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GvHD is a common complication following allogeneic tissue transplantation. It is typically associated with stem cell transplantation, but the term also applies to other forms of tissue grafts. In GvHD, immune cells (white blood cells) in the tissue (the graft) recognize the recipient (the host) as “foreign,” and then attack the host’s body cells.
GvHD occurs in 30% to 70% of patients who undergo allogeneic hematopoietic stem cell transplantation (HSCT), i.e. transfer of cells from a healthy allogeneic (non-self) bone marrow donor, usually as a treatment for leukemia or other blood cancers or blood conditions. One of the most common and dangerous complications of HSCT is GvHD. GvHD is expressed in damage to the recipients’ tissues, most prominently liver, gastrointestinal system, skin and mucosal tissues, and is a major cause of morbidity and mortality in these patients.
Intravenous glucocorticoids such as prednisone are the standard of care in the treatment of acute GvHD and chronic GvHD. The use of these glucocorticoids is directed to suppressing the T cell-mediated immune onslaught on the host tissues; however, in high doses this immune suppression raises the risk of infections and leukemia relapse. More than 50% of patients do not respond well to steroids, and consequently have very low survival rates.
Preliminary human and animal studies indicate that AAT may be able to treat and reduce the severity of GvHD. It is well known that plasma-derived AAT has been used since the 1980’s and its safety profile is very high.
In recent years, AAT has been investigated extensively and found to have anti-inflammatory, tissue-protective, immune-modulatory and anti-apoptotic properties in direct or indirect consequence of its underlying anti-protease capabilities. These properties may attenuate inflammation by lowering levels of pro-inflammatory mediators such as cytokines, chemokines and proteases that are associated with this severe disease.
In January 2018, Kamada announced a collaboration with the Mount Sinai Acute GvHD International Consortium (MAGIC) for the conduct of a clinical trial assessing the safety and preliminary efficacy of our AAT product as preemptive therapy for patients at high-risk for the development of steroid-refractory acute GvHD (SR-aGvHD). The study will be conducted in five U.S. centers, all of which are members of MAGIC, which consists of 23 Bone Marrow Transplantation (BMT) centers in the United States, Europe and Asia, and conducts clinical trials to prevent and treat GvHD following BMT. This is an investigator-initiated study, co-funded by Mount Sinai and our company, and is sponsored by the Icahn School of Medicine at Mount Sinai (ISMMS).
Kamada also collaborates with myTommorows, a company which provides services to patients and physicians in need of diagnostic tests and drugs in development, to provide early access throughout Europe to Kamada’s proprietary, highly-purified, liquid form of Alpha-1 Antitrypsin (AAT) to treat bone marrow transplant patients who develop steroid refractory Graft-Versus-Host Disease (GvHD).
Through myTomorrows’ web-based platform, Kamada’s AAT is now available to physicians and patients in Europe via Early Access Programs. These programs provide physicians and patients facing unmet medical needs with access to development stage drugs in instances that meet regulatory requirements.
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