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March 5, 2014
07:14 EDTKMDAKamada initiates Glassia Phase 2/3 clinical trial
Kamada announced the initiation of a Phase 2/3 clinical trial of Glassia. This double-blind, placebo-controlled, multicenter Phase 2/3 clinical trial of 190 pediatric patients with newly diagnosed T1D will evaluate the safety and efficacy of intravenous Glassia to halt disease progression and maintain the ability of the pancreas to produce insulin. This two-year study follows U.S. Food and Drug Administration and European Medicines Agency guidelines for clinical trials evaluating beta cell preservation and will measure C-peptide parameters HbA1C, hypoglycemic events and insulin daily dose, among others. Interim data are expected after approximately 90 patients complete one year of treatment, which will be in approximately two years. Initially, the trial will be conducted at four pediatric T1D medical centers in Israel with plans to expand the scope of the trial to include centers in other countries. Kamada previously reported positive preliminary data from the extension portion of its Phase 1/2 clinical trial of Glassia. That preliminary data showed that at approximately 20 months from diagnosis and approximately 10 months following the last Glassia infusion, 60% of study subjects who participated in the extension portion of the trial had peak C-peptide levels greater than 0.2 pmol/ml, which indicates a functioning beta cell capacity and is considered to be a higher percentage than would be expected without intervention.
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July 1, 2015
07:07 EDTKMDAKamada says ILPO issues patent for inhaled AAT and eFlow Nebulizer System
Kamada reports that the Israeli Patent Office, or ILPO, has issued the patent titled, “SYSTEM FOR PULMONARY DELIVERY OF ALPHA-1 PROTEINASE INHIBITOR” under patent number, 193318. The patent is co-owned by Kamada and Pari Pharma GMBH, the producers of the eFlow nebulizer system, and covers claims regarding the unique combination of Kamada’s inhaled alpha-1 proteinase inhibitor, or AAT, with a customized eFlow nebulizer system. This patent application has been approved in Europe, Russia and Australia.
June 22, 2015
06:32 EDTKMDAKamada collaborates with Baxter on clinical trial with Alpha-1 antitrypsin
Kamada (KMDA) reports that the company has entered into a collaboration with Baxalta International, a wholly-owned subsidiary of Baxter (BAX) on a Phase 1/2 clinical trial of Kamada’s proprietary alpha-1 antitrypsin treatment for the prevention of lung transplant rejection. Under the agreement, Baxalta will collaborate in the development and funding of the study, which will be conducted in Israel. The study is expected to initiate in the first half of 2016, with more details on trial design to be provided at a later date. Kamada’s proprietary, highly-purified, liquid form of human AAT has shown positive interim results in a proof-of-concept Phase II study in Graft-versus-Host-Disease conducted at the Fred Hutchinson Cancer Research Center in cooperation with Baxalta. Based on those results, preclinical data published in Blood, and at the American Society of Hematology meeting, and a similar mechanism of action, the companies now plan to expand the AAT indication to the prevention of lung transplant rejection and may use this data to support clinical development worldwide. Baxalta has distribution rights to intravenous AAT for all indications in the U.S., Canada, Australia and New Zealand, while Kamada has rights in all other territories and all other formulations.

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