July 21, 2008
Verto’s Lupus Trial Meets Study End Point
Hadasit Bio-Holdings, a subsidiary of Hadasit, has announced that one of its portfolio companies, Verto, 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.
Verto is said to be 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.
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.
Ophir Shahaf, CEO of Hadasit Bio-Holdings, said: "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."