Release date: 2017-05-08
Recently, BrainStorm Cell Therapeutics, a leader in the treatment of adult stem cell technology for neurodegenerative diseases, announced that it will announce NurOwnTM treatment of amyotrophic lateral cord at the annual meeting of the International Society for Cell Therapy (ISCT) in London and the World Conference on Advanced Therapy and Regenerative Medicine. Phase II clinical study data for sclerosing ALS. (It is said that the election was announced in the UK, considering that Hawking’s walking is inconvenient, that is to say, Hawking may arrive at the scene that day, regardless of whether the news is true or not, Hawking’s hearing of this news will be very open.)
Brainstorm Cell Therapeutics is a biotechnology company dedicated to the development of adult stem cell therapies for neurological diseases. The company has the right to develop and commercialize NurOwn technology through an exclusive, global licensing agreement with Tel Aviv University technology transfer company Ramot.
As the core technology of the company, NurOwnTM Cell Therapy can utilize the multi-differentiation potential mesenchymal stem cells in the human body to treat various diseases. NurOwnTM technology is based on a new differentiation protocol that involves inducing human bone marrow mesenchymal stem cells to differentiate into neural cells, forming glial cells and secreting cells, releasing various neurotrophic factors, thereby promoting the growth, survival and differentiation of developing neurons. . The company's core NurOwnTM technology addresses neurodegenerative diseases including amyotrophic lateral sclerosis, multiple sclerosis, and autism.
BrainStormCell Therapeutics clinical research pipeline
Among them, NurOwn has the fastest clinical progress in the treatment of amyotrophic lateral sclerosis (ALS).
Unlike Neuralstem's stem cell therapy NSI-566, because NSI-566 is essentially a spinal stem cell transplant, reconstructing motor neurons. BrainStorm's NurOwnTM provides a modified mesenchymal stem cell that acquires mesenchymal stem cells (MSCs) from patients with ALS and then modifies these cells using proprietary NurOwnTM technology, hoping to enhance their secretion of neurotrophic factors (NFT). ) the ability to protect and promote neuronal growth.
Mesenchymal stem cells produce neurotrophic factors
NurOwn TM migration process
FDA granted fast track review eligibility in October 2014
The US FDA has awarded the company's adult stem cell therapies for rapid pathway review of amyotrophic lateral sclerosis (ALS). BrainStorm's treatment, NurOwn, was being tested in patients with ALS in a mid-term trial. Fiorino, CEO of BrainStorm, said the FDA's eligibility for fast-track review of the drug is a confirmation of the unmet medical needs of ALS.
Announced results of the first personal ALSI/II study in January 2016
BrainStorm published a paper in the JAMA Neurology journal, announcing the results of NurOwnTM's first human phase I/II study and phase II dose escalation study for ALS. The data provided meaningful clinical results, and the patient's condition slowed down after treatment. At the same time, BrainStorm announced that it has signed a cooperation agreement with Hadassah Medical Center for NurOwnTM Phase II trials for multiple doses of ALS. This trial explores the safety and efficacy of NurOwnTM multiple-dose therapy, an important step in validating the treatment.
July 2016 ALS Phase II clinical perfect ending
BrainStorm announced that its Phase II clinical trial of NurOwn's technology platform for treatment of ALS has reached a major end point, showing good safety and tolerability, as well as significant clinical benefit for up to 24 weeks. The Phase II clinical trial was conducted at three centers in the United States: Massachusetts General Hospital, Massachusetts University School of Medicine, and Mayo Clinic. A randomized, placebo, controlled study designed to evaluate NurOwn's single treatment of 48 patients with ALS. The primary outcome was safety and tolerability. Secondary endpoints included ALS functional scale scores, biomarkers, and so on.
The results obtained are inspiring. The world's top scientists in the field have issued cheers and agreed that it is worth further to promote clinical development.
