Octapharma Announces Two New Clinical Trials
Octapharma USA recently announced that its product WILATE®, a human-derived von Willebrand factor/coagulation factor VIII therapy, will be used in two upcoming clinical trials slated to launch in December 2016. WILATE® is currently indicated in the US for children and adults with von Willebrand disease for on-demand treatment and control of bleeding episodes; and perioperative management of bleeding. WILATE® is not currently indicated for the treatment of hemophilia A in the US.
The company will fund an investigator-initiated clinical trial that aims to determine the time it takes to decrease inhibitor levels using immune tolerance induction (ITI), in which the body begins to tolerate the therapy after daily doses of factor are administered over time. The new trial will determine the optimal concentration of WILATE® that can be used to help hasten the achievement of inhibitor tolerance.
The trial, “Individualized ITI Based on FVIII Protection by VWF (INITIATE),” is being led by investigators Jonathan Ducore, MD, MPH, of the University of California Davis School of Medicine, and Courtney Thornburg, MD, MS, of the Rady Children's Hospital-San Diego. According to an Octapharma press release, the study evaluates a “personalized medicine approach” to eradicating inhibitors in hemophilia A treatment.
In one arm of the study, a patient’s plasma will be tested against different lots of WILATE® in vitro before treatment to determine the specific batch that has the highest residual factor VIII activity left after incubation with the patient’s plasma. “ITI can result in inhibitor resolution, but can take several years to achieve success,” explained Ducore. “Preliminary studies have suggested that individualized lot selection (batch-matching) can shorten this time by 67 percent.”
The second trial, a prospective multi-center phase three study, will investigate the pharmacokinetics, efficacy, safety and immunogenicity of WILATE® in previously treated patients with severe hemophilia A. Investigators are in the process of recruiting up to 55 male participants at clinical trial sites in the US and Europe.
Source: Octapharma press release dated November 14, 2016