May 7, 2010
VBL Therapeutics Announces Positive Preclinical Data for VB-201 against Psoriasis — First in New Class of Orally Available Anti-Inflammatory Compounds

FOR IMMEDIATE RELEASE

 

Media Contacts:

 

Dan Budwick, Pure Communications

973-271-6085

 

Jenna Conley, Pure Communications

215-684-9476

 

 

 

VBL Therapeutics Announces Positive Preclinical Data for VB-201 against Psoriasis – First in New Class of Orally Available Anti-Inflammatory Compounds

– Data Presented at 2010 Society for Investigative DermatologyAnnual Meeting –

 

TEL AVIV, Israel, May 7, 2010 – VBL Therapeutics today announced positive preclinical results evaluating VB-201 for the treatment of psoriasis. VB-201 is a first-in-class, orally administered immune response modifier expected to reduce inflammation by targeting key pro-inflammatory cytokines. Today’s data suggest that VB-201 has significant anti-inflammatory properties that are active against psoriasis; an ongoing Phase 2 efficacy and safety study is currently evaluating VB-201 for the treatment of patients with psoriasis.These results were presented today at the 2010 Society for Investigative Dermatology (SID) Annual Meeting, in Atlanta, Ga., by Eyal Breitbart, Ph.D., vice president of research at VBL.

 

 

VB-201 is the lead candidate of several proprietary phospholipid analogs from VBL’s proprietary Lecinoxoid platform. Recent studies have indicated that oxidized phospholipids can downregulate the production of pro-inflammatory cytokines by mature dendritic cells. VB-201 acts by inhibiting the production of pro-inflammatory cytokines interleukin (IL)-12, IL-23 shared p40 sub-unit, which have been clinically shown to be involved in the pathogenesis of psoriasis.

 

 

“These data demonstrate the potential of VB-201 against psoriasis, a chronic, progressive autoimmune disease that can be physically debilitating and significantly impact patients’ quality of life,” said Dr. Breitbart.

 

 

This study evaluated the efficacy of VB-201 in a validated preclinical model of psoriasis (mouse xenotransplantation of human skin model). Mice were divided and treated orally for 14 days with VB-201 or placebo, or with topical dexamethasone, serving as positive control. The study evaluated the histological features of the psoriasiform and measured skin thickness. Researchers found that while nine out of 10 mice who received placebo expressed psoriasiform, only four out of 10 mice expressed psoriasiform when treated with 4 mg/kg of VB-201, and five out of 10 mice expressed psoriasiform when treated with 0.04 mg/kg of VB-201. Seven out of 10 mice treated with dexamethasone saw a complete recovery.

 

 

“The data presented today highlight VB-201’s profile as a first-in-class, oral anti-inflammatory drug candidate, and differentiate it from other compounds in development to treat psoriasis. Our team is excited to present these findings at this prestigious scientific meeting, and we look forward to further evaluating VB-201’s clinical relevance in our ongoing Phase 2 trial,” said Professor Dror Harats, M.D., chief executive officer of VBL.

 

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 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 and 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 Psoriasis

 

Psoriasis is a chronic, progressive autoimmune disease with debilitating physical and quality-of-life consequences for patients. World Health Organization estimates indicate that more than 125 million people suffer from psoriasis worldwide, with more than seven million patients in the United States. Psoriasis is characterized by inflamed, swollen, scaly patches of skin. It can be limited to a few spots or can involve more extensive areas of the body, appearing most commonly on the scalp, knees, elbows and body. Currently, there is no cure for psoriasis.

 

The psoriasis market was worth $2.4 billion in 2008 and expected to exceed $4 billion in 2015. The biologics created over $1 billion sales in 2008 across the seven major markets, contributing 55 percent of the psoriasis market. While advances have been made in the treatment of psoriasis over the last decade with the advent of biologics, many of these treatments require subcutaneous injection by patients, often have serious side effects (e.g., infections, malignancies, progressive multifocal leukoencephalopathy), and are cost prohibitive for a number of patients and payers. There remains a significant, unmet need for a safe, effective, oral treatment option for psoriasis.

 

About VBL Therapeutics

 

VBL Therapeutics is an innovative, clinical-stage biotechnology company committed to the development of novel treatments for immuno-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 55 granted patents and more than 115 patents pending. For more information on the company, please visit www.vblrx.com.