Following disappointing results from a Phase II trial, Cerulean Pharma is reducing its workforce by approximately 48%, to a total of 23 employees. This workforce reduction is designed to reduce operating expenses while the company refocuses its clinical strategy for CRLX101.
CRLX101, the company’s lead candidate, was being evaluated in patients with advanced renal cell carcinoma (RCC). A total of 115 patients received either CRLX101 in combination with Avastin or investigator's choice of standard of care (SOC) therapy. SOC agents included axitinib, bevacizumab, everolimus, pazopanib, sorafenib, sunitinib, and temsirolimus.
The study demonstrated no statistically significant difference in median progression-free survival (PFS) and objective response rate for the CRLX101 combination compared to SOC. Median PFS was 3.7 months for the CRLX101 combination compared with a median PFS of 3.9 months for SOC.
“We are disappointed with this outcome and will undertake a thorough analysis of the data to understand why CRLX101 plus Avastin underperformed compared to the results we saw in an earlier investigator-sponsored trial,” said Christopher D.T. Guiffre, president and CEO of Cerulean. “This outcome did not support our hypothesis that targeting hypoxia-inducible factor (HIF) in combination with vascular endothelial growth factor (VEGF) inhibitor in RCC, a HIF-overexpressing tumor type, would be beneficial, so we will not pursue HIF as a target going forward.”
Cerulean expects the reduction in force to result in approximately $5 million in reduced expenses once the plan is fully implemented.