Business Wire - Thursday April 15, 1999
The FDA's 30-day review period for the T-1249 IND has passed and the Company intends to initiate a Phase I clinical trial in the second quarter of 1999. T-1249 is a synthetically designed proprietary peptide which blocks fusion of HIV with host cells. It has demonstrated high potency against primary isolates in the laboratory, as well as in an animal model of HIV infection. T-1249 is active against T-20-resistant isolates. T-20, the first member of this pharmacological class, is currently in Phase II clinical trials.
"We are excited about T-1249 because it possesses unique properties and demonstrates our capability to engineer novel peptide fusion inhibitors," stated Dr. Dani Bolognesi, Chief Executive Officer of Trimeris. "There is an unmet medical need for agents that are active against HIV viruses resistant to current therapies. Science and medical practice indicate that multiple agents in a single class are required to combat these strains. T-20 and T-1249 expand the therapeutic options for patients with the greatest need."
The first T-1249 clinical trial will be a multi-center, dose-ranging study which will evaluate safety, pharmacokinetics and antiviral activity of T-1249 in HIV-infected adults. It will be conducted in up to 60 patients who will receive T-1249 monotherapy by subcutaneous injection for 14 days. Due to the attractive pharmacokinetic properties that were observed in non-clinical studies, once-daily dosing will be explored in this first clinical trial.
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 product candidate, T-20, which inhibits fusion of HIV with host cells, is currently in Phase II clinical trials.
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 matierally 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 1998 Form 10-K filed with the Securities and Exchange Commission on March 31, 1999, 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.
Contact: Trimeris Inc., Durham Matthew A. Megaro, President/Chief Financial Officer 919/419-6050 or Burns McClellan Inc., New York Jonathan M. Nugent (investors) Justin Jackson (media) 212/213-0006
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