Jules Levin, NATAP
Trimeris presented 16-week data on T-20 from the on-going Phase II clinical trial (known as study T20-205) at the European Conference on Clinical Aspects and Treatment of HIV Infection in Lisbon. The clincal data was previously reported at ICAAC. New information was reported that T-20 antibodies in 55 patients who received 50 mg/twice daily by subcutaneous injections with combination therapy
regimens did not impact the serum levels of T-20 peptide after 16-weeks of therapy.
In addition, it was recently reported that Trimeris recently entered into an agreement with Mallinckrodt to augment Roche's manufacturing capabilities and supply large quantities of T-20 peptide for clinical trials. This may help alleviate concerns about drug availability for launch and expanded access.
Preliminary data from the combination study (T20-206) will be presented at IDSA in November 1999. T-20 Pivotal Trial expected to begin 2nd quarter 2000. 16-week T20-206 data, T-1249 Phase I/II data expected to be reported at Retrovirus Conference.