Wow, this would be such a blessing if it pans out

 
Thanks,
Tamar  

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

It is not our differences that divide us.
It is our inability to recognize, accept, and celebrate those differences.
~ Audre Lorde

----- Forwarded Message -----
From: Jonathan Gold <[log in to unmask]>
To: Berkeley-Disabled <[log in to unmask]> 
Sent: Sunday, July 29, 2012 10:06 AM
Subject: [berkeley-disabled] ALS Patients Improve with Experimental Treatment
 

  
By Tova Cohen

TEL AVIV | Mon Jul 23, 2012

(Reuters) - A clinical trial of ALS patients conducted by BrainStorm
Cell Therapeutics shows its adult stem cell therapy is well-tolerated,
appears to be safe and does not present undue risk, according to an
interim safety review.

Moreover, in some patients signs of stabilization of the disease were detected.

Israel-based BrainStorm is developing NurOwn for the treatment of
amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's
Disease, a progressive neurodegenerative disease that affects nerve
cells in the brain and spinal cord.

"It's very uncommon to give at such an early point in a clinical study
efficacy data, but we cannot ignore the fact on an individual basis we
could see improvement in many of the patients involved, each one in
different areas," Moshe Neuman, CEO of Biomedical Research Design,
which serves as a contract research organization for the trial, said.

In some patients breathing improved, in others it was muscle strength
and in others it was speech, he told Reuters.

Neuman said a final report was expected by the end of the year after
each patient has been observed for nine months.

BrainStorm President Chaim Lebovits said the preliminary results
demonstrate that the stem cells have the potential not only to stop
deterioration but perhaps even cure ALS.

"The coming phases in the trial will have to prove this, but these
results also reaffirm our belief that we have an enormous potential of
being successful with less severe indications such as multiple
sclerosis and Parkinson's," he said.

Patients in the trial were transplanted with stem cells derived from
their own bone marrow and treated with the NurOwn stem cell
technology.

The Phase I/II trial, designed to evaluate the safety and preliminary
efficacy of BrainStorm's therapy, is being conducted at Jerusalem's
Hadassah Medical Center. The company submitted the interim safety
report to Israel's Health Ministry.

"This important safety and tolerability data are reassuring as we
progress to the next half of this trial," said Dimitrios Karussis of
the Neurology Department at Hadassah, who is leading the trial.
"Although this is an interim safety summary report documenting
achievement of the study's primary endpoint, we cannot ignore some
possible promising indications of clinical efficacy observed in single
patients."

In one patient in particular, Rabbi Rafael Shmuelevitz of Jerusalem,
significant improvement was seen. Shmuelevitz, who in addition to ALS
also has a neuromuscular disease called myasthenia gravis, was
received as a compassionate patient and given a higher dose than other
patients.

In a letter to BrainStorm, a copy of which was obtained by Reuters,
the rabbi said the treatment raised him "up from the depths and I have
become like a new man."

Before the treatment he suffered from disequilibrium and could not
walk without help from both sides, he said.

"Today, after the stem cell treatment, I am able to walk consistently
and with stability even without the help of a cane. In my voice there
is also immense improvement," he said.

BrainStorm is awaiting U.S. Food and Drug Administration approval to
begin ALS trials at the University of Massachusetts Medical School and
Massachusetts General Hospital.

"The next steps are to explore additional dosages and a Phase II
safety and preliminary efficacy study that we plan to assist in
designing," Merit Cudkowicz, chair of the neurological department at
Massachusetts General Hospital, said.

According to the ALS Association, 5,600 people in the United States
are diagnosed each year with the disease, which has severely disabled
British physicist Stephen Hawking.

The FDA last year granted NurOwn orphan drug designation, which
encourages the development of treatments for rare diseases by
providing financial incentives.

(Reporting by Tova Cohen; Editing by Maureen Bavdek)

from

http://tinyurl.com/cx2vpbx

Jonathan
Berkeley, CA

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