Israel-Medical-Healthcare

[genisi]

I do not know them. They are cardiologists but are making some waves. They transfect the cells with growth factors and pray for the best.

http://www.mgvs.co.il/about.htm

First Patient Treated With MultiGeneAngio
Novel Therapy for Blocked Arteries

``He had deteriorated to the point where he couldn`t walk for more than five minutes and because the arterial blockage in his leg was diffuse, therapies like a balloon or surgery couldn`t help him,`` says Dr. Moshe Flugelman, CEO of MGVS which developed the therapy that could prevent close to 70,000 amputations in the US alone each year.

Last month at a Michigan hospital, a middle-aged American man, with blocked arteries in his leg that could lead to leg amputation, became the first patient to be treated with a new form of cell therapy that could restore mobility to him and to hundreds of thousands of people suffering from blocked arteries.

``He had deteriorated to the point where he couldn`t walk for more than five minutes and because the arterial blockage in his leg was diffuse, therapies like a balloon or surgery couldn`t help him,`` explains Dr. Moshe Flugelman, a cardiologist and the inventor of the new therapy. ``Inevitably gangrene sets in and we have no choice but to amputate,`` he says, noting that in the United States alone close to 70,000 amputations are performed each year as a result of blocked arteries.

The novel therapy, known as MultiGeneAngio (MGA) was developed by MultiGene Vascular Systems Ltd. (MGVS) of Haifa, a company founded by Dr. Flugelman and Dr. Basil Lewis in 2000. The technology is named after the conceptual breakthrough that it represents – the use of more than a single gene and cell type.

The procedure harnesses cells taken from the patient`s own body, processing them in a lab and then injecting them back into the patient. The empowered cells are designed to trigger a process of angiogenesis whereby small arteries become bigger, enabling a higher blood flow to the leg. The same therapy can be used to improve blood supply to the heart muscle in patients with blocked coronary arteries.

In the case of the Michigan patient, a vein was stripped from his arm in January to serve as an autologous cell source. Then, a team of scientists from MGVS in collaboration with clinicians and researchers at the Medical Center of the University of Michigan at Ann Arbour isolated the required cells from the vein and processed them. Dr. Blake Roessler who is the head of the Human Application Laboratory, a GMP facility within the medical center, leads the research team in Michigan. In mid-February Dr. Michael Grossman, a Medical Center cardiologist, injected the patented combination of genes and cells into the patient.

Three weeks later the patient is doing well and Dr. Flugelman and his team are excited. They are confident that they have passed the important first hurdle – the patient has recovered and all the safety indicators are as they should be.
``It will take several weeks to see if the therapy also demonstrates efficacy though this is not the primary objective at this point – safety is – as the initial patient received only a small dosage in accordance with FDA guidelines, `` explains Dr. Flugelman.
In the coming few months another 11 patients will undergo the therapy and after a year`s follow-up the company will be prepared for Phase II trials involving a larger number of patients. If everything goes as expected the product could be on the market by 2011.

This may not be exactly around-the-corner but with no alternative on the horizon, MGVS is positioned to be a leader in the treatment of peripheral arterial disease and coronary artery disease.

The company business model is based on setting up cell processing centers in collaboration with leading medical centers.

The company has made rapid progress during the past six years, working with a limited budget of just $7 million. Dr. Flugelman credits the years he spent as a researcher at the NIH during the early nineties as paving the way. ``I gained an understanding of the science behind gene therapy from some of the pioneers in the field, leading scientists like French Anderson, Stephen Epstein and David Dichek ,`` he recalls.

Back in Israel Dr. Flugelman continued his reseach through academic grants, eventually founding MGVS in the Naiot Incubator in order to commercialize the technology.

MGVS achieved another important milestone recently when the FDA approved a Phase I study for a second company product. Known as MultiGeneGraft, the tissue- engineered product is intended to improve bypass surgery. The product is derived from the same platform technology as MGA and also is being developed in collaboration with the University of Michigan at Ann Arbour and the University of Pennsylvania.

The company has several other products in its pipeline that utilize breakthroughs in protein therapy as well as cell and gene therapy, and that aim to improve stent and other devices.

Dr. Flugelman, who continues to work as a cardiologist at the Lady Davis Carmel Medical Center in Haifa, is well-familiar with the difficulties faced by many patients who can`t be helped by currently-available therapies. ``What we are developing is an opportunity to save patients from amputatons and other severe consequences of cardio-vascular disease.``