New Drug Approvals

VBL Therapeutics announced FDA has granted Fast Track designation to its lead oncology drug VB-111

November 28, 2013 3:37 am

GT-111
VB-111

GT-111 is a gene therapy product candidate in early clinical development for the treatment of advanced differentiated thyroid cancer, for the treatment of relapsed glioblastoma multiform and for the treatment of ovarian cancer.

patents, VBL Therapeutics

WO 2011083466, WO-2011083464, WO-2012052878

VBL Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead oncology drug VB-111, for prolongation of survival in patients with recurrent glioblastoma multiforme (rGBM).

VB-111 – highly targeted anti-angiogenic agent for the specific inhibition of tumor vascular growth

VB-111 is the first highly targeted anti-angiogenic agent for the specific inhibition of tumor vascular growth to use VTS™™, our proprietary platform technology, for cancer therapy. VB-111 is an IV-administered anti angiogenic agent that works in a manner akin to a “biological knife” to destroy tumor vasculature, thus cutting off blood vessels feeding the tumor.

Preclinical Insights

VB-111 has shown significant promise as a targeted cancer treatment with the potential to work synergistically in combination with conventional chemotherapy treatments to provide an effective treatment regimen for cancer patients. Pharmacological and toxicology studies of VB-111 have showed tissue specificity for the tumor tissue, no significant damage to normal non-cancerous tissues or to the normal vasculatures in the body and more than 90 percent tumor burden reduction in a metastatic lung cancer model with only one injection. Similar efficacy was shown in other tumor models.

Completed Clinical Trials

Phase 1 Clinical Trial – in a Phase 1 “all comers” dose escalation study in 33 patients with advanced metastatic cancer, therapeutic doses of VB-111 demonstrated antitumor activity and was found to be safe and well tolerated with no effect on liver function or major changes in complete blood count. Findings have been presented at the American Association of Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) annual meetings.

Posted by DR ANTHONY MELVIN CRASTO Ph.D

Categories: FAST TRACK FDA, Phase2 drugs

Tags: Anthony crasto, Fast Track status, fda, medicinal chemistry, NEW DRUGS, organic chemistry, phase 2, VB-111, world drug tracker

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One Response to “VBL Therapeutics announced FDA has granted Fast Track designation to its lead oncology drug VB-111”

Reblogged this on MedCheminSingapore by Sushma Wang.

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By sushmawang on November 29, 2013 at 1:09 am

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