Contact Information: Contact information: Thomas D. Ingolia CEO Email Contact: Email Contact 480-385-3800
HEPI Pharmaceuticals, Inc. Announces Initiation of U.S.-Based Clinical Trial of ProAlgaZyme to Corroborate Previous Clinical Trial Results in Metabolic Syndrome
Trial Will Study Potential Effect of ProAlgaZyme on Cholesterol and C-Reactive Protein Levels
| Source: HEPI Pharmaceuticals, Inc.
SCOTTSDALE, AZ -- (MARKET WIRE) -- March 22, 2007 -- HEPI Pharmaceuticals, Inc., a wholly owned
subsidiary of Health Enhancement Products, Inc. (OTCBB : HEPI ), announced
today that an Institutional Review Board (IRB) has granted approval to
initiate a clinical study of the potential effects of ProAlgaZyme on
Metabolic Syndrome patients. The double-blinded, placebo-controlled study
will be conducted by MAPS Applied Research Center, Inc., a research firm
based in Edina, Minnesota, U.S.A. This study is designed to build on the
results of a recently completed study of ProAlgaZyme in which statistically
significant improvements (p=0.05 or lower) were seen in key prospective
markers in Metabolic Syndrome patients, including C-reactive protein down
57% in the ProAlgaZyme group vs. down 7% in the placebo group; total
cholesterol down 32% in the ProAlgaZyme group vs. down 2% in the placebo
group, and HDL ("good cholesterol") levels up 41% in the ProAlgaZyme group
vs. down 7% in the placebo group. Results from this new study are expected
to be received in September 2007.
The coordinator for the clinical trial will be Dr. Terence Pertile, a
research scientist at MAPS Applied Research Center. Dr. Pertile commented,
"We are pleased to be asked to conduct this study. ProAlgaZyme is an
interesting product and the data we obtain should help focus its potential
use in the marketplace." Thomas Ingolia, CEO of HEPI Pharmaceuticals,
added, "We are delighted to be able to work with a highly competent and
credible research facility, MAPS Applied Research Center, and are looking
forward to receiving the result of this trial, which we anticipate will
corroborate the previously announced results, which were very encouraging."
About Metabolic Syndrome, Cholesterol, and C-Reactive Protein
Metabolic Syndrome, also called Syndrome X, is a collection of symptoms
including metabolic and lipid imbalances. It is estimated that the
condition afflicts about 1 in every 4 persons in the U.S., and as high as 4
out of every 10 individuals aged 60 and above. According to the American
Heart Association, Metabolic Syndrome is associated with obesity and Type
II Diabetes. Cardiovascular risk is associated with the imbalances in
cholesterol levels and ratios often seen in the syndrome, including
elevated total cholesterol and low ratios of HDL ("good cholesterol") to
LDL. Another marker associated with cardiovascular risk is C-Reactive
Protein (CRP), a blood marker that according to the American Heart
Association is elevated in patients with systemic inflammation and can be
used as an indicator of cardiovascular risk, with low, moderate and high
cardiovascular risk assigned to ranges of CRP.
About ProAlgaZyme and HEPI Pharmaceuticals, Inc.
ProAlgaZyme is a nutraceutical product which is manufactured using only
pure, all-natural ingredients. ProAlgaZyme is a liquid product produced
from algae grown in 100% distilled water. The liquid in which the algae are
grown is drawn off, filtered, tested and bottled as ProAlgaZyme. HEPI
Pharmaceuticals, Inc., a wholly owned subsidiary of Health Enhancement
Products, Inc., is focused on development of pharmaceutical opportunities
represented by ProAlgaZyme.
Except for any historical information, the matters discussed in this press
release contain forward-looking statements within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. These forward-looking statements involve risks and
uncertainties. A number of factors could cause actual results to differ
from those indicated in the forward-looking statements, including the
timing of completion of a trial, actual future clinical trial results being
different than the results the company has obtained to date, our inability
to obtain regulatory approvals necessary to market and sell PAZ as a
pharmaceutical, and the company's ability to secure funding, including for
the subsidiary's pharmaceutical development of PAZ. Such statements are
subject to a number of assumptions, risks and uncertainties. Readers are
cautioned that such statements are not guarantees of future performance and
that actual results or developments may differ materially from those set
forth in the forward-looking statements. The company undertakes no
obligation to publicly update or revise forward-looking statements, whether
as a result of new information or otherwise.
For more information, please visit www.heponline.com.