Trimeris's website includes a list of clinical trials it has conducted on T-20 from the first Phase I trial through the two Phase III trials it plans on submiting to the FDA for marketing approval. There are a total of eight trials. Two are Phase I/II, four are Phase II and two are Phase III. Trimeris plans two more Phase II and two more Phase III, though these trials had not begun as of March 25, 2002, when the firm submitted its Annual 10-K to the SEC.
• List of Trials from the website
• SEC Form 10-K of r Year Ending December 31, 2001. The first section of this document includes more details about some of the trials.

• TRI-001: This was the first study, and the results were published on November 5, 1998 in Nature Medicine Magazine, under the title "Potent suppression of HIV-1 replication in humans by T-20, a peptide inhibitor of gp41-mediated virus entry." See the full Abstract, and the Nature Science Update story. (For more information, contact the principle investigators at the University of Alabama, Birmington: J. Michael Kilby and Michael S. Saag.) The abstract reads, in part:

  We administered intravenous T-20 (monotherapy) for 14 days to sixteen HIV-infected adults in four dose groups (3, 10, 30 and 100 mg twice daily). There were significant, dose-related declines in plasma HIV RNA in all subjects who received higher dose levels... This study provides proof-of-concept that viral entry can be successfully blocked in vivo. Short-term administration of T-20 seems safe and provides potent inhibition of HIV replication comparable to anti-retroviral regimens approved at present.

• T-20 204 / PACTG 1005: This trial was the first pediatric trial for the drug. Roche released preliminary on January 31, 2000 in the press release Trimeris, Inc. and Hoffmann-La Roche Release New Data on Investigational HIV Fusion Inhibitors T-20 and T-1249.

  welve treatment-experienced or treatment-naïve children ages three to 12 were evaluated in a Phase I/II study being conducted in collaboration with the Pediatric AIDS Clinical Trials Group (PACTG) of the National Institute of Allergy and Infectious Diseases. The preliminary findings suggest that short-term (up to 12 weeks) subcutaneous dosing with T-20 is well tolerated by children and that in the highest dose group (60 mg/m2), T-20 caused rapid suppression of HIV RNA of approximately 10-fold average reduction from baseline levels in seven days.

• TRI-003: This was the first Phase II clinical test. The results were released January 25, 1999 in Trimeris press release. First in New Class of Drugs Continues to Show Potency and Safety.

  In the Phase II clinical trial, T-20 was given for twenty-eight days to 78 HIV infected adults. T-20 was administered via continuous subcutaneous infusion or subcutaneous injection and was added to a stable antiretroviral regimen or administered as monotherapy. Mild to moderate local skin irritation at the site of infusion or injection was observed in most patients. However, only 3% of patients discontinued T-20 due to side effects during this trial.

• T-20 2005: Reults released July 10, 2000 in Roche press release. T-20, First Investigational Anti-HIV Fusion Inhibitor, Is Well-Tolerated Over 48 Weeks of Combination Therapy.

  In the T20-205 Phase II single arm, open label roll-over trial, 70 patients received T-20 50 mg twice daily (BID) by subcutaneous injection in combination with other anti-HIV drugs. Prior to starting the trial, the patients had failed on average 10 HIV/AIDS medications and entered with high viral load (median 4.8 log10 copies/mL) and low CD4 cell count (median 135 cells/mm3), characteristic of advanced HIV disease. At 48 weeks, 23 patients exhibited reductions in the amount of HIV in their blood that were 10-fold lower than baseline and/or were reduced below the lower limit of the Roche AMPLICOR HIV-1 MONITORTM assay (400 copies/mL). This translates to a response rate of 56% (23/41) of patients completing 48 weeks of treatment or 33% of the entire population who entered the study.

• T-20 206: This was the first controlled study of T-20 in Combination with oral antiretrovirals. See the Trimeris press release T-20 In Combination Therapy Achieves Viral Suppression And Is Well-Tolerated Over 48 Weeks.

  Forty-eight week results of T-20 in combination with oral antiretrovirals suggest that the addition of T-20 to a standard antiretroviral regimen was well tolerated and provided additional decreases in plasma viral load than that provided by the antiretroviral control regimen alone. In the strict intent-to-treat, missing equals failure analysis, 55 percent of patients (28 of 51) in the combined T-20 arms achieved undetectable HIV-RNA levels of less than 400 copies/mL, and 47 percent (24 of 51) reached the lower threshold of HIV-RNA levels of less than 50 copies/mL. In the control group, 37 percent of patients (seven of 19) achieved HIV-RNA levels of less than 50 copies/mL and 400 copies/mL. CD4+ cell count increases were also higher in patients treated with T-20 containing regimens - 132 cells cells/?l compared to 90 cells/?l in the control group.

• T-20 208: Formulation Comparison Study in Heavily Treatment-Experienced Patients. See press release: T-20 In Combination Therapy Achieves Viral Suppression And Is Well-Tolerated Over 48 Weeks.

  "After long term treatment (48 weeks), half (23 of 46) of the triple-class experienced patients who used T-20 in combination therapy had their viral loads reduced beneath the limit of detection of the Roche AMPLICOR( viral load assay (<400 copies/mL). This is an impressive result for this growing and difficult to treat population," stated Dr. Joseph Wheat, Professor of Medicine, Indiana University School of Medicine, Division of Infectious Diseases. "We are also delighted to see that virtually all patients in the study (93 percent of 46 patients) completed a full year of treatment, indicating that long term treatment with T-20 administered subcutaneously twice-daily is tolerable and acceptable to these patients."

Phase III Trials

In early 2002, Trimeris and Roche jointly report that they had reached "24-Week Results" for the two Phase III trails being conducted for submission to the FDA for marketing approval, and that the companies will "proceed with filing US and EU registration packages." The trials includes included "approximately" 1,000 patients and each last for a total of 48 weeks.

• July 8, 2002. Trimeris press release. Treatment-Experienced Patients Twice As Likely To Achieve Undetectable HIV Levels With T-20 Than Without.
• May 16, 2002. Trimeris press release. Roche And Trimeris Announce 24-Week Results From Second Pivotal Study Of HIV Fusion Inhibitor T-20.
• April 18, 2002. Trimeris press release. Roche And Trimeris Announce 24-Week Results From First Phase III Study Of HIV Fusion Inhibitor T-20.
• October 20, 2002. Roche press release. Trimeris and Roche to Start T-20 Phase III Clinical Trials.
• June 28, 2001/ Roche press release. Roche and Trimeris Complete Enrollment in T-20 Phase III Clinical Trial.