NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--

BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that its CEO, Dr. Adrian Harel, has issued an Annual Letter to Shareholders summarizing the companys extremely significant developments of 2012:

Dear BrainStorm Shareholders,

2012 has been a pivotal year for BrainStorm, as the company has achieved the most significant milestones since its inception. Weve made dramatic progress in our clinical trials, establishing the safety of NurOwn cells in a first group of ALS patients and demonstrating promising indications of clinical improvement in some patients. As a result weve been fast-tracked to a Phase IIa preliminary efficacy trial after only one year of testing. Weve also made key advances in product development, and secured the largest amount of financing in any single year of operations. I am proud to share with you the major highlights of the past twelve months:

I. Clinical Trials Progress

In early June, we performed the 12th ALS patient transplantation in our Phase I/II clinical trial with NurOwn at Hadassah Medical Center in Jerusalem. In July, we submitted a positive interim safety report to the Israeli Ministry of Health (MOH) on the first 12 ALS patients in the study, demonstrating that treatment was well-tolerated and that there were promising indications of clinical improvement in some of the patients.

Just as we welcomed in 2013, the MOH approved acceleration to a Phase IIa dose-escalating trial to further evaluate the safety and preliminary efficacy of NurOwn treatment. In the Phase IIa trial, which we are launching this month, a second group of 12 patients will receive combined intramuscular and intrathecal administration of NurOwn cells in three cohorts, with increasing doses. The study participants, who have already been recruited, will be monitored for three to six months after transplantation.

In addition, preparations are well underway for a Phase II clinical trial in the USA, scheduled for 2013, pending FDA approval.

II. Advances in Product Development

In December 2012, we signed a strategic agreement with Octane Biotech of Kingston, Ontario, to jointly develop a proprietary bioreactor for production scale-up of NurOwn. The customized bioreactor will enable us to significantly increase our production capabilities by using a single clean room for multiple patients, reducing costs and time. We are very excited to be working with Octane, given their expertise in developing automated production processes for mesenchymal cell therapy technologies. The project is currently being launched.

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BrainStorm’s CEO Issues Annual Letter to Shareholders