Dr. Robert H. Brown, Professor of Neurology, University of Massachusetts Medical Center, Professor of Neurology, Harvard Medical School, Dr. Merit E. Cudkowicz, Director of Neurology, Massachusetts General Hospital, Dr. Anthony J. Windebank, Professor of Neurology, Mayo Clinic, and Health Science, University of Texas Dr. Carlayne E. Jackson, a professor of neuro-tonology and rheumatology at the center, all agreed that the single-use NurOwn treatment in this trial had a significant clinical benefit response (improvement of the ALSFRS-R scale score) and improved neuronal recovery. Cerebrospinal fluid markers, these good data clearly suggest a further evaluation of the role of multiple treatments using NurOwn.
Brainstorm clinical trial completion
So far, Brainstorm has completed Phase I, Phase II, and Phase II clinical trials in Israel and the United States.
The last unfinished trial was BrainStorm's third clinical trial at the Hadassah Medical Center to provide guidance for the NurOwnTM Cell Therapy Phase III project for ALS. The trial is expected to recruit 24 patients and undergo 3 consecutive stem cell transplants to explore the safety and efficacy of multi-dose treatment.
Application for listing in Canada in March 2017
BrainStorm has signed an agreement with the Renewables Commercialization Center (CCRM) in Toronto, Canada to support its ALS therapy NurOwn's marketing approval request.
Located in Toronto, CCRM is a leader in the development and commercialization of regenerative medicine technology, cell and gene therapy. CCRM is helping BrainStorm find an opportunity to receive Health Canada's early access pathway for patients with amyotrophic lateral sclerosis (ALS). If NurOwn is eligible for the “Eligible†notice, it will likely be licensed and will begin distribution in Canada in early 2018.
Chaim Lebovits, President and CEO of BrainStorm, said: "We are very pleased to have a partnership with CCRM. We will continue to work hard to develop and commercialize NurOwn for ALS patients as soon as possible. We look forward to discussing with the Health Canada staff. The results of the ALS Clinical Program so far, we believe these results demonstrate convincing evidence of safety and efficacy, and may be subject to expedited review under the Canadian Drug Regulations for Severe or Fatal Diseases."
About gradual freezing
Freezing, medically known as ALS, is muscle atrophic lateral sclerosis, and Hawking's disease is a rare subtype of "frozen human disease."
The world of frozen people can't imagine that the body is like being frozen by ice and snow. Today is the leg. Tomorrow is the arm. In the end, it may spread to the fingers. Even the muscles that control the vocal vocalization and the rotation of the eyeball are no exception... but from beginning to end. The patient's mind is always awake, but it is necessary to watch the whole function of the body gradually lose with muscle atrophy until respiratory failure.
This is a progressive neurodegenerative disease that invades neurons (nerve cells) in the brain and spinal cord. In ALS patients, motor neuron cells are dying, and eventually patients lose the ability to control muscle activity, leading to complete paralysis or death.
About BrainStorm
Brainstorm Cell Therapeutics was founded in 2000 and is headquartered in New York, USA. It is a biotechnology company that uses autologous bone marrow stem cells to culture adult stem cell technology to treat bone marrow degenerative diseases. The company holds the right to develop NurOwn technology and has signed an exclusive, global patent use contract agreement with Ramot, a technology transfer company of Tel Aviv University. In previous clinical trials, NurOwn drugs have been used in more than 50 ALS patients in Israel and the United States, and randomized, double-blind, placebo-controlled clinical trials are currently conducted in the United States.
About the Regenerative Drug Commercialization Center (CCRM)
CCRM is a non-profit organization funded by the Government of Canada, Ontario and leading academic and industry partners to support the development of regenerative medicine and related support technologies, with a special focus on cell and gene therapy.
As a network that brings together researchers, leading companies, strategic investors and entrepreneurs, CCRM aims to leverage professional teams, funding and infrastructure to accelerate the transformation of scientific discoveries into marketable products available to patients. CCRM is a commercialization partner for drug design at the Ontario Institute of Regenerative Medicine and the University of Toronto.
Reference source
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http://ir.brainstorm-cell.com/phoenix.zhtml?c=142287&p=irol-newsArticle&ID=2167845
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Source: Medical Microphone (micro signal cell-culture-club)
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