Curis Announces Publication of CUDC-907 Data in Clinical Cancer Research

LEXINGTON, Mass., June 25, 2012 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), a drug development company seeking to develop proprietary targeted medicines for cancer treatment, today announced that the journal Clinical Cancer Research published an article on CUDC-907, an orally-available small molecule drug candidate that is designed to simultaneously inhibit PI3K and HDAC. The publication, titled "Cancer network disruption by a single molecule inhibitor targeting both histone deacetylase (HDAC) activity and phosphatidylinositol 3-kinase (PI3K) signaling," was authored by several members of Curis' scientific team and published online by Clinical Cancer Research. The article is expected to be published in the print version of the journal shortly.

"We are encouraged by the publication of CUDC-907 data in Clinical Cancer Research. We believe that these data support our development strategy for this molecule, under which we plan to initiate a Phase I clinical trial in patients with diffuse large B-cell lymphoma or multiple myeloma later this year," stated Dan Passeri, Curis President and Chief Executive Officer. "We developed CUDC-907 to target PI3K as well as HDAC, which is known to induce multiple epigenetic modifications affecting signaling networks and also to act synergistically with PI3K inhibitors. The objective of CUDC-907 is to provide for a broad disruption of several pathways that are implicated in hematologic malignancies in order to achieve a better outcome for patients."

The publication focused on CUDC-907's potential for further development in various cancers, particularly hematological cancers. The paper noted that CUDC-907 displays potent anticancer activity in both cultured cancer cells and xenograft models and that the molecule may offer therapeutic benefits in multiple cancers through broad signaling network disruption. For example, data show that CUDC-907 durably inhibits both the primary PI3K-AKT-mTOR pathway and also many compensatory signaling molecules that cancer cells often utilize to evade the efficacy of single target kinase inhibitors, including RAF, MEK, MAPK and STAT-3, among others. Curis scientists believe that
CUDC-907 may offer improved therapeutic benefit through this simultaneous, sustained disruption of multiple signaling pathways.

Curis' discovery and development efforts are focused on building a portfolio of small molecule network-targeted inhibitors against a wide range of cancer types. The leading compounds within Curis' research and development programs are designed to inhibit one or more cancer targets, including EGFR, Her2 and PI3K, as well as the inhibition of histone deacetylase, or HDAC, a validated non-kinase cancer target.
Each target combination is chosen for its potential of mechanistic synergy, offering a differentiated, potential breakthrough approach to cancer therapy, intended to disrupt cancer resistance networks.

About CUDC-907

CUDC-907 is a potent inhibitor of the Class I PI3K and Class I and II HDAC subtypes, the combination of which Curis scientists believe has synergistic interaction against cancer cells. CUDC-907 has demonstrated the ability to suppress multiple nodes of survival, proliferation and cell death pathways. In addition, preclinical data have shown that
CUDC-907 also inhibits compensatory pathways often utilized in cancer cells during the emergence of resistance to standard of care agents and induces apoptosis in treated cancer cells.

CUDC-907 exhibits anti-proliferation activity against a broad range of cancer cell types in in vitro studies, including cell lines that exhibit reduced sensitivity to single-target PI3K inhibitors.
CUDC-907's anti-proliferation activity has been demonstrated to be up to 100 times more potent than that of two leading PI3K inhibitors in development. The molecule outperforms both the combination of the commercially available HDAC inhibitor vorinostat plus the investigational pan-PI3K inhibitor GDC-0941, and the investigational delta isoform-specific inhibitor CAL-101 in all cell lines tested.

CUDC-907 also inhibits tumor growth in preclinical xenograft models of hematology cancers and solid tumors with K-RAS mutations that exhibit reduced sensitivity to known PI3K inhibitors, indicating that this compound may have broader activity than other leading PI3K inhibitors currently in clinical development. Based on its synergistic mechanism of cancer signaling network disruption, efficacy in a number of preclinical xenograft models and favorable preclinical safety profile, Curis is advancing CUDC-907 towards an IND filing later this year.

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 the Hedgehog pathway, in its effort to develop proprietary targeted cancer programs. For more information, visit Curis' website at www.curis.com.

The Curis, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=11347

Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding our estimated timeline for our filing an IND application for CUDC-907 and our belief that CUDC-907 may be more effective than other drugs. Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates", "assumes", "will", "may,"
"could" 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. For example, we may not successfully complete the preclinical studies and drug product manufacturing that are required to file an IND and begin Phase I clinical testing year, or at all. Curis also faces other important risks relating to its business, operations, financial condition and future prospects generally, that are discussed in its Quarterly Report on Form 10-Q for the quarter ended March 31,
2012 and other filings that it periodically makes with the Securities and Exchange Commission.

In addition, any forward-looking statements represent the views of Curis 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.


CONTACT: Michael P. Gray
Chief Financial and Chief Operating Officer
Curis, Inc.
617-503-6632
mgray@curis.com
 

Posted: June 2012

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