Pivotal Vascazen-Reveal trial meets primary endpoint

10th April 2013 (Last Updated April 10th, 2013 18:30)

Specialty pharmaceutical company Pivotal Therapeutics has announced that its Vascazen - Reveal trial met its primary endpoint, the correction of omega-3 deficiency.

Specialty pharmaceutical company Pivotal Therapeutics has announced that its Vascazen - Reveal trial met its primary endpoint, the correction of omega-3 deficiency.

Vascazen also achieved statistical significance in different secondary endpoints in patients presenting with elevated triglycerides (>200mg/dL < 500mg/dL).

Vascazen is a prescription-only medical food, designed for the dietary management of an omega-3 deficiency in patients with cardiovascular conditions.

Pivotal chairman and chief scientific officer Dr George Jackowski said the results are significant milestone for Vascazen as a treatment option for Omega-3 deficient people suffering from elevated triglycerides that remain below the threshold of very high triglycerides required for treatment with currently available prescription medications.

"Vascazen is a prescription-only medical food, designed for the dietary management of an omega-3 deficiency in patients with cardiovascular conditions."

"This landmark study is among the first that examined Omega-3 deficiency pre and post-treatment and brings the importance of its correction to the forefront as an important part in managing CVD patients," Jackowski said.

"We are very excited to be presenting our top line results at this premier conference as it attracts the top clinicians and scientists in all areas of cardiovascular disease focusing on lipids and heart disease."

The double-blind, placebo-controlled, multi-centre US-based study enrolled 110 patients.

The randomised study was designed to assess the effects of Vascazen in the correction of omega-3 deficiency in patients with one or more risk factors associated with CVD, and to assess Vascazen's concomitant effects on cardiovascular risk factors.

Secondary endpoints of the study include positive effects on lipid profiles, without any adverse events.