Thoughts on this release? Stock suffering on a bad day:
>>NUTLEY, N.J. & DURHAM, N.C.--(BW HealthWire)--Feb. 19, 2002-- Roche and Trimeris, Inc. (Nasdaq: TRMS - news) today announced 48-week results from two Phase II clinical trials evaluating T-20, the furthest in clinical development of an investigational class of antiretrovirals called fusion inhibitors.
The results, to be presented at an upcoming scientific conference, indicate that T-20 contributes to the suppression of plasma viral load and is well tolerated over the course of nearly a year as part of antiretroviral combination therapy. The T20-208 study assessed the pharmacokinetics, safety, tolerability and antiviral activity of high-strength formulations of T-20 in combination with oral antiretrovirals among patients with advanced HIV disease and prior exposure to all three classes of available antiretrovirals. The T20-206 study compared the tolerability and antiviral activity of combination therapy with T-20 to a fixed background regimen in a more moderately treatment-experienced patient population (patients not previously exposed to non-nucleoside reverse transcriptase inhibitors, or nNRTIs).
``These two trials round out our Phase II experience with T-20. We are very pleased that T-20 continues to demonstrate consistent trends in activity and tolerability now over a duration of 48 weeks,'' said David Reddy, Franchise Leader and Disease Area Strategy Head-HIV/AIDS, Roche Pharmaceuticals. ``We are looking forward to the results of our two large, pivotal Phase III trials to evaluate the safety and efficacy of T-20. It is anticipated that the results from the 24-week endpoint will serve as the basis for our regulatory submissions in the U.S. and Europe in the second half of this year.''
T20-208: Formulation Comparison Study in Heavily Treatment-Experienced Patients
Forty-six triple-class, treatment-experienced patients participated in T20-208, a formulation comparison study of T-20. Patients in the trial had advanced disease with prior exposure to all three classes of available antiretrovirals, an average HIV-RNA level of 5.37 log10 copies/mL and an average CD4+ cell count of 24 cells/(mu)l.
``After long term treatment (48 weeks), half (23 of 46) of the triple-class experienced patients who used T-20 in combination therapy had their viral loads reduced beneath the limit of detection of the Roche AMPLICOR® viral load assay (<400 copies/mL). This is an impressive result for this growing and difficult to treat population,'' stated Dr. Joseph Wheat, Professor of Medicine, Indiana University School of Medicine, Division of Infectious Diseases. ``We are also delighted to see that virtually all patients in the study (93 percent of 46 patients) completed a full year of treatment, indicating that long term treatment with T-20 administered subcutaneously twice-daily is tolerable and acceptable to these patients.''
Furthermore, the results support the development of T-20 in Phase III trials at two injections per day. Injection site reactions were the most frequent adverse event; all patients experienced at least one event, but none discontinued the study due to an injection site reaction. Only three patients (6.5 percent) had discontinued participation in the study at 48 weeks.
T20-206: First Controlled Study of T-20 in Combination with Oral Antiretrovirals
Forty-eight week results of T-20 in combination with oral antiretrovirals suggest that the addition of T-20 to a standard antiretroviral regimen was well tolerated and provided additional decreases in plasma viral load than that provided by the antiretroviral control regimen alone. In the strict intent-to-treat, missing equals failure analysis, 55 percent of patients (28 of 51) in the combined T-20 arms achieved undetectable HIV-RNA levels of less than 400 copies/mL, and 47 percent (24 of 51) reached the lower threshold of HIV-RNA levels of less than 50 copies/mL. In the control group, 37 percent of patients (seven of 19) achieved HIV-RNA levels of less than 50 copies/mL and 400 copies/mL. CD4+ cell count increases were also higher in patients treated with T-20 containing regimens - 132 cells cells/(mu)l compared to 90 cells/(mu)l in the control group.
``We are pleased to report that T-20 was shown to contribute to the activity of a conventional combination regimen and was an acceptable therapy to most patients over 48 weeks,'' said Dr. Jacob Lalezari, Director of Quest Clinical Research Institute, San Francisco. ``As in previous studies, those receiving T-20 demonstrated enhanced virologic and immunologic responses above the oral ARV regimen alone, although this time in patients with less advanced disease and less previous antiretroviral drug experience.''
T20-206 was an open label, randomized Phase II controlled study of T-20 comparing three doses of T-20 in combination with a regimen of oral antiretrovirals (abacavir, amprenavir, ritonavir and efavirenz) in 71 nNRTI-naive and protease inhibitor (PI)- and nucleoside reverse transcriptase inhibitor (NRTI)-experienced HIV patients. Patients were enrolled in one of four treatment groups: control regimen without T-20 (arm A) or control regimen with either 50 mg, 75 mg, or 100 mg of T-20 given subcutaneously twice daily. This Phase II study was not designed to show differences among treatment arms.
There was no increase in adverse events between those patients in the control arm and those patients receiving T-20. Approximately two-thirds of patients taking T-20 experienced local reaction at the site of injection, but only three patients experienced sufficient discomfort to discontinue treatment.
More About T-20
T-20 is administered as a twice-daily subcutaneous injection. In all studies completed to date, the most frequent side effect observed is a mild to moderate local skin reaction at the site of the injection of T-20. Such reactions occur in nearly all patients, but are rarely severe or cause the patient to discontinue treatment. Diarrhea, nausea, dizziness, fatigue, and headache are other commonly reported side effects, although we are unable to establish whether T-20 is the cause of these side effects.
Meeting the Growing Need For a New Class of HIV Drugs
One of the biggest challenges facing people living with HIV is resistance to currently available therapies. Thirty to fifty percent of patients are infected with a strain of the virus that has developed resistance to one or more antiretrovirals, reducing the treatment options available to them. Roche and Trimeris are committed to discovering and developing treatments for patients in need of new options and are planning to invest approximately half a billion U.S. dollars to bring fusion inhibitors to people living with HIV/AIDS.<<
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