Vasogen preparing VP025 program to enter phase 2; planning to share Acclaim data with FDA

By Jennifer Lanning Drey

Eugene, Ore., Sept. 20 - Vasogen Inc.'s VP025 drug development program is nearing phase 2 clinical trials, David Elsley, chief executive officer of the company, said Wednesday at the AG Edwards emerging growth conference.

The new class of compounds consists of chemical structures designed to mimic apoptotic cells. The drugs have been optimized for neuro-inflammatory disease or central nervous system disorders based on data presented by the company during the past two years, he said.

In earlier studies, VP025 showed a favorable safety profile. The drug also demonstrated a significant reduction of several pro-inflammatory cytokines in a preclinical model of diabetes and diabetic retinopathy, a complication of diabetes that results in the loss of vision.

Elsley said by moving into phase 2, the neuro-inflammatory program is "becoming an increasingly important part of Vasogen."

Vasogen is also preparing to present the full data set from the Acclaim trial to the Food and Drug Administration in order to get the agency's views on a formal regulatory submission for Celacade, he said.

The company believes the consistency between its phase 2 and phase 3 clinical data for Celacade warrants consideration for regulatory approval, Elsley said.

In a 2,414-patient trial, Celacade did not meet its primary endpoint of significantly reducing the risk of death or first cardiovascular hospitalization for patients; however, the study did find that a majority of patients showed significant risk reduction from Celacade on top of optimal therapy for heart failure.

"This data, we believe, is very strong and compelling with respect to our ongoing discussions on the U.S. front for partnering, and we are pushing forward with those discussions now with the full data set in hand," Elsley said.

The company also believes the data supports commercialization in the European Union, he said.

Mississauga, Ont.-based Vasogen is focused on the development of technologies targeting chronic inflammation underlying cardiovascular and neurological disease.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.