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Resverlogix RVX-208 Second Clinical Trial Demonstrates Success on Key Reverse Cholesterol Transport Markers
Date:9/30/2009

ded our original expectation for enhancing ApoA-l production in humans," stated Donald J. McCaffrey, President and CEO of Resverlogix. "We know that the enhancement of ApoA-l and key RCT particles in the body is widely recognized by international experts as the necessary markers to potentially impact atherosclerosis regression. Hence, we have achieved another critically important clinical milestone for our Company," noted McCaffrey.

The Phase 1b/2a trial was a double blind safety and tolerance study which investigated the pharmacokinetics and also early pharmacodynamics effects of RVX-208. A total of 72 subjects enrolled in the trial. The study had three arms, a low dose arm with 24 subjects, a dose-escalation arm with 24 subjects, and a third high dose arm with 24 subjects. This trial also examined early markers for reverse cholesterol transport such as ApoA-l, HDL-c, pre-beta HDL and alpha HDL subparticles. Approximately half of the subjects had low levels of baseline HDL cholesterol.

Highlights from the study are as follows:

    -   The primary endpoint, plasma ApoA-I increase compared to placebo,
        achieved a range in all subjects of 5.1% - 10.4% in all doses at days
        8 and 28 respectively.
    -   At the lowest dose of 1mg/kg b.i.d. in subjects with low levels of
        HDL-c, plasma ApoA-l increases reached statistical significance of
        5.7% (p(less than)0.05) at day 8 and 7.8% (p(less than)0.05) at
        day 28.
    -   A critical RCT functionality marker, alpha-1 HDL particles,
        illustrated highly statistical significance with an increase of
        46.7% (p(less than)0.004), in all subjects and
        57.2% (p(less than)0.02) in the low dose arm over placebo at day 28.
    -   Pharmacokinetic parameters of RVX-208 were dose dependant with oral
        administration.
    -   RVX-208 was shown to be compatible with simvastatin (40mg).
    -   Seventy out of seventy two subjects completed the tria
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Resverlogix Corp.
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