New HIV Drugs - Fusion Inhibitors - Likely to Successfully Tackle Resistant HIV
Athens, 30th October 2001 � A new class of HIV drug, �Fusion Inhibitors', appears set to help meet the growing need for new medicines to combat the resistant strains of HIV. At an HIV conference in Athens today (ECCATH), Dr. Frank Duff, Director, Roche Clinical Science, announced that the Fusion Inhibitor T-20, currently in clinical trials, is showing promising results in studies of patients with a demonstrated need for new HIV treatments.
T-20 and the follow up molecule T-1249, are the first antiretroviral agents to reach clinical development that act by inhibiting HIV fusion. There is increasing enthusiasm for T-20, the fusion inhibitor furthest along in clinical development, as its pivotal trials progress and consideration for marketing approval draws nearer. While the number of patients with drug resistant strains of HIV continues to grow, the urgent need for these new drugs is constantly increasing.
Unlike existing anti-HIV drugs that work inside the cell and target viral enzymes involved in replication of the virus, T-20 and T-1249 purport to inhibit fusion of HIV with host cells before the virus enters the cell and begins to replicate. These drugs have an entirely different mode of action so cross-resistance to existing anti-HIV agents is not expected.
"Roche and Trimeris are aware of the pressing need for new drug classes that have the potential to treat resistant viral strains," commented Dr. Duff. "We are pleased with the available data and with feedback from researchers who see an exciting role for Fusion Inhibitors in the antiretroviral armamentarium. In the long-term, we are committed to researching and developing more effective new drugs, especially for patients with resistant HIV strains, and to delivering more advanced healthcare solutions to people living with HIV."
Dr. Duff summarised the current trials evaluating T-20 and T-1249: He described the safety, tolerability and antiviral activity of prolonged subcutaneous administration of T-20 in combination therapy in a 48-week trial of heavily pre-treated individuals with advanced disease 1 (median 100,000 HIV RNA copies/mL, CD4 count 90 cells/mm3). Of the 41 patients who completed the 48 weeks, 56% showed a sustained response (>1 log10 decrease from baseline), with 39% attaining less than 400 copies/mL. An intent to treat analysis demonstrated this sustained response of >1 log in 33% of the 70 patients. Additional data demonstrates that T-20 suppresses HIV replication in both moderately treatment-exposed children and extensively treatment-exposed adults. T-20 was well tolerated in both groups, and in the study of 71 patients, twice-daily subcutaneous administration appears acceptable to most patients.
"T-1249 is well tolerated in short-term use showing dose related viral suppression, furthermore it has demonstrated activity against T-20 resistance in the majority of viral isolates in vitro, and we anticipate initiating Phase II trials in 2002," added Dr. David Reddy, Franchise Leader & Disease Area Strategy Head-HIV/AIDS, Roche. "Based on these extremely promising results from both the T-20 and T-1249 trials we hope our range of therapies will increase further treatment options for many people living with HIV."
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References
1.Cohen et al. Ist International AIDS Society Conference on HIV Pathogenesis and Treatment.2001.
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 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 inhibit 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 in the US and are expected to have a priority/accelerated review in the US and EU respectively for the treatment of HIV-infected individuals. Fast-track is granted to expedite the development of products that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease.
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, which is now being co-developed with Roche, is currently in Phase III clinical trials. Trimeris and Roche are currently co-developing a fusion inhibitor product candidate, T-1249, which inhibits HIV fusion. For more information on Trimeris, Inc., visit the company's Web site 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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