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news.Irish firm Kamada has started a US-based proof-of-concept (POC) trial with its proprietary, highly-purified, liquid form of human Alpha-1 Antitrypsin (AAT) 'Glassia' for the treatment of graft-versus-host disease (GVHD).
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The POC study is a Phase I/II trial 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 trial is being conducted in cooperation with Baxter International at the Fred Hutchinson Cancer Research Center in Seattle, Washington, US.
The company said that Baxter currently markets Glassia in the US for AAT Deficiency.
The results from the POC study are expected to 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.
Kamada co-founder and chief executive officer David Tsur said the company is happy to be advancing Glassia to treat GVHD.
"Glassia is expected to decrease GVHD-related symptoms including the progressive tissue damage and thereby potentially increase the survival rates of this complication and possibly reducing or eliminating the need for steroid therapy," Tsur said.
"GVHD occurs in 30% to 70% of patients who undergo allogeneic hematopoietic stem cell transplantation, usually as a treatment for leukemia or other blood cancers, and is a major cause of morbidity and mortality in these patients.
"We are encouraged about Glassia’s prospects as an effective new therapy for this serious, life threatening orphan disease for which a therapeutic answer has not been provided yet."