Patent applications covering similar claims have issued in Canada and are under review in the US.
Preliminary human and animal studies indicate that AAT may considerably reduce the severity of GvHD, which is one of the key, life threatening complications of mismatched donor and recipient tissues or cells. GvHD can result in significant damage to the recipients’ tissues including damage to the liver, gastrointestinal tract, skin and mucosal membranes.
The immuno-modulatory effect of AAT may attenuate inflammation by lowering levels of pro-inflammatory mediators such as cytokines, chemokines and proteases that are associated with this severe disease. As the global demand for transplants increases the risks of developing transplant rejection or GvHD are significant.
Intravenously administered glucocorticoids, such as prednisone, are the standard of care in acute and chronic GvHD. The use of these glucocorticoids is designed to suppress the T-cell-mediated immune response that are directed to host tissues; however, in high doses, this immune-suppression raises the risk of infections and cancer relapse. In addition, more than 50% of patients do not respond well to steroids, and consequently have very low survival rates.
The issuance of this patent highlights the rationale for another treatment option to reduce the risk of these serious medical conditions and the potential for reduced side effects when compared to an immunosuppressant or other immune modulating agent.
Omni Bio CEO Dr Bruce Schneider noted that the allowance of this patent reinforces our premise that AAT may be an effective therapeutic in a variety of medical conditions, including islet cell transplantation, GvHD treatment or prevention, and Type 1 diabetes.
"We are currently supporting proof of principle clinical trials for the use of AAT in the treatment of steroid-refractory GvHD at the University of Michigan and the Fred Hutchinson Cancer Research Center. We believe our own proprietary recombinant AAT molecule, Fc-AAT, which had a composition of matter patent recently issued in the U.S., will have application to GvHD and other important medical conditions," Schneider added.