Kamada's Glassia Granted FDA Orphan Drug Status For Graft Versus Host Disease
By Cyndi Root
Kamada announced in a press release that the Food and Drug Administration (FDA) has granted Glassia Orphan Drug status for the treatment of Graft-versus-host-disease (GVHD). The alpha1-proteinase inhibitor (Alpha1-PI) treatment was FDA approved in 2010 for adults with clinically evident emphysema due to severe congenital AAT deficiency and is marketed with Baxter in the U.S.
David Tsur, CEO of Kamada, said, “Given the favorable safety profile of Glassia, there is a strong rationale to support the development of this new indication and an increased likelihood of it becoming an effective therapy for this potentially life threatening disease. We will pursue discussion with the U.S. and European regulators with regard to our development pathway with an aim to move forward with a more advanced study of Glassia to treat GVHD.”
Glassia
Glassia is a ready-to-infuse liquid, administered intravenously once a week to emphysema patients to augment the levels of Alpha-1 Antitrypsin (AAT) in the blood. Derived from human plasma, AAT is a protein with immunomodulatory, anti-inflammatory, tissue protective and antimicrobial properties. Orphan status for Glassia indicates the FDA’s agreement that the agent shows promise in treating the GVHD, a rare and life-threatening complication from allogeneic stem cell transplantation. Glassia lowers pro-inflammatory mediators, including the cytokines, chemokines, and proteases associated with GVHD.
Currently, Kamada and Baxter are conducting a Phase 1/2 study of Glassia at the Fred Hutchinson Cancer Research Center in Seattle, Washington. A total of 24 GVHD patients in four cohorts with an inadequate response to steroid treatment following allogeneic bone-marrow stem cell transplant are enrolled. Kamada expects study results by the end of this year. Mr. Tsur said that results may support
global clinical development activities and spur development for many types of organ transplantations.
About Kamada
Kamada’s headquarters and manufacturing plant are located in Israel. The company focuses on plasma-derived protein products for orphan indications. In development are five late-stage plasma-derived therapeutics, including an inhaled formulation of AAT. In October 2014, the company published data on AAT’s mechanism of action in type 1 diabetes treatment in the Journal of Diabetes Science and Technology. In September 2014, Kamada announced the second extension to supply Glassia to Baxter, securing an additional $26 million in revenue.