new class of drugs: cholesterol absorption inhibitors

From: Zee (zwalanga_at_yahoo.com)
Date: 02/02/05 

Date: 2 Feb 2005 14:15:54 -0800

http://www.rxpgnews.com/article_297.shtml

>>From rxpgnews.com

Pharmacology
Cholesterol Absorption Inhibitors: A New Class in Cholesterol-Lowering
Drugs May Serve as 'Statin Saviors'
By Akanksha,Pharmacology Correspondent
Feb 2, 2005, 08:18

Forbes Medi-Tech Inc.,today announced that it has commenced a 90-day
toxicity study for its cholesterol-lowering drug, FM-VP4. This study is
required to support an extended US Phase II human trial planned for
later this year.Results from an earlier 28 day European trial of FM-VP4
suggest that LDL cholesterol levels may continue to decrease when
FM-VP4 is given to patients for longer than 4 weeks and that optimal
efficacy may not have been achieved.

"The toxicity study is an important precursor to our US Phase II trials
for FM-VP4 and an opportunity to further demonstrate the drug's
positive safety profile," said Charles ***, President and CEO of
Forbes Medi-Tech Inc. "An excellent safety profile represents a
distinct advantage in potential therapies for cardiovascular and
related diseases."

FM-VP4 is a novel analogue representing a new class in
cholesterol-lowering drugs called cholesterol absorption
inhibitors.FM-VP4 has demonstrated dramatic cholesterol-lowering and
anti-atherosclerotic properties in pre-clinical studies.

The National Cholesterol Education Program (NCEP) ATP III guidelines in
the United States have been increased to include a significant number
of people with marginally high cholesterol.These people potentially
could achieve their treatment goals with a non-systemic, safe treatment
such as FM-VP4.

Almost 20%of the target population are hyper-absorbers of cholesterol
and cannot be effectively treated with statins.Intolerance to statins
based on drug interactions as well as both real and perceived safety
concerns further increase the market potential for FM-VP4.

The strength of a cholesterol absorption inhibitor,such as FM-VP4,will
likely be as a combination dosage form with statins.With a different
mechanism of action,the LDL cholesterol lowering effect of absorption
inhibitors may be additive when the drugs are used in combination with
statins.

A combination therapy may allow for a significant reduction in statin
dosage and hence may reduce the risk of dose dependent side
effects,without compromising efficacy.A cholesterol absorption
inhibitor-statin combination could essentially extend the patent life
of currently protected statins,or restore patent protection to generic
statins.For this reason,it has been suggested that a cholesterol
absorption inhibitor could serve as a 'statin savior'.

Preclinical studies indicate the FM-VP4 may be developed for other
indications that address a broader range of Cardiovascular disease
(CVD)risk factors,or Metabolic Syndrome X. This syndrome is of epidemic
proportions in the Western World,affecting 25%of the population, and
includes lipid and non-lipid risk factors such as abdominal obesity and
insulin resistance.

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