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Expands OVAL Phase 3 Potential Registration Study of VB-111 for the Treatment of Platinum-Resistant Ovarian Cancer into Europe
TEL AVIV, Israel, Dec. 29, 2020 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced the expansion of its ongoing OVAL Phase 3 study investigating ofranergene obadenovec (VB-111), for the treatment of platinum-resistant ovarian cancer into Europe, where the first patient has now been enrolled. The study continues to actively recruit patients in the U.S. and Israel, with over 200 patients enrolled to date.
“VB-111 is our proprietary anti-cancer gene therapy product candidate that has shown overall survival benefit across multiple tumor types,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “We are pleased to expand the OVAL potential registration study of VB-111 in patients with late stage ovarian cancer to Europe, which is expected to accelerate our recruitment pace, diversify the patient population in the study and support our dialogue with European regulatory authorities as we get closer to potential commercialization. If successful and approved, VB-111 has the potential to establish a new standard of care in a challenging disease setting where patients currently have limited options.”
Interim analysis from OVAL demonstrated VB-111’s significant response rate of 58% or higher in the first 60 patients. According to the Company update on November 16, 2020, the high response rate of >50% in the total evaluable patient population was still maintained with approximately 200 patients enrolled.
The EU expansion follows two completed analyses by the independent Data Safety Monitoring Committee (DSMC) which recommended to continue the study as planned. The next DSMC review is expected in the first quarter of 2021.
VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission.
About the OVAL study (NCT03398655)
OVAL is an international Phase 3 randomized pivotal potential registration 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 quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies.
About VB-111 (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 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 rGBM. VB-111 successfully demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970).
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.
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 our programs, including VB-111, including 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 our financial resources do not last for as long as anticipated, and that we may not realize the expected benefits of our 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 we 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 our regulatory filings with the U.S. Securities and Exchange Commission, including in our annual report on Form 20-F for the year ended December 31, 2019, 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.