Baxter International Inc.
) announced positive results from its Phase III clinical trial
evaluating the efficacy of BAX 855, which is an extended half-life,
recombinant factor VIII (rFVIII) protein used for hemophilia A
treatment. The results revealed that BAX 855 met its primary
endpoint in the control and prevention of bleeding, routine
prophylaxis and perioperative management for hemophilia patients.
Built on the same protein used in ADVATE [Antihemophilic Factor
(Recombinant) Plasma/Albumin-Free Method], BAX 855 has been
modified to include the PEGylation technology from Nektar
). Notably, the PEGylation technology is designed to extend the
duration of protein activity in the body.
The pivotal trial was conducted with the aim to evaluate the
effectiveness of BAX 855 in reducing annualized bleed rates (ABR)
during the treatment as compared to on-demand treatments. The study
also appraised the safety and immunogenicity of the compound when
administered on either prophylaxis or on-demand treatment regimens.
The multi-center, open-label trail called PROLONG-ATE evaluated BAX
855 on 138 adolescent and adult patients with previously-treated
hemophilia A. The study revealed that patients in a twice-weekly
prophylaxis arm experienced a 95% reduction in median ABR as
compared to those in the on-demand arm.
Results from the Phase III study were consistent with the findings
from the Phase I study which established that the half-life
(measuring the duration of activity of the drug in the body) of the
investigational compound was approximately 1.5 times higher than
Furthermore, no patients developed inhibitors to BAX 855 and no
treatment-related serious adverse events, including
hypersensitivity, were reported. However, the most common (three
patients) product-related adverse event was headache.
BAX expects to submit a Biologics License Application (BLA) for BAX
855 to the U.S. Food and Drug Administration (FDA) before the end
of 2014 and also plans to present additional data in the coming
In addition to an ongoing study on patients who have completed the
pivotal trial, BAX will initiate a Phase III, prospective,
open-label, multi-center study to evaluate the safety and efficacy
of BAX 855 among 60 previously treated severe hemophilia A patients
below the age of 12.
Moreover, BAX intends to file a Marketing Authorization Application
with the European Medicines Agency (EMA) upon completion of the
pediatric study, consistent with the guidelines published by the
Currently, BAX carries a Zacks Rank #3 (Hold). Better-ranked
medical product stocks include ICU Medical, Inc. (
) and Abaxis, Inc. (
). ICU Medical sports a Zacks Rank #1 (Strong Buy) while Abaxis
carries a Zacks Rank #2 (Buy).
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