The OVAL study will be conducted in collaboration with the Gynecologic Oncology Group (GOG) Foundation.
TEL AVIV, Israel, Dec. 27, 2017 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq:VBLT) today announced the study initiation and first patient in its Phase 3 pivotal registration trial, OVAL, studying its lead candidate VB-111 (ofranergene obadenovec) in platinum-resistant ovarian cancer. The OVAL study will be conducted in collaboration with the Gynecologic Oncology Group (GOG) Foundation, Inc., a leading organization for research excellence in the field of gynecologic malignancies.
“There is a tremendous need for effective treatments for women with platinum resistant and refractory ovarian cancer, estimated at 50,000 cases in the United States, for whom therapeutic options often fail to prolong survival. We are excited to be working with the GOG, a standard-setting organization for clinical research on pelvic malignancies, in addressing this important medical need,” said Dror Harats, MD, chief executive officer of VBL Therapeutics.
“GOG is an organization dedicated to clinical research in the field of gynecologic cancer. Interest in the VB-111 development program is based on positive clinical data generated using this agent, including the Phase 2 study that VBL completed in ovarian cancer, which showed a high response rate and better survival with the therapeutic dose of VB-111,” said Richard Penson, MD, MRCP, associate professor of Medicine, Harvard Medical School, clinical director of Medical Gynecologic Oncology, Massachusetts General Hospital, Primary Investigator for the VB-111 Phase 2 trial and the Principal Investigator of the new OVAL study.
In December 2016, VBL held an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the clinical path forward for VB-111 in ovarian cancer. The company has reached an agreement with the agency on the VB-111 Phase 3 pivotal study in platinum-resistant patients, with overall survival as the primary endpoint.
The randomized, controlled, Phase 3 OVAL study in recurrent platinum-resistant ovarian cancer has been designed to enroll up to 350 adult patients at approximately 70 clinical sites in the United States and Israel. Patients will be randomized 1:1 to VB-111 in combination with chemotherapy, or chemotherapy alone. The primary endpoint is overall survival. Additional endpoints include objective response rate (ORR), progression free survival (PFS), combined CA-125 and RECIST 1.1 response (GCIG criteria) and patient reported outcome measures.
At the 2016 ASCO, the company presented data in platinum-resistant ovarian cancer, demonstrating a meaningful and significant increase in overall survival with VB-111 given in combination with chemotherapy (810 days vs. 172 days, p=0.042), along with a 60% durable CA-125 response rate—approximately two times the historical response observed with bevacizumab (Avastin®) plus chemotherapy in ovarian cancer.
VB-111 is also being studied in the GLOBE Phase 3 pivotal trial for recurrent glioblastoma (rGBM), conducted under an FDA Special Protocol Assessment (SPA), with top-line data expected in the first quarter of 2018.
About Gynecologic Oncology Group (GOG) Foundation, Inc. (www.gog.org)
The GOG Foundation, Inc. is a not-for-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. The GOG is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. The GOG is the only group in the United States that focuses its research on women with pelvic malignancies, such as cancer of the ovary, uterus and cervix. The GOG is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, nurses, statisticians, basic scientists, quality of life experts, data managers and administrative personnel.
About VB-111 (Ofranergene Obadenovec)
Lead candidate VB-111 is a first-in-class anticancer targeted gene therapy-based biologic that has demonstrated statistically significant long-term survival in patients, and offers broad potential to treat a wide range of cancers. VB-111 harnesses natural processes in the body to target tumors by employing a dual mechanism – a proprietary anti-angiogenic gene therapy that leads to targeted elimination of the tumor’s blood supply, and a viral immuno-oncology mechanism that educates the immune system to fight the tumor.
After demonstrating statistically significant overall survival (OS) and a PFS benefit in a Phase 2 trial in patients with rGBM, VB-111 is currently being studied in a Phase 3 pivotal trial for rGBM under a SPA with the FDA. VB-111 has received Fast Track designation from the FDA in the US for significant prolongation of survival in patients with rGBM, and Orphan Drug designation for treatment of GBM in both the US and Europe. VB-111 also has received an Orphan Designation for the treatment of ovarian cancer by the European Medicines Agency (EMA), and a Phase 3 study of VB-111 in ovarian cancer has now commenced. VBL intends to launch an exploratory Phase 1/2 study in non-small cell lung cancer (NSCLC), in combination with a checkpoint inhibitor, in the first quarter of 2018.
VB-111 is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in more than 300 cancer patients and has demonstrated efficacy signals in an “all comers” Phase 1 trial, as well as in three tumor-specific Phase 2 studies.
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 cancer. The Company’s lead oncology product candidate, VB-111, is a first-in-class, targeted anti-cancer gene-therapy biologic with broad potential to treat a wide range of solid tumors.
Earlier this year VBL opened its new gene therapy manufacturing plant in Modiin, Israel. This plant will be the commercial facility for production of the Company’s lead product candidate. The Modiin facility is the first commercial-scale gene therapy manufacturing facility in Israel and currently one of the largest gene-therapy designated ones in the world (20,000 sq. ft.).
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 include, but are not limited to, statements about our cash position and resources, statements regarding the clinical development of VB-111, including our expectations regarding the timing of results from the OVAL and GLOBE studies, and its 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, and the risk that historical clinical trial results may not be predictive of future trial results. In particular, results from our pivotal Phase 3 clinical trial of VB-111 in rGBM and other indications may not support approval of VB-111 for marketing in the United States, notwithstanding the positive results seen in prior clinical experience. 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, including in our annual report on Form 20-F for the year ended Dec. 31, 2016. 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.
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