Liponex Inc. Reports Phase I/II Clinical Trial Data for CRD5
Liponex Inc. 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 High density Lipoprotein (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.
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