A new drug being tested by a local company may give AIDS patients a new weapon to fight their disease.
Trimeris, a Durham-based company, is currently running clinical trials on a peptide drug called T-20. In initial tests involving over 150 patients, T-20 has shown short-term, immediate success and has lowered the concentration of HIV in the bloodstream by as much as two orders of magnitude.
"These results should present renewed hope for people who have exhausted their options in fighting AIDS," said Dr. Dani Bolognesi, CEO of Trimeris and former director of the Duke Center for AIDS Research. "T-20 has increased these people's quality of life and that's very important."
T-20 works by interfering with the fusion process through which the AIDS virus infects healthy cells, thus limiting the spread of the virus.
Trimeris, which has been involved in ongoing drug testing since 1996, recently finished various short-term trials with more than 150 patients across the nation and will expand testing to over 1,000 individuals
The patients used in the trial are those who have advanced AIDS and who have cycled through or exhausted all other treatments.
Because of T-20's tremendous success in short-term trials, it has received fast-track designation by the U.S. Food and Drug Administration, meaning the review process is being expedited for approval. Dusec estimates the drug will be available for HIV-infected individuals by early 2002.
T-20 is the first AIDS treatment that works outside of the virus itself to block the virus' replication. Currently, the only available treatments target the protease and reverse transcriptase enzymes in the AIDS virus that are critical for its reproduction. However, because AIDS easily mutates to build resistance, researchers have had problems targeting these enzymes and effectively administering these drugs.
"T-20 works in a different mechanism [than other drugs] which is important because of AIDS and its diversity," explained Bolognesi.
Another important attribute of T-20 is its safety. Bolognesi said there have been no reported side effects, and the drug has responded exceptionally well when used in combination with other drugs.
Bolognesi and his colleague Dr. Thomas Matthews actually stumbled upon T-20 in the early '90s while they were both researchers at Duke. They were working on vaccines and studying proteins when they discovered a peptide that exhibited fusion-blocking characteristics. Further testing indicated that it may even have therapeutic qualities.
Currently, HIV and AIDS affects 33.6 million people worldwide, and has killed nearly 16.5 million people since the virus' discovery in 1981.
However, with the availability of this drug, Dusec predicts that the drug will make a large impact in both reducing the number of newly infected people as well as giving current AIDS patients new hope. "To me, T-20 will make a dent in the epidemic. To offer affected patients another treatment option is very important to Trimeris," Dusec said.
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