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Curis Presents CUDC-305 Preclinical Data at the AACR 100th Annual Meeting 2009

Orally available Hsp90 inhibitor demonstrates potent anti-cancer activity across solid and hematological preclinical cancer models

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr 22, 2009 - Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop proprietary targeted medicines for cancer treatment, today announced data provided in two presentations on the Company's Hsp90 development candidate, CUDC-305. These presentations were given by Curis scientists at the American Association for Cancer Research (AACR) 100th Annual Meeting 2009, which is being held in Denver, Colorado from April 18-22.

“The preclinical data for CUDC-305 continue to support seeking to advance the drug toward clinical testing. It has unique pharmacological properties and demonstrated efficacy in preclinical models across a diverse number of solid and hematological tumor types, which we believe indicates that it may have the potential for broad therapeutic use in multiple cancer indications, alone or in combination,” stated Dan Passeri, President and Chief Executive Officer. “As we continue our preclinical development of CUDC-305, we also are engaged in collaboration discussions with pharmaceutical and biotechnology companies and remain optimistic that we will consummate a partnering transaction for this asset in 2009.”

The first presentation entitled, "Antitumor activity of CUDC-305, a novel Hsp90 inhibitor, in solid and hematological tumor xenograft models," provides preclinical data in which CUDC-305 demonstrated potent anti-tumor activity in preclinical non-small cell lung cancer (NSCLC) models, including those containing mutations conferring resistance to marketed drugs. In addition to NSCLC, CUDC-305 demonstrated tumor regression in breast, colorectal and glioblastoma preclinical cancer models as a single agent or in combination with other targeted drugs or standard chemotherapeutics. The compound exhibited significant brain penetrability and also significantly enhanced survival in preclinical intracranial tumor models. CUDC-305 also demonstrated efficacy in preclinical hematological cancer models, inducing complete regression in an acute myloid leukemia model. Overall, the compound exhibited a favorable safety profile in these studies.

The second presentation, a poster entitled "A Novel Tumor-specific Hsp90 Inhibitor with Long Lasting Biological Activity,” reported that CUDC-305 exhibited significant potency against a broad range of solid and hematological tumor cell lines in anti-proliferation assays. The poster highlighted data demonstrating that CUDC-305 induced tumor regression in a subcutaneous xenograft model for glioblastoma. The poster also provided data demonstrating CUDC-305's favorable pharmacological profile in vitro, including a higher binding affinity to cancer chaperone complex and prolonged biological effects to cancer-associated Hsp90 client proteins. In addition, the presentation includes data indicating that the potency of the compound was unaffected by the expression level of a key mediator of drug resistance, the multi-drug resistance protein 1 (MDR-1). The compound displayed significant tumor retention of 20.5 hours and an oral bioavailability of 96%. With respect to safety, CUDC-305 demonstrated specificity for tumor cells over normal cells and was consistently well tolerated in animal models. The Company intends to continue to study CUDC-305 in preclinical studies and is optimistic that its findings may serve as the basis for an IND filing to commence a clinical trial of the drug under FDA guidelines in mid-2009.

About Hsp90

Hsp90 is a member of a class of proteins called molecular chaperones that play a fundamental role in the folding, stabilization and degradation of other cellular proteins, or clients, under normal or stressful conditions. Hsp90, in particular, has become an attractive therapeutic target for the treatment of cancer because a majority of its client proteins are involved in cellular signaling transduction and have been identified as potential contributors to various aspects of cancer cell growth and survival. Inhibitors of Hsp90 activity may be of therapeutic value if they can prevent Hsp90 proteins from protecting the particular client proteins involved in cancer and allow them to be degraded, thereby inducing cancer cell death.

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 for cancer. In expanding its drug development efforts in the field of cancer through its targeted cancer programs, 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

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 management's expectation that the Company may enter into a collaboration agreement for CUDC-305 in 2009 and its expectations regarding the potential safety, efficacy and broad therapeutic benefits of this compound in multiple cancer indications. 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 factors that may cause the actual results to be materially different from those indicated by such forward-looking statements including, among other things:

  • The Company may experience adverse results, delays and/or failures in its internal drug development programs, including without limitation unplanned delays and/or failures in its ability to further advance its drug candidates, CUDC-101 and CUDC-305, and any other of its targeted cancer programs. For example, further preclinical testing of CUDC-305 may produce inconsistent, negative or inconclusive results which could cause the Company to delay or terminate its planned IND application for this drug candidate. Moreover, the timing and completion of the Phase I clinical trial of CUDC-101 may be delayed or interrupted by a number of factors including difficulties in achieving and maintaining patient enrollment, undesirable side effects and toxicities caused by the drug candidate, and the Company's failure to achieve study objectives.
  • The Company's collaborator, Genentech, may experience adverse results, delays and/or failures in the Hedgehog pathway inhibitor program currently under clinical development and the Company may have no control over, or foreknowledge of, the progress of this program.
  • The Company may experience difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through its collaborations with Genentech.
  • The Company may not be able to obtain or maintain the patent and other proprietary intellectual property protection necessary for the development and commercialization of drug candidates based on its technologies.
  • There may be adverse changes in the Company's ability to execute its business plan.
  • The Company may not be able to obtain the additional funding required to conduct research and development of its drug candidates.
  • The Company may experience 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 2009 and beyond.
  • The Company faces risks relating to its ability to enter into and maintain planned collaborations for development candidates under its targeted cancer programs, including the risks that it may not successfully enter into a collaboration for CUDC-305, it may be unable to maintain its current collaborations with Genentech any such collaborators may not perform adequately.
  • The Company may experience competitive pressures.
  • The Company also faces other risk factors identified in the Annual Report on Form 10-K for the year ended December 31, 2008 and other filings that it 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 Company's 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.

Contact: Curis, Inc.
Michael P. Gray, 617-503-6632
Chief Financial and Chief Operating Officer


Posted: April 2009