Published on Jul 5, 2012 by Brainstorminvestors
July 3, 2012
Israeli Channel 2 reports: Dramatic Change in Patient with ALS and MG following Compassionate Use of BrainStorm’s Nurown™ Cell Therapy
NY, Petach Tikva, July 2, 2012. — BrainStorm Cell Therapeutics Inc. (OTC BB: BCLI), Israeli Channel 2 TV interviewed today a patient suffering from Myasthenia Gravis (MG) and recently diagnosed with ALS. The patient reported that he has experienced visible improvement in his speech, walking, balance, posture, muscle strength, appetite, digestion, and weight gain following compassionate treatment with BrainStorm’s NurOwn cell therapy.
“Due to the rare disease combination of MG and ALS, this patient was approved for compassionate treatment with BrainStorm’s NurOwn cell therapy” says Professor Dimitrios Karussis of the Neurology Department at The Hadassah Medical Center in Jerusalem, and Principal Investigator of BrainStorm’s current Phase I/II clinical trial. “Within a few weeks following injection with NurOwn cells, the patient showed dramatic improvement in a variety of functions including breathing, speech, walking, muscular strength, and overall well-being. While we cannot draw scientific conclusions based on the outcome of an individual patient, these results are extremely encouraging.”
“We are moved by the remarkable results observed following treatment with NurOwn,” said Professor Avi Israeli, BrainStorm’s Chairman of the Board. “We are hopeful that we will continue to see this kind of improvement in all the patients participating in our current and future clinical trials.”
In January 2012 the Company reported initial safety data from the first four patients in BrainStorm’s ALS Phase I/II human clinical trial, indicating that treatment with NurOwn did not present any significant side effects and demonstrated some beneficial clinical effects. After reviewing this safety data, the Hadassah Medical Center ethical committee granted approval for the trial to continue. Interim results for the first 12 patients are expected in July 2012.
BrainStorm expects to expand its ALS clinical development into the United States. Orphan-drug designation for NurOwn has been granted by the US Food and Drug Administration. In addition, the Company has entered into a Memorandum of Understanding with the University of Massachusetts Medical School and Massachusetts General Hospital to begin ALS human clinical trials at these institutions.
About BrainStorm Cell Therapeutics, Inc.
BrainStorm Cell Therapeutics Inc. Is a biotechnology company engaged in the development of adult stem cell therapeutic products derived from autologous bone marrow cells and intended for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn™ technology through an exclusive, worldwide licensing agreement with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel-Aviv University. For more information, visit the company’s new website at www.brainstorm-cell.com.
Safe Harbor Statement
Statements in this announcement other than historical data and information constitute “forward-looking statements” and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.’s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as “may”, “should”, “would”, “could”, “will”, “expect”, “likely”, “believe”, “plan”, “estimate”, “predict”, “potential”, and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm’s limited operating history, history of losses; minimal working capital, dependence on its license to Ramot’s technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm’s annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm’s forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management’s beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
FOX Medical Team
Henry County man undergoes experimental ALS stem cell surgery
Posted: Aug 27, 2012 4:20 PM EDT
Updated: Aug 27, 2012 6:07 PM EDT
By Beth Galvin, FOX Medical Team reporter -
A Henry County father of three has gambled on a risky, cutting-edge spinal surgery not once, but twice.
Ted Harada is the 15th and final patient to undergo a human stem cell transplant for amyotrophic lateral sclerosis (ALS) patients. He’s part of an Emory study being watched all over the world.
The surgeons aren’t just injecting cells into the spinal cord — they’re exposing the spinal cord, It controls every breath, every movement, every muscle.
Ted and Michelle Harada have been down this road before. The two have been married 18 years. Ted, 40, was diagnosed with ALS two years ago.
“I know it’s the right thing. And I know it’s the right thing not just because it will help me, but because there’s a lot of people out there that need help,” said Harada.
Ted knows ALS, also known as Lou Gehrig’s disease, will progressively shut down his muscles, until he can’t breathe on his own.
Ted volunteered for the first-ever human stem cell trial for ALS at Emory. He said that he’s taking the risks for his three children – a 14-year-old son, 12-year-old daughter and 8-year-old daughter.
“But that fact that it was so cutting edge of science and medicine is what appealed to me,” said Harada.
Doctors are using stem cells taken from a fetus aborted 12 years ago. They’ve been cultured and multiplied in a lab by a company called Neuralstem. They’re injecting them directly into the spinal cords of people with ALS.
Seventeen months ago, the cells transplanted into Ted’s lower spine, which controls his legs.
“Now this is a disease that doesn’t get better. So we don’t see patients who spontaneously get better. It just doesn’t happen,” said Emory neurologist Dr. Jonathan Glass.
But Ted did get better. Soon he could walk through his McDonough neighborhood without a cane — the one patient of 15 study volunteers to measurably get stronger.
“How could I not believe in it, when I’ve seen what it’s done, for whatever reason? I mean, I understand it’s a safety trial, but you still can’t deny or ignore the results I’ve seen,” said Herada.
“I have difficulty explaining it – it was unexpected,” said Glass. “It was nice to see.”
But recently the weakness has come back, So, Ted returned for one more surgery.
“I told him the risks, he knows the risks, and the risks are large,” said Glass.
“But there’s part of me that has to say, ‘Hey, it worked once, why can’t it help again,’” said Ted.
Before Ted’s second surgery began, Glass had to make sure the stem cells were still viable. To go forward, at least 70 percent have to be alive. In Ted’s case, 86.3 percent were alive.
It was neurosurgeon Nick Boulis’ 18th stem cell transplant at Emory.
“We’re going to do five injections of the cervical spinal cord,” said Boulis.
The Emory/University of Michigan team focused on the neck because the nerves there control breathing.
“Because that’s why people die. People die of ALS because they can’t breathe,” said Glass.
Dr. Boulis and the team carefully teased open the most delicate, dangerous, real estate in the body: the cervical spinal cord. A few feet away, Dr. Glass drew the stem cells into a hair-thin tube, about 100,000 at a time.
“And then we’ll do that five times, so it will be 500,000 cells he’ll get,” said Glass.
The cells were injected into a two centimeter section of Ted’s spinal cord. The only goal of this trial is to prove this surgery, and these cells are safe, not whether they work. But lab studies show the stem cells may help damaged or dying spinal nerve cells repair themselves.
After almost six hours in the operating room, the surgery was complete.
Nothing is promised, nothing guaranteed. But there’s hope. And for the Haradas that’s enough.
Five days out, Ted says he’s doing OK.
Now, the Emory-Michigan team will take all of its safety data to the Food and Drug Administration to ask permission to move on to the next phase of the trial. That could take about a year.