Seeking Alpha (SA) is another business oriented site I find offering great value--lots of deep thinkers with not a lot of egoistic junk littering the field of focus. There's an atmosphere of genuine respect and encouragement. That said, here's an item from SA on BCLI:
BrainStorm Tackles Neurodegenerative Diseases With Novel Cell Therapy Jason Napodano, CFA • Thu, Jun. 12 • 21 Comments
•BrainStorm Cell Therapeutics, Inc. (BCLI) is a biotechnology company developing adult stem cell therapies for a range of neurodegenerative diseases. •The company has a proprietary process called NurOwn™ that harvests and propagates autologous Mesenchymal Stem Cells (MSC) and then induces their differentiation into neurotrophic factor (NTF) secreting cells. •Brainstorm recently initiated a multi-center, randomized, double blind, placebo controlled trial Phase 2 clinical trial in the U.S. for ALS. •While limited, we are intrigued by the clinical data seen thus far. We believe the shares are worth at least $0.50, which is a handsome 67% return from today.
****************************************************** It should be noted that Jason, the author, is part of Zacks of Zacks Advisory Service and it may well be the best source of analytics anywhere. Much of it is available without cost. ****************************************************** Another entry from SA, released just three days ago:
Brainstorm Cell Therapeutics, Inc.: A Small Biotech With Big Plans And Huge Potential JMY Investments • Tue, Jun. 24 • 40 Comments
•Stem cell therapies are finally entering human trials, and initial results are validating the science and providing hints of strong efficacy. •StemCells, Inc. was an obvious investment opportunity, based on the four Cs of biotech investing. Brainstorm Cell Therapeutics, based on the same set of criteria, will follow suit. •With a recent capital raise, Brainstorm is poised to deliver results from its Phase II ALS trial, which will drive appreciation in stock value. ************************************************************* Still another piece dating back somewhat earlier demonstrates the unusually positive character of BCLI as viewed by analysts.
Brainstorm's Breakthrough ALS Clinical Data Shows The Promise In Stem Cell Therapy
Mar. 28, 2013 9:14 AM ET | 6 comments | About: BrainStorm Cell Therapeutics Inc. (BCLI), Includes: ACTC, BTX, CUR, MKGAY, PSTI, STEM, TEVA, UTHR
Brainstorm Cell Therapeutics (OTCQB:BCLI) is an Israeli biotech company developing a stem cell-based treatment for amyotrophic lateral sclerosis (ALS), a progressive chronic neurological disease that attacks nerve cells responsible for controlling skeletal muscles. With only one FDA-approved drug [Sanofi Aventis' (SNY) Rilutek], which offers few benefits for patients, ALS patients are in dire need for new therapies.
Brainstorm's treatment is based on autologous (patient's own cells) transplantation of adult bone marrow-derived mesanchimal stem cells that are differentiated using the company's proprietary technology, NurOwn™, into cells that secrete neurotrophic factors.
BCLI recently reported final results from the first stage of its Phase I/IIa clinical study that evaluated the company's ALS treatment in 12 patients. The study demonstrated that the stem cells transplantation resulted in "a significantly slower decline in overall clinical and respiratory function, as measured by the ALS Functional Rating Score (ALSFRS-R) and Forced Vital Capacity (FVC) score respectively, in the six patients that received an intrathecal injection of the cells in the six months following treatment, as compared to the three months preceding treatment". The study also tested, and initially confirmed, the safety of the treatment protocol.
BCLI's stock, which has dropped about 4% from the beginning of the year, responded to the good clinical news with a 6% increase, with trading volumes up 5 fold compared to the 3 months average. The modest stock movement following the company's announcement could be explained by the shortage of cash at hand - around $4m, which might mean that a financing round is right around the corner.
The results presented by Brainstorm are very encouraging, both for the company and the patients, but are preliminary, and require further validation. In the second stage of the ALS study, which began in February this year, 12 additional ALS patients will be administered with Brainstorm's stem cells in increasing doses. The first cohort of four patients is expected to complete treatment by the end of April. BCLI is currently awaiting FDA approval to expand its ALS clinical development to the U.S., which is planned to commence during 2013. The NurOwn technology for treatment of ALS has been granted orphan-drug designation by the FDA.
Brainstorm's major competitor in the ALS cell therapy field is Neuralstem (CUR), whose treatment is based on human spinal cord-derived neural stem cells (NSI-566). Neuralstem completed a Phase I/IIa study in ALS patients in February 2013 and also reported of promising results in several patients, in which the disease was stabilized for nearly one year. Neuralstem is expected to commence an ALS Phase II trial during 2013.
BCLI is one of several Israeli companies that are advancing R&D programs with stem cell-based therapeutics (table 1). Interestingly, Israeli companies take up a surprising share among companies that develop stem cell-based therapies, especially when considering the small size of this country. This could be attributed to the strong presence of stem cells research in Israeli academic institutes, support from the government for stem cell research and lack of ethical barriers for the use of embryonic stem cells, as experienced by U.S. researchers during the Bush Administration. In the second part of this article we will briefly review several Israeli stem cell companies. **************************************************** There is more to this article but rather than burden folks with over-information, you can go to Seeking Alpha and type in the ticker symbol and pull up a lot of great info. This link will get you to SA and the above piece as well: http://seekingalpha.com/article/1306501-brainstorms-breakthrough-als-clinical-data-shows-the-promise-in-stem-cell-therapy ******************************************************** From this morning's PR---notice the upbeat stance being portrayed by both participating companies:
BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, and Octane Biotech Inc., a Canadian firm that focuses on clinical systems for cell and tissue therapy, announced today that they have reached an important milestone in their technology collaboration, successfully constructing an Alpha prototype of a customized bioreactor for BrainStorm's NurOwn(TM) neurotrophic-factor secreting mesenchymal stem cells. The proprietary bioreactor under development will provide BrainStorm with large-scale manufacturing capabilities, enabling it to achieve economies of scale for its autologous stem cell product.
