TEL AVIV, Israel, Feb. 21, 2017 (GLOBE NEWSWIRE) — VBL Therapeutics (NASDAQ:VBLT), appear today abounding after-effects from its basic Phase 2 abstraction of VB-111 (ofranergene obadenovec) in patients with advanced, differentiated thyroid cancer. The abstracts will be presented today by Dror Harats, M.D., CEO of VBL Therapeutics, at the Alliance of the Israel Societies for Beginning Analysis (FISEB) appointment in Eilat, Israel.
The primary endpoint of the trial, authentic as 6-month progression-free-survival (PFS-6) of 25%, was met with a dosage response. Forty-seven percent (47%; 8/17) of patients in the therapeutic-dose accomplice accomplished PFS-6, against 25% (4/12) in the sub-therapeutic cohort, both groups affair the primary endpoint. Abridgement in bump altitude afterwards the aboriginal dosage was apparent in 44% (7/16) of patients in the therapeutic-dose cohort, compared to 9% (1/11) in the sub-therapeutic-dose cohort. An all-embracing adaptation account was apparent with a appendage of added than 40% at 3.7 years for the therapeutic-dose accomplice (mOS 684 days). This is agnate to absolute abstracts for pazopanib* (Votrient®), a tyrosine kinase inhibitor; however, best patients in the VB-111 abstraction had tumors that ahead had progressed on pazopanib or added kinase inhibitors.
“We are encouraged to see dose-dependent responses and an all-embracing adaptation account with VB-111 monotherapy, in thyroid blight patients with end-stage ache whose tumors had not responded to assorted curve of therapies, including kinase inhibitors,” said Dr. Dror Harats, CEO. “This trial, calm with our Phase 2 trials assuming affiance for VB-111 in alternate glioblastoma and platinum-resistant ovarian cancer, point to the abeyant ameliorative appliance of VB-111 beyond assorted solid tumors. We attending avant-garde to advancing VB-111 appear commercialization, through our advancing Phase 3 cardinal GLOBE balloon in rGBM and our planned Phase 3 balloon in ovarian cancer,” added Dr. Harats.
The open-label dose-escalating abstraction enrolled patients with advanced, recently-progressive, differentiated thyroid blight that was above to radioactive iodine, in two cohorts. Best patients had tumors that had not responded to assorted therapies above-mentioned to enrollment, including radiation and kinase inhibitors. In the aboriginal cohort, thirteen patients accustomed a distinct intravenous beverage of VB-111 at a sub-therapeutic dosage of 3X1012 viral particles (VPs). The additional accomplice included seventeen patients, who accustomed VB-111 at a ameliorative dosage of 1013 VPs every two months until ache progression. One accommodating proceeded from a distinct low dosage to accept afterwards assorted aerial doses at progression and was included in both groups (for PFS only). VB-111 was well-tolerated in this study, with no signs of clinically cogent assurance issues.
About the Alliance of the Israel Societies for Beginning Analysis (FISEB)ILANIT/FISEB is a alliance of 31 Israeli societies of beginning biology. ILANIT’s appointment is captivated every three years in Eilat, with appearance by advisers and students. This year’s conference, demography abode February 20-23, is the acme of the best agitative analysis performed in Israel in abounding disciplines. For added information, accredit to http://fiseb.org/.
About Thyroid CancerThyroid blight occurs in the thyroid gland, a hormone-producing agency at the abject of the close that regulates affection rate, claret pressure, anatomy temperature and weight. According to the National Blight Institute, there are an estimated 535,000 bodies currently active with thyroid blight in the United States, with an estimated 60,000 new cases anniversary year. The blazon of analysis depends on the blight corpuscle type, bump admeasurement and severity of the disease. First-line analysis is surgical abatement of the thyroid gland, and is recommended for best patients. Analysis with radioactive iodine afterwards anaplasty to abort any absolute thyroid tissue may be recommended for added avant-garde disease. If radioactive iodine is ineffective, added treatments are prescribed, such tyrosine kinase inhibitors and systemic chemotherapy. However, if such treatments are unsuccessful, the therapeutic options for patients are currently absolute limited. There are an estimated 1,850 anniversary deaths in the U.S. as a aftereffect of the disease. This subset of patients has an unmet charge for atypical ameliorative options.
