Liponex Reports Phase I/II Clinical Trial Data for CRD5
- Company Outlines Development Plans -
OTTAWA, Canada – March 7, 2007 – Liponex Inc. , 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.â€
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.â€
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 5grams 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.
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 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.