Curis Announces Preclinical Efficacy Data for CUDC-101 at AACR Annual Meeting 2008
"As the medical community seeks to customize therapeutic treatments to particular cancers based on what is known about disease etiology, we believe that CUDC-101 is a promising therapeutic for the treatment of liver cancer because its mechanism of action specifically targets biological networks that are believed to be directly involved in this type of cancer," commented Dan Passeri, President and Chief Executive Officer. "Provided that CUDC-101 successfully initiates and completes Phase I clinical testing and subsequently progresses into Phase II clinical trials, we currently anticipate that liver cancer would be a potential indication in such Phase II testing."
The presentation provided preclinical data supporting the potential of a promising new multi-targeted small molecule drug candidate, CUDC-101, as a therapeutic for liver cancer. In addition to inhibiting EGFR, CUDC-101 simultaneously inhibits the related receptor, Her2, and histone deacetylase (HDAC). Published reports have demonstrated a correlation between liver cancer development and abnormal HDAC expression. Based on data generated internally and by outside third parties, the combination of HDAC and EGFR/Her2 inhibition may be synergistic, meaning that HDAC inhibition sensitizes tumor cells to the effects of EGFR inhibition and suppresses several components of the resistance pathways that compensate for EGFR blockade.
The poster highlighted the potent cancer cell killing effects of CUDC-101 in several liver cancer cell lines, with twelve- to eighteen-fold enhancement in potency over the combination of a marketed HDAC inhibitor and EGFR inhibitor. Data from preclinical liver cancer animal models demonstrated CUDC-101's ability to effectively induce tumor growth inhibition or regression while maintaining a favorable safety profile. The animal models also included comparisons of CUDC-101 to marketed HDAC or EGFR inhibitors.
An effective treatment for liver cancer remains a significant unmet need. The American Cancer Society estimates that there will be over 18,400 deaths in the United States attributed to liver cancer in 2008, with close to 21,400 new cases of liver cancer diagnosed. The World Health Organization further estimates that there are over 660,000 deaths a year worldwide that are attributable to this cancer. In published reports, researchers at the Massachusetts General Hospital have recently provided compelling evidence that aberrant signaling of the epidermal growth factor (EGF) and its receptor (EGFR) play a key role in the development of liver cancer. Although drugs that specifically inhibit EGFR signaling have been developed and marketed, none have yet been approved for the treatment of liver cancer.
About Curis, Inc.
Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new medicines, primarily for cancer. In expanding its drug development efforts in the field of cancer through its targeted cancer drug development platform, Curis is building upon its previous experiences in targeting signaling pathways for the development of next generation targeted cancer therapies. For more information, visit Curis' website at www.curis.com.
Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation: statements regarding Curis' belief that CUDC-101 may be tested in liver cancer in potential future Phase II clinical trials, should Phase II testing of CUDC-101 ever occur. Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates", "will", "may" or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements including, among other things:
-- adverse results, delays and/or failures in the Company's internal product development programs, including without limitation unplanned delays and/or failures in the Company's efforts to file an investigative new drug application and further advance its product candidate, CUDC-101, and the other programs under its targeted cancer drug development platform;
-- adverse results, delays and/or failures in the Hedgehog pathway antagonist program currently under clinical development by the Company's collaborator, Genentech, for which the Company may have no foreknowledge and over which the Company will have no control;
-- difficulties or delays in obtaining or maintaining required regulatory approvals for products being developed by the Company internally and through its collaboration with Genentech;
-- Curis' ability to obtain or maintain the patent and other proprietary intellectual property protection necessary for the development and commercialization of products based on its technologies;
-- changes in, or Curis' inability to execute, its business plan;
-- the risk that the Company does not obtain the substantial additional funding required to conduct research and development of its product candidates;
-- unplanned cash requirements and expenditures which, among other things, could shorten the estimated period in which the Company will have cash to fund its operations and which could also adversely affect the Company's estimated operating expenses for 2008 and beyond;
-- risks relating to the Company's ability to enter into and maintain important strategic collaborations, including its current collaboration with Genentech, and the risk that any such collaborators will not perform adequately;
-- competitive pressures; and
-- other risk factors identified in the Annual Report on Form 10-K for the Year ended December 31, 2007 and other filings that the Company periodically makes with the Securities and Exchange Commission.
In addition, any forward-looking statements represent the views only as of today and should not be relied upon as representing the views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise.
Michael P. Gray, 617-503-6632
Chief Financial Officer
Posted: April 2008