris, Inc., and Hoffmann-La Roche.
"The green light to proceed with our pivotal trials is a significant milestone for the Trimeris and Roche partnership," said Dani Bolognesi, Ph.D., chief executive officer, director and co-founder of Trimeris, Inc. "By entering the final stage of drug development, we are bringing T-20 a step closer to patients who are in need of new options to treat HIV disease." The studies that will form the basis of the regulatory submissions to health authorities around the world will evaluate T-20 when used as part of combination therapy in both HIV-infected adults and children.
The pivotal trials will provide access to T-20 for approximately 700 advanced, antiretroviral experienced adults living with HIV/AIDS in over 100 sites around the world. The primary efficacy comparison in the pivotal studies will be the change in the amount of virus in the blood among patients who do and do not receive T-20 when given as a twice daily subcutaneous injection over a 24-week period.
"Starting the Phase III program confirms our initial belief in this exciting new>head of Global Drug Development at F. Hoffmann-La Roche, Basel,Switzerland. "By embarking on the Phase III program, we are mobilizing considerable resources to support the rapid development of T-20." |
