SA Transcripts • Thu, Nov. 13
There is research on this stock available only to PRO subscribers.
From other sites
Brainstorm Cell Therapeutics, Inc.: A Small Biotech With Big Plans And Huge Potential
- 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.
BrainStorm Tackles Neurodegenerative Diseases With Novel Cell Therapy
- 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.
Neuralstem And Brainstorm Cell Therapeutics: The Race To Treat ALS
- Neuralstem Inc and Brainstorm Cell Therapeutics are neck to neck in their race to treat ALS.
- Both companies have demonstrated an excellent safety profile and strong hints of efficacy, which is truly a "breakthrough" therapy for a very difficult, incurable disease.
- Based on market cap, Brainstorm Cell Therapeutics looks undervalued based on the value of their therapy in relation to Neuralstem.
Thu, Nov. 13, 10:01 AM| Comment!
Thu, Nov. 13, 7:16 AM
Mon, Oct. 20, 10:57 AM
- Cytokinetics (CYTK +5.5%) reports that its lead drug candidate, tirasemtiv, demonstrated clinically meaningful improvements in Slow Vital Capacity (SVC) versus placebo in ALS patients in a Phase 2b study. SVC is a measure of skeletal muscle strength for breathing and is an important predictor of ALS disease progression and survival.
- The company has begun discussions with the FDA on a Phase 3 trial which would begin in 2015.
- ALS-related tickers: (CUR -6.9%)(BCLI -2.6%)(MNOV -13.7%)(BIIB +1%)
Mon, Oct. 20, 8:27 AM
- In two Phase 2a clinical trials, privately-held Genervon Biopharmaceuticals' drug candidate for Amyotrophic Lateral Sclerosis (ALS), GM6 (known as GM604 in the ALS trial and GM608 in a Parkinson's disease study), showed encouraging disease-modifying results albeit in a small number of patients.
- In the ALS study, GM604 significantly reduced the decline in ALSFRS-R versus the historical control (p=0.0047). Seven of eight patients has their ALS disease progression slowed or stopped at week 12 after six doses of GM604. Five of seven treated patients had their forced air capacity (FVC) disease progression slowed or reversed at week 12 compared to historical placebo (-11.5% compared to -4.7% after treatment).
- In the Parkinson's study, the difference in the treated patients' UPDRS scores versus historical placebo at week 12 were statistically significant (p=0.0085). Changes in secondary clinical outcomes measures at week 2 were statistically significant at the one-tailed 10% level for four of eight patients.
- Genervon has submitted these results to the FDA for guidance on how to make GM6 available for ALS and PD patients. GM604 for ALS has been designated Fast Track and an Orphan Drug by the FDA.
- ALS-related tickers:(NYSEMKT:CUR) (NASDAQ:BCLI) (NASDAQ:MNOV) (NASDAQ:BIIB) (NASDAQ:CYTK)
- PD-related tickers: (NASDAQ:ACOR) (Pending:CVTS) (NASDAQ:ACAD) (OTCQX:CYNAF) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRAN) (NASDAQ:CHTP) (NASDAQ:PRTA) (NASDAQ:FOLD) (NASDAQ:AVNR) (NYSE:BSX) (NYSE:MRK)
Thu, Oct. 16, 9:13 AM
Tue, Oct. 7, 7:07 AM
- The FDA grants Fast Track status to Brainstorm Cell Therapeutics' (NASDAQ:BCLI) adult stem cell treatment, NurOwn, for amyotrophic lateral sclerosis (ALS).
- NurOwn is currently in Phase 2 development. The last patient visit was completed recently at Hadassah Medical Center in Jerusalem in a Phase 2a trial. The company expects to release top-line results this quarter.
Tue, Sep. 16, 8:20 AM
- Brainstorm Cell Therapeutics (OTCQB:BCLI) completes a 1:15 reverse split of its common stock as it continues its path to an uplisting on NASDAQ Capital Market. At today's open of the OTCBB, shares will trade under the symbol (BCLID). After 20 trading days, the symbol will revert back to (OTCQB:BCLI).
Mon, Aug. 18, 9:20 AM
- The Mayo Clinic Human Cellular Therapy Laboratory achieves regulatory clearance to produce BrainStorm Therapuetics' (OTCQB:BCLI) NurOwn autologous mesenchymal stem cells secreting neurotrophic factors (MSC-NTF). The Mayo clinical team will begin enrolling patients in the Phase 2 clinical trial evaluating the safety and efficacy of NurOwn in patients with Amyotrophic Lateral Sclerosis (ALS) after completing some additional work with the company. It is the third and final site involved in the ALS trial.
