>>Cyclacel Pharmaceuticals Initiates Phase I Study of CYC116 in Patients with Advanced Solid Tumors
Friday June 29, 12:41 pm ET
- First clinical trial with oral Aurora Kinase A/B and VEGFR2 inhibitor -
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP) announced today that the company has begun a multicenter Phase I pharmacologic clinical trial of CYC116, an orally-available inhibitor of Aurora kinases A and B, and VEGFR2, in patients with advanced solid tumors. The study will be conducted by Nithya Ramnath, M.D., Alex A. Adjei, M.D. and colleagues at Roswell Park Cancer Institute in Buffalo, New York, and Anthony Tolcher, M.D. and colleagues at South Texas Accelerated Research Therapeutics (START) in San Antonio, Texas. The study is the first of two clinical trials the company plans to begin this year to evaluate CYC116's potential in solid and hematological tumors.
The multicenter Phase I trial is designed to examine the safety and tolerability of CYC116 in patients with advanced solid tumors. The primary objective of the study is to determine the maximum tolerated dose. Secondary objectives are to evaluate the pharmacokinetic and pharmacodynamic effects of the drug and to document anti-tumor activity.
"CYC116 is a novel anticancer compound with a unique target profile involving both cell cycle and angiogenesis inhibition mechanisms. In preclinical studies, CYC116 has demonstrated antitumor activity in both solid tumors and hematological cancers," said Judy Chiao, Vice President of Clinical Development and Regulatory Affairs of Cyclacel.
"This study marks the entry of our third drug candidate into clinical development," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "The CYC116 program is part of our strategy to develop a portfolio of drugs that affect the cell cycle. Cyclacel's other development-stage programs include sapacitabine, an orally available nucleoside analog, in Phase II clinical trials for patients with advanced cutaneous T-cell lymphoma and in Phase I for patients with advanced leukemias or myelodysplastic syndromes and seliciclib, an orally-available CDK (cyclin dependent kinase) inhibitor, in a Phase IIb clinical trial for non-small cell lung cancer."
CYC116 was discovered in-house through Cyclacel's cancer drug discovery program. The research effort was led by Cyclacel's Chief Scientist, Professor David Glover, a world leader in the biology of mitosis and the discoverer of the Aurora kinase gene family.
About Aurora kinases and VEGFR2
Aurora kinases are a family of serine/threonine protein kinases that are critical to mitosis, the process of cell division. Aurora kinases are important for the progression through the M-phase of the cell cycle and are known to be over-expressed in a number of tumor types, including breast, colon, pancreas and bladder. Over-expression of Aurora kinases have been correlated with poor prognosis in these diseases.
VEGFR2 is a receptor protein that is part of the signaling pathways regulating angiogenesis, or blood vessel formation. Several drugs that block angiogenesis, including VEGFR2 inhibitors, have been approved for clinical use after showing safety and efficacy in the treatment of breast, colorectal, kidney and lung cancers.
CYC116 is the only targeted drug in clinical trials in patients with cancer that combines both anti-mitotic and anti-angiogenesis mechanisms.<<
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This one might be interesting. Sort of like EXEL stuff, but with a different mix of targets. Thanks for the thoughts; one cannot be reminded too often about the dangers of those uncontrolled open label trials. Do you happen to follow this; you seem to know when "randomized results" are "coming." Do you happen to know when? I'm just trying to get up to speed here.
TIA & Cheers, Tuck |
