Clinical Trials
Clinical trials—health-related research studies in human beings that follow a pre-defined protocol—are currently underway at leading centers throughout the United States, Europe and Israel to evaluate new VBL Therapeutics’ drugs that target psoriasis and cancer. For detailed information on clinical trials involving VBL’s investigational new drugs, please visit www.clinicaltrials.gov.
While advances have been made in the treatment of psoriasis over the last decade, there remains a need for safe, targeted and effective oral treatments for psoriasis. Current treatments can be very successful at managing the flare ups associated with psoriasis, but they can cause significant side effects (including infection and malignancies), making them problematic for long-term use. In addition, many of these treatments require patients to inject the drug themselves and can be cost-prohibitive for patients and payers. Thus, there is a widespread need for a specific, targeted, oral controller medication that will provide long-term management for psoriasis and other inflammatory diseases.
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 from the study 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.
VB-201 has successfully completed four Phase 1 clinical trials involving 120 healthy volunteers. These trials demonstrated the drug is safe and well tolerated. In addition, preclinical studies indicated that VB-201 has significant potential to treat inflammation across other chronic diseases including rheumatoid arthritis, atherosclerosis, inflammatory bowel disease and multiple sclerosis.
We have entered Phase 2 clinical development with VB-111, our lead oncology drug candidate, which has already completed single-dose Phase 1/2 clinical trials.
To date, 33 patients have been treated with VB-111. The results indicate that VB-111 has an excellent safety profile and promising clinical efficacy in a dose dependant manner.
In Q42010, we initiatated 2 clinical trials to evaluate VB-111 as a treatment for thyroid cancer and glioblastoma.
Detailed information on our clinical trials can be found at www.clinicaltrials.gov
