CYTOS RELEASES RESULTS FROM HYPERTENSION VACCINE STUDY

Cytos Biotechnology has announced positive results from a Phase IIa study of CYT006-AngQb, a therapeutic vaccine candidate for the treatment of hypertension. The study was a double-blind, placebo-controlled clinical trial conducted with 72 participants with mild to moderate hypertension. It was designed to evaluate safety, tolerability and exploratory efficacy of two dose levels of the vaccine (100 and 300 micrograms).

CYT006-AngQb is a therapeutic vaccine in development for treatment of hypertension. It is designed to instruct the patient's immune system to produce a specific anti-angiotensin II antibody response. For efficacy evaluation in the study, the change in blood pressure from baseline to post-treatment was assessed in individual subjects by 24-hour ambulatory blood pressure monitoring.

Treatment with CYT006-AngQb was safe and very well tolerated, the company said. The majority of side effects observed were transient and mostly mild local injection site reactions. Mild flu-like symptoms were present in 10 percent of the participants and resolved within one to two days.

All patients who received the vaccine mounted a strong antibody response against angiotensin II upon the first injection, which was boosted by the two subsequent injections. The antibody response was long-lived with a half-life of three to four months. A significant reduction of the ambulatory daytime blood pressure was observed in the group who received the 300-microgram dose.

As expected, during nighttime, when the renin-angiotensin system is less active, differences were smaller and not significant.