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Lung transplantation is the last resort for patients who suffer from an end stage lung disease. While survival rates are improving, there is a constant need for reducing acute and chronic rejection rates.
Long term graft and patient survival are limited by both acute and chronic allograft rejection, with a median survival of just over six years.1 Fully one-third of all lung transplant recipients experience acute rejection in the first year and 40% will develop chronic rejection within the first five years.
AAT has been investigated extensively in recent years and has been found to have anti- inflammatory,tissue-protective, immune-modulatory and anti-apoptotic properties in direct consequence of its underlying anti-protease capabilities. These properties may attenuate inflammation by lowering levels of pro-inflammatory mediators such as cytokines and proteases that are associated with organ transplantation rejection, such as lung transplantation.
Kamada collaborates with Baxalta to Initiate a Phase 2 clinical trial with intravenous Alpha-1 Antitrypsin for the prevention of lung transplant rejection
The Phase 2 trial is a randomized, open-label, single-site study of 30 lung transplant recipients to evaluate the safety and efficacy of IV AAT on top of standard-of-care (SOC) versus SOC. The study is randomized 2:1 with 20 patients in the treatment group receiving IV AAT treatment every other day for 14 days, then once every two weeks until week eight, followed thereafter by monthly treatments. The 10 patients in the control group will be treated with SOC, which includes systemic corticosteroids and immunosuppressants. Following one year of AAT treatment, there will be a one-year follow-up.
Current treatment options, such as immunosuppressants, have limited efficacy and can have significant adverse side effects and co-morbidities. Preclinical data published in Blood suggest that IV AAT has an immunomodulatory and anti-inflammatory mechanism of action that would support its role in the prevention of lung transplant rejection.
The study is being conducted at Rabin Medical Center – Beilinson Hospital in Israel and is being led by principal investigator, Prof. Kramer.
Kamada reported interim results which summarize data from the first six months of treatment for the initial 16 patients in the study.
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