HIV Entry Inhibitors Featured in Keynote Session At Major Scientific Meeting; Fusion Inhibitors T-20 and T-1249, Furthest in Clinical Development, Among Those Discussed Business Wire
click here to return to Business Wire main menu
DonateNow





HIV Entry Inhibitors Featured in Keynote Session At Major Scientific Meeting; Fusion Inhibitors T-20 and T-1249, Furthest in Clinical Development, Among Those Discussed

Business Wire - December 17, 2001


CHICAGO--Responding to the need for HIV treatments that work against the virus in a new way, scientists and clinicians are gathering this week at the 41st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), being held here December 16-19, 2001, to review the latest research on "entry inhibitors."

A broad category of investigational HIV drugs, entry inhibitors work in various ways to block the virus before it enters and takes over a host cell. Classes of drugs within the entry inhibitor category include attachment inhibitors, co-receptor inhibitors and fusion inhibitors. The investigational fusion inhibitors T-20 and T-1249 - the furthest along in clinical development in the entry inhibitor category - will be among those discussed in the keynote session and other presentations. Roche and Trimeris (Nasdaq: TRMS) are co-developing T-20, currently in Phase III pivotal trials, and T-1249, currently in Phase I/II trials.

In the keynote session on HIV/AIDS, John P. Moore, Ph.D., Professor of Microbiology and Immunology at Cornell University's Weill Medical College and leading expert in the process of HIV entry, gave a presentation titled, "HIV-1 Entry into Cells: A Target for Antivirals, Vaccines and Vaginal Microbicides." Dr. Moore's research at Cornell focuses on the processes by which HIV attaches to, and fuses with, host cells.

"We're learning more and more about potential targets in the viral lifecycle to disarm the virus, including the blocking of viral fusion," said Dr. Moore. "Novel antiretrovirals that disrupt this step in viral entry may become an important addition to the HIV treatment mix."

"Emerging studies, as well as experience in my own clinical practice, tell me that many HIV patients are exhibiting resistance to current treatments and are in need of new options," said Michael Saag, M.D., director of the AIDS Outpatient Clinic at the University of Alabama at Birmingham, host of the keynote session and an investigator in T-20 clinical trials. "The fusion inhibitors T-20 and T-1249 hold significant promise for the treatment of patients with prior antiretroviral experience and resistance."

In addition to the keynote lecture, T-20 and T-1249 will be the subject of three presentations at ICAAC:

Antiretroviral Therapy II, 194, Tuesday, Dec. 18, 3:00 p.m. - 4:30 p.m.

Abstract 1942: "Chronic Subcutaneous T-20 in HIV-1 Infected Children: Safety and Anti-Viral Activity"

The preliminary findings suggest that short-term (up to 24 weeks) subcutaneous dosing with T-20 is well tolerated by children. In the highest dose group (60 mg/m2), T-20 containing therapy caused rapid suppression of HIV RNA of approximately 10-fold average reduction from baseline levels in seven days. Dose ranging studies are ongoing.

Antiretroviral Therapy II, 194, Tuesday, Dec. 18, 3:00 p.m. - 4:30 p.m.

Abstract 1936: "Comparative Pharmacokinetics of Carbonate (CO3) and Tris Buffer Formulations of the Peptide HIV Fusion Inhibitor T-20"

Data from this study support the administration of T-20 via subcutaneous injections delivered as one injection twice daily, rather than by two injections twice daily, a procedure used in earlier clinical studies.

Session I, 071, Monday, Dec. 17, 8:30 a.m. - 11:00 a.m. tract 669: "Genotypic Resistance to Protease and Reverse Transcriptase Inhibitors and Antiretroviral History Do Not Affect Virologic Response to T-1249"

An analysis of the T-1249 Phase I/II dose-ranging clinical trial (T1249-101) suggests that a daily dose of T-1249 - and not prior antiretroviral treatment experience, including mutations to all approved classes of HIV drugs - was the only variable that was associated with the viral load reduction among treatment-experienced patients. In the T-1249 study, two serious adverse events possibly related to T-1249 occurred, including hypersensitivity reaction (oral ulcers, maculopapular rash, fever) and grade four neutropenia. Injection site reactions (pain, induration, erythema) were mild and reported in 40 percent of patients.

More About T-20

T-20 is administered as a twice-daily subcutaneous injection. In all studies completed to date, the most frequent side effect observed is a mild to moderate local skin reaction at the site of the injection of T-20. Such reactions occur in nearly all patients, but are rarely severe or cause the patient to discontinue treatment. Diarrhea, nausea, dizziness, fatigue, and headache are other commonly reported side effects, although we are unable to establish whether T-20 is the cause of these side effects.

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 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 planning to invest 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 from the FDA in the U.S. 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

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 Manning Selvage & Lee Mike Nelson, 212/213-7620 On-site: 917/568-4450
011217
BW011206


Copyright © 2001 - Business Wire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Business Wire, Permissions Desk, Business Wire, 1185 Avenue of the Americas, 3rd Floor, New York, NY 10036; Tel: (212) 575-8822; FAX: (212) 575-1854. http://www.businesswire.com.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.

Always watch for outdated information. This article first appeared in 2001. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2001. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .