Date: 2014-04-03
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: Kamada (Israel) Baxter (USA - IL)
Product: Glassia® (liquid form of human Alpha-1 Antitrypsin (AAT) administered intravenously)
Action
mechanism: 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 allogeneic stem cell transplantation. 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.
Disease: graft-versus-host disease (GVHD)
Therapeutic area: Transplantation
Country: USA
Trial
details: The POC study is a Phase 1/2 study of 24 patients with steroid-resistant GVHD following allogeneic bone-marrow stem cell transplant who will receive six to ten doses of intravenously delivered Glassia to determine safety, optimal dose and clinical response. The Phase 1/2 clinical study is being conducted at the Fred Hutchinson Cancer Research Center in Seattle, Washington and is currently enrolling patients.
Latest
news: * On April 3, 2014, Kamada, a plasma-derived protein therapeutics company focused on orphan indications, has announced a U.S.-based proof-of-concept (POC) study with Glassia® to treat graft-versus-host disease (GVHD) in cooperation with Baxter International Inc. conducted at the Fred Hutchinson Cancer Research Center in Seattle, Washington. Glassia® is Kamada’s proprietary, highly-purified, liquid form of human Alpha-1 Antitrypsin (AAT) administered intravenously and Baxter currently markets the treatment in the U.S. for AAT Deficiency. Results from this POC study in GVHD may support global clinical development activities and may serve as a platform to apply for an expansion of the AAT indications to include general organ transplantation, based on a similar mechanism of action.
