- Company Outlines Development Plans -
OTTAWA, March 7 /CNW/ - Liponex Inc. (TSX:LPX), a biopharmaceutical
company specializing in developing advanced products related to High Density
Lipoprotein (HDL), often called "good cholesterol," today announced results of
the Phase I/II Clinical Trial of its lead product, CRD5. CRD5 is being
developed for the treatment of dyslipidemia and heart disease. Results showed,
to date, that CRD5 was safe and that the drug formulation was stable
throughout the trial. However, the mean increase in HDL levels from the
baseline, in both the 1 and 3 gram dosages was less than 5% and not
statistically significant. The patient to patient variation was high and while
some patients showed a strong increase in HDL, other patients had negative
response. The Company will continue to assess the data from this trial over
the next several weeks.
"This trial data did not meet expectations consistent with the efficacy
data seen in earlier preclinical and clinical studies. However the trial
provided us with important information to continue development and we remain
confident that this compound is still a viable drug candidate in a hugely
attractive market space," said Bill Dickie, President and CEO of Liponex. "At
this point, we can best add value by continuing our formulation development
work, culminating in a second Phase I/II trial with results anticipated in
early 2008. The goal of this trial will be to finalize a formulation and dose
level for a U.S. FDA submission to advance clinical development."
With cash and short-term investments of approximately $6 million as of
December 2006, Liponex believes it has adequate financial resources to
complete this trial without the need for additional funding.
"Optimizing the oral delivery of lipid-based drugs to consistently give
efficacy is complex but, based on our evolving understanding of the
bioavailability of CRD5, we believe that we may be able to develop a superior
formulation that could lead to improved efficacy," said Dr. Dan Sparks,
founder and CSO of Liponex. "What we have learned from this trial and from our
ongoing research and development programs, has already resulted in a new
formulation patent filing."
The single-blinded Phase I/II dose ranging trial enrolled 56 dyslipidemic
patients, including patients with both low HDL and high LDL. Following a
dietary lead in period, patients were given daily doses of CRD5 in capsule
form. In this trial, 50 patients completed placebo; 49 patients completed the
1 gram dose; 38 patients completed the 3 gram dose; and 11 patients completed
the 5 gram dose. The primary endpoints for the trial were safety and an
increase in serum HDL, with triglyceride and LDL reductions as secondary
endpoints. After receiving and reviewing a letter from the Principal
Investigator of CRD5's Phase I/II trial in January 2007, the Company suspended
patient treatment at the highest dose level of 5 grams per day. The
modification to the trial was based on the incidence of gastrointestinal
adverse events that resulted in an unacceptable high level of patient
withdrawal from the highest dose group.
A conference call is planned for 5 p.m. ET, on Wednesday, March 7, 2007
to which participants may listen via an audio webcast, accessible through the
Company website at www.liponex.ca or via telephone. The telephone conference
number is 416-644-3428 or toll free at 1-800-588-4942. The conference call
will be archived for replay until March 14, 2007 at midnight. To access the
archived conference call, dial 416-640-1917 or 1-877-289-8525 and enter the
reservation number 21222455 followed by the number sign.
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 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.
For further information:
For further information: Investor Relations, Joanna Longo, The Equicom
Group Inc., (416) 815-0700 ext. 233, firstname.lastname@example.org; Media Relations,
Linda Forrest, inmedia Public Relations, (613) 234-7227 ext. 234,