In the past, an ALS patient was treated with the drug, in compassionate care, in a similar therapeutic format. His disease was greatly slowed down and his condition stabilized to a large extent with the IPL344 treatment given to him for over two years.
The biotechnology company Immunity Pharma announces the start of treatment for the first patient as part of a clinical study in ALS patients with the original drug IPL344. The purpose of the study is to examine the effectiveness and safety of the drug in long-term use in patients. Measures of success will be slowing down the progression of the disease according to estimates of muscle strength, breathing capacity and other functions that require the use of muscles. The study will be conducted at the ALS clinic at the Hadassah Ein Kerem Medical Center in Jerusalem, which is headed by Dr. Mark Gutkin, the main researcher in this study.
In the past, an ALS patient was treated with the drug, in compassionate care, in a similar therapeutic format. His disease was greatly slowed down and his condition stabilized to a large extent with the IPL344 treatment given to him for over two years.
IPL344 was discovered in the research laboratory of Prof. Yaron Cohen from the Department of Immunology at the Weizmann Institute of Science. The drug activates in various vital cells, including nerve cells, a central control mechanism, Akt/GSK which prevents cell death and destructive inflammation, and can also activate additional defense mechanisms. Activating these mechanisms is expected to slow the progression of the disease, by reducing the damage caused by ALS to nerve cells, muscles and cells of the immune system.
In the first part of the study, phase 1/2, the safety of the drug will be tested in daily intravenous administration for a month and patients will participate in one treatment arm without placebo. After that, the patients will move to phase 2a of the study and will be treated with the drug for an extended period. The research makes use of a wide variety of clinical and biological research methods in order to collect quality information that will assist the advanced stages of the research.
"The research was formulated with the help of the best ALS researchers in the world and is supported by them," explains Dr. Ilana Cohen, the company's development manager. "From studies we conducted in cellular systems, in animals and in light of the success of compassionate treatment in an ALS patient whose disease rapidly deteriorated before treatment and stabilized for a period of over two years with treatment, we believe that the drug will have a significant and long-term contribution in the treatment of ALS patients."
Eran Ovadia, the company's CEO and founder: "We note with satisfaction the opening of the clinical study with a drug that works with a breakthrough mechanism, after successfully meeting all the pre-clinical research challenges and the regulatory approval processes required to conduct the trial. We believe that success in this trial will lead us directly to a phase 2b trial which, subject to its results, can form the basis for marketing approval by the FDA. The drug activates healing intracellular processes, which are common to a number of neurodegenerative diseases, which have a similar biological background, for which there is currently no adequate medical response, and we are also keeping an eye on the treatment of these diseases."
"Our goal is to turn ALS from a terminal disease into a chronic disease. We believe in the innovative scientific idea underlying our technology, and in the promising business potential of its application. There is a huge need for effective drugs in the field of neurodegenerative diseases and especially in ALS," said Rony Pfeiffer, Chairman of the Immunity Pharma Board of Directors.
ALS is among the most severe and incurable muscular dystrophy. Most patients die within less than five years of their diagnosis. This is after their movement muscles, which are also responsible for breathing, speaking and swallowing, are paralyzed one by one.
Efrat Carmi, CEO Israels Association: "We accompany the development of the drug from the first stages, and our research grants helped carry out the first applicability tests of the drug. We are in close contact with the company and closely monitor the progress of the development and its success."
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