Cylene commences CX-4945 Phase I trial in multiple myeloma

Cylene Pharmaceuticals, Inc. announced today the initiation of a Phase I clinical trial of their first-in-class, oral CK2 inhibitor CX-4945 in patients with multiple myeloma. Cylene also announced the simultaneous closing of a $12 million financing with participation from existing investors including Sanderling Ventures, HBM BioVentures (Cayman) Ltd., Novartis BioVenture Fund, BioVentures Investors, Lilly Ventures, Mitsui & Co. and Morningside Venture Investments Ltd. Proceeds from the financing will be used to expand the human clinical trials program for CX-4945, including the Phase I trial in patients with multiple myeloma and a series of randomized Phase II trials.

The multi-center Phase I study with CX-4945 will be conducted in patients with relapsed or refractory multiple myeloma. The primary objectives of the study are to determine the safety, tolerance and pharmacokinetic (PK) properties of CX-4945 in multiple myeloma patients and to select the appropriate dose for Phase II trials. Secondary objectives are to investigate the pharmacodynamic (PD) activity of CX-4945 using mechanism and tumor-related PD biomarkers that have been validated in both preclinical and clinical studies. In preclinical studies with multiple myeloma cell lines, CX-4945 inhibited critical CK2-mediated events including key signaling pathways and mediators (PI3K/Akt, NFkB, IL-6) that are known to drive the proliferation of multiple myeloma. These findings, coupled with the need for new agents that target molecular pathways shared by all subtypes of multiple myeloma, highlight CX-4945 as a promising therapeutic agent for multiple myeloma.

A separate Phase I clinical trial in patients with solid tumors evaluating CX-4945 as an orally administered single agent has already established favorable pharmacokinetic and safety profiles. Measurement of mechanism and tumor-related biomarkers in patients established that CX-4945 hits the CK2 target and down-modulates the PI3K/Akt pathway. Together, the PK and PD data demonstrate that CX-4945 is achieving pharmacologically active levels in plasma and in tumor cells and elicits a clear pharmacodynamic response.

"Clinical advancement of our first-in-class CK2 inhibitor, CX-4945, in patients with multiple myeloma represents another major milestone for Cylene. Moreover, the accompanying financing enables us to support the clinical trials and the expansion of our pipeline with high quality candidates emerging from our internal drug discovery platform.  The financing also illustrates the enthusiasm our investors have for CX-4945 and our highly original drug discovery platform," said Dr. William G. Rice, President and CEO of Cylene Pharmaceuticals.

"Our firm invests in companies that have the potential to lead innovations critical to the needs of patients, possess strong management expertise, perform novel proprietary science coupled with a mechanistic understanding of target diseases, and are capital-efficient with the potential to deliver substantial returns to shareholders. Cylene certainly fits these parameters," said Dr. Reinhard Ambros, Executive Director of the Novartis Venture Funds and Director of Cylene.  "Cylene's clinical development efforts, led by Dr. Daniel Von Hoff, lead the industry in targeting CK2 with potent and selective inhibitors for the treatment of various forms of cancer. This combination of features makes Cylene an attractive and exciting investment."