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ProtAb Begins Planning Phase I Clinical Study of Proximab
EIN KEREM, Israel | December 3, 2008 | ProtAb Ltd., a wholly owned subsidiary of Hadasit Bio-Holdings (TASE:HDST), announced today the receipt of an allowance of a key patent underlying its technology, an antibody called Proximab. The patent covers its structure as well as its immune and therapeutic activity against rheumatoid arthritis and Type-1 diabetes. Proximab is the basis for what will be the company’s flagship product. The company currently has a wide estate of patents registered in the United States, Australia, and European countries.
The notice of allowance reported today relates to patent application 10/931,944, entitled: B-Cell epitope peptides of HSP65, DNA encoding said peptides, antibodies directed against said peptides and the different uses thereof in the treatment of inflammatory and autoimmune diseases.
“This patent arrives at a favorable moment for the company. We recently completed the last stage of an important process known as humanization of Proximab. Essentially, we now have a version of this antibody specifically meant for humans rather than animals,” said Shira Yair, CEO of ProtAb Ltd. “Today’s news is the last in a series of steps required to make the antibody ready for clinical trials. The patent process, which was carried out in cooperation with the British firm Antitope, Ltd., and pursuant to the guidelines of regulatory agencies in Israel and the United States, is critical for the clinical development of Proximab.”
Pre-clinical studies have shown Proximab to be safe and efficacious in an animal model. More specifically, after humanization, the antibody has demonstrated to preserve its properties and appears to be the appropriate configuration for clinical trials in humans. ProtAb is now currently readying production of the antibody for use in a phase I clinical safety study to take place at the new Hadassah Clinical Research Center in Ein Kerem.
“Approval of the patent in a key market like the United States is a significant milestone for the company. It provides important protection for the technology and the antibody developed by the company. It also makes it possible for us to move ahead toward clinical trials in human beings,” said Professor Yaakov Naparstek, chairman of medicine at the Hadassah–Hebrew University Hospital in Ein Karem, ProtAb’s chief scientific officer and the inventor of the technology.
ProtAb is a portfolio company fully controlled by Hadasit Bio-Holdings Ltd. (HBL), which is listed on the Tel Aviv Stock Exchange (symbol: HDST). For more information please visit www.hbl.co.il Press contact: Marjie Hadad, media liaison, Hadasit, +972-54-536-5220;
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SOURCE: Hadasit Bio-Holdings |
