BOULDER, Colo., April 15 /PRNewswire-FirstCall/ -- Tapestry Pharmaceuticals, Inc. today announced the results of new preclinical studies of TPI 287 at the 2007 Annual Meeting of the American Association for Cancer Research (AACR). The data demonstrated that TPI 287, an orally available next-generation taxane, crosses the blood-brain barrier in rodents and demonstrates single agent activity and additive activity with temozolomide in an orthotopic model of glioblastoma. In addition, the drug demonstrated significant cytotoxic activity when administered either orally or intravenously.
"The treatment of glioblastoma with chemotherapeutic agents is hampered by the inability of most drugs to penetrate the blood-brain barrier sufficiently and deliver adequate drug exposure," commented Donald Picker, Ph.D., president of Tapestry Pharmaceuticals. "We are very encouraged by the preclinical data on rodent studies presented today as it demonstrates the ability of this unique taxane to cross the blood-brain barrier and to be orally bioavailable in murine models, which suggests the potential to treat tumors not responsive to the currently marketed taxanes."
The data were reported during a poster presentation entitled "TPI 287 crosses the blood brain barrier and contributes to antitumor activity in the U251 glioblastoma intracranial tumor model in nude mice" and showed that TPI 287:
-- Crosses the blood-brain barrier
Preclinical studies showed that TPI 287 accumulates in the brains of
rats and mice. After a single intravenous dose of 20 mg/kg of TPI 287,
the maximum drug concentration and area under the curve were several
fold higher than the corresponding plasma values, and the clearance of
the drug from the brain was slower than that found in plasma.
-- Is orally active
When TPI 287 was given orally in a flank model of glioblastoma, the
percent tumor growth inhibition of 91% was similar to that of
intravenous administration.
-- Increases the efficacy of temozolomide in glioblastoma
In an orthotopic brain xenograft study using the U251 glioblastoma cell
line, a combination of low dose TPI 287 with temozolomide proved to be
more efficacious than temozolomide alone, increasing the percent
increased life span from 380% for temozolomide alone to 650% for a low
dose of TPI 287 in combination with temozolomide (p = 0.046). TPI 287
alone showed activity that was statistically different from control but
not as active as temozolomide alone.
-- Demonstrates greater cytotoxic effect than other taxanes in
neuroblastoma
In the SK-N-FI neuroblastoma xenograft model, which is inherently
resistant to chemotherapy, TPI 287 was shown to be more active than
other taxanes. TPI 287 demonstrated 89% tumor growth inhibition,
higher than the tumor growth inhibition rates observed for paclitaxel
(13%), docetaxel (24%) and Abraxane(R) (38%).
About TPI 287
TPI 287 is a proprietary next-generation taxane being studied for the treatment of various forms of cancer. In preclinical testing, TPI 287 has demonstrated the ability to inhibit tumor cell growth in a number of in vitro cell lines. In some cell lines resistant to taxanes, TPI 287 has demonstrated greater inhibition of tumors 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 and 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, uterine and non-small cell lung cancer. Taxane resistant cell lines in which TPI 287 shows greater activity than standard comparative agents include lines derived from breast and colon cancer.
TPI 287 is currently in clinical studies in the United States. Tapestry plans to initiate multiple Phase II trials for TPI 287 in 2007.
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 web site at http://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" or comparable terminology or by discussions of strategy. Such forward-looking statements include the statements suggesting that TPI 287 may have utility in brain tumor treatment and to treat tumors not responsive to currently marketed taxanes, and that the Company plans to initiate multiple Phase II trials for TPI 287 in 2007. 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 Phase II 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 Annual Report on Form 10-K for the year ended December 27, 2006. 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.
Contact: Investor:
Tapestry Pharmaceuticals, Inc. Lilian Stern
Gordon Link Stern Investor Relations, Inc.
Senior Vice President, 212-362-1200
Chief Financial Officer
