June 20, 2014
VBL Therapeutics Announces Completion of Enrollment in Phase 2 Clinical Studies of VB-201 in Psoriasis and Ulcerative Colitis
TEL AVIV, Israel, June 20, 2014 (GLOBE NEWSWIRE) — VBL Therapeutics, a clinical-stage biotechnology company committed to the development of first-in-class treatments for immune-inflammatory diseases and cancer, today announced that it has completed enrollment of two Phase 2 studies evaluating the efficacy of lead Lecinoxoid compound VB-201 in psoriasis and ulcerative colitis. A total of 194 patients with psoriasis and of 112 patients with ulcerative colitis were enrolled in the study. The Company expects to report top line results from each of the studies in the first quarter of 2015.
“We are excited to announce the completion of enrollment in these two studies, as this represents an important step forward in our development of the Lecinoxoid family of small molecules for the treatment of chronic inflammatory disorders,” said Professor Dror Harats, M.D., Chief Executive Officer of VBL. “We are hopeful these studies will confirm the findings seen in patients to date, and affirm the potential of our novel approach.”
The Phase 2 clinical study in patients with psoriasis is a randomized, double-blind, placebo-controlled study in patients with moderate to severe plaque psoriasis, designed to evaluate the efficacy and safety of VB-201. The trial is being conducted at sites in Germany, Poland, Spain and Israel. This is the second Phase 2 trial for VB-201 in psoriasis. VBL recently completed a pilot double-blind, placebo-controlled Phase 2 trial in which VB-201 (administered at daily doses of 20 or 80 mg) was well-tolerated and showed statistically significant improvements across multiple measures of disease severity over a twelve-week period. Disease measures continued to improve throughout the study and did not reach a plateau at the study’s conclusion.
The Phase 2 clinical study in patients with ulcerative colitis is a randomized, double-blind, placebo-controlled trial with 24 weeks of daily oral administration of 160mg (80mg BID) VB-201. This trial is being conducted at centers in Poland, Bulgaria and Hungary, with central endocopic evaluation by BioClinica Inc. in Newtown, PA, USA.
VB-201 is a proprietary, first-in-class, orally-available, specific innate immunity disease modifying medicine in development for the effective treatment of chronic immune-inflammatory diseases. VB-201 offers the potential to deliver long-term maintenance therapies of a number of immune-inflammatory indications with a favorable safety profile. VB-201 has completed several Phase 2 studies in patients with moderate-to-severe psoriasis and a sub-study in patients with cardiovascular risk which have successfully achieved its primary endpoint demonstrating a statistically significant reduction in vascular inflammation. Altogether, the compound has successfully completed five clinical trials involving more than 400 subjects under U.S. investigational new drug (IND) applications. These trials demonstrated that VB-201 was well tolerated. VB-201 has potential applicability across a range of inflammatory diseases including atherosclerosis, psoriasis, and inflammatory bowel disease.
About the Lecinoxoid Platform:
VBL’s proprietary Lecinoxoid platform technology comprises a family of orally administered small molecules designed to modulate the body’s inflammatory response. Lecinoxoids are compounds that are structurally and functionally similar to naturally occurring molecules, known as oxidized phospholipids, which possess immune modulating anti-inflammatory properties, modified to enhance stability and activity. The Lecinoxoid platform technology seeks to harness the ability of oxidized phospholipids to regulate and attenuate key immune-inflammatory signaling.
Lecinoxoids mimic the structure of oxidize phospholipid molecules and are synthetically manipulated to increase their stability and ability to target specific receptors. Lecinoxoids have the potential to act on two specific mechanisms: the inhibition of cellular signaling cascades associated with the innate immune system, known as toll-like receptor, or TLR, signaling, and the inhibition of the migration of monocytes toward chemo attractants present in areas of inflammation.
VBL Therapeutics is a biopharmaceutical company committed to the discovery, development and commercialization of first-in-class treatments for cancer and immune-inflammatory diseases. VBL’s clinical pipeline is based on two distinct, proprietary platform technologies, an oncology program and an anti-inflammatory program, that leverage the body’s natural physiologic and genetic regulatory elements. The Company’s lead oncology product candidate, VB-111, is a gene-based biologic initially being developing for recurrent glioblastoma, or rGBM, an aggressive form of brain cancer. VB-111 has received orphan drug designation in both the United States and Europe and VBL expects to begin a Phase 3 pivotal trial for VB-111 in rGBM in the first quarter of 2015. VBL’s lead product candidate from its anti-inflammatory program, VB-201, is an oral small molecule currently being evaluated in Phase 2 clinical trials for psoriasis and for ulcerative colitis, with top line results expected in the first quarter of 2015.
For more information, please visit www.vblrx.com.
Paul Cox, Stern Investor Relations;
(212) 362 1200, firstname.lastname@example.org