Oncology News Updates
Curis Announces Dosing of First Patient in Phase I Clinical Trial of CUDC-101
Curis News Release
Aug 26, 2008
Curis, Inc., a drug development company focused on developing next generation proprietary targeted medicines for cancer treatment, today announced that the first patient has been treated in a Phase I clinical trial of CUDC-101, a first-in-class small molecule drug candidate that has been designed as an inhibitor of epidermal growth factor receptor (EGFR), epidermal growth factor receptor 2 (Her2) and histone deacetylase (HDAC). CUDC-101 has been designed to simultaneously inhibit kinase activity of EGFR and Her2 while also interfering with other key drivers of the cancer cell signaling network involved in tumor cell growth and survival through its HDAC inhibitory activity.
"We are very pleased to be participating in a trial with this promising new drug candidate," 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 preclinical data suggesting that CUDC-101 may have activity across a broad range of cancer types, particularly those that are resistant to currently marketed drugs. We look forward to exploring the potential of CUDC-101 in the clinic."
"This is an important milestone for the company as we focus on advancing our targeted small molecule drug candidates for cancer treatment into the clinic," said Curis President and CEO Dan Passeri. "We believe that CUDC-101's combination of clinically-validated cancer targets in a single agent may represent an important advance in targeted cancer therapy with respect to efficacy and safety. Moreover, single multi-targeted agents may have potentially significant cost advantages over multiple drugs with the same target 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 fourteen day cycle. The first patient enrolled in the Phase I study has completed five days of dosing. The primary objectives of the Phase I trial are to evaluate 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 will be to assess the pharmacokinetics, efficacy and ability 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 between 18 and 40 patients across several dose-escalating cohorts. Further trial details are posted at ClinicalTrials.gov.
About Curis' Targeted Cancer Drug Development Programs
The goal of Curis' targeted cancer drug development programs is to rationally design and develop novel, proprietary small molecules that target one or more clinically validated targets or pathways known to play 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 drug development platform, Curis has generated single agent, multi-target small molecules that are being designed to combine HDAC inhibition with suppression 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 have the potential to achieve best-in-class status among existing single target drugs. The first candidate to be selected from Curis' single targeted inhibitors is CUDC-305, an orally available, synthetic small molecule inhibitor of heat shock protein 90 (Hsp 90).
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