About VBLVascular Biogenics Ltd., operating as VBL Therapeutics, is a analytic date biopharmaceutical aggregation focused on the discovery, development and commercialization of first-in-class treatments for cancer. The Company’s advance oncology artefact candidate, ofranergene obadenovec (VB-111), is a first-in-class, targeted anti-cancer gene-therapy abettor that is positioned to amusement a advanced ambit of solid tumors. It is calmly administered as an IV beverage already every two months. It has been empiric to be well-tolerated in >200 blight patients and we accept empiric its ability signals in an “all comers” Phase 1 balloon as able-bodied as in three tumor-specific Phase 2 studies. Ofranergene obadenovec is currently actuality advised in a Phase 3 cardinal balloon for alternate Glioblastoma, conducted beneath an FDA Special Protocol Assessment (SPA).
About Ofranergene Obadenovec (VB-111)Ofranergene obadenovec is a different biologic abettor that uses a bifold apparatus to ambition solid tumors. Based on a non-integrating, non-replicating, Adeno 5 vector, ofranergene obadenovec utilizes VBL’s proprietary Vascular Targeting System (VTS™) to ambition the bump vasculature for blight therapy. Unlike anti-VEGF or TKIs, ofranergene obadenovec does not aim to block a specific pro-angiogenic pathway; instead, it uses an angiogenesis-specific sensor (VBL’s PPE-1-3x proprietary promoter) to accurately abet corpuscle afterlife in angiogenic endothelial beef in the bump milieu. This apparatus retains action behindhand of baseline bump mutations or the character of the pro-angiogenic factors buried by the bump and shows ability alike afterwards abortion of above-mentioned analysis with added anti-angiogenics. Moreover, ofranergene obadenovec induces specific anti-tumor allowed response, which is accompanied by application of CD8 T-cells and apoptosis of bump cells.
Ofranergene obadenovec completed a Phase 2 abstraction in rGBM, which showed a statistically cogent advance in all-embracing adaptation in patients advised with ofranergene obadenovec through progression, compared to either patients advised with ofranergene obadenovec followed by bevacizumab alone, or to absolute bevacizumab data. In a Phase 2 balloon for alternate platinum-resistant ovarian cancer, ofranergene obadenovec approved a statistically cogent access in all-embracing adaptation and 60% abiding acknowledgment amount (as abstinent by abridgement in CA-125), about 2x the absolute acknowledgment with bevacizumab additional chemotherapy in ovarian cancer. In a Phase 2 abstraction in recurrent, iodine-resistant differentiated thyroid cancer, ofranergene obadenovec met the primary endpoint and provided affirmation of ache stabilization and a absolute assurance profile. Ofranergene obadenovec has accustomed Fast Track Designation for alternate glioblastoma in the U.S. and drop biologic cachet for glioblastoma in both the U.S. and EU.
Forward-Looking StatementsThis columnist absolution contains advanced statements. All statements added than statements of absolute actuality are advanced statements, which are about adumbrated by agreement such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look avant-garde to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and agnate expressions. These advanced statements include, but are not bound to, statements apropos the analytic development of ofranergene obadenovec (VB-111) and its ameliorative potential, analytic trials and analytic results, including the timing thereof. These advanced statements are not promises or guarantees and absorb abundant risks and uncertainties. Among the factors that could account absolute after-effects to alter materially from those declared or projected herein accommodate uncertainties associated about with analysis and development, analytic trials and accompanying authoritative reviews and approvals, and the accident that absolute analytic balloon after-effects may not be predictive of approaching balloon results. In particular, after-effects from our cardinal Phase 3 analytic balloon of ofranergene obadenovec (VB-111) in rGBM may not abutment approval of ofranergene obadenovec for business in the United States, admitting the absolute after-effects apparent in above-mentioned analytic experience. A added account and description of these risks, uncertainties and added risks can be begin in the Company’s authoritative filings with the U.S. Securities and Exchange Commission, including in our anniversary address on Form 20-F for the year ended December 31, 2015. Existing and -to-be investors are cautioned not to abode disproportionate assurance on these advanced statements, which allege abandoned as of the date hereof. VBL Therapeutics undertakes no obligation to amend or alter the advice independent in this columnist release, whether as a aftereffect of new information, approaching contest or affairs or otherwise.
* Lancet Oncol 2010; 11: 962–72
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