First patient treated in Phase Ib expansion study of CUDC-101

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 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.”

"We are pleased to be participating in this trial with this promising new drug candidate," 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. "The 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."

"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," said Dan Passeri, Curis' President and Chief Executive Officer. "We 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."