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Curis Announces Dosing of First Patient in CUDC-101 Phase Ib Expansion Trial

^{Published on 2010-08-03 11:05:30 - Market Wire}
 

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 first patient has been treated in a Phase Ib expansion study for CUDC-101 in patients with advanced head and neck, gastric, breast and liver cancers. CUDC-101 is a first-in-class small molecule drug candidate that has been designed as an inhibitor of histone deacetylase (HDAC), epidermal growth factor receptor (EGFR) and epidermal growth factor receptor 2 (Her2).

"The Phase Ib expansion trial is designed to target several tumor types that we believe may respond to CUDC-101 based on findings in our Phase I clinical trial and preclinical data, several published reports and clinical outcomes from other drugs that target HDAC, EGFR and Her2"

aWe are pleased to be participating in this trial with this promising new drug candidate,a commented Dr. John Nemunaitis, M.D., Executive Medical Director at the Mary Crowley Cancer Research Centers, and a principal investigator on the CUDC-101 phase Ib expansion trial. aThe preliminary data from the dose escalation phase I study is intriguing, with CUDC-101 having a favorable safety profile and interesting signs of clinical activity being observed, including a partial response in a patient with gastric cancer.a

aThe Phase Ib expansion trial is designed to target several tumor types that we believe may respond to CUDC-101 based on findings in our Phase I clinical trial and preclinical data, several published reports and clinical outcomes from other drugs that target HDAC, EGFR and Her2,a said Dan Passeri, Curisa™ President and Chief Executive Officer. aWe plan to initiate a Phase I/II clinical trial of CUDC-101 in head and neck cancer patients later this year and are currently working to formalize the design of this study. We are optimistic that the data from the Phase Ib expansion and the Phase I/II trials could generate additional important results as we continue to progress our CUDC-101 development efforts.a

About the Phase Ib Expansion Trial

The Phase Ib clinical trial expansion is designed as an open-label study in which a total of approximately 40 patients with advanced, refractory head and neck, gastric, breast and liver cancers are expected to be treated with CUDC-101 at the maximum tolerated dose of 275 milligrams per meter² at between 5 and 8 study centers in the United States. The primary objectives of this study are to compare the safety and tolerability of CUDC-101 in subjects with specific advanced solid tumors when the drug is administered either on a 5 days per week schedule (1 week on/1 week off) or on a 3 times per week schedule (3 weeks on/1 week off). The secondary study objectives include further evaluation of the pharmacokinetics and pharmacodynamic biomarkers following CUDC-101 administration and to assess the efficacy of CUDC-101 in this patient population.

About CUDC-101

CUDC-101 is designed as a first-in-class therapeutic to simultaneously inhibit HDAC, EGFR and Her2. In preclinical studies, CUDC-101 demonstrated the potential to inhibit all three molecular targets resulting in the potent killing of a wide range of cancer cell lines that are representative of a variety of human cancer types, many of which have demonstrated resistance to various approved targeted agents.

Curis-generated data suggest that CUDC-101a™s mechanism of action involves the sensitization of cancer cells to EGFR and Her2 inhibition through HDAC inhibition. CUDC-101 is designed to simultaneously inhibit both EGFR and Her2 at the receptor level while inhibiting downstream HDAC activity within the cancer cells. Despite the existence of other multi-targeted inhibitors, CUDC-101 is unique in its choice of targets, which may enable a synergistic attack on multiple nodes or points in the overall cancer pathway network that are used by tumors to survive, grow, and invade surrounding tissue. Utilizing the same targeted strategy with other currently available drugs would require combining two or three separate agents, which often have mismatched pharmacokinetic and distribution properties and often display additive dose limiting toxicities. In contrast, CUDC-101, as a single small molecule, may have the potential to act in the same cancer cells at the same time with fewer toxic side effects and thus potentially represents an important advance in targeted agent cancer therapy.

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 statements regarding the potential application of CUDC-101 as a treatment for a variety of cancer types, as well as its potential benefits and advantages over existing therapies; Curisa™ plans to initiate a Phase I/II clinical trial of CUDC-101 in head and neck cancer patients and the timing of such a trial; and the potential for important data to be generated from ongoing and planned studies of CUDC-101. 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, and with respect to its ongoing 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 2010 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 March 31, 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.