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 clinical study of CUDC-907 in patients with relapsed or refractory lymphoma or multiple myeloma. CUDC-907 is an orally-administered first-in-class small molecule drug candidate that has been designed as a dual inhibitor of phosphatidylinositol-3-kinase (PI3K) and histone deacetylase (HDAC). As a result of this clinical advance, Curis is entitled to receive an additional $350,000 in milestone payments under the terms of its agreement with The Leukemia and Lymphoma Society (LLS).
“We're very pleased to announce the initiation of the CUDC-907 Phase I clinical study in patients with advanced hematological cancers,” said Dan Passeri, Curis' President and Chief Executive Officer. “The synergistic effects of targeting PI3K and HDAC with CUDC-907 have shown very potent antitumor activity in preclinical models of lymphoma and multiple myeloma. We are hopeful that CUDC-907 will demonstrate an adequate safety profile and also provide clinical activity in this study population. We look forward to seeking to advance this important molecule through this Phase I dose escalation study and further clinical trials.”
“LLS is pleased that Curis has met this significant milestone,” said Richard Winneker, Ph.D, LLS senior vice president of research. “Initiating this first human clinical trial for this drug candidate is a major advance, and we are hopeful that this therapy could yield promising outcomes for patients with lymphomas and multiple myeloma, who are often in critical need of new treatment options.”
This clinical trial is designed as a standard dose escalation study in which CUDC-907 will be orally administered to patients with relapsed or refractory lymphoma or multiple myeloma at up to four study centers in the United States. The primary objectives of the study are to determine the maximum tolerated dose and recommended oral dose of CUDC-907 for Phase II study. The secondary objectives of this study are to assess safety and tolerability, to assess pharmacokinetics, to evaluate biomarker activity and to assess preliminary anti-cancer activity of CUDC-907 in this patient population.
In the absence of dose limiting toxicity, each patient will receive oral CUDC-907 once daily for a minimum of 21 days of continuous daily dosing (1 cycle), and may continue to receive additional cycles of study treatment until disease progression or other treatment discontinuation criteria are met. Additional details about this study can be found on clinicaltrials.gov (NCT01742988).
