Clinical Trials

We are currently advancing several drugs through clinical trials, including VB-201, which targets chronic inflammatory conditions such as psoriasis, and VB-111, which holds promise for the treatment of cancer. For detailed information about our clinical trials, please visit www.clinicaltrials.gov and search under VB-201 or VB-111 for a list of ongoing trials.

Ongoing Trials - Psoriasis and inflammation in atherosclerosis

 

Our lead compound, VB-201, has significant potential as a specific, targeted oral disease-modifying agent for psoriasis and other chronic inflammatory diseases.
· Preclinical Insights - In extensive preclinical studies, VB-201 demonstrated efficacy in multiple immune-inflammatory conditions, including psoriasis. VB-201 showed a unique disease-modifying mechanism for attenuating cell-mediated, pro-inflammatory processes. The favorable safety and efficacy profile observed in preclinical model paved the way for a U.S. IND and Phase 1 clinical trials. 
· Phase 1 Clinical Trials Complete – VB-201 successfully completed four Phase 1 clinical trials involving 120 healthy volunteers under a U.S. IND. These trials included single- and multiple-dose studies in which safety and tolerability were similar to placebo. 
· Phase 2 Clinical Trial Complete - We recently completed dosing of our lead compound, VB-201, inPhase 2 clinical triasl evaluating VB-201 for the treatment of psoriasis and inflammation in atherosclerosis and expect to announce results in the first half of 2012. VB-201 has the potential to be an orally administered disease-modifying agent that will control chronic inflammatory disorders. 
A double-blind, randomized, dose-ranging, placebo-controlled study was designed to enroll approximately 180 patients with moderate to severe psoriasis. Patients received VB-201 or placebo once-daily for 12 weeks. The primary endpoint in the study is improvement in the Psoriasis Area and Severity Index (PASI 75) at week 12. The study is being conducted at multiple centers in the United States, Germany and Israel. Detailed information on the clinical trial can be found at www.clinicaltrials.gov. 

Our lead compound, VB-201, has significant potential as a specific, targeted oral disease-modifying agent for psoriasis and other chronic inflammatory diseases.

  • Preclinical Insights - In extensive preclinical studies, VB-201 demonstrated efficacy in multiple immune-inflammatory conditions, including psoriasis. VB-201 showed a unique disease-modifying mechanism for attenuating cell-mediated, pro-inflammatory processes. The favorable safety and efficacy profile observed in preclinical model paved the way for a U.S. IND and Phase 1 clinical trials. 

 

  • Phase 1 Clinical Trials Complete – VB-201 successfully completed four Phase 1 clinical trials involving 120 healthy volunteers under a U.S. IND. These trials included single- and multiple-dose studies in which safety and tolerability were similar to placebo. 

 

  • Phase 2 Clinical Trial Complete - We recently completed dosing of our lead compound, VB-201, in Phase 2 clinical trials evaluating VB-201 for the treatment of psoriasis and inflammation in atherosclerosis and expect to announce results in the first half of 2012. VB-201 has the potential to be an orally administered disease-modifying agent that will control chronic inflammatory disorders. 

 

A double-blind, randomized, dose-ranging, placebo-controlled study was designed to enroll approximately 180 patients with moderate to severe psoriasis. Patients received VB-201 or placebo once-daily for 12 weeks. The primary endpoint in the study is improvement in the Psoriasis Area and Severity Index (PASI 75) at week 12. The study is being conducted at multiple centers in the United States, Germany and Israel. Detailed information on the clinical trial can be found at www.clinicaltrials.gov. 

 

Ongoing Trial - Thyroid Cancer

 

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 a 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. 
· Phase 1 Clinical Trial - in a Phase 1 “all comers” dose escalation study in 33 patients with advanced metastatic cancer, a single dose of VB-111 demonstrated antitumor activity and was found to be safe and well tolerated with no effects 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.   
· Ongoing Phase 2 clinical trial - Initiated in December 2010, this Phase 2a trial is evaluating the efficacy and safety of VB-111 among patients with advanced radioiodine resistant differentiated thyroid cancer (DTC). This is a multi-site study that will enroll up to 82 total subjects with thyroid cancer. Participants will be divided into two cohorts, the first including patients with no former anti-angiogenic treatment and the second including patients who have received at least one conventional anti-angiogenic therapy. Detailed information on the clinical trial can be found at www.clinicaltrials.gov. 

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 a 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. 

 

  • Phase 1 Clinical Trial - in a Phase 1 “all comers” dose escalation study in 33 patients with advanced metastatic cancer, a single dose of VB-111 demonstrated antitumor activity and was found to be safe and well tolerated with no effects 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.   

 

  • Ongoing Phase 2 clinical trial - Initiated in December 2010, this Phase 2a trial is evaluating the efficacy and safety of VB-111 among patients with advanced radioiodine resistant differentiated thyroid cancer (DTC). This is a multi-site study that will enroll up to 82 total subjects with thyroid cancer. Participants will be divided into two cohorts, the first including patients with no former anti-angiogenic treatment and the second including patients who have received at least one conventional anti-angiogenic therapy. Detailed information on the clinical trial can be found at www.clinicaltrials.gov. 

 

Ongoing Trial - Glioblastoma

  • Ongoing Phase 1/2 clinical trial - Initiated in December 2010, this Phase 1/2 trial is a prospective, open-label, single-dose, multi-center study enrolling patients with relapsed GBM. Researchers will evaluate the effect of VB-111, as measured by six months of progression-free survival. The study will also examine the bio-distribution of VB-111 in the body. Finally, the study will assess and characterize VB-111’s safety and tolerability. Detailed information on the clinical trial can be found at www.clinicaltrials.gov. 

Physician Inquiries

If you are interested in learning more about VBL’s investigational new drugs and clinical trials, please contact us via email at: naama@vblrx.com