New Evidence that T-20 Adds Potency to Conventional HIV Therapies
Results from two studies show T-20 reduces HIV in treatment experienced patients over a one year period
Basel, February 19 - The body�s immune response can be improved and HIV viral levels reduced when the ground-breaking investigational HIV drug, T-20, is added to conventional powerful combination therapy "cocktails". These promising research results for the first in a new class of HIV drugs known as "fusion inhibitors" will be welcome news as Roche and Trimeris lead the way in the challenge to keep one step ahead of growing drug resistance. Unlike existing AIDS drugs, Fusion Inhibitors prevent HIV entering human cells.
Promising results are reported from two Phase II studies, one (T20-208) compared several formulations of T-20 in patients experienced with the three currently available classes of antiretrovirals (triple class experienced) and the other (T20-206) studied people who have taken just two of the existing classes (nucleoside reverse transcriptase inhibitors and protease inhibitors) but have not yet been exposed to non-nucleoside reverse transcriptase inhibitors (known as NNRTI na�ve patients).
T20-208 assessed the antiviral activity, safety, tolerability, and pharmacokinetics of three T-20 formulations in treatment-experienced patients over a 48-week period. The patients entering this study had advanced disease with average blood levels of over half a million copies of HIV per mL and an average CD4 cell count of just 24 cells/mm3.
"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 (<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% 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."
In the other study, T20-206, among patients with exposure to only two classes of antiretroviral therapies, and earlier stage HIV disease, the addition of T-20 to a fixed highly active anti-retroviral (HAART) regimen enhanced virologic and immunologic response over the oral antiretroviral (ARV) regimen at 48 weeks.
The 48-week controlled study, T20-206, compared three doses of T-20 in combination with a regimen of oral antiretrovirals (containing abacavir, amprenavir, ritonavir and efavirenz) in 71 NNRTI na�ve patients.
A comparison between the combined T-20 containing arms of the study versus the control arm highlighted that by the end of a year more than half (55%) of the patients taking drug regimens containing T-20 had their plasma viral load reduced to less than 400 copies per mL, whereas, 37% of the patients taking the control regimen succeeded in attaining this level of viral load reduction. Almost half (47%) of T-20-treated patients achieved viral loads reduced beneath the limit of detection (<50 copies/mL) compared to only 37% treated with the background regimen alone. CD4 cell counts were also higher in patients on T-20 containing regimens. 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.
"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 P. 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".
Notes to editors
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 have a strain of the virus that has developed resistance to a number of the various antiviral treatments and the therapy options available to them are therefore reduced. 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 US dollars to bring the fusion inhibitors to people living with HIV/AIDS.
Long-Term Commitment to HIV Research and Development
Roche and Trimeris are working together to mobilize the considerable resources required to support the rapid development of T-20 and T-1249, the first members of a new class of investigational anti-HIV drugs known as Fusion Inhibitors. T-20, currently in Phase III clinical trials is the furthest along in clinical development in the entry inhibitor class while T-1249 is currently being evaluated in Phase I/II clinical trials. Unlike existing AIDS drugs that work inside the cell and target viral enzymes involved in the replication of the virus, T-20 and T-1249 block fusion of HIV with host cells before the virus enters the cell and begins its replication process. In June 2001, Roche and Trimeris announced a joint research agreement to identify and develop additional HIV Fusion Inhibitor Peptides
T-20 and T-1249 have fast track designation from the FDA in the US for the treatment of HIV-infected individuals. Fast track is granted to facilitate the development and expedite the review of applications for drugs that are intended to treat serious or life-threatening disease and that demonstrate the potential to address an unmet medical need.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world�s leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche�s innovative products and services address needs for the prevention, diagnosis and treatment of disease, thus enhancing people�s well-being and quality of life. For more information on Roche and its commitment to research in HIV, visit the: roche-hiv.com website.
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, inhibits fusion of the human immunodeficiency virus (HIV) with host cells. T-20 is being co-developed with Roche and is currently in Phase III clinical trials. Trimeris and Roche are also co-developing a second HIV fusion inhibitor drug candidate, T-1249, that is in Phase I/II clinical testing. For more information on Trimeris, Inc., visit the company's website at www.trimeris.com.
Trimeris Safe Harbor Statement
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' previous clinical 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 differences include, but are not limited to, those discussed in the "Risk Factors" section included in Trimeris' Form 10-K/A for the year ended December 31, 2000, filed with the Securities and Exchange Commission on July 24, 2001.
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