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March 4, 2014
08:03 EDTKMDAKamada completes enrollment in KamRAB U.S. clinical trial
Kamada announced that it has completed enrollment in its U.S. Phase 2/3 clinical trial of KamRAB as a post-exposure prophylaxis for rabies. Kamada has a strategic agreement with Kedrion for the clinical development and marketing of KamRAB in the U.S. The Phase 2/3 clinical trial is a prospective, randomized, double-blind, non-inferiority study of 118 healthy subjects to evaluate the safety and effectiveness of KamRAB. The study assesses whether KamRAB interferes with the development of self-active antibodies. The primary and secondary endpoints of this study are pharmacokinetic parameters of anti-rabies IgG levels in serum at different time points. In addition, safety and tolerability are assessed. The company said, "We look forward to completing this pivotal study in the coming months and, pending a favorable outcome, to filing a submission for approval with the FDA thereafter.”
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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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