http://biz.yahoo.com/bw/010212/nc_trimeri.htmlI'm posting the text because yahoo tends to throw these things away.First Controlled Safety Study Suggests That T-20, in Combination With Oral Antiretrovirals, Reduces Viral Load Below Limit of Detection in More Patients Than Oral Regimen AloneFirst Results for T-20 In Moderately Treatment Experienced Patients Are Among Data Presented at Scientific ConferenceDURHAM, N.C. & NUTLEY, N.J--(BW HealthWire)--Feb. 12, 2001-- Trimeris, Inc. (Nasdaq: TRMS - news) and Hoffmann-La Roche today provide a brief summary of data on the investigational agents T-20 and T-1249, the first in a new class of anti-HIV compounds known as fusion inhibitors. The preliminary data were presented this week over several sessions at the Eighth Annual Conference on Retroviruses and Opportunistic Infections in Chicago. Meeting Highlights T20-206 Trial: Late breaker presentation 5 The open label, randomized, controlled Phase II clinical study of T-20 compared three doses of T-20 in combination with a potent regimen of oral antiretrovirals (abacavir 300mg BID, amprenavir 1200 mg BID, ritonavir 200mg BID, and efavirenz 600 mg QD) in 71 non-nucleoside reverse transcriptase inhibitor-naive and protease inhibitor- and nucleoside reverse transcriptaseinhibitor-experienced HIV patients. The subjects were enrolled in one of four treatment groups: control regimen without T-20 (arm A) or control regimen with either 50 (arm B), 75 (arm C), or 100 mg (arm D) of T-20 given subcutaneously twice daily. Among all patients who were randomized, dosed and underwent at least one on-treatment plasma HIV RNA assessment, 82 percent (37 of 45) in the combined T-20 arms achieved an undetectable viral load (less than 400 copies/mL) as measured by the standard AMPLICOR® viral load assay, compared to 58 percent (11 of 19) in the control group. In the strict intent-to-treat missing=failure analysis including all patients, 71 percent (37 of 52) of patients receiving T-20 achieved an undetectable viral load, compared to 58 percent (11 of 19) in the control group. These analyses were consistent with the trends observed in all analyses performed (i.e., the percent of patients with viral load reduced to less than 50 copies/mL, change from baseline in viral load and CD4+ cell count), suggesting additional antiviral activity for T-20. ``This is the first controlled study to show the safety and activity of T-20 in combination with other antiretroviral therapy,' said Dr. Jay Lalezari, Director, Quest Clinical Research Institute in SanFrancisco, and lead investigator for the trial. ``These results were demonstrated in patients with less advanced disease and complements ongoing work with T-20 in patients with extensive prior therapy and more advanced disease.' Mild to moderate local injection site reactions were the most frequently reported T-20 related adverse events, occurring in approximately two-thirds of patients on T-20. The incidence of other clinical adverse events and laboratory abnormalities was similar between the T-20 arms and control arm and demonstrated no T-20 dose-dependence. First Data on T-20 in Children: Posters 681 and 726 Twelve treatment-experienced or treatment-naive children ages three to 12 were evaluated in a Phase I/II study being conducted in collaboration with the Pediatric AIDS Clinical Trials Group (PACTG) of the National Institute of Allergy and Infectious Diseases. The preliminary findings suggest that short-term (up to 12 weeks) subcutaneous dosing with T-20 is well tolerated by children and that in the highest dose group (60 mg/m2), T-20 caused rapid suppression of HIV RNA of approximately 10-fold average reduction from baseline levels in seven days. When oral anti-HIV drugs were added to T-20, this 10-fold reduction was maintained in the majority of children (three of four subjects in 30 mg/m2 and six of seven subjects in 60 mg/m2) who had crossed the eight week time point. In the study, T-20 was well tolerated. One child discontinued treatment due to aversion to injections but no child discontinued due to adverse events. Mild to moderate injection site reactions (erythema, induration, pruritis, discomfort) occurred in eight of 12 children but were usually mild. First T-1249 Human Data: Oral Presentation 14 The first human data from a Phase I/II dose escalation study of the second-generation fusion inhibitor, T-1249, evaluating safety, PK and antiviral activity were presented by