Hadasit Bio Holdings Ltd. (TASE:HDST) subsidiary Verto has received US Food and Drug Administration (FDA) approval for a clinical trial. The company is preparing a combined Phase I and Phase II trial. The trial will include 10 patients at Hadassah Hospital Ein Karem.
Hadasit Bio owns 75% of Verto. Ofer Hi Tech Ltd. is also a shareholder in the company.
Verto developed its Lupusorb product which is a combination drug and medical device for treating the autoimmune disease Lupus. The medicinal part of the product is a peptide which specifically binds with an antibody found in Lupus patients which is probably responsible for part of the illness' mechanism. Verto's device removes the patient's plasma, rids his body of the problematic antibody using the peptide, and returns the plasma into the body. A treatment exists in which all of the patient's blood is replaced with donor blood, however such treatment risks infection. The disease is also treated with immunosuppressants which are accompanied by unwanted side-effects.
Lupus is an autoimmune disease in which the body creates antibodies that bind to normal tissue like joints or kidneys and cause inflammation and damage to the organ.
Following the approval of the trial, Hadasit announced a forced conversion of half of the bonds which it issued in its second fundraising round. The conversion will leave the company with NIS 21.9 million in cash to fund the trial.
Published by Globes [online], Israel business news - www.globes.co.il - on January 10, 2007
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