Data Published in Journal of Neuroimmunology Suggest Anti-Inflammatory Role for Lead VBL Therapeutics Compound in CNS

Preclinical Data Suggest VB-201 May Delay Onset and Severity of Multiple Sclerosis

TEL AVIV, Israel--(BUSINESS WIRE)-- VBL Therapeutics, a clinical-stage biotechnology company committed to the development of novel treatments for immune-inflammatory diseases and cancer, today announced the publication of preclinical data in the Journal of Neuroimmunology finding that its lead development candidate VB-201 significantly delayed the onset and severity of experimental autoimmune encephalomyelitis (EAE) in mice, the commonly used Multiple sclerosis (MS). These data further elucidate VB-201’s mechanism of action and, for the first time, suggest an anti-inflammatory role of VB-201 in central nervous system (CNS) diseases including MS. The article appears in the September 14, 2010 issue of the journal.

VB-201 is a phospholipid analog and the first in a new class of drug candidates called Lecinoxoids, which have been rationally designed to be orally available anti-inflammatory medicines. The published data detail studies performed by VBL to better understand VB-201’s properties and explore its potential use as a treatment for MS and other CNS autoimmune diseases.

The researchers tested the ability of VB-201 to protect against the development of EAE. With a statistically significant difference between control and groups dosed with 0.04 and 0.4 mg/kg of VB-201, the data demonstrated that orally administered VB-201 prevented the development of EAE and inhibited the ability of adoptive T-cells to cause EAE. These data suggest that VB-201 and other oxidized phospholipids may play an anti-inflammatory role in CNS autoimmune diseases.

“We are excited by these results, which suggest that VB-201 may have potential to treat MS, a disease in serious need of treatment options,” said Professor Dror Harats, M.D., chief executive officer of VBL. “We are currently evaluating VB-201 in a Phase 2 clinical trial to treat psoriasis, and it has also demonstrated anti-inflammatory activity in rheumatoid arthritis, inflammatory bowel disease and atherosclerosis. We believe that these published data both broaden the clinical utility of VB-201 and suggest its potential as a chronic therapeutic option in the future. The results of this study will continue to inform our clinical strategy and help advance our mission to create treatments for life-threatening diseases inadequately addressed by current therapies.”

About VB-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 work either as a standalone or a combined therapy.

VB-201 has successfully completed four Phase 1 clinical trials involving 120 healthy 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 suggest VB-201 could 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. VB-201 is the company’s lead candidate from this program, currently in 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 is based in Tel Aviv, Israel. VBL has 62 granted patents and more than 115 patents pending. For more information on the company, please visit www.vblrx.com.



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