Cylene Pharmaceuticals, Inc, a San Diego-based, private biotechnology company, announced the expansion of their CX-4945 multiple myeloma related clinical trials late last week.Cylene Pharmaceuticals, Inc, a San Diego-based, private biotechnology company, announced the expansion of their CX-4945 multiple myeloma related clinical trials late last week.
Here is the first part of the press release from PRNewswire.com:
Cylene Initiates Phase I Trial in Multiple Myeloma With CX-4945 Inhibitor of CK2 and Closes Accompanying Financing
$12 million financing to be used for the expansion of CX-4945 clinical trials
SAN DIEGO, Sept. 24 /PRNewswire/ — 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.
Read the second half of the release by going to: Cylene Initiates Phase I CX-4945 Trial.
I don’t feel qualified to comment about any of this at this time. I will follow-up and keep everyone updated as I learn more.
Feel good and keep smiling! Pat