Vasogen Inc. received FDA clearance to start a Phase III pivotal trial of its immune modulation therapy in patients with advanced chronic heart failure.
The trial, referred to as ACCLAIM (advanced chronic heart failure clinical assessment of immune modulation therapy), follows a successful Phase II study that showed a 60 percent reduction in death and hospitalization rates, David Elsley, president and CEO of Toronto-based Vasogen, told BioWorld Today.
Immune modulation therapy is 20-minute outpatient procedure involving the stressing of a small sample of a patient's blood using a medical device. "We trigger apoptosis [cell death] in a small sample of the immune cells, and then we re-administer these apoptotic cells as a therapeutic, and that up-regulates the normal anti-inflammatory response by the immune system, and that leads to a down-regulation of chronic inflammation, which is a key culprit in cardiovascular disease and heart failure in general," Elsley explained.
ACCLAIM's primary endpoint is the composite endpoint of all-cause mortality or first cardiovascular hospitalization (time to first event). The double-blind, placebo-controlled study is approved for up to 2,000 patients in U.S. and Canadian cardiac centers. It will end when a minimum of 701 events have occurred and all patients have been followed for at least six months.
Elsley expects the trial to take up to two years, with possible FDA approval in 2005 followed by an immediate launch.
Vasogen's U.S. partner is Quest Diagnostics Inc., a Teterboro, N.J.-based company that has invested US$10 million in Vasogen to date. The company hasn't identified a partner for the remainder of the world.
Elsley said company officials received a positive response from clinicians on presenting data from the Phase II study at the American Heart Association's 75th Scientific Sessions in Chicago and at the American Heart Failure Society in Boca Raton, Fla.
In addition to demonstrating a reduction in the risk of death and hospitalization in the Phase II, the trial also showed improvements in the clinical composite score and improvements in key electrocardiogram measures among chronic heart failure (CHF) patients receiving immune modulation therapy, the company said.
Elsley said news of the CHF Phase III marks a very significant milestone for the company.
"This brings our second Phase III online and we obviously see both these opportunities as significant for the company," he said.
The other ongoing Phase III trial is in peripheral arterial disease patients. Elsley expects full enrollment by the end of the year with reporting in 2004, and commercialization in late 2004 or early 2005.
Vasogen's stock (AMEX:VSV) closed Tuesday at $2.43, down 24 cents.