FDA Grants Orphan Status to Sirtris Drug
Food and Drug Administration Grants Orphan-Drug Status to Sirtris'
MELAS Syndrome Treatment
April 02, 2008: 09:00 AM EST

NEW YORK (Associated Press) - Sirtris Pharmaceuticals Inc. said
Wednesday that the Food and Drug Administration has granted orphan-
drug status to resveratrol, or SRT501, for the treatment of MELAS
syndrome, a fatal and progressive disorder.

The orphan-drug designation provides Sirtris with seven years of
marketing exclusivity upon FDA approval of the drug. The special
status was designed as an incentive for companies to develop
treatments for diseases affecting fewer than 200,000 people in the
U.S.

MELAS, which currently has no known treatments, stands for
mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke-
like episodes. The disease is caused by a mutation that leads to the
development of poorly functioning mitochondria, which supply cellular
energy.

Some of the earliest symptoms are muscle weakness, fatigue, recurring
headaches and seizures. As the disease progresses, patients experience
seizures, dementia, impaired muscular function and other signs of
neurological breakdown.

MELAS patients also have high glucose levels and about 30 percent have
Type 2 diabetes. Most patients first show symptoms between the ages of
5 and 15, although the age of onset can range from 3 to 40 years.

In preclinical testing, Sirtris said SRT501 was shown to increase the
number and function of mitochondria. In early human trials, the
company said the treatment was shown to be safe and well-tolerated.

The company expects data from an ongoing early trial involving 20
patients in the first half of 2009.

Sirtris plans to seek orphan drug status for SRT501 in Europe.

Sirtris gained 25 cents to $14.10 in premarket trading, after closing
on Tuesday at $13.85.

-------------------------

Researchers Show Resveratrol
Works In The Brain By Metal Chelating Effects

Researchers now convincingly show that, via its iron-chelating
effects, resveratrol is able to cross barriers that protect the brain
from entry of toxins (blood/brain barrier) and reduce oxidation
(spoilage) of fats and increase the activity of protective
antioxidant
enzymes in the brain of healthy rodents.  The research has
application
for age-related brain disorders such as Alzheimer's and Parkinson's
disease.

Resveratrol decreased malondialdehyde (an end product of oxidation
of
fats) in brain tissues by -300%.  Doses ranging (in human
equivalents)
from 87.5 to 875 milligrams were effective in this regard.  Higher
doses were not more effective.

Resveratrol also significantly increased the activity of antioxidant
enzymes superoxide dismutase, catalase and peroxidase by 160%, 270%
and 210% (see above chart).  The forms of most of these protective
enzymes were iron-controlling proteins, confirming that resveratrol's
primary action is via its ability to control metallic metals.  Loose
(free) iron causes tissue damage in all forms of age-related brain
disease.   While a relatively high dose of resveratrol was shown to
be
most effective (875 milligrams human equivalent dose), this was only
a
7-day study.  It is expected that a life-long accumulation of iron in
brain tissues will require a high loading dose and a lower
maintenance
dose.  The current fad of ultra-high dose resveratrol supplementation
may be beneficial initially, but lead to anemias over longer term
use.  -Resveratrol News April 2007

http://www.resveratrolnews.com/page77.htm

Who loves ya.
Tom

Jesus Was A Vegetarian!
http://tinyurl.com/2r2nkh

Man Is A Herbivore!
http://tinyurl.com/a3cc3

DEAD PEOPLE WALKING
http://tinyurl.com/zk9fk