BOULDER, Colo., Jan. 10 /PRNewswire-FirstCall/ -- Tapestry Pharmaceuticals, Inc. announced today that it has initiated the treatment of patients in a second Phase I clinical trial for TPI 287, a proprietary third generation taxane. The purpose of the study is to determine the maximum tolerated dose of a single intravenous administration of TPI 287 in each 21-day treatment cycle. Like the ongoing Q7 day Phase I study, this second Phase I clinical trial of TPI 287 is an open label, multi-center dose escalation trial designed to evaluate the safety and pharmacokinetic profile of the compound in eligible patients with recurrent and/or refractory malignancies. As a result of the experience in the first Phase I trial, dosing in the second trial is beginning at 56 mg/m2, which is the dose used in the fourth cohort of the every-seven day trial.
Cohorts in the new study will consist of a single patient until there is initial evidence of grade 2 drug-related toxicities at which point that cohort and all future cohorts will enroll at least three patients at that dose level. The study will be conducted at the Rocky Mountain Cancer Center in Denver, Colorado under the direction of its Principal Investigator, Dr. Allen Cohn, Chairman of the GI Research Committee, and at the Sheba Medical Center in Tel Aviv, Israel under the direction of Dr. Yaacov Baram.
The initial Phase I trial began dosing last May at 7mg/m2. We anticipate treating our first patient in our fifth cohort later this week at 85 mg/m2. The trial is currently enrolling the fifth cohort of patients. This Phase I study is evaluating a once weekly administration of TPI 287.
“The human safety experience with TPI 287 to date in our first trial has been promising. By starting our second trial at 56 mg/m2, we anticipate completing this second study in an accelerated timeframe compared to our first study,” commented Leonard Shaykin, Chairman and Chief Executive Officer of Tapestry. “We anticipate beginning the first of our multiple Phase II trials for TPI 287 in mid-2006 and are increasing our efforts to evaluate TPI 287 as an orally administered agent.”
“With regards to our other development programs, we have terminated our peptide linked taxane (TPI 284) program and our Huntington’s program. The progress and data generated to date by these programs do not merit continued investment of the Company’s resources. We will continue limited preclinical evaluation of certain Quassinoids and other natural products,” commented Mr. Shaykin.
About Tapestry Pharmaceuticals, Inc.
Tapestry Pharmaceuticals, Inc. is a company focused on the development of proprietary therapies for the treatment of cancer.
For more information about Tapestry and its technologies, visit Tapestry’s web site at www.tapestrypharma.com.
Forward Looking Statements
Statements in this press release that are not historical facts are “forward-looking statements” that involve risks and uncertainties. Forward-looking statements can be identified by the use of words such as “opportunities,” “trends,” “potential,” “estimates,” “may,” “will,” “should,” “anticipates,” “expects” or comparable terminology or by discussions of strategy. Such forward-looking statements include statements relating to the clinical development program for TPI 287, the safety and effectiveness of TPI 287, the potential of TPI 287 as an orally administered compound, the commencement of Phase II studies, and the enrollment of patients in the existing Phase I studies. Such statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks, uncertainties and other factors include risks that Tapestry will be unable to manufacture additional TPI 287 according to GMP standards or in sufficient quantities to complete clinical trials; that clinical trials for TPI 287 will be delayed due to institutional approvals, patient recruitment, formulation and manufacturing difficulties or other factors; and that human clinical trials may show that TPI 287 is unsafe and/or ineffective in treating cancer in human patients. General implementation risks associated with development of any of our products include those that we are blocked or limited in the development of our product candidates because of the intellectual property rights of third parties; that we are limited in our ability to obtain, maintain and enforce our own intellectual property; that development of our product candidates is delayed or terminated because the costs of further development exceed the value of such candidates; and that the Company’s resources are insufficient to continue development and the Company will be unable to raise sufficient additional capital to continue operations and development. Additional risks, uncertainties and other factors are identified under the captions “Risk Factors” and “Special Note Regarding Forward-Looking Statements” in the Company’s reports filed from time to time with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update publicly or revise any forward-looking statements, whether as a result of new or additional information, future events or otherwise.
For further information, please contact Gordon Link, Senior Vice President, Chief Financial Officer, at 303 516 8500.
Tapestry Pharmaceuticals, Inc.
CONTACT: Gordon Link, Senior Vice President, Chief Financial Officer ofTapestry Pharmaceuticals, Inc., +1-303-516-8500, glink@tapestrypharma.com;or Investors, Michael Wachs of CEOcast, Inc., +1-212-732-4300, for TapestryPharmaceuticals, Inc.; or Media, Peter Steinerman, +1-516-374-3031, forTapestry Pharmaceuticals, Inc.
Web site: http://www.tapestrypharma.com/
