TRMS has their aids presentation tomorrow in Chicago I believe. It may or may not get much play on it after...they have developed a different approach than the aids cocktail.
Instead of fighting the disease after it has entered the cells, they are hitting it earlier on.
Trimeris, Inc. (NASDAQ: TRMS - news) announced today that preliminary results from TRI-003, a Phase II clinical trial of T-20, a fusion inhibitor, will be presented at the upcoming 6th Conference on Retroviruses and Opportunistic Infections in Chicago. T-20 attacks HIV in an entirely different way than currently approved agents. In TRI-003, T-20 was well tolerated at all doses and a dose-related reduction of viral load was observed in HIV infected subjects with extensive prior antiretroviral exposure and high viral loads.
Dr. Joseph Eron, a TRI-003 investigator from the University of North Carolina at Chapel Hill, will present the findings from the trial in detail during the late-breaking scientific session on February 4. ''These results from TRI-003 are impressive, particularly when one considers the population that enrolled in this clinical trial is extremely difficult to treat,'' said Dr. Eron. ''The average number of anti-HIV medications that the patients in this trial had failed was nine, including an average of 3 protease inhibitors. Additionally, the average baseline viral load of the study population, 100,000 copies/mL, represents a difficult hurdle for any drug when administered as a single agent. T-20 performed well by reducing HIV in the blood by greater than 90% in the higher dose groups without significant side effects.''
In the Phase II clinical trial, T-20 was given for twenty-eight days to 78 HIV infected adults. T-20 was administered via continuous subcutaneous infusion or subcutaneous injection and was added to a stable antiretroviral regimen or administered as monotherapy. Mild to moderate local skin irritation at the site of infusion or injection was observed in most patients. However, only 3% of patients discontinued T-20 due to side effects during this trial. Preliminary pharmacokinetic analyses indicate that both continuous subcutaneous infusion and twice-daily subcutaneous injection resulted in consistent plasma concentrations of T-20, with little peak-to-trough variation throughout the dosing period.
''An unexpected positive outcome from this trial was the demonstration that twice-daily injection may be a feasible method to deliver T-20 on a chronic basis,'' said Trimeris CEO, M. Ross Johnson, PhD. ''In both twice-daily injection groups evaluated, targeted blood levels of T-20 were sustained throughout the entire dosing interval. This result expands our options for administering T-20.''
''There is genuine excitement in the medical community for T-20, because it is the only drug in Phase II clinical trials which works by an entirely novel mechanism of action,'' commented TRI-003 lead investigator Dr. Jacob Lalezari, from San Francisco. ''T-20 attacks HIV before it enters the cell, and the chance for cross-resistance with current treatments is minimal. The encouraging results from this trial affirm that T-20 continues to hold promise for the growing number of HIV-infected people who are failing currently approved drugs.'' |