The phase 2/3 clinical trial is a randomized, double-blind trial involving 118 healthy participants. The purpose of the trial is to evaluate the safety and effectiveness of the KamRAB product. The study examines whether the KamRAB is involved in the development of autoantibodies in the blood.
The Kamada biopharmaceutical company, which develops, manufactures, markets and sells unique life-saving drugs, using a unique technology for the purification and separation of proteins, and which focuses on orphan drugs, announces that it has completed the recruitment of participants in a phase 2/3 trial in the USA of the KamRAB product as a preventive treatment for rabies in the event of exposure to an animal suspected of being infected.
KamRAB is an antibody produced by Kamada, produced from human plasma for rabies, and marketed in 6 countries around the world. Kamada has a strategic agreement with Kedrion SpA for the clinical development and marketing of the KamRAB product in the USA.
The phase 2/3 clinical trial is a randomized, double-blind trial involving 118 healthy participants. The purpose of the trial is to evaluate the safety and effectiveness of the KamRAB product. The study examines whether the KamRAB is involved in the development of autoantibodies in the blood.
The primary and secondary indicators of the experiment are pharmacokinetic (PK) indicators that estimate, among other things, the antibody levels in the blood at different time points. In addition, safety and efficiency indicators are tested. Detailed information about this trial can be found on the US government's clinical trial tracking website.
"Completing the recruitment of participants for the Phase 2/3 trial of the KamRAB product brings us another step closer to entering the American market, which is estimated at 40,000 treatments each year," said David Tzur, founder and CEO of Kamada. "We expect to complete this pivotal trial in the coming months and, subject to positive results, to submit an application for approval by the FDA thereafter."
"According to the World Health Organization, about 10 million people in the world need anti-rabies treatment each year after being bitten by an animal suspected of having rabies. In the US there is currently one main supplier of rabies antibody and we believe that the health organizations will strive to diversify the sources of supply if a competing high-quality product is approved for marketing" added Zur.
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In the past there were certain successes (2 cases) in at least partial healing of unvaccinated people who had rabies and due to special treatment they survived and recovered (as mentioned relatively). Why can't they now cure those who have an ovary? This is considered a very deadly disease
Lasaf, Masaf, in my opinion, the innovation is that an Israeli company succeeds in entering the American market, with a product that is difficult and complicated to produce. This shows that the technological level in Israel is the highest in the world!
There is a drug on the market for prophylactic treatment after "contact with an animal that is suspected to be infected",
There is also a serum for the rabies vaccine that can be given to humans as well as to humans,
Where is the innovation?