Cylene Presents Encouraging Clinical Data for Oral CK2 Inhibitor at ASCO

SAN DIEGO, June 6, 2011 /PRNewswire/ -- 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."

About CK2 and CX-4945

Protein kinase CK2 has emerged as a validated drug target for cancer therapy due to its dysregulation and overexpression in tumors, and its regulatory roles in multiple oncogenic pathways including EGFR-regulated pathways, Akt and WNT signaling cascades, NF-κB transcription, angiogenesis, Hsp90 chaperone pathway and the DNA damage response. CK2 activity and levels are elevated in many cancers of diverse genetic background and this overexpression leads to a dependence on its continued expression and activity. Because CK2 is essential for cancer cell survival, is up-regulated in many different cancers and is not mutated, it is a cancer target ideally suited for the development of a dynamic combination agent.  Cylene's leadership in exploiting CK2 pathways for rational combination therapies identifies and enables numerous drug combinations for improved treatment outcomes.

CX-4945 is a potent and selective inhibitor of CK2 to which Cylene owns all IP. As a small molecule with drug-like physicochemical properties and ease of synthesis, it has flexible routes and schedules of administration. Preclinical data and the findings from the Phase I clinical trials have positioned CX-4945 for advancement to Phase II trials. The Phase II randomized drug combination trials are supported by compelling mechanistic rationales which guide selection of indications and shape trial designs. As such Cylene plans to initiate a trial with gemcitabine/carboplatin in ovarian cancer (DNA damage repair) and also a trial with erlotinib in NSCLC (EGFR pathway).

About Cylene Pharmaceuticals

Cylene Pharmaceuticals is a clinical stage private company designing and developing small molecule drugs against newly validated cancer targets.  Cylene's leadership in exploiting CK2 pathways enables rational drug combinations for improved treatment outcomes against many cancer indications.  The Company's Pol I program provides a non-genotoxic mechanism for activating p53 to kill cancer cells.  Cylene's unique approaches deliver innovative cancer agents that enable pharmaceutical companies to expand their portfolios and extend the efficacy, lifecycle and reach of current cancer therapeutics. For more information on Cylene and its programs, please visit www.cylenepharma.com.

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SOURCE Cylene Pharmaceuticals, Inc.

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