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Resverlogix Announces Two New Findings from the Phase 2b ASSURE Trial

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Resverlogix Corp. has announced two additional results from the ongoing analysis of its Phase 2b ASSURE clinical trial using intravascular ultrasound (IVUS) to study high-risk cardiovascular disease (CVD) patients for assessing benefits of RVX-208.

This lead molecule is a member of a new class of compounds that affects cellular epigenetics by specifically inhibiting a BET protein leading to enhanced apoA-I gene transcription and the creation of functional HDL particles for treating atherosclerotic CVD.

Since the completion of the ASSURE trial the continued analysis of the data have yielded two new findings that detail the effects of RVX-208 on vascular inflammation and virtual histology.

First, the data showed statistically significant improvements in coronary IVUS atheroma measurements and Major Adverse Cardiac Events (MACE) in patients with a high (>2.0 mg/dL) serum high sensitivity C-Reactive Protein (hsCRP).

Serum levels of this biomarker when >2.0 mg/dL reflect a heightened state of inflammation that is a well-known and major component of CVD risk. Patients with hsCRP>2.0 mg/dL at time of entry into ASSURE totaled n=184 of which n=54 were given placebo while n=130 received RVX-208. In the RVX-208 treated patients, there was a 60% reduction (p<0.0001) in hsCRP vs. baseline and (p=0.054) vs. placebo.

Furthermore atheroma regression was observed in patients treated with RVX-208 as measured by percent atheroma volume (PAV), total atheroma volume (TAV) regressed, and the worst 10mm TAV segment by -0.75% (p<0.03), -6.3mm3 (p<0.001) and -2.63mm3 (p<0.001), respectively vs. baseline.

Equally intriguing and perhaps more important is that in RVX-208 treated patients with hsCRP>2.0 mg/dL the incidence of MACE was lower by 63% (p=0.023) vs. placebo. The preceding observation is of value in that hsCRP of >2.0 mg/dL is well known to be clinically important in predicting CVD risk.

The second new observation arises from a pre-specified exploratory endpoint in ASSURE gathered using a new catheter (Volcano Revolution 45mghz) designed for radiofrequency analysis of the IVUS signal.

Data from this catheter reveals so called virtual histology IVUS (VH-IVUS), an emerging technology that is useful for assessing tissue characteristics of an atherosclerotic plaque. VH-IVUS data was analyzed to provide insight into vulnerability of an atherosclerotic plaque to rupture and its relationship to future cardiovascular risk.

In ASSURE, while all (n=323) patients were studied using IVUS, 87 of these were examined using the Volcano Revolution catheter to gather VH-IVUS information. This information was used to reflect plaque vulnerability by calculating the ratio of necrotic core to dense calcium (NC/DC) as established by Missel et al. (Am J Cardiol 2008; NC/DC ratio).

The NC/DC ratio in RVX-208 treated patients (n=61) was significantly lower by -7.5% (p<0.03) vs. baseline while those (n=24) given placebo had a non-significant reduction of -3.8% (p=0.47) vs. baseline.

The initial VH-IVUS findings show that the actions of RVX-208 improved the NC/CS ratio pointing to less vulnerability of the atherosclerotic plaque for rupture.

"The ongoing analysis of the ASSURE data continues to yield positive findings that provide valuable information as to the large market segment where RVX-208 will have the best impact in reducing CVD risk", stated Donald McCaffrey, President and Chief Executive Officer of Resverlogix.

"The addition of today's findings to the previously announced impact of RVX-208 to regress PAV (-1.43%, p=0.001) in ASSURE patients with low HDL-C given rosuvastatin further define a large high risk population where RVX-208 illustrates profound effects to reduce atheroma volume and plaque vulnerability. Together these findings help explain the observed reduction in MACE events. Continued analysis of the ASSURE data will not only broaden our understanding but also provide a clear pathway for our future clinical trials of RVX-208", said Mr. McCaffrey.

"We are delighted to see that RVX-208 had a pronounced effect in patients with established CVD, low HDL-C and a heightened state of inflammation" remarked Dr. Jan Johansson, Senior Vice President of Medical Affairs of Resverlogix.

"This is very useful information that will lead to a personalized medicine approach for patient selection in our future trials of RVX-208. The pathogenesis of atherosclerosis is known to involve a complex interplay between lipids and inflammation. Lessons learned from the exploratory ASSURE trial show us how to maximize the clinical benefits of RVX-208 in combating these factors as development of RVX-208 progresses", Dr. Johansson added.