VBL Therapeutics to Provide an Update on the OVAL Phase 3 Registration Enabling Study of VB-111 in Ovarian Cancer at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting
VBL Therapeutics announced a significant update regarding the OVAL Phase 3 clinical trial of VB-111 in platinum-resistant ovarian cancer, which will be presented at the ASCO Annual Meeting. The trial is on track to enroll about 400 patients, comparing the efficacy of VB-111 combined with paclitaxel to a placebo with paclitaxel. VB-111 has previously shown promise in clinical studies and has received several designations for its potential benefits in cancer treatment.
- OVAL trial remains on track for its primary endpoint, overall survival.
- VB-111 has shown activity signals in Phase 1 and Phase 2 studies.
- Trial collaboration with GOG Foundation enhances credibility.
- No assurance that OVAL trial will meet its primary endpoint upon completion.
- Uncertainties remain regarding clinical trial results and financial resources.
TEL AVIV, Israel, May 20, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced that a poster providing an update on the OVAL Phase 3 registration enabling clinical trial of VB-111 in ovarian cancer will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting.
“We are encouraged by the continued progress of the OVAL clinical trial, which remains on track,” said Dror Harats, M.D., CEO of VBL Therapeutics. “The poster will provide an important update on the trial.”
Title: Clinical Trial in Progress: Pivotal Study of VB-111 Combined with Paclitaxel vs. Paclitaxel for Treatment of Platinum-Resistant Ovarian Cancer (OVAL, VB-111-701/GOG-3018)
Authors: Arend, R.C., et al.
Session: Gynecologic Cancer
Session type: Poster Session
Abstract: 5599
About the OVAL study (NCT03398655)
OVAL is an international Phase 3 randomized pivotal registration enabling clinical trial that compares a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum resistant ovarian cancer. The study is planned to enroll approximately 400 patients. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies.
About VB-111 (ofranergene obadenovec)
VB-111 is an anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is a unique biologic agent that uses a dual mechanism to target solid tumors. Its mechanism combines blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission. VB-111 has also received orphan drug designation in both the US and Europe, and fast track designation in the US, for prolongation of survival in patients with recurrent glioblastoma. VB-111 demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970).
About VBL
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for areas of unmet need in cancer and immune/inflammatory indications. VBL Therapeutics has developed three platform technologies: a gene-therapy based technology for targeting newly formed blood vessels with focus on cancer, an antibody-based technology targeting MOSPD2 for anti-inflammatory and immuno-oncology applications, and the Lecinoxoids, a family of small-molecules for immune-related indications. VBL Therapeutics’s lead oncology product candidate, ofranergene obadenovec (VB-111), is an investigational, first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is currently being studied in a VBL Therapeutics-sponsored Phase 3 potential registration trial for platinum-resistant ovarian cancer.
Forward Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements may include, but are not limited to, statements regarding VBL Therapeutics’s programs, including VB-111, and their clinical development, therapeutic potential and clinical results. 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, the risk that historical clinical trial results may not be predictive of future trial results, that financial resources do not last for as long as anticipated, and that VBL Therapeutics may not realize the expected benefits of its intellectual property protection. In particular, the DSMC recommendation that the OVAL trial proceed is not assurance that the trial will meet its primary endpoint of overall survival once completed, or that VBL Therapeutics will obtain positive results to support further development of this candidate. A further list and description of these risks, uncertainties and other risks can be found in VBL Therapeutics’s regulatory filings with the U.S. Securities and Exchange Commission, including in its annual report on Form 20-F for the year ended December 31, 2020, and subsequent filings with the SEC. 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.
CONTACT:
Burns McClellan for VBL Therapeutics
Lee Roth (investors) / Ryo Imai (media)
lroth@burnsmc.com / rimai@burnsmc.com
+1-212-213-0006
FAQ
What is the purpose of the OVAL trial by VBL Therapeutics for VBLT?
When will the results of the OVAL Phase 3 trial be available?
What are the key findings expected from the ASCO presentation regarding VB-111?
What is VB-111 and its significance for VBL Therapeutics (VBLT)?
