Hadasit Bio Holdings Ltd. (TASE:HDST), portfolio company Verto (in which it has a 75% stake), has successfully completed a human clinical trial of a device for treating patients who suffer from systemic lupus erythematosus.
The goals of the trial at the Hadassah Medical Center in Ein Kerem, in which ten lupus patients took part, were to demonstrate the safety and efficacy of the Lupusorb, developed by Verto. The treatment was successful and achieved the goals.
Hadasit Bio Holdings is a subsidiary of Hadasit (the technology transfer company of the Hadassah - Hebrew University Medical Center).
Jerusalem-based Verto was established to commercialize the research of Prof. Yaakov Naparstek, the head of the Department of Internal Medicine at the Hadassah Hospital in Ein Kerem. The company is developing the Lupusorb for the treatment of systemic lupus erythematosus.
The device is a filter column that can be incorporated into the standard process of plasmapheresis (in which the blood is removed from the patient’s body, cleansed of immune-system compounds, and returned to the body) for lupus patients.
The column contains a peptide (short protein), designated VRT101, which specifically binds a subgroup of auto-antibodies that the body has developed against itself, and which cause the disease. At the end of the process the blood is returned to the body with all the vital components intact, except for the auto-antibodies, which have been bound to the peptide in the column.
During the trial, ten patients underwent plasmapheresis. Results indicated a statistically significant decrease in the level of disease-related antibodies in the patients’ blood (anti-VRT). The antibody level remained low for three weeks and only than returned to its pre-treatment levels (increased four weeks into the trial) but there was no rebound effect (in which the antibody level exceeds that before treatment), as is usually found in routine plasmapheresis . There was also an improvement in other components of the immune system that bolsters the body’s resistance to the disease. No significant harmful side-effects associated with use of the device were observed.
According to Hadasit Bio-Holdings CEO Ophir Shahaf, based on the study's results, the firm has scheduled a series of meetings with potential strategic partners to cooperate on developing the device. Shahaf added, "As a medical device, it is attractive with regard to the odds for quick regulatory approval to market.”
On the Tel Aviv Stock Exchange (TASE), shares in Hadasit Bio rose 2.1% yesterday, and today its shares are up 3.2% to NIS 1.94. For the year to date, its shares are down 58%. Its market cap is NIS 36.48 million.
Published by Globes [online], Israel business news - www.globes-online.com - on July 21, 2008
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