Dr. Joe Eron, University of North Carolina, Chapel Hill and lead T-1249 investigator. The study assessed 72 HIV positive, treatment-experienced adults with no concomitant antiretroviral therapy. Patients received T-1249 monotherapy for 14 days at doses ranging from 6.25 mg/day to 50 mg/day on a once or twice daily regimen. The results indicate that T-1249 is well tolerated over 14 days, has PK characteristics thatsupport once-daily dosing and confers dose-related suppression of plasma HIV RNA.. On day 14, the median change from baseline ranged from -0.10 (6.25 mg/day) to -1.40 (50 mg/day) log10 c/mL. Based on the favorable tolerability and activity observed with T-1249, Trimeris and Roche will continue to explore higher doses in subsequent cohorts of this trial. In the study, two serious adverse events possibly related to T-1249 occurred, including hypersensitivity reaction (oral ulcers, maculopapular rash, fever) and grade 4 neutropenia. Otherwise, no treatment-related, clinically important laboratory abnormalities occurred. Injection site reactions (pain, induration, erythema) were mild and reported in 40 percent of patients. New Virology Data: Posters 473 and 474 Two separate in vitro studies yielded additional insight on the profiles of T-20 and T-1249. In particular, poster 473 displayed data exploring whether there is a relationship between chemokine coreceptor phenotype of the virus and sensitivity to the fusion inhibitors. Trimeris scientists (poster 474) evaluated the relationship between binding affinity and resistance to fusion inhibitors. More on T-20 Phase III trials of T-20 were initiated last year in treatment-experienced patients; these trials will be conducted at over 100 sites around the world. The first pivotal trial, T20-301, has begun enrolling patients at centers in the United States. The second pivotal trial, T20-302, has been submitted to numerous Investigational Review Boards (IRBs) in Europe and Australia, and enrollment is ongoing. This new class of anti-HIV drugs known as fusion inhibitors belongs to a broader category of investigational drugs known as ``entry inhibitors.' Classes of drugs within the entry inhibitor categoryinclude attachment inhibitors, chemokine receptor inhibitors and fusion inhibitors, all of which act in various ways to block the HIV virus before it takes over the cell. The fusion inhibitors, led byT-20, are the furthest along in development in the entry inhibitor category. About Trimeris Inc. Trimeris is a development stage, biopharmaceutical company engaged in the discovery and development of novel therapeutic agents that block viral infection by inhibiting viral fusion with host cells.Trimeris' lead product candidate, T-20, which inhibits fusion of the human immunodeficiency virus (HIV) with host cells, is currently in Phase III clinical trials and has received fast-track designationfrom the FDA. Trimeris' second fusion inhibitor product candidate, T-1249, which also inhibits HIV fusion, has received fast-track designation from the FDA and is in Phase I/II clinical testing. For more information on Trimeris, Inc., visit the company's web site at www.trimeris.com. About Hoffmann-La Roche Inc. Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leadersin pharmaceuticals, diagnostics and vitamins. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality oflife. Among the company's areas of therapeutic interest are: virology, including HIV/AIDS and hepatitis C; infectious diseases, including influenza; cardiology; neurology; oncology; transplantation;dermatology; and metabolic diseases including obesity and diabetes. For more information on the Roche pharmaceuticals business in the United States, visit the company's web site at www.rocheusa.com. Trimeris Safe Harbor Statement Note: Except for any historical information presented herein, matters presented in this release are forward-looking statements that involve risks and uncertainties. The results of Trimeris' previousclinical trials are not necessarily indicative of future clinical trials, and future results could differ materially from the results presented herein. Factors that could cause or contribute to such differencesinclude, but are not limited to, those discussed in the ``Risk Factors' section included in Trimeris' Form 10-K for the year ended December 31, 1999, filed with the Securities and ExchangeCommission on March 29, 2000.
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