Health & Fitness
Health and Fitness
Health and Fitness
Fri, January 7, 2011
Thu, January 6, 2011
Curis Selects Dual Pi3 Kinase and HDAC Inhibitor CUDC-907 as Development Candidate
CAMBRIDGE, Mass.--([ BUSINESS WIRE ])--Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the Company has selected CUDC-907, an orally available, synthetic small molecule inhibitor of phosphatidylinositol-3-kinase (PI3K) and histone deacetylase (HDAC) as a development candidate from its targeted cancer programs.
"We expect to initiate IND-enabling studies for CUDC-907 shortly and following a favorable outcome, anticipate that we will file an IND application in late 2011."
"We are pleased to announce the addition of CUDC-907 to our growing proprietary portfolio of innovative targeted cancer development programs. We believe that this compound, along with previously selected candidates CUDC-101, our EGFR, Her2 and HDAC inhibitor that is currently in Phase Ib testing, and CUDC-305, an HSP90 inhibitor that we licensed to Debiopharm and is currently in Phase I testing, continue to provide validation of the quality of our science and our efforts for developing innovative next generation targeted cancer therapies against a wide range of cancer types,a said Curis President and CEO Dan Passeri. aWe expect to initiate IND-enabling studies for CUDC-907 shortly and following a favorable outcome, anticipate that we will file an IND application in late 2011.a
Activation of the PI3K signaling pathway is believed to play a crucial role in cancer development and progression. The inhibition of this pathway is currently extensively being investigated as a potential cancer therapy. However, primary or acquired resistance appears to present a major challenge to the success of inhibitors targeting the PI3K pathway due to the existence of redundant and compensatory pathways in cancer cells. Curis scientists believe that CUDC-907a™s synergistic inhibition of HDAC and PI3K may enhance anti-tumor activity and overcome these limitations through durable blockade of cancer networks as opposed to single target inhibition.
About CUDC-907
CUDC-907 is an orally bioavailable, multi-targeted small molecule that is designed to inhibit HDAC and PI3K, the combination of which Curis scientists believe have synergistic interaction against cancer cells. In vitro mechanism of action studies demonstrate that CUDC-907 is able to inhibit Class I PI3K and upregulate molecules involved in cancer cell death. CUDC-907 has also demonstrated the ability to suppress multiple nodes of other survival pathways as a result of the epigenetic modification resulting from the inhibition of its non-kinase HDAC target. By contrast, single-target PI3K inhibitors only target the primary PI3K survival pathway and reportedly have only limited effects on tumors with disregulation of other signaling pathways.
CUDC-907 displays high exposure and long half-life in tumor tissue after IV administration and is orally bioavailable in animals. CUDC-907 exhibits anti-proliferation activity against a broad range of cancer cell types in in vitro studies, including cell lines that are insensitive to single-target PI3K inhibitors. CUDC-907's anti-proliferation activity is up to 100-fold more potent than that of two leading PI3K inhibitors in development. CUDC-907 also inhibits tumor growth in preclinical xenograft models of hematology cancers and solid tumors with K-RAS mutations that are insensitive to Pi3K inhibitors, indicating that this compound may be more efficacious than other leading PI3K inhibitors currently in clinical development. This compound also displays a favorable safety profile in our early safety evaluation. Its synergistic mechanism of cancer signaling network disruption, efficacy in a number of preclinical xenograft models and favorable safety profile could translate into clinical advantages over single agents.
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 targeted small molecule drug candidates for cancer. Curis is building upon its previous experiences in targeting signaling pathways, including in the Hedgehog pathway, in its effort to develop proprietary targeted cancer programs. For more information, visit Curis' website at [ www.curis.com ].
Curis Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation the Companya™s belief that its approach to developing cancer drug candidates may represent a breakthrough in cancer therapy and that CUDC-907 may offer potential benefits as compared to single-targeted PI3K inhibitors. Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimatesa, aassumesa, "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 the actual results to be materially different from those indicated by such forward-looking statements including, among other things:
- Curisa™ collaborators, Genentech and Roche, may experience adverse results, delays and/or failures in their development program under collaboration with Curis. For example, Genentech and Roche may not be able to replicate in later trials any favorable safety and efficacy data from earlier trials of GDC-0449, or may otherwise fail to meet applicable regulatory standards for approval of GDC-0449.
- Curis may experience adverse results, delays and/or failures in its internal drug development programs, including with respect to its ongoing and planned clinical trials of CUDC-101, with respect to its efforts to advance CUDC-907 into Phase I clinical testing and with respect to its ongoing discovery research and preclinical studies of its other targeted cancer programs.
- Curisa™ collaborator Debiopharm may experience adverse results, delays and/or failures in its development program under collaboration with Curis. For example, Debiopharm may not be able to successfully advance Debio 0932 through its ongoing Phase I clinical trial as planned.
- Curis may experience difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through its collaborations.
- Curis may not be able to obtain or maintain the intellectual property protection necessary for the development and commercialization of drug candidates based on its technologies.
- Curis may not be able to obtain the substantial additional funding required to conduct research and development of its drug candidates.
- Curis may experience unplanned cash requirements, and may not receive additional anticipated payments under its collaborations, any of which could shorten the estimated period in which Curis will have cash to fund its operations and which could also adversely affect Curis' estimated operating expenses for 2011 and beyond.
- Curis faces risks relating to its ability to enter into and maintain planned collaborations for development candidates under its targeted cancer programs, its ability to maintain its current collaborations with Genentech/Roche and Debiopharm, and the risk that any such collaborators will not perform adequately or may terminate such collaborations on short notice and/or for circumstances outside of our control.
- Curis also faces other risk factors identified in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 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 Curis' 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.
