Brainstorm Recycles ALS Stem Cell Data to Boost Sagging Stock

January 11, 2016 - als

“Breakthrough,” “revolutionary” and “dramatic” were adjectives deployed by Brainstorm Cell Therapeutics (BCLI) in an email representation mouth-watering reporters to a press discussion being hold Monday morning. The association is announcing results of a tiny clinical hearing of an initial stem-cell therapy in patients with amyotrophic parallel sclerosis (ALS), a degenerative and deadly haughtiness illness also famous as Lou Gehrig’s disease.

A some-more honest outline of a tangible Brainstorm ALS investigate information would be recycled, vague and rarely promotional.

Israel-based Brainstorm initial announced formula of a investigate one year ago. In 12 patients receiving an injection of their possess cultivated branch cells, a course of ALS during 6 months was slowed compared to baseline, totalled by an alleviation in an ALS illness astringency measure or an boost in lung function. 

As we wrote during a time, Brainstorm’s stem-cell therapy looked earnest in ALS patients though a information were early and distant from decisive since a investigate usually enrolled a handful of patients and all were treated during a same Israeli hospital. Most importantly, a investigate lacked a comparator arm so there was unequivocally no approach to decider objectively how good a branch dungeon therapy was working. 

In April, Brainstorm updated a same investigate during a neurology meeting, stretched to embody research of 14 ALS patients. The formula were similar, again display a negligence of ALS course when patients were assessed 6 months after injection of a branch dungeon therapy compared to baseline.

Which brings us to Monday’s press discussion in San Francisco, where investors are entertainment for a J.P. Morgan Healthcare Conference. The usually new expansion is a announcement of a same investigate in this week’s book of JAMA Neurology. The branch dungeon therapy formula are unvaried from what was reported by Brainstorm in April.

Brainstorm is creation a large understanding about a recycled stem-cell information since a batch cost is in difficulty — down 30% over a past year. The association has prolonged found it formidable to remonstrate institutional investors in a U.S to buy a stock. Brainstorm’s financier family bid grew some-more severe in Sep when U.S.-based CEO Tony Fiorino quiescent and was transposed by Chairman (and largest shareholder) Chaim Lebovits.

Brainstorm’s ALS therapy, NurOwn, starts with a harvesting of bone pith from any ALS patient. Mesenchymal branch cells are removed from a bone pith representation and sent to a lab, where a exclusive Brainstorm routine initial expands their numbers and afterwards transforms them into specialized cells secreting haughtiness expansion factors. [Neuralstem (CUR – Get Report) is building a identical stem-cell therapy for ALS though ran in difficulty final year with unsatisfactory clinical hearing results.]

After a duty and potential of a NurOwn cells are confirmed, a “drug” is delivered behind into a ALS studious around injections into flesh and a spine. Once injected, a NurOwn branch cells wash a shop-worn neurons of ALS patients with secretions of haughtiness expansion factors. 

When Fiorino was CEO of Brainstorm final year, a Nurown proviso I/II investigate formula were earnest though inconclusive. Under Lebovitz, a same information are insubordinate and a breakthrough for ALS patients. 

In a company’s email representation to reporters final week, Dr. Dimitrios Karussis of Hadassah Medical Organization in Israel, where a investigate was conducted, is quoted as saying, “Close to 90% of patients who were injected intrathecally [in a spine] were responders to a diagnosis possibly in terms of their respiratory duty or their ubiquitous engine disability.” 

The “close to 90%” response to NurOwn, however, includes any ALS studious in a investigate who showed any negligence of their illness progresson. And Brainstorm was usually means to consider 10 of a 14 enrolled ALS patients during 6 months after a NurOwn injection.

Without a remedy arm for comparison, interpreting a formula of a proviso I/II investigate is challenging, during best.

Brainstorm is conducting a larger, proviso II investigate in a U.S. right now that randomizes ALS patients to diagnosis with NurOwn or a placebo. Results are approaching after this year. 

 

Adam Feuerstein writes frequently for TheStreet. In gripping with association editorial policy, he doesn’t possess or brief particular stocks, nonetheless he owns batch in TheStreet. He also doesn’t deposit in sidestep supports or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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