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Liponex Develops
Improved Formulation of CRD5
New formulation of primary drug
candidate shows significant improvements in efficacy at lower doses
OTTAWA, ON – September 6, 2005 – Liponex Inc. (LPX-T), a
biopharmaceutical company specializing in developing advanced products related
to High Density Lipoprotein (HDL), often called "good cholesterol," today
updated the status of formulation work on its lead drug candidate, CRD5. The new
CRD5 formulation, which is planned for use in its upcoming Phase II clinical
trial, demonstrated a significant increase in bioavailability and efficacy in
animal models, which will translate into considerably lower doses for evaluation
in future human clinical trials.
"This is an important step forward in the development of CRD5," said Bill Dickie,
President and CEO of Liponex. "Increased efficacy and lower dosing will improve
the commercial appeal of CRD5 and should allow Liponex to develop a product with
a more patient friendly dosing regimen, comprising of as little as one pill a
day."
The new formulation, which includes a small amount of a well accepted
non-medicinal ingredient commonly used in food and drug products, demonstrated a
very significant increase in HDL protein (APO A1) levels in rat models at doses
more than eight times lower than with the unformulated material.
Liponex has taken steps to protect the IP around the new formulation, filing a
new patent in the United States, strengthening the company’s existing portfolio
of issued and pending patents. Formulation work is ongoing and Liponex intends
to further enhance the product and IP portfolio.
Liponex recently received approval from Health Canada for a Clinical Trial
Application (CTA) to initiate a Phase II trial for CRD5 covering a lower range
of doses than those used in the Phase I trials. Liponex now intends to submit an
amendment to the recently approved CTA incorporating the new formulation for use
in the Phase II clinical trial scheduled to begin in early 2006. The Phase II
dose-ranging trial will take place in Ottawa and enroll about 50 dyslipidemic
patients (patients with low HDL and high Low Density Lipoprotein (LDL)). The
dosing data obtained from this trial will be used to determine an optimal dose
for use in a second Phase II trial to assess the efficacy of CRD5.
About CRD5
CRD5 is being developed to treat and prevent heart disease by increasing the
level of HDL in the blood and controlling the actions of HDL in the body. It is
well established that statin therapy to reduce LDL, the so-called "bad
cholesterol," results in a 25% reduction in the risk of developing heart
disease. By treating LDL and HDL together, the risk may be reduced by up to 90%.
CRD5 is derived from soybean extract and has a novel mechanism of action. It was
demonstrated to be safe and showed indications of efficacy in raising HDL in
three completed Phase I clinical trials.
About Liponex
Liponex is a biopharmaceutical company specializing in developing products
related to High Density Lipoprotein (HDL), often called "good cholesterol." Its
drug candidates relate to the various roles of HDL as a transport vehicle,
including removing excess cholesterol from the body, delivering molecules to
cells and removing unwanted materials from the body. Liponex recently completed
its IPO, raising gross proceeds of $11.5 million and is listed on the TSX under
the ticker "LPX". For more information on Liponex, visit
www.liponex.ca .
Certain of the statements contained in this press release contain
forward-looking statements which involve known and unknown risks, uncertainties
and other factors which may cause the actual results, performance or
achievements of the Company, or industry results, to be materially different
from any future results, performance or achievements expressed or implied by
such forward-looking statements. The Company does not expect to update
forward-looking statements continually as conditions change. Investors are
referred to the full discussion of risk factors associated with the Company's
business contained in the Company's periodic regulatory filings, which can be
found in the SEDAR database at www.sedar.com
.
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For further information, or to arrange for interviews, contact:
Liponex Inc.
Linda Woods
inmedia Public Relations
(613) 234-7227 ext 234
lwoods@inmedia.com
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