Keystone Symposium Highlights Positive Preclinical Data on Novel Immune Modulator

Data Demonstrate that VB-201 May Affect Development of Autoimmune Disease

TEL AVIV, Israel & KYOTO, Japan--(BUSINESS WIRE)--Jun 7, 2010 - VBL Therapeutics, a clinical-stage biotechnology company committed to the development of novel treatments for immune-inflammatory diseases and cancer, today announced preclinical data demonstrating that VB-201 regulates inflammatory pathways, suggesting that it may effectively control inflammatory responses associated with autoimmune diseases and atherosclerosis. These results were presented today at the Keystone Symposium on Bioactive Lipids: Biochemistry and Diseases in Kyoto, Japan by Eyal Breitbart, Ph.D., vice president of research at VBL.

VB-201 is the first in a new class of drugs and the lead candidate of several proprietary phospholipid analogs from VBL's proprietary Lecinoxoid family that were designed to be orally available, anti-inflammatory medicines. Oxidized phospholipids are abundantly generated in sites of inflammation and recent studies suggest that they may also exert anti-inflammatory activities.

“Today's data demonstrating that VB-201 has anti-inflammatory activity suggest that it may have utility in the treatment of a range of autoimmune diseases, including atherosclerosis, rheumatoid arthritis, multiple sclerosis, psoriasis and inflammatory bowel disease,” said Dr. Breitbart.

This study evaluated the anti-inflammatory activity of VB-201 both in vivo and in vitro. In vivo, the efficacy of VB-201 was tested in ApoE knock-out mice (mice unable to produce apolipoprotein E, a key glycoprotein essential for the transport and metabolism of lipids). In this validated atherosclerosis model, VB-201 reduced the burden of atherosclerosis.

Both in vitro and in vivo, researchers examined the effect of VB-201 on cytokine levels produced by activated mouse and human dendritic cells and on the migration of human and mouse monocytes toward a wide range of chemokines and inflammatory insults. The researchers found that VB-201 significantly inhibited the production of IL-12/23 common chain p40 by activated dendritic cells. VB-201 also impaired migration of monocytes toward several chemo-attractants and inflammatory insults.

“We are honored to have the opportunity to present this data on VB-201 at a meeting widely recognized as a forum for scientific dialogue,” said Professor Dror Harats, M.D., chief executive officer of VBL. “These data contribute to the growing body of knowledge about VB-201 and we look forward to the results of our ongoing phase 2 clinical trial in patients with psoriasis.”

The Keystone Symposium on Bioactive Lipids: Biochemistry and Diseases is a forum for scientists to share their progress in lipid mediators and the translation from model systems to an understanding of their role in human physiology, disease and drug action. Keystone Symposia are recognized as catalysts for advancing biomedical and life sciences by connecting scientists within and across disciplines in an environment conducive to information exchange, the generation of new ideas, and acceleration of applications that benefit society.

About VBL-201

VB-201 is the first in a new class of drugs and the lead candidate of several proprietary phospholipid analogs from VBL's proprietary Lecinoxoid family that were designed to be orally available, anti-inflammatory medicines. VB-201 is believed to act by inhibiting the production of the pro-inflammatory cytokines IL-12/23p40 by dendritic cells and macrophages. VB-201 acts as a counterbalance to the pro-inflammatory immune system activity that occurs in chronic disorders without significantly affecting system-wide immune factors, and is well-positioned to either work as a standalone or a combined therapy.

VB-201 has successfully completed four Phase 1 clinical trials involving 120 subjects under a U.S. investigational new drug (IND) application. These Phase 1 trials demonstrated that VB-201 was well tolerated with a favorable safety profile. Preclinical studies indicate that VB-201 has significant potential to treat inflammation in chronic diseases such as psoriasis, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and also found to bring about regression of atherosclerosis. VB-201 is currently being evaluated in a Phase 2 efficacy and safety study for the treatment of patients with psoriasis.

About VBL Therapeutics

VBL Therapeutics is an innovative, clinical-stage biotechnology company committed to the development of novel treatments for immune-inflammatory diseases and cancer. VBL has pioneered the Lecinoxoid class of oral anti-inflammatory agents and VB-201 is the lead candidate from this program, which has entered Phase 2 clinical development in patients with psoriasis. In addition, VBL has a proprietary Vascular Targeting System (VTS™) technology platform that has yielded VB-111, the first dual-action, anti-angiogenic and vascular disruptive agent (VDA) for cancer, which is expected to enter Phase 2 clinical trials in 2010. The company was founded in 2000 and is based in Tel Aviv, Israel. VBL has more than 60 granted patents and more than 115 patents pending. For more information on the company, please visit www.vblrx.com.

 

Contact: Pure Communications
Dan Budwick, 973-271-6085

 

 

Posted: June 2010

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