Hadasit Bio-Holdings

In the News - 2007

Verto, a Subsidiary of Hadasit Bio-Holdings (HBL), Announced Commencement of Human Clinical Trials for LupusorbTM for the Innovative Treatment of Lupus (Phase I/II)

Jan. 9, 2007

Verto Ltd., a portfolio company of Hadasit Bio-Holdings (traded on the Tel-Aviv Stock Exchange: HDST), today announced the Health Ministry's approval for the commencement of human clinical trials on their product LupusorbTM, which they have developed for the treatment of Lupus. The purpose of the trial is to check the safety and efficacy of the product. Trials will be performed on Lupus patients and are classified as clinical trials Phase I/II.

Verto, founded based on the research of Professor Yaakov Naparstek, Head of Internal Medicine at Hadassah University Hospital, Jerusalem, developed the product based on short protein fragments (a proprietary peptide termed VRT101), which has been very specifically connected to the antibody that appears to be involved in the cause of the disease and must therefore be removed from the patient. This peptide is included in LupusorbTM in order to allow the most efficient filtering process of the patient's blood from the destructive antibody.

Lupus is a chronic, multisystem disease that belongs to the group of autoimmune diseases in which the body's immune systems turns against the body itself. In the Lupus disease, independent antibodies are created which attach themselves to specific areas in normal tissue of the body, such as joints and kidneys, causing infections and destruction of these organs. The disease mainly affects women, and is accompanied by symptoms such as facial rashes, ongoing fever, fatigue, weakness, weight loss, joint swelling and pain, as well as severe kidney disease.

The treatment developed by Verto, focuses on the basic cause of the disease and is meant to make a major breakthrough. In the current situation, the treatment of the disease takes place with steroids, leading to an overall depressed immunological response and severe side affects. The treatment will take place using the plasmapheresis process- connecting the patient to a pump that passes the plasma (blood components which do not include red blood cells) of the patient via the device in order to remove the antibodies specific to the disease, without adversely affecting the rest of the immune system.

On the basis of the scientific and technological abilities of Verto, and as a result of the pressing need for the treatment of this unmet clinical need, the company received approval from the Supreme Helsinki Committee (who works in conjunction with the Ministry of Health) for immediate commencement of human clinical trials.

The trial will take place using 10 patients at Hadassah University Hospital, Ein Kerem, Jerusalem. Its purpose is to check the safety and preliminary efficacy of the suggested treatment.

Professor Yaakov Naparstek, Head of Internal Medicine at Hadassah University Hospital, the founder and chief scientist of Verto Ltd. said today, "Currently there is no approved medicine for the treatment of the outbreak of lupus. The treatment for this disease is based on unspecific suppression of the immune system and is naturally accompanied by significant side effects. The treatment that we are suggesting and are about to test, can potentially be the first specific treatment of this difficult disease".

Dr. Rafi Hofstein, CEO of Hadasit Bio-Holdings said, "HBL is extremely proud of this process which is the first of a series of entries into clinical trials from the cluster of Hadasit Bio-Holdings".

Ophir Shahaf, Managing Director of Hadasit Bio-Holdings said, "the approval to begin clinical testing on humans is a significant milestone in the life of the company. At this time, there is no treatment that can successfully deal with the cause of Lupus, and we hope to generate initial information on the efficacy of the treatment on patients within a short time, in order to progress toward the commercialization of the device".

Verto is a portfolio company of Hadasit Bio-Holdings Ltd. (HBL) which is traded on the Tel Aviv Stock Exchange under the symbol HDST.


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