Encouraging data from Cylene CX-4945 Phase I dose-escalation trial presented at ASCO 2011

Cylene Pharmaceuticals, Inc. today announced the presentation of encouraging data from an ongoing Phase I dose-escalation trial of CX-4945 in patients with solid tumors at the 2011 American Society of Clinical Oncology (ASCO) annual meeting held on June 4-8 in Chicago, IL. Dr. Robert Marschke, the Principal Investigator from Front Range Cancer Specialists, Fort Collins, CO, presented clinical data highlighting the safety, pharmacokinetic (PK) and exposure-related pharmacodynamic (PD) responses observed in the Phase I trial.

CX-4945 is an orally delivered small molecule that inhibits the protein kinase CK2, a target ideally suited for rational drug combination therapy as it promotes multiple oncogenic pathways, and targeting CK2 represents a dynamic new approach for the treatment of cancer.

"Findings from the phase I clinical trials of CX-4945, an orally available inhibitor of CK2", was presented during a General Poster session on Monday, June 6, from 8am-12pm at McCormick Place Hall A. The results featured safety observations, and the extensive PK and PD measurements analyzed throughout the dose-escalation trial. These data establish that CX-4945 safely modulates the CK2 and downstream pathway biomarkers in an exposure-related manner. Inhibiting CK2 produces measurable biological effects, as evidenced by reductions in IL-6 and IL-8 levels and circulating tumor cells (CTCs).  During the study 20% of evaluable patients had disease stabilization for at least 16 weeks, with 67% of these patients remaining on-study for at least half a year. Together, these findings establish that the first-in-class CK2 inhibitor, CX-4945, is a promising therapeutic agent for targeting multiple cancers, supporting its advancement into randomized Phase II combination trials.

"We are delighted to unpack such positive clinical data at ASCO. CX-4945 has a favorable safety profile, has demonstrated linear PK, and clearly modulates the expected markers and pathways in patients. The data Cylene is presenting establishes, for the first time, that targeting CK2 in humans is both a safe and viable strategy for treating many cancers," commented William G. Rice, PhD, President and CEO of Cylene Pharmaceuticals. "The success of these trials allows us to explore the unprecedented combinability provided by a CK2 inhibitor in the Phase II setting, where we expect our strategy of rational, mechanism-based combination to deliver robust patient benefit."