Pacific Biomarkers Comments on Dramatic Benefits Reported for Experimental Cholesterol Drug Anacetrapib
Commenting on these findings, Amar A. Sethi, MD, PhD, Vice President of Research and Development at PBI, said that therapy focused on increasing HDL-C is highly warranted.
Online, November 22, 2010 (Newswire.com) - Pacific Biomarkers, Inc. (OTCBB: PBMC), a provider of biomarker laboratory services to the pharmaceutical, biotechnology and diagnostics industries, today announced that it has noted, with great interest, a study on the experimental cholesterol drug Anacetrapib and its ability to boost good cholesterol dramatically and drop bad cholesterol dramatically, soliciting renewed hopes for a different new way of preventing heart attacks, strokes and deaths.
The Anacetrapib study, led by Dr. Christopher Cannon of Brigham and Women's Hospital in Boston on behalf of Merck & Co., was reported at the American Heart Association's annual meeting. The drug works by lowering LDL-C ("bad cholesterol") similar to statins, and by increasing HDL-C ("good cholesterol") responsible for removing excess cholesterol from the bloodstream to the liver for disposal. The present six-month study, involving 1,623 people, reduced LDL-C levels from 81 mg/dL to 45 mg/dL in the treatment group (versus 82 mg/dL to 77 mg/dL in the placebo group) and increased HDL-C from 41 mg/dL to 101 mg/dL (versus 40 mg/dL to 46 mg/dL in the placebo group).
Commenting on these findings, Amar A. Sethi, MD, PhD, Vice President of Research and Development at PBI, said that therapy focused on increasing HDL-C is highly warranted. Currently available therapy, he said, relies on only one class of drugs called Niacin which, although efficient at increasing HDL-C levels, have side effects preventing clinicians from increasing dosage and boosting HDL-C up to a significantly beneficial value.
"The present study was necessary to perform for Merck after Pfizer-with a drug in the same drug class-was proven unsuccessful in reducing cardiovascular events due to off-target effects, which increased blood pressure. The results from this safety study were much awaited and will have a huge positive impact on the future of this class of drugs," Dr. Sethi said. "It is encouraging that the investigators have reported no changes in the test subjects' blood pressure or aldosterone levels. Although the 36% reduction in LDL-C and 138% increase in HDL-C reported in the study are astounding, this study is too small to definitively provide evidence for improved cardiovascular outcome." Thus, Merck has announced the initiation of a 30,000-patient study to finally determine whether this drug is able to reduce cardiovascular mortality and morbidity. This study will last for four years.
Dr. Sethi cautioned that current available data does not provide evidence whether the huge increase in HDL-C levels will translate into comparable definite protection against heart disease. The exact mechanism by which HDL protects against heart disease is still poorly understood. Ever since the failure of a previous drug, Torcetrapib, demand has surged for developing methods that can reliably assess the function of the HDL-C particle. Although the initial results from the Anacetrapib trial suggest a trend toward overall protection, more research is required. Future studies of Anacetrapib, said Dr. Sethi, should include analysis of the functional properties of the raised HDL-C.
About Pacific Biomarkers, Inc.
Established in 1989, PBI provides biomarker laboratory services and contract research services to support pharmaceutical and diagnostic manufacturers conducting human clinical trial research. PBI provides expert services in the areas of cardiovascular and musculoskeletal diseases, diabetes, obesity, and nutrition. The PBI laboratory is accredited by the College of American Pathologists, New York State, and the Lipid Standardization Program. PBI's clients include many of the world's largest pharmaceutical, biotech, and diagnostic companies. PBI also provides clinical biomarker services focusing on the emerging field of biomarker assay development and testing. Services include validating and performing custom assays for novel clinical biomarkers, immunogenicity testing, cell-based assays, mass spectrometry, and multiplex testing.
PBI is headquartered in Seattle, Washington, and its common stock trades on the OTC Bulletin Board under the symbol "PBMC".
For more information about PBI, visit PBI's website at www.pacbio.com.
