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www.fdanews.com/articles/67883-tapestry-to-proceed-with-phase-i-trial-for-tpi-287

Tapestry to Proceed With Phase I Trial for TPI 287

January 24, 2005

Tapestry Pharmaceuticals has announced that the FDA has raised no objections that would preclude the company from entering Phase I clinical trials for its investigational new drug, TPI 287, a novel proprietary taxane.

Tapestry expects to begin human clinical testing in the first half of 2005. The initial clinical study of TPI 287 will be a traditional open-label, multicenter, Phase I study designed to evaluate the safety and pharmacokinetic profile of the compound in eligible patients with recurrent and/or refractory malignancies, using a carefully designed dose-escalating scheme.

The study will be conducted at two to three U.S. sites and is designed to determine an appropriate dose for the compound. It is anticipated the trial will enroll up to 50 patients.