BUSINESS WIRE; Wednesday, September 16, 1998
The protocol for this trial ("TRI-003") sets a 28-day period of T-20 therapy to assess the antiviral activity, safety and plasma pharmacokinetics of T-20 in six treatment arms. Four distinct doses will be administered by continuous subcutaneous infusion via an infusion device developed by MiniMed Inc. (NASDAQ: MNMD), a product currently approved for insulin infusion by diabetics, and two distinct doses will be administered via intermittent subcutaneous injection. TRI - 003 will enroll up to 78 HIV-infected individuals at up to 12 sites in the United States. At entry all enrolled patients may either be on no other antiretroviral therapy or a stable regimen which will not change during the trial.
M. Ross Johnson, president and chief executive of Trimeris, said, "The pace of patient screening and enrollment in TRI-003 is going well. TRI-003 is expected to define the optimal dose(s), demonstrate the effectiveness of continuous infusion versus intermittent injection, and provide additional data regarding the effect of T-20 on viral load. These results will be used to refine the clinical plan for development of T-20."
The current clinical plan for T-20 anticipates the initiation of a pivotal clinical trial during 1999, pending the results of TRI-003 and other Phase II trials.
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 a Phase I/II trial that demonstrated 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 in humans.
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.
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 1997 Form 10K filed with the Securities and Exchange Commission on March 31, 1998, and 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: Matthew A. Megaro Chief Financial Officer 919-419-6050 or Shellie M. Roth Investor Relations Partners 973-535-8389
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