CPI-613 begins Ph. II Trial Against MDS

Cornerstone Pharmaceuticals, Inc. has begun a Phase II trial of CPI-613, its lead Altered Energy Metabolism Directed (AEMD) drug candidate. The pilot study, sponsored by the Comprehensive Cancer Center of Wake Forest Baptist Medical Center, will evaluate the overall response rate for CPI-613 in patients with myelodysplastic syndrome (MDS) who have been unresponsive to previous therapies. Secondary endpoints include overall survival, progression-free survival, safety, and transfusion frequency.

Earlier this year, the Company announced the initiation of a Wake Forest Baptist-sponsored Phase I trial investigating the combination of CPI-613 with high dose cytarabine and mitoxantrone in relapsed or refractory acute meylogenous leukemia (AML) patients. Both of these trials have been launched following the encouraging results of a recently completed Phase I single agent trial of CPI-613 in patients with hematological malignancies.

CPI-613 is the lead drug candidate from Cornerstone’s proprietary AEMD platform. Cornerstone’s AEMD drug platform disrupts biochemical alterations in the conversion of glucose to energy that occur in many types of cancer cells. CPI-613 is currently being evaluated in Phase I, I/II and Phase II trials.