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Phase 2 VB-201 Trial Successful

By Drug Discovery Trends Editor | May 10, 2010

VBL Therapeutics 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. The 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 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.

Date: May 7, 2010
Source: VBL Therapeutics vblrx.com

 


Filed Under: Drug Discovery

 

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