Liponex Inc. Reports Phase I/II Clinical Trial Data for CRD5

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Liponex Inc., a biopharmaceutical company specializing in developing advanced products related to High Density Lipoprotein (HDL), often called 'good cholesterol,' announces 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.

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.