BUSINESS WIRE; Thursday, March 19, 1998, 07:31 EST
This trial was previously announced by Trimeris in a January 9, 1998 press release. The trial will enroll up to 48 HIV-infected individuals at three sites in the US. All enrolled patients will be those who have begun to fail their existing triple combination therapy. Prior exposure to non-nucleoside reverse transcriptase inhibitors and protease inhibitors other than indinavir will be among the exclusion criteria for the study.
The first 10 days of the study is a dose optimization period that will assess the safety, plasma pharmacokinetics, and antiviral activity of multiple ascending doses of T-20. After completion of this period, subjects will be eligible to participate in an extension period of at least 6 months, during which T-20 will be administered in combination with Sustiva(tm) and two protease inhibitors. DuPont Merck has agreed to provide Sustiva(tm) to Trimeris to conduct this phase of the trial.
This advanced HIV patient trial will assess the optimal dosing for T-20 and the feasibility of T-20 administration via a continuous subcutaneous infusion pump. Trimeris is currently conducting non-human hypersensitivity studies with T-20 administered subcutaneously before initiation of continuous subcutaneous dosing in HIV positive subjects, as was requested by the U.S. Food and Drug Administration. Trimeris will submit a protocol amendment to the institutional review boards at each site to seek their approval for using Sustiva(tm) in this study.
T-20, Trimeris' novel anti-viral compound, is designed to block both virus-to-cell and cell-to-cell membrane fusion, thereby preventing a critical early step in the spread of viral infection. In August 1997, T-20 completed Phase I/II trials, demonstrating potent anti-HIV activity. No drug-related adverse effects were seen in any of the 16 patients tested. This study provided the first clinical evidence that inhibition of membrane fusion results in significant anti-HIV-1 activity.
Sustiva(tm) is the most advanced DuPont Merck HIV clinical candidate. The company plans to submit the NDA to the U.S. Food and Drug Administration and European regulatory authorities in the second quarter of 1998. Sustiva(tm) is currently available through expanded access programs in the United States, Canada and Europe.
M. Ross Johnson, president and chief executive officer of Trimeris, said, "We are delighted that our advanced HIV patient trial will include Sustiva(tm). This trial is the first step in determining the importance of a new combination therapy as a critical component in fighting HIV infection."
About the Companies
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. The company's lead development candidate is T-20, which inhibits fusion of the human immunodeficiency virus (HIV) with host cells.
The DuPont Merck Pharmaceutical Company is a world-wide, research-based pharmaceutical company, which markets its products under the DuPont Pharma name. Formed in 1991 as a partnership between DuPont and Merck & Co., Inc., DuPont Merck is focused on research, development and delivery of pharmaceuticals to treat unmet medical needs in the fight against HIV, cardiovascular disease, central nervous system disorders, cancer and arthritis-related disorders. The company is also a leader in radiopharmaceuticals.
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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 the company's 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 the company's Registration Statement on Form S-1 as declared effective by the Securities and Exchange Commission on October 6, 1997, and those discussed from time to time in Trimeris' filings with the Securities and Exchange Commission.
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CONTACT: Trimeris, Inc., Durham Matthew A. Megaro, 919-419-6050 or Investor Relations Partners (for Trimeris) Shellie M. Roth, 973-535-8389 or The DuPont Merck Pharmaceutical Co. Sandra K. James, 302-892-1306 sandra.k.james@dupontmerck.com
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