Business Wire - November 7, 2001
This study, running parallel with two ongoing, controlled Phase III clinical trials, will initially enroll a total of 450 adults around the world. Drug supply of T-20 for this trial will be made available across all participating countries simultaneously.
The study will make T-20 available prior to market approval for 168 patients in the U.S. with advanced HIV disease who are unable to construct a viable antiretroviral regimen with currently approved agents. In the U.S., the site selection process begins on November 27, 2001 at 3:00 p.m. EST. Physicians in the U.S. who wish to enroll patients in the program may call the T-20 Coordinating Center at (888) 722-6321. Physicians will be asked to call and register themselves into the program on a "first-come, first-served" basis. Participation will be limited to the first 56 qualified physicians to call in, and each physician must have exactly three eligible patients to enroll. The planned start for this study is the first quarter of 2002 and is contingent upon securing adequate drug supply. The enrollment process for the study in the countries outside the U.S. is different and will commence at the same time as in the U.S., subject to national regulations.
To access the letter distributed to doctors concerning the initiation of the study, visit the "In The News" section of www.rocheusa.com or visit www.trimeris.com.
Entry Criteria
Patients must be HIV infected adults or adolescents (over 16 years of age) with HIV RNA viral loads of at least 10,000 copies/mL and CD(4) counts of less than 50 cells/mm(3). First preference should be given to patients who have had an AIDS defining opportunistic infection, neoplasm or condition and a CD(4) count of less than 50 cells/mm(3), both while on HAART within the last 90 days. Secondary preference should be given to patients who have a CD(4) count of less than 50 cells/mm(3) (without an AIDS defining event) while on HAART within the last 90 days.
Phase III Program for T-20
Approximately 1,000 people living with HIV across North America, Europe, Brazil and Australia are currently participating in T-20 Phase III studies, the final stage of testing before a drug is submitted to the U.S. Food and Drug Administration and other health authorities for review. T20-301, being conducted in North America and Brazil, and T20-302, being conducted in Europe and Australia, are both fully enrolled. Roche and Trimeris aim to submit T-20 for U.S. and European regulatory approval in the early second half of 2002.
More About T-20
T-20 is administered as a twice-daily subcutaneous injection. In clinical studies, the most common adverse events observed with T-20 were mild to moderate in severity. The most frequent adverse events include injection site reaction, headache, nausea, fever, increased energy levels, asthenia, diarrhea, and dizziness, although a causal relationship to T-20 cannot be established for some of these results.
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 50 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 investing approximately half a billion U.S. dollars to bring 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 U.S. 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
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 leaders in pharmaceuticals, diagnostics and vitamins. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company's areas of therapeutic interest are: dermatology; genitourinary disease; infectious diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C.
For more information on the Roche pharmaceuticals business in the United States, visit the company's Web site at: http://www.rocheusa.com.
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 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 in Phase I/II clinical testing.
For more information on Trimeris, Inc., visit the company's Web site at www.trimeris.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' 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.
CONTACT: Roche Shelley Rosenstock, 973/562-2373 or Trimeris Inc. Robin Fastenau, 919/419-6050 or For inquiries outside the U.S.: Roche Basel Maria Vigneau, +41 61 688 9291 or +41 79 506 9941
SOURCE: Roche
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