Fuzeon[TM], the novel treatment for HIV-1 conceived by Trimeris (Nasdaq: TRMS) of Durham, and later co-developed with Roche of Nutley, N.J., was recently approved by the U.S. Food and Drug Administration under its accelerated review process.
Fuzeon will be prescribed in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients who are losing their resistance to the virus despite ongoing antiretroviral therapy.
"With Fuzeon, what we've essentially done is to take a piece of the virus and turn it against itself," said Dani Bolognesi, Ph.D., Trimeris' CEO. "Together with our partner Roche, Trimeris is proud to bring this innovative new therapy to the growing number of people with HIV who are in need of new treatment options."
Fuzeon is a fusion inhibitor, the newest crass of anti-HIV treatments in seven years. Unlike all currently approved anti-HIV drugs, Fuzeon blocks the virus from entering the human immune cell, preventing HIV replication that can devastate the immune systems of HIV-infected individuals. Fuzeon is administered as a twice-daily subcutaneous injection.
"This new fusion inhibitor is a significant breakthrough and its approval is a milestone event in the HIV epidemic," said Dr. Michael Saag, director of the AIDS Outpatient Clinic at the University of Alabama at Birmingham, where the drug underwent clinical trials.
The Fuzeon approval is also a milestone in North Carolina's efforts to catalyze a vibrant biotechnology industry, since it is the first "home Brown" human therapeutic to obtain FDA approval.
Trimeris was launched in 1993 as a spin-out of Duke University in Durham and was initially led by veteran entrepreneur Max Wallace, who saw the potential of the technology while managing technology transfer activities at Duke.
Wallace helped Trimeris attract venture capital in its early days, and the company also received start-up funding through the North Carolina Biotechnology Center.
The manufacturing of Fuzeon is currently being perfected in Roche's manufacturing facility in Boulder, Col. The process involves 106 steps, and is considered to be a major advancement in the large-scare chemical synthesis of peptides.
For more information visit the company's Web site.
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