Octane and BrainStorm have successfully developed a sophisticated Alpha prototype of the NurOwn(TM) Bioreactor, utilizing a customized disposable cartridge that is dedicated to the intricacies of BrainStorm's NurOwn(TM) process. Operating within the Cocoon(TM) clinical delivery platform pioneered by Octane, the Alpha prototype automates the entire NurOwn(TM) process for unmatched process control and production economy. Based on this first working prototype, BrainStorm and Octane are quickly advancing to the next stage of system qualifications in anticipation of adopting all the benefits of cell production automation as quickly as possible for full clinical use.
BrainStorm's Chief Executive Officer Tony Fiorino, MD, PhD, said that "Improving in the scale and efficiency of our manufacturing process is an important focus area for the company, and the achievement of this milestone in our collaboration with Octane is an important indicator of our commitment to and progress in advancing NurOwn(TM) manufacturing. I look forward to entering the next phase of the collaboration with Octane."
"The positive results we have achieved so far provide the partnership team with confidence that the scale-up objectives of the program are achievable through the use of the Octane technology," further commented Dr. Timothy Smith, CEO of Octane Biotech. "Our strong working relationship with BrainStorm across the many areas of biology, engineering and quality control has been highly productive. This type of close collaboration with clear clinical, technical and commercial goals is critical to success and is how Octane interacts with all our global partners."
"We are excited about this significant milestone for the Octane-BrainStorm team as well as for the autologous stem cell industry in general," commented Chaim Lebovits, President of BrainStorm. "We look forward to continued progress from this outstanding technology collaboration and are grateful to CIIRDF for their funding of this important project." ********************************************************* Following is a bit of news that came out recently establishing that the first cohort involved in an ALS clinical trial was enrolledd. More typically, enrollments are likely to be considerably smaller. I believe Neuralstem's first clinical was limited to just 12 but I'm not certain of this. Still, 48 is huge when we remember that we're no dealing with lab mice. These are human beings with terrible afflictions. The entire world is watching in the hopes that there will be relief from this little Israeli company that "could." From June 6th:
First Patient Enrolled in BrainStorm's Phase II ALS Trial at Massachusetts General Hospital 8:40a ET June 6, 2014 (Market Wire) Print
BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the first patient was enrolled in its Phase II ALS trial at Massachusetts General Hospital (MGH) in Boston.
BrainStorm's Phase II trial is a randomized, double-blind, placebo controlled multi-center study designed to evaluate the safety and efficacy of transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors ("MSC-NTF" or NurOwn(TM)) in 48 ALS patients. The trial is also being conducted at the University of Massachusetts Memorial (UMass) Hospital in Worcester, MA and the Mayo Clinic in Rochester, Minnesota. **************************************************** One more item: You'll recall I said the number of cohorts is expanding. I've seen this via factual data but haven't turned it up just yet. However, I just ran across this which I'm presenting in part. Note that it refers to just twelve patients scheduled, quite a difference. It dates back by several months, predating an item included herein in which it's revealed that there are 48 cohorts scheduled for clinical treatment:
Brainstorm (BCLI.OB), an Israeli company.
Each has its own prototype patient whose ALS has been beaten back. Neuralstem has Harada, and Brainstorm has Rabbi Refael Shmulevitz. The two companies' technologies are similar, with Neuralstem using an embryonic stem cell line, and Brainstorm using a system it calls NurOwn, where adult stem cells are taken from a patient's own bone marrow and used to create nerve cells.
In terms of the clinical race, Brainstorm has begun a phase IIa trial authorized by Israel's health ministry, though it is unclear where that trial stands with the FDA or if Israeli's health ministry has any leverage with its sister bureaucracy in the US. In any case, the first patient in that trial was treated at the beginning of last month. Brainstorm's trial will involve only 12 patie[color=red][/color]nts, all of whom have already been recruited, though at such a small sample it is more like a phase I. Then again, numbers of patients with ALS are extremely limited, especially in Israel where the trial is being conducted. ******************************************************** This was a fine exercise for me as I think it is always good to meet analytical challenges head on. By pooling related stories and clinical data results, we get to become part of the learning process ourselves, something I greatly appreciate.
I sincerely hope some of our board members are enriched by this study. There is so very much we can learn from each other!
PS: We investors are always wondering where other find their picks---especially the major gainers. Well, I don't know how I turned up BCLI but I do know that my Neuralstem (CUR) shares were doing so well that I knew I had to explore the possibility of other unusually promising stocks. I remember running into BCLI and not trusting it because shares were so cheap. But then I remembered that my first CUR shares cost just $1.20 on 1/3/13. They closed today @ $4.17. I'm convinced they will rise above $5 before long.
I first bought BCLI on March 12, 2014 at 28.8 cents per share. Today's close: 37.2 cents. My revised cost basis is now 30 cents after adding 10,000 shares to the earlier 20,000.
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