TRIMERIS/HOFFMAN LA ROCHE PROGRESS WITH HIV FUSION INHIBITORS.A member of a new class of anti-HIV drugs, called fusion inhibitors is demonstrating its ability to suppress viral replication and remain well-tolerated in patients in an ongoing Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II . The investigational drug T-20, being developed through the collaboration of Trimeris, Inc., and Hoffmann-La-Roche, is the first member of a class of compounds known as fusion inhibitors. A second-generation fusion inhibitor, T-1249, is currently being evaluated in Phase I clinical studies. T-20 and T-1249 are the only fusion inhibitors currently in clinical development.
Fusion inhibitors work specifically on the virus to prevent it from fusing with the cell. Because they target a unique part of the viral lifecycle, T-20 and T-1249 are not expected to be cross-resistant to existing anti-HIV drugs.
"Developing regimens that include anti-HIV drugs designed to attack the virus in new ways is one of the most pressing unmet medical needs in HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. therapeutics today," said Dr. David Ho, director of the Aaron Diamond Center for AIDS Research. "As many as 40 percent of HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome patients have failed multiple treatment regimens or have developed resistance to existing options, and while AIDS-related deaths have declined, the number of people living with HIV continues to grow. Fusion inhibitors may very well be the first new class of anti-HIV drugs since the introduction of protease inhibitors Protease Inhibitors Definition
A protease inhibitor is a type of drug that cripples the enzyme protease. An enzyme is a substance that triggers chemical reactions in the body. in 1995."
Thirty-two week results from an ongoing Phase II clinical study of T-20 (T20-205) are demonstrating consistent trends in tolerability and a decline in plasma viral load viral load
The concentration of a virus, such as HIV, in the blood.
n a measure of the number of virus particles present in the bloodstream, expressed as copies per milliliter. as was observed with initial 16-week data, announced in September 1999 at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy Antimicrobial Agents and Chemotherapy (print-ISSN 0066-4804, CODEN AMACCQ; canceled ISSN 0074-9923, canceled CODEN AACHAX) is an academic journal published by the American Society for Microbiology. . New data from this study suggest a substantial CD4 cell CD4 cell CD4+ lymphocyte A circulating T cell with a 'helper' phenotype; in AIDS Pts, the levels of CD4+ cells is a crude indicator of immune status and susceptibility to certain AIDS-related conditions; these Pts may suffer KS as CD4+ cells fall below 0. increase in addition to the observed viral load decline. The open label single-arm study is evaluating T-20 in combination with other antiretrovirals in 71 HIV-positive adults who had received T-20 during earlier trials.
"Based on the encouraging results we're seeing, we have recently extended this trial to allow these advanced patients to continue using T-20 beyond 48 weeks," said Dr. Sam Hopkins, senior vice president of medical affairs at Trimeris. "When administered on a chronic basis, as a twice-daily subcutaneous injection, T-20 appears to be well-tolerated."
Trimeris and Roche also report that accrual is nearly complete in two additional ongoing studies involving their fusion inhibitors: a Phase II study (T20-206) evaluating the safety and dosing of T-20 in NNRTI-naive, protease protease /pro·te·ase/ (pro´te-as) endopeptidase.
Any of various enzymes, including the proteinases and peptidases, that catalyze the hydrolytic breakdown of proteins. inhibitor-experienced patients, and a Phase I study of T-1249 (T1249-101), assessing the safety, pharmacokinetics and tolerability of this compound.
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 asthenia /as·the·nia/ (as-the´ne-ah) lack or loss of strength and energy; weakness.
neurocirculatory asthenia , diarrhea, and dizziness, although a causal relationship to T-20 cannot be established for some of these results.
In addition to clinical advances, Trimeris and Roche are making progress on the manufacturing of T-20 and T-1249. The companies are announcing the successful transfer of methods to the Roche Colorado manufacturing facility for the production of large-scale clinical batches. In July 1999, Trimeris and Roche signed an agreement for the full-scale clinical testing and development of T-20 and T-1249.
Both T-20 and T-1249 have received fast-track designation by the U.S. Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) 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. T-20 and T-1249 will be investigated to meet a growing need for new anti-HIV therapies for the mounting number of patients who have failed or developed resistance to current medications.
This new class of anti-HIV drugs known as fusion inhibitors belongs to a broader category of investigational drugs known as "entry inhibitors." Entry inhibitors work in various ways to block HIV before it takes over the cell, either on the virus itself or on the cell. The entry inhibitor category includes the fusion inhibitor class, as well as two other classes: attachment inhibitors and co-receptor inhibitors. The fusion inhibitors, led by T-20, are the furthest along in development in the entry inhibitor category.
About Trimeris Inc.
Trimeris is a development stage, biopharmaceutical company engaged in the discovery and development of novel therapeutic agents that block viral infection viral infection,
n an infection by a pathogenic virus. A virus acts on the cell nucleus, taking over the genetic material within the nucleus and replicating itself. by inhibiting viral fusion with host cells. Trimeris' lead product candidate, T-20, which inhibits fusion of the human immunodeficiency virus human immunodeficiency virus
Human immunodeficiency virus (HIV)
A transmissible retrovirus that causes AIDS in humans. (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 in Phase I clinical testing.
For more information on Trimeris, Inc., visit the company's web site at www.trimeris.com.
About Hoffmann-La Roche Inc.
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug, unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leaders in pharmaceuticals, diagnostics, vitamins, and fragrances and flavors. 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: virology virology, study of viruses and their role in disease. Many viruses, such as animal RNA viruses and viruses that infect bacteria, or bacteriophages, have become useful laboratory tools in genetic studies and in work on the cellular metabolic control of gene expression , including HIV/AIDS and hepatitis C Hepatitis C Definition
Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild. ; infectious diseases, including influenza; cardiology; neurology; oncology; transplantation; dermatology; and metabolic diseases including obesity and diabetes.
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