VBL Therapeutics, a clinical-stage biotechnology company committed to the development of novel treatments for immune-inflammatory diseases and cancer, announced the initiation of a phase 2 study to evaluate the efficacy and safety of its lead compound, VB-201, among patients with elevated high sensitivity C-reactive protein (hsCRP) who are currently taking statins.
hsCRP (a protein found in the blood, whose levels rise in response to inflammation) is an important inflammation-related biomarker for cardiovascular disease. Statins, used in patients at high risk for cardiovascular disease, are not always able to effectively control hsCRP levels, resulting in suboptimal control of patients’ inflammation and inadequate risk management.
“Current treatments for inflammatory diseases aim to reduce flare ups and can be very successful at treating these acute symptoms, but because they are often inappropriate for chronic use, there is a clear and compelling need for a safe, long-term oral control medication to treat these diseases,” said Bennett Shapiro, M.D., chairman of VBL. “This study will evaluate whether VB-201 can provide an additive anti-inflammatory effect in patients for whom statins alone are not enough and thus test the hypothesis that VB-201 can work as a long-term controller medication for inflammatory disease.”
The phase 2, double-blind, randomized, placebo-controlled, multi-site, dose-ranging study will enroll 320 patients 18 years of age and older who have elevated hsCRP levels and have been taking statins for at least three months. Patients will receive one of several doses of VB-201 or a placebo orally once daily for four weeks. The study will examine the effect of VB-201 on hsCRP and other inflammatory biomarker levels at a broad range of doses, allowing researchers to evaluate the relationship between dose and anti-inflammatory response. The study will also assess and characterize the safety and tolerability of VB-201.
“We are hopeful that this study will validate our belief that VB-201 has great promise as a long-term controller medication for inflammatory diseases, including atherosclerosis, which we have previously demonstrated in earlier stage research,” said Professor Dror Harats, M.D., chief executive officer of VBL. “Because VB-201 treats a specific target rather than broadly affecting the immune system, it has the potential to result in better patient outcomes with fewer side effects than currently available treatment options, and we expect this could make it appropriate for long-term, chronic use.”
VB-201 is the lead candidate in a novel family of anti-inflammatory compounds developed by VBL called Lecinoxoids. Preclinical and phase 1 studies have suggested that VB-201 has potential utility across multiple inflammatory diseases, including psoriasis, rheumatoid arthritis and atherosclerosis, and that it is safe and tolerable. Phase 1 results also suggest that long-term use could be appropriate. Currently, there is a major need for an oral, safe and efficient medication for long-term treatment of chronic inflammatory diseases.
Growing evidence suggests that chronic inflammatory diseases often eventually result in cardiovascular complications, including atherosclerosis. VB-201 has a unique profile and potential application for a range of inflammatory diseases, including atherosclerosis.
Date: December 21, 2010
Source: VBL Therapeutics