-- Phase 2 Studies of VB-201 in Patients with Psoriasis and Ulcerative Colitis Did Not Meet Primary Endpoints --
-- Company to Continue Focus on VB-111 Development in rGBM with Phase 3 to Initiate in Mid-2015 --
TEL AVIV, Israel, Feb. 17, 2015 (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, today announced that its Phase 2 studies evaluating lead Lecinoxoid compound VB-201 in patients with psoriasis and ulcerative colitis did not meet their primary endpoints. The Company does not plan to continue development of VB-201 in these indications.
"We continue to focus on advancing VB-111 into Phase 3 for recurrent glioblastoma (rGBM). We believe that this drug candidate has significant potential as an anti-angiogenic agent for the treatment of cancer and we look forward to initiating the trial," commented Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We are disappointed by the outcome of these Phase 2 studies in psoriasis and ulcerative colitis. Immune-inflammatory conditions are difficult-to-treat diseases with a limited array of effective treatments. We were honored to work with an excellent team of clinical investigators and would like to thank the patients who participated in the clinical studies for these drug candidates."
In a simultaneous press release, VBL also announced today that the U.S. Food and Drug Administration (FDA) determined that VBL may proceed with a pivotal Phase 3 trial in rGBM and removed the clinical hold previously imposed on the study. VBL plans to initiate this trial in mid-2015 under a special protocol assessment with the FDA.
Psoriasis Study Details
This Phase 2 randomized, double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of VB-201 dosed at 80 mg or 160 mg daily for 24 weeks. The study evaluated 194 patients with moderate to severe plaque psoriasis. The primary efficacy endpoint of the study was PASI 50, or the proportion of patients who achieve at least 50 percent improvement from baseline PASI score, at weeks 16 and 24.
No effect of VB-201 compared to placebo was observed on the primary or secondary endpoints at either dose level tested. The PASI 50 for VB-201 patients was 26.4% at 16 weeks and 34% at 24 weeks, with no significant difference between the 80 mg and 160 mg dose cohorts. The placebo PASI 50 at week 16 was 38%.
Ulcerative Colitis Study Details
This Phase 2 randomized, double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of VB-201 dosed at 160 mg daily for 24 weeks. The study evaluated 112 patients with mild to moderate ulcerative colitis. The primary endpoint of the study was disease remission at weeks 12 and 24.
No statistically significant effect of VB-201 was observed compared to placebo on the primary or secondary endpoints. Remission rate for VB-201 was 10.5% at 12 weeks and 22.8% at 24 weeks, a meaningful improvement over week 12 (p=0.02). However, remission rate for the placebo arm was 15.1% at 12 weeks. The 7.7% difference of VB-201 over placebo was not statistically significant.
VB-201 was safe and well-tolerated in both trials. There were no drug-related serious adverse events.
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. 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 mid-2015, under a special protocol assessment agreement granted by the FDA.
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.