TEL AVIV, Israel, Dec. 15, 2014 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company committed to the discovery, development and commercialization of first-in-class treatments for cancer and immune-inflammatory diseases, today announced that it has achieved completed dosing of the last patient in both of its Phase 2 studies evaluating the efficacy of lead Lecinoxoid compound VB-201 for the treatment of psoriasis and ulcerative colitis. Top line results from both studies are expected in the first quarter of 2015.
"We are excited to announce the last patients out of our two Phase 2 clinical trials, as this represents an important milestone in the development of our Lecinoxoid molecules for the treatment of chronic inflammatory diseases," said Dror Harats, M.D., chief executive officer of VBL. "We are hopeful that these studies support the potential of our novel approach, and confirm the promising safety and efficacy data shown to date. We look forward to reporting top line data from these studies in the months ahead."
The Phase 2 clinical trial in patients with psoriasis is a randomized, double-blind, placebo-controlled study in patients with moderate to severe plaque psoriasis, designed to evaluate the safety and efficacy of VB-201. Patients received 24 weeks of daily oral administration of 80 mg or 160 mg VB-201. This is the second Phase 2 clinical trial for VB-201 in psoriasis. In earlier studies, 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. Additional information regarding this study is available at: http://clinicaltrials.gov/ct2/show/NCT01837420.
The Phase 2 clinical trial in patients with ulcerative colitis is a randomized, double-blind, placebo-controlled study in patients with mild to moderate ulcerative colitis, also designed to evaluate the safety and efficacy of VB-201. Patients received 24 weeks of daily oral administration of 160 mg VB-201. Additional information regarding this study is available at: http://clinicaltrials.gov/ct2/show/NCT01839214.
About VB-201:
VB-201 is a proprietary, first-in-class, orally-available, disease-modifying medicine in development for the treatment of chronic immune-inflammatory diseases. VB-201 is the first product candidate to emerge from VBL's proprietary Lecinoxoid platform technology, which comprises a family of orally administered small molecules designed to modulate the body's inflammatory response by harnessing the ability of oxidized phospholipids to regulate and attenuate key immune-inflammatory signaling. VB-201 offers the potential to deliver long-term maintenance therapies in 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 achieved its primary endpoint, demonstrating a statistically significant reduction in vascular inflammation. Altogether, the compound has completed five clinical trials involving more than 400 subjects under U.S. IND applications. VB-201 has potential applicability across a range of inflammatory diseases, including atherosclerosis, psoriasis and inflammatory bowel disease.
About VBL:
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of first-in-class treatments for cancer and immune-inflammatory diseases. VBL Therapeutics' 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 that is initially being developed 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 was granted Fast Track designation by the FDA for prolongation of survival in patients with glioblastoma that has recurred following treatment with standard chemotherapy and radiation. VBL Therapeutics expects to begin the pivotal Phase 3 trial for VB-111 in rGBM in the first half of 2015, under a special protocol assessment agreement granted by the FDA. VBL Therapeutics' 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.
Forward Looking Statements:
This press release contains forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and the risk that historical clinical trial results may not be predictive of future trial results. A further list and description of these risks, uncertainties and other risks can be found in the Company's regulatory filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL Therapeutics undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.