BOULDER, Colo., Oct. 3 /PRNewswire-FirstCall/ -- Tapestry Pharmaceuticals, Inc. announced today that it has initiated a Phase 2 open- label, multi-center study of TPI 287 in patients with advanced pancreatic cancer. This is the second Phase 2 trial exploring the activity of TPI 287 in various tumor types: the first Phase 2 trial began earlier this year in advanced hormone refractory prostate cancer.
“Currently available taxanes are not approved for pancreatic cancer and effective treatment options for this difficult tumor are quite limited,” commented Leonard Shaykin, chairman and chief executive officer of Tapestry Pharmaceuticals. “This pancreatic trial, combined with our experience in both the Phase 1 and in the Phase 2 trial currently running in refractory prostate cancer, will further characterize the safety and efficacy profile of TPI 287 in classically resistant and hard to treat tumors.”
Trial Design
The pancreatic cancer trial for TPI 287 is a multi-center, open-label, single arm Phase 2 study for up to 65 patients with advanced stage, unresectable pancreatic cancer who have failed a prior gemcitabine-containing chemotherapy regimen for their disease. The trial will be conducted in approximately 10 to 15 centers in the U.S., Europe and India. Patients will receive TPI 287 administered as a 60 minute (+/- 10 min) IV infusion.
The primary endpoint of the trial will be the six-month survival (percent of patients alive at six months after starting the study). Secondary efficacy endpoints will be the six-month progression free survival (percent of patients whose disease has not advanced by six months), response to therapy (reduction in radiographically measurable disease as defined by RECIST criteria), decreases in CA 19-9 (a tumor marker in some patients with pancreatic cancer), and the overall duration of response in those patients achieving a response. In addition, amelioration of pain and reduction in analgesic use will be quantified as another measure of clinical benefit.
Patients will remain on study until tumor progression or death, unacceptable toxicity, withdrawal of consent or discontinuation based upon investigator discretion. Patients will be followed for survival for up to one year after enrollment in the study.
“We are structuring a diversified Phase 2 program for TPI 287 that will allow us to effectively evaluate this unique taxane as a treatment option for patients who have failed other therapeutic regimens,” commented Dr. Sandra Silberman, chief medical officer of Tapestry Pharmaceuticals. “Our primary goal in this study is to rigorously explore the activity of TPI 287 in patients with advanced pancreatic cancer who have failed first line therapy. We are also interested in building more experience with this compound in the clinic, defining its safety and side-effect profile and tracking its impact on the quality of patients’ lives, particularly as it relates to pain and pain management.”
Clinical Program for TPI 287
In addition to the dosing of the first patient in this Phase 2 advanced pancreatic cancer trial and the on-going Phase 2 clinical trial in patients with advanced, hormone refractory prostate cancer, the Company may begin a third Phase 2 clinical trial in patients with glioblastoma multiforme, a primary cancer of the central nervous system. In all of these Phase 2 studies, TPI 287 will be administered as an intravenous dosage form.
In parallel to these Phase 2 studies, the company plans to initiate a Phase 1b study evaluating the oral bioavailability of TPI 287. In 2008, assuming feasibility of oral dosing from this study, the company may initiate a Phase 1b/2 study of the combination of escalating doses of TPI 287 and temozolomide, both orally administered, in tumors of the central nervous system.
At the meeting of the American Society of Clinical Oncology in June 2007, the Company reported interim data from two Phase 1 studies, each evaluating a different dosing regimen for the compound. The data demonstrated the safety and tolerability of TPI 287 in both schedules, and included evidence of anti- tumor activity in four patients at or near the maximum tolerated dose in three different tumor types.
About Pancreatic Cancer
Pancreatic cancer is a tumor that forms in the pancreas, a small, thin gland located behind other organs in the abdomen. Pancreatic cancer is difficult to detect and diagnose due to a lack of noticeable symptoms of the disease in its early stages. For newly diagnosed patients who are eligible for surgical treatment of the disease, surgery is typically followed by a combination of radiation and chemotherapy. Patients whose disease has become inoperable because of extensive local spread of the disease receive a combination of radiation and chemotherapy. Advanced stage patients with more widespread or metastatic disease are generally treated with chemotherapy alone. In patients with inoperable cancer, therapy is only palliative, which means that it only slows the disease’s progress rather than providing a cure. Gemcitabine is approved as the initial chemotherapy for patients with inoperable pancreatic cancer. Other drugs are only marginally effective, including fluoropyrimidine and Tarceva (erlotinib).
About TPI 287
TPI 287, a proprietary next-generation taxane, is Tapestry’s lead clinical compound. This compound was designed to overcome multiple drug resistance in solid tumors that are innately resistant to taxane therapy or have become resistant to taxanes following exposure to chemotherapy drugs. In preclinical testing, TPI 287 demonstrated the ability to inhibit tumor cell growth in a number of in vitro cell lines and has shown inhibition of human tumor growth in certain animal xenograft models when tested against standard comparative agents. The in vitro activity was seen across multiple cell lines including cell lines known to be sensitive to taxanes as well as cell lines known to be resistant to taxanes. Taxane sensitive cell lines in which TPI 287 has shown activity include cell lines derived from breast cancer, uterine cancer and non-small cell lung cancer. Taxane resistant cell lines in which TPI 287 has shown activity include cell lines derived from breast cancer, colon cancer and prostate cancer.
About Tapestry Pharmaceuticals, Inc.
Tapestry Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development of proprietary therapies for the treatment of cancer.
For more information about Tapestry and its technologies, visit Tapestry’s website 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,” “hopes,” “plans” or comparable terminology or by discussions of strategy. Such forward-looking statements include the statements that the Company will initiate additional Phase 2 trials of TPI 287 and initiate an oral Phase 1b/2 trial. 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 clinical trials for TPI 287 will be delayed due to institutional approvals, patient recruitment, formulation and manufacturing difficulties, delays in finalizing and receiving approval of protocols, negotiations with regulatory agencies, or other factors; that human clinical trials may show that TPI 287 is unsafe and/or ineffective in treating cancer in humans. General implementation risks associated with development of TPI 287 include those that we are blocked or limited in the development of TPI 287 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 TPI 287 is delayed or terminated because the costs of further development exceed its value; and that the Company’s resources will be insufficient to continue 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, including its Quarterly Reports on Form 10-Q for the periods ended March 28, 2007, and June 27, 2007. The Company cautions investors not to place undue reliance on forward-looking statements. 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.
glink@tapestrypharma.comlilian@sternir.comtapestry@schwartz-pr.com
CONTACT: Gordon Link, Senior Vice President, Chief Financial Officer of
Tapestry Pharmaceuticals, Inc., +1-303-516-8500, glink@tapestrypharma.com;
or Investors, Lilian Stern of Stern Investor Relations, Inc.,
+1-212-362-1200, lilian@sternir.com; or Media, Andrea tenBroek of Schwartz
Communications, +1-781-684-0770, tapestry@schwartz-pr.com
