�Curis, Inc. (NASDAQ: CRIS), a drug development party focused on developing following generation proprietorship targeted medicines for cancer treatment, announced that the first patient role has been treated in a Phase I clinical trial of CUDC-101, a first-in-class low molecule drug candidate that has been designed as an inhibitor of epidermic growth factor receptor (EGFR), epidermal growth factor receptor 2 (Her2) and histone deacetylase (HDAC). CUDC-101 has been intentional to simultaneously inhibit kinase activity of EGFR and Her2 patch also meddlesome with other key drivers of the cancer cell signaling network involved in tumor electric cell growth and survival through its HDAC inhibitory body process.
"We are very pleased to be participating in a trial with this promising new drug campaigner," commented Dr. Anthony W. Tolcher, Director of Clinical Research at South Texas Accelerated Research Therapeutics (START), and lead investigator of the CUDC-101 Phase I trial. "This trial aims to build on presymptomatic data suggesting that CUDC-101 may have activity across a all-embracing range of cancer types, particularly those that ar resistant to currently marketed drugs. We look forward to exploring the potency of CUDC-101 in the clinic."
"This is an important milepost for the company as we focus on advancing our targeted small corpuscle drug candidates for malignant neoplastic disease treatment into the clinic," said Curis President and CEO Dan Passeri. "We believe that CUDC-101's compounding of clinically-validated cancer targets in a single agent may present an significant advance in targeted malignant neoplastic disease therapy with respect to efficacy and safety. Moreover, single multi-targeted agents may have potentially significant monetary value advantages over multiple drugs with the same butt profile."
The Phase I trial is designed as an open-label dose escalation study of CUDC-101 in patients with advanced, refractory solid tumors. CUDC-101 will be administered on days one to five of a xIV day bike. The outset patient enrolled in the Phase I study has completed five days of dosing. The primary objectives of the Phase I trial are to appraise the safety and tolerability of escalating doses of the Phase I molecule and to establish the maximum tolerated dose and dose limiting toxicities. Secondary objectives testament be to assess the pharmacokinetics, efficacy and power of CUDC-101 to inhibit HDAC, EGFR and Her2 in this patient population. The study is expected to be conducted at two sites within the United States and to enroll betwixt 18 and 40 patients across various dose-escalating cohorts. Further trial details ar posted at ClinicalTrials.gov.
About Curis' Targeted Cancer Drug Development Programs
The end of Curis' targeted crab drug development programs is to rationally design and develop novel, proprietary little molecules that target one or more than clinically validated targets or pathways known to wreak key roles in the development or maintenance of cancer. By focusing on these validated targets, Curis hopes to reduce risk, time and costs associated with the drug development process. Using its targeted cancer dose development platform, Curis has generated single agent, multi-target small molecules that are being intentional to aggregate HDAC inhibition with crushing of targets that include EGFR, Her2, VEGFR, BCR-Abl/Src, MET, CDK, Aurora, RAF and MEK, with a goal of potentially providing enhanced efficacy over existing drugs. The first developmental candidate selected from this multi-target program is CUDC-101, a first-in-class small molecule designed to inhibit EGFR, Her2 and HDAC. Curis is also using its targeted cancer drug development platform to design single agent, single-targeted drug candidates that it believes give the voltage to reach best-in-class condition among existing single object drugs. The first candidate to be selected from Curis' undivided targeted inhibitors is CUDC-305, an by word of mouth available, synthetic small molecule inhibitor of heat cushion protein 90 (Hsp 90).
About Curis, Inc.
Curis is a drug development company that is committed to leverage its innovative signaling pathway drug technologies to seek to make new targeted small molecule drug candidates for cancer. In expanding its dose development efforts in the field of cancer through its targeted cancer drug development chopine, Curis is building upon its old experiences in targeting signaling pathways for the maturation of next generation targeted cancer therapies. For more information, see Curis' internet site at hypertext transfer protocol://www.curis.com.
Cautionary Statement
This iron release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the expected benefits of CUDC-101, the planned development of drug candidates pursuant to the Company's targeted cancer drug development platform and the Company's plans for its form I trial run of CUDC-101 . The Company may use words such as "believes", "expects", "anticipates", "plans", "seeks", "estimates", "testament", "may" or similar expressions to identify these modern statements. There are important factors that may cause actual results to be materially dissimilar from those indicated by such forward-looking statements including, among other things, risks relating to: the potential for untoward results, delays and/or failures in the Company's targeted cancer drug development program, including without limitation unintentional delays and/or failures in its clinical trial of CUDC-101 and its ongoing preclinical studies of CUDC-305; the success of the Company's coaction with Genentech, including the risks that Genentech whitethorn experience untoward results, delays and/or failures in the Hedgehog pathway antagonist program currently below clinical development and that the Company may take no control over, or foreknowledge of, the advancement of this program; difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through the Genentech collaborationism; the Company's ability to obtain or maintain necessary intellectual property protection; inauspicious changes in the Company's ability to successfully action its business plan, including the Company's ability to obtain the substantial extra funding required for such execution; unplanned cash requirements and expenditures which, among other things, could shorten the estimated period in which the Company will have hard currency to fund its operations and which could also adversely dissemble the Company's estimated operating expenses for 2008 and beyond; risks relating to the Company's ability to enter into and maintain planned collaborations and maintain its stream collaborations with Genentech; and competitive pressures. The Company also faces other risk factors identified in the Quarterly Report on Form 10-Q for the quarter ended June 30, 2008 and former filings that it periodically makes with the Securities and Exchange Commission.
In addition, whatever forward-looking statements represent the Company's views only as of today and should not be relied upon as representing the views as of any subsequent date. Curis disclaims whatsoever intention or obligation to update whatever of the forward-looking statements after the date of this push release whether as a result of new information, future events or otherwise.
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