Verto, a Subsidiary of Hadasit Bio-Holdings, Completes Successful Human Clinical Trial of a Treatment for Lupus
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(TM), developed by Verto. The treatment was successful and achieved the goals.
Verto, established to commercialize the research of Prof. Yaakov Naparstek, the head of the Department of Internal Medicine at the Hadassah Hospital in Ein Kerem, is developing the Lupusorb(TM) 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. Over the next two months they came in for regular check-ups, which included blood and urine tests and medical examinations.
The 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 bolster the body's resistance to the disease. With regard to safety, no significant harmful side-effects associated with use of the device were observed.
According to Ophir Shahaf, CEO of Hadasit Bio-Holdings, "We are proud of the results of the trial, which represent a breakthrough in the treatment of lupus, given that until now there has been no treatment specific to the disease and the standard approach has been based on the use of steroids and chemotherapy that suppresses the immune system, with severe side-effects. Lupusorb(TM) has been found safe and effective in removing harmful antibodies from patients. The decline in the plasma antibody level is statistically significant after the first week and at week 3. Based on these encouraging results, we have scheduled a series of meetings with potential strategic partners who can cooperate with us in developing the device. As a medical device, it is attractive with regard to the odds for quick regulatory approval to market."
Shahaf added: "We are particularly proud of the completion of the first full clinical trial by a Hadasit Bio-Holdings portfolio company. Our strategic model, which includes leveraging the abilities of the Hadassah Medical Center and funding by the public platform, has proven itself in this case. We hope that three more companies will enter clinical trials during the next 12 months. This point is a significant milestone in the development of any biotechnology firm. Now, with the successful completion of the trial, and our accumulated experience and the abilities of the experienced management team, we believe we will be able to sign agreements with strategic partners."
Mr. Ophir Shahaf, CEO of HBL, +972-54-520-1177
Posted: July 2008