Navigation Links
FDA Grants Resverlogix Approval to Commence a Phase 1 Clinical Trial for RVX-208
Date:12/10/2007

New class of ApoA-I/HDL drugs to reverse atherosclerosis enters the clinic

TSX Exchange Symbol: RVX

CALGARY, Dec. 10 /PRNewswire-FirstCall/ - Resverlogix Corp. ("Resverlogix") (TSX:RVX) announced today that it has received approval by the US Food and Drug Administration (FDA) to initiate a Phase 1a clinical trial of oral RVX-208 in the USA. RVX-208 is a novel first-in-class small molecule that increases the production of ApoA-I and HDL. ApoA-I is regarded as the critical cardioprotective protein for the treatment of cardiovascular diseases.

The Phase I clinical trial is taking place at a leading US contract research organization. The trial consist of three arms, an ascending single dose, a fed and fasted dose effect study, and a 7-day ascending multiple dose that will enroll a total of 70-80 healthy volunteers. The primary objective of the trial is to evaluate oral RVX-208 in healthy adult subjects for safety, tolerability, and pharmacokinetics. Results from this Phase 1a trial will be used for optimizing dosing for future trials including our Phase 1b trial.

Gregory S. Wagner, PhD, Senior Vice President, Preclinical Development of Resverlogix, stated that, "RVX-208 possesses a very favorable pharmacological and pharmaceutical profile. This compound is an excellent choice to be the first drug candidate from our preclinical pipeline, our research and development team has worked aggressively to rapidly advance it into clinical development."

"This field has been developing for 50 years. In multiple human and animal studies over-expression or repeated infusion of ApoA-I inhibit progression and induce regression of atherosclerosis in both animals and humans," stated Dr. Jan Johansson, MD, PhD. Senior Vice President of Clinical Affairs of Resverlogix. "We have identified a way to increase the endogenous production of ApoA-I via a small molecule drug. The initiation of this clinical trial is a milestone for the field of ApoA-I research," confirmed Dr. Johansson.

"Clearance of our investigational new drug application from the US Food and Drug Administration was a major accomplishment for our company; however, beginning the clinical assessment is, to date, Resverlogix's most important milestone," said Mr. Donald McCaffrey, President and CEO of Resverlogix. "We are thrilled to expedite the RVX-208 clinical program during 2008 illustrating its clinical benefit to treat atherosclerosis disease. To be able to increase ApoA-I and functional HDL with a novel small molecule in humans represents not only the next major milestone for our Company, but also for cardiovascular patients worldwide," Mr. McCaffrey added further.

About Cardiovascular Disease (CVD)

CVD can be generally defined as any abnormal condition characterized by dysfunction of the heart and blood vessels. CVD includes atherosclerosis (especially coronary heart disease which can lead to heart attacks), cerebrovascular disease (stroke), and hypertension (high blood pressure). The underlying cause of most CVD is a gradual clogging of the arteries (atherosclerosis) that supply blood to the heart, brain and other vital organs.

The American Heart Association estimates that almost 80 million American Adults have one or more types of cardiovascular disease. CVD remains the number one killer of developed nations. Nearly 2400 Americans die each day from cardiovascular disease - that is 1 person will die every 36 seconds.

About Resverlogix Corp.

Resverlogix Corp. is a leading biotechnology company engaged in the development of novel therapies for important global medical markets with significant unmet needs. The NexVas(TM) program is the Company's primary focus which is to develop novel small molecules that enhance ApoA-I. These vital therapies address the grievous burden of atherosclerosis and other important diseases such as acute coronary syndrome, diabetes, Alzheimer's and other vascular disorders. The Company's secondary focus is TGF-Beta Shield(TM), a program that aims to address burgeoning grievous diseases, such as cancer and fibrosis. Resverlogix Corp. trades on the Toronto Stock Exchange (TSX:RVX). For further information please visit http://www.resverlogix.com.

This news release may contain certain forward-looking statements that reflect the current views and/or expectations of Resverlogix Corp. with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly. The TSX Exchange does not accept responsibility for the adequacy or accuracy of this news release.


'/>"/>
SOURCE Resverlogix Corp.
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Mirus Bio Awarded Grants & Contracts of Over $5 Million
2. FDA Grants Orphan Drug Designation to TREANDA, an Investigational Treatment for Chronic Lymphocytic Leukemia
3. Anesiva Grants Specific-Use License of Its Needle-Free Drug Delivery Technology to Particle Therapeutics for Diabetes Drug
4. NIH grants $750,000 to develop device to determine temperature of neonates brain
5. Edwards Lifesciences Grants UC Irvine $5 Million to Establish the Edwards Lifesciences Center for Advanced Cardiovascular Technology
6. Radius Grants Major Pharmaceutical Company Exclusive Option to License BA058 for Osteoporosis
7. Poniard Pharmaceuticals Announces European Commission Grants Orphan Medicinal Product Designation to Picoplatin for Treatment of Small Cell Lung Cancer
8. CV Therapeutics Reports Option Grants Under Nasdaq Marketplace Rule 4350
9. NASDAQ Panel Grants Merge Technologies Additional Time to Regain Compliance
10. Resverlogix Presents Key Apo-Al/HDL Scientific Data at DALM
11. Resverlogix is Presenting at IAS HDL Workshop
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... the Netherlands and LAGUNA HILLS, Calif. ... The Institute of Cancer Research, London ... use MMprofiler™ with SKY92, SkylineDx,s prognostic tool to risk-stratify patients ... trial known as MUK nine . The University of ... trial, which is partly funded by Myeloma UK, and ICR ...
(Date:10/11/2017)... Florida (PRWEB) , ... October 11, 2017 , ... ... Drug Administration (FDA) has granted orphan drug designation to SBT-100, its novel anti-STAT3 ... for the treatment of osteosarcoma. SBT-100 is able to cross the cell membrane ...
(Date:10/10/2017)... ... October 10, 2017 , ... ... FirstHand program has won a US2020 STEM Mentoring Award. Representatives of the FirstHand ... Excellence in Volunteer Experience from US2020. , US2020’s mission is to change the ...
(Date:10/10/2017)... 10, 2017 SomaGenics announced the receipt of ... develop RealSeq®-SC (Single Cell), expected to be the first ... (including microRNAs) from single cells using NGS methods. The ... to accelerate development of approaches to analyze the heterogeneity ... "New techniques for measuring levels of mRNAs in individual ...
Breaking Biology Technology:
(Date:3/29/2017)... , March 29, 2017  higi, the health IT ... North America , today announced a ... the acquisition of EveryMove. The new investment and acquisition ... of tools to transform population health activities through the ... data. higi collects and secures data today ...
(Date:3/27/2017)... N.Y. , March 27, 2017  Catholic ... Information and Management Systems Society (HIMSS) Analytics for ... EMR Adoption Model sm . In addition, CHS ... of U.S. hospitals using an electronic medical record ... for its high level of EMR usage in ...
(Date:3/24/2017)... Research and Markets has announced the addition of the ... Forecast to 2025" report to their offering. ... The Global Biometric Vehicle Access System ... over the next decade to reach approximately $1,580 million by 2025. ... forecasts for all the given segments on global as well as ...
Breaking Biology News(10 mins):