BrainStorm Cell Therapeutics Inc (BCLI)

[sokol]

Early on reports about the benefit and length of benefit from NurOwn, although not sufficient in numbers of patients, offer some encouragement that multiple administrations possibly slow ALS down for a significant period of time.

This is from the report about the soldier an the rabbi.

Four ALS patients in an advanced stage of disease received NurOwn transplants at Hadassah starting in 2012 as “compassionate use” cases, including Omri Chotam, a former paratrooper in his 20s, and octogenarian sage Rabbi Rafael Shmuelevitz.

....All four had, at least for three to six months, a response of improvement in respiratory function or muscle power,” reports Karussis.

”The most impressive response was in the rabbi, who had a very severe and unique combination of ALS and myasthenia gravis. He improved for about six months substantially, started walking and speaking, and then the effects faded and then we did a second injection and he had even more impressive improvement. This makes it highly unlikely to be a placebo effect, which is important to note.”

Chotam also received two additional NurOwn injections through the compassionate use program, resulting in functional improvements and halting the progression of the disease for about 18 months now.

“According to the data we have, the treatment makes a beneficial change in the progression of the disease. This is the first step. Now the US study is starting, and we are collaborating and consulting with them,” says Karussis. “We probably need to improve the protocol to do multiple injections for the longer term, and find the best way of administration in each individual patient.”

https://www.israel21c.org/revolutionary-stem-cell-als-treatment-begins-advanced-trials/

In May of this year, Brainstorm leased an Israeli facility to manufacture NurOwn for the EU.

BrainStorm Leases a New Cleanroom Facility at The Tel Aviv Sourasky Medical Center to Manufacture NurOwn® for The European Union

May 7, 2020: https://www.globenewswire.com/news-release/2020/05/07/2029044/0/en/BrainStorm-Leases-a-New-Cleanroom-Facility-at-The-Tel-Aviv-Sourasky-Medical-Center-to-Manufacture-NurOwn-for-The-European-Union.html

Here is a petition for accelerated approval in the UK:

Accelerated Access for Motor Neurone Disease (MND / ALS) treatment in the UK - NurOwn

https://www.change.org/p/boris-johnson-accelerated-assessment-access-review-for-motor-neurone-disease-mnd-als-treatments-in-the-united-kingdom-nurown-stemcells

All of this reminds me of the fight for approval of Sarepta's drug for Duchenne.