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Trimeris, Inc. (Nasdaq: TRMS) and Hoffmann-La Roche Inc. haved announced new 16-week results from an evaluation of T-20 in an on-going Phase II clinical trial (T-20-205). T-20 is a peptide that inhibits HIV, the virus known to cause AIDS, and is the first member of a new class of investigational antiretroviral compounds known as fusion inhibitors. In this Phase II clinical trial, patients received T-20 (50 mg/twice daily via subcutaneous injection) in combination with individualized oral antiretrovirals. The new results for 55 evaluable patients show that anti-T-20 antibodies do not appear to affect the levels of T-20 in the blood over time, nor the tolerability of chronic T-20 therapy through 16 weeks of treatment.

These data were gathered specifically to assess the pharmacokinetic and immunological consequences of 16 weeks of T-20 administration to HIV-1 positive adults. Results showed that administration of T-20 by twice daily subcutaneous injection for 16 weeks does not induce the formation of new anti-T-20 antibodies that affect the clearance or elimination of T-20 from the bloodstream. No significant changes in the pattern of circulating levels of anti-T-20 IgG antibody were observed during this period.

"The data through 16 weeks show that in addition to having antiviral activity and being well-tolerated, T-20 does not appear to produce an immune response in the body that could theoretically compromise its efficacy," said Dr. Dani Bolognesi, CEO of Trimeris. "This represents an important advance since it shows that since T-20 is a peptide, the body's natural immune system has not altered the drug's bioavailability or compromised its activity against HIV. In addition, the data add to our prior findings that sustained peptide therapy with T-20 could be a viable strategy for treating HIV infection."

More about T-20

T-20 belongs to a new class of investigational anti-HIV treatments called fusion inhibitors. Unlike traditional AIDS drugs that work in the cell after the virus has taken over the machinery, T-20 attacks HIV outside the cell before it begins replicating and infecting other cells.

Sixteen-week data presented last month at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy showed that 33 of 55 (60%) heavily pre-treated patients who were given 50 mg of T-20 twice-daily by subcutaneous injection in combination with oral antiretroviral agents responded with a clinically significant reduction of HIV in the blood (viral suppression of greater than 1 log10 from baseline or below the level of quantification of 400 copies/mL using the Roche Amplicor Assay). Indeed, 20 of the 55 (36%) had virus levels below the level of quantification. The average decrease in viral load for all patients was greater than 90% over the 16-week period.

In all clinical studies to date, the most common adverse events reported on T-20 were mild to moderate in severity. The most frequent adverse events include fever, headache, and lymph node abnormalities in addition to local irritation resulting from the sub-cutaneous injection.

This past July, Trimeris and Roche signed an agreement for the full-scale clinical testing, development and commercialization of Trimeris' two novel anti-HIV fusion inhibitors, T-20 and T-1249.

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 II clinical trials and has received fast-track designation from 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 currently being tested in a Phase I clinical trial.

About Hoffmann-La Roche Inc.

Hoffmann-La Roche Inc. is a leading research-intensive pharmaceutical company that discovers, develops, manufactures and markets numerous important prescription drugs that improve, prolong and save the lives of patients with serious illnesses. 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.

The company provides a wide range of medications in the United States through its marketing and sales subsidiary, Roche Laboratories Inc. Headquartered in Nutley, N.J., both companies are members of the Basel, Switzerland-based Roche Group, a global leader in health care with principal businesses in pharmaceuticals, diagnostics, vitamins, and fragrances and flavors. For more information on Roche Pharmaceuticals in the United States, visit the company's Web site at:

For more information, call 919/419-6050.
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Publication:Biotech Business
Geographic Code:1USA
Date:Dec 1, 1999

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