Tue, Jul. 15, 11:05 AM
- The University of Massachusetts Memorial Medical Center in Worcester is now enrolling patients in BrainStorm Cell Therapeutics' (BCLI +0.8%) Phase 2 clinical trial evaluating the safety and efficacy of NurOwn in ALS patients. The medical center is the second of three sites participating in the 48-patient trial. Mass General started in June and the Mayo Clinic will come on line in Q3.
- NurOwn is an autologous adult stem cell therapy that differentiates bone marrow-derived mesenchymal stem cells (MSC) into specialized neuron-supporting cells.
- The study's primary endpoint is the safety of intrathecal and intramuscular injections of NurOwn. Secondary endpoints are efficacy-related (change in slow vital capacity and change in ALS Functional Rating Scale).
- Related ticker: (CUR -3.2%)
Fri, Jun. 13, 10:20 AM
- BrainStorm Cell Therapeutics (BCLI -10.9%) raises gross proceeds of $10.5M in a private placement of common stock and warrants. It sells 42M shares of common at $0.25 (15% discount). Buyers also receive warrants to purchase 42M shares of common at $0.348/share. They are immediately exercisable and have a term of three years.
Mon, Jun. 9, 7:04 AM
Fri, Jun. 6, 9:03 AM
- The first patient has been enrolled in BrainStorm Cell Therapeutics' (BCLI) Phase 2 ALS clinical trial at Mass General Hospital in Boston. The study will evaluate the safety and efficacy of the transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors ("MSC-NTF" or "NurOwn") in 48 ALS patients at three hospitals (Mass General, UMass Hospital in Worcester and the Mayo Clinic in Rochester, NY).
- NurOwn is an autologous adult stem cell therapy technology that differentiates bone marrow-derived mesenchymal stem cells (MSC) into MSC-NTF cells. These neuron-supporting cells secrete elevated levels of neurotrophic factors that protect existing motor neurons, promote motor neuron growth and re-establish nerve-muscle interaction.
Thu, May. 29, 7:26 AM
Mon, Apr. 28, 10:12 AM
- The FDA approves the commencement of a Phase 2 double-blinded clinical trial for Brainstorm Cell Therapeutics' (BCLI +2.1%) NurOwn mesenchymal stem cells for the treatment of ALS patients.
- The trial will begin at Mass General Hospital in Boston and the UMass Memorial Hospital in Worchester after the respective IRB approvals. The Mayo Clinic will also participate.
- Dana-Farber Cancer Institute's Connell O-Reilly Cell Manipulation Core Facility will manufacture the NurOwn cells for the two MA sites.
- The trial will evaluate the safety and efficacy of the transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (NurOwn) in 48 ALS patients. The cells will be administered in combined intramuscular and intrathecal injections.
- The primary endpoint is safety and tolerability as defined by the number of patients with adverse events. Secondary endpoints will measure the changes in ALS Functional Rating Scale and Slow Vital Capacity.
- Last week, Cytokinetics (CYTK -5.3%) announced the failure of its ALS drug in a Phase 2b trial.
- Neuralstem's (CUR +0.5%) Phase 2 trial for NSI-566 in ALS patients began in Q4 2013.
Mon, Mar. 24, 7:48 AM
- BrainStorm Cell Therapeutics (BCLI) has received a U.S. patent for its stem cell technology, which it is developing for neurodegenerative conditions.
- The IP covers stem cells that are induced to secrete elevated levels of neurotrophic factors.
- Separately, Brainstorm has signed an agreement with Massachusetts General Hospital to conduct a Phase II trial of BrainStorm's NurOwn therapy in Lou Gehrig's, pending FDA approval.
- The other two sites are set to be University of Massachusetts Memorial Hospital and Mayo Clinic. (PR)
Mon, Jan. 6, 9:47 AM
- BrainStorm Cell Therapeutics' (BCLI) NurOwn adult stem cells helped a patient with Lou Gehrig's Disease and myasthenia gravis (MG) show significant improvement in cognition, speech, and muscle power a month after treatment.
- After six months, the patient's symptoms had worsened again but improved when he was given another injection of NurOwn.
- "The results suggest that repeated therapy may maintain and enhance the clinical benefits of NurOwn cell therapy in neurological diseases," a case report that is being published in "Muscle & Nerve" says.
- BrainStorm expects to finalize a Phase IIa clinical trial in H1.
- Shares are +5.6%. (PR)
BCLI vs. ETF Alternatives
Other News & PR