Kamada starts Alpha-1 Antitrypsin phase 2 clinical trial to prevent lung transplant rejection

6th April 2016 (Last Updated April 6th, 2016 18:30)

Kamada has started a phase 2 clinical trial with its proprietary drug Alpha-1 Antitrypsin (AAT) for preventing rejection in lung transplants, as part of a collaboration with Baxalta.

Kamada has started a phase 2 clinical trial with its proprietary drug Alpha-1 Antitrypsin (AAT) for preventing rejection in lung transplants, as part of a collaboration with Baxalta.

Baxalta has distribution rights to the company's intravenous (IV) AAT for all indications in the US, Canada, Australia and New Zealand.

The phase 2 trial, being conducted at Rabin Medical Center, Beilinson Hospital in Israel, is a randomised, 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 trial is randomised 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 by monthly treatments.

The ten patients in the control group are expected to be treated with SOC that covers systemic corticosteroids and immunosuppressants. After one year of AAT treatment, there will be a follow-up for 12 months later.

"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."

The is being led by principal investigator Mordechai Kramer, who is the director of the Institute of Pulmonary Medicine, Rabin Medical Center, Beilinson Hospital. Primary endpoints include safety and tolerability, the incidence of acute lung transplant rejection and changes in Forced Expiratory Volume (FEV1) from baseline and overall effect (a measure of Bronchiolitis Obliterans, chronic rejection).

Other endpoints measured will include various inflammatory biomarkers and functional capacity.

Kramer said: "Lung transplantation can be a life-saving procedure for those with end-stage lung diseases.

"Unfortunately, long-term graft and patient survival are limited by both acute and chronic allograft rejection, with a median survival of just over six years. 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. As such, I am pleased to be leading this trial to assess the potential of IV AAT in the prevention of lung transplant rejection.

"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 efficacy in the prevention of lung transplant rejection."

Kamada noted that its proprietary, highly-purified, liquid form of human AAT showed positive interim results in a phase 1/2 clinical trial to treat steroid-refractory Graft-versus-Host-Disease (GvHD) conducted in collaboration with Baxalta at the Fred Hutchinson Cancer Research Center in Seattle, US.