Curis initiates CUDC-101 Phase I combination trial in advanced head and neck cancer

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 I combination trial of CUDC-101. The Phase I trial is the Company's first CUDC-101 combination study and is designed to test CUDC-101 when administered concurrently with radiation and cisplatin in human papillomavirus negative (HPV-) locally advanced head and neck cancer patients. CUDC-101 is a first-in-class small molecule drug candidate that has been designed as an inhibitor of epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (Her2) and histone deacetylase (HDAC).

The first patient was treated at the University of Colorado Cancer Center under the care of Antonio Jimeno, M.D., Ph.D. "We are excited to participate in this trial, which primarily aims to establish the optimal combination dose of CUDC-101 when combined with current standard of care radiation and cisplatin as well as to build on Curis' previous clinical observations in which signs of biological activity were observed with single-agent CUDC-101 in advanced head and neck cancer patients," commented Dr. Jimeno. "We believe that CUDC-101 is a potentially promising drug candidate in the head and neck cancer setting and we look forward to exploring the potential of CUDC-101 in combination with radiation and cisplatin in this study."

Dan Passeri, Curis' President and Chief Executive Officer, added, "This trial is significant for Curis as it provides the first combination study of CUDC-101 with other agents in a clinical setting, and it also advances the development of this molecule in a front-line indication that we believe is ideally-suited for CUDC-101. It has been shown that most head and neck cancers overexpress EGFR and that a portion of these tumors also overexpress Her2, both molecular targets of CUDC-101. Furthermore, CUDC-101 has demonstrated clinical activity in head and neck cancer in Curis' previous dose escalation and expansion studies. In addition, preclinical data suggests that HDAC inhibition, the third target of CUDC-101, can enhance the effects of both radiation and cisplatin therapy. A majority of head and neck cancers are HPV-, and patients with these tumors experience a poorer clinical outcome than patients whose tumors are HPV positive. We are pleased to have begun this important trial and we look forward to providing updates on our progress in the future."