|Over a week ago|
BrainStorm announces NurOwn trial data published in Multiple Sclerosis Journal » 06:0909/1509/15/22
BrainStorm announced the…
BrainStorm announced the peer reviewed publication of data from the Phase 2 trial of NurOwn in progressive multiple sclerosis, or MS, in Multiple Sclerosis Journal. Results from the Phase 2, single-arm, open-label study demonstrated NurOwn's safety and provided preliminary evidence of its efficacy in people with progressive MS. Additionally, biomarker analyses confirmed NurOwn's proposed mechanism of action by showing consistent treatment effects in neuroinflammation and neuroprotection pathways. Twenty participants were enrolled into the Phase 2 trial, with seventeen receiving all three scheduled NurOwn treatments. The mean age of study participants was 47 years with a mean expanded disability status scale, or EDSS, score of 5.4 at screening. Results from the trial were compared to 48 matched control patients who were selected from the from the Comprehensive Longitudinal Investigation of Multiple Sclerosis, or CLIMB, registry at the beginning of the trial. Treatment with NurOwn resulted in large, clinically meaningful improvements in some patients, as defined by response criteria, across all endpoints measured. These endpoints included timed 25-foot walk speed, 9-hole peg test, multiple sclerosis walking scale, symbol digit modality test and low contrast letter acuity. These observed improvements diverged from what was seen in matched patients with progressive MS from the CLIMB registry. Key data from the trial, as well as relevant comparisons to the matched CLIMB registry patients, are shown below. In total, 19% of treated trial participants were responders, compared to 4% of the matched CLIMB registry patients; 38% of treated trial participants showed a 10-point improvement from baseline in the 12-item MSWS; 27% of treated trial participants showed a =8-letter improvement in LCLA binocular at a 2.5% contrast threshold, compared to 6% of the matched CLIMB registry patients; 67% of treated trial participants showed a 3-point improvement in the SDMT, compared to 18% of the matched CLIMB registry patients; 47% of treated trial participants showed a 8-point improvement in LCLA binocular at a 1.25% contrast threshold. Across all participants, improvements in function as measured by LCLA, SDMT and MS Functional Composite were observed. Mean improvements from baseline of 3.3 points in the LCLA binocular, 3.8 points on the SDMT, and 0.18 points in MSFC were observed in treated trial participants. The corresponding changes in matched CLIMB registry patients estimated at 28 weeks showed declines in function on the LCLA and MSFC. The average change in function decline as measured by T25FW, 9HPT, and EDSS across all treated trial participants demonstrated stabilization of functional decline, with similar or slightly worse findings observed in the matched CLIMB registry patients for the same endpoints.There were no adverse events related to worsening of MS disease and no clinically significant changes in safety lab results/vital signs, confirming NurOwn's favorable safety profile. Two patients developed symptoms of low back and leg pain, consistent with arachnoiditis, occurring in one of three treatments in both participants.Treatment also consistently resulted in increases in cerebrospinal fluid neuroprotective factors and reductions in inflammatory biomarkers, confirming NurOwn's proposed mechanism of action in progressive MS.
|Over a month ago|
Fly Intel: Pre-market Movers » 08:5608/1508/15/22
VRDN, AGS, LOCL, DOYU, YOU, BCLI, UPH, LI, IDYA, AKUS, CLNN, ITW
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BrainStorm reports Q2 EPS (19c), consensus (15c) » 07:0708/1508/15/22
"Brainstorm Cell Therapeutics is at a pivotal moment as a company as we finalize the regulatory filing for NurOwn in the treatment of ALS. The continued analysis and the feedback received from the many scientific presentations of NurOwn's Phase 3 data have uncovered key insights that furthered our understanding of the product mechanism of action and therapeutic potential and strengthened the conclusions of NurOwn's efficacy," said Chaim Lebovits, CEO. "After carefully considering these learnings, the totality of the evidence from NurOwn's clinical studies, and the feedback received from key opinion leaders and the broader ALS community, we will submit a Biologics License Application to the FDA. We are deeply grateful to the ALS clinical experts, members of the ALS community and faithful investors for their contribution to the development of NurOwn and what it may mean to those living with ALS. Their contributions and commitment made our current progress possible and continue to inspire us as we prepare for the considerable work ahead. We intend to provide additional updates upon learning whether the FDA files our BLA submission."
|Over a quarter ago|
BrainStorm receives patent in Brazil covering methods to manufacture NurOwn » 07:3602/1502/15/22
Brainstorm Cell Therapeutics announced that the Brazilian Patent Office has granted the patent application titled: "A method of generating cells which secrete Brain Derived Neurotrophic Factor, or BDNF, Glial Derived Neurotrophic Factor, or GDNF, Hepatocyte Growth Factor, or HGF, And Vascular Endothelial Growth Factor, or VEGF, wherein said cells do not Secrete Nerve Growth Factor, or NGF." The granted claims cover a method of manufacturing MSC-NTF cells, or NurOwn.
Fly Intel: Pre-market Movers » 09:0412/2712/27/21
MBOT, BORR, STRO, BCLI, GDDY, BBIO, DIDI, VLD, DAL, JBLU, UAL, AAL, SYK
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BrainStorm announces FDA authorizes further NurOwn dosing under EAP » 07:0312/2712/27/21
BrainStorm Cell Therapeutics announced plans for a dosing extension of NurOwn for participants who completed the Expanded Access Protocol, EAP. The U.S. Food and Drug Administration recommended that BrainStorm submit an EAP protocol amendment to provide additional dosing for these participants. Under the original EAP protocol, participants who had completed the Phase 3 NurOwn trial and who met specific eligibility criteria had the opportunity to receive 3 doses of NurOwn. Under the amended EAP protocol, these eligible participants will receive up to 3 additional doses. Data collected from the original EAP treatments informed the decision to move forward with additional doses for participants who completed it. Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics, commented, "We are pleased to be able to provide additional treatments to these patients. This program is an outcome of a fruitful collaboration between the FDA, Patient Advocacy groups and Brainstorm. We look forward to continuing this dialogue with the FDA for the best path forward."
BrainStorm announces presentation of new analyses from Phase 3 trial of NurOwn » 07:3211/2911/29/21
BrainStorm Cell Therapeutics announced the presentation of new analyses from the Phase 3 trial of NurOwn at the 4th Annual ALS ONE Research Symposium. The presentation, which will be delivered Tomorrow, showed that although the Phase 3 trial did not reach statistical significance on the primary and secondary endpoints, pre-specified and post hoc analyses leveraging different methods of exploring the heterogeneity of baseline disease in the trial, revealed the potential for a meaningful treatment effect across endpoints when focusing on a subset of participants with less severe disease at baseline. Additional key findings from the presentation included: The observed potential treatment effect of NurOwn on ALS disease progression in participants with less severe disease was protected by randomization; The Phase 3 trial of NurOwn in ALS included a higher percentage of participants with advanced ALS at baseline compared to other trials, resulting in a lower baseline mean; In the subgroup of participants that are predicted by the ENCALS model to have long to very long survival, NurOwn treated participants had a greater percentage of responders compared to placebo; In the pre-specified subgroup of participants with ALSFRS-R greater than or equal to 35 at baseline, NurOwn had a greater percentage of responder compared to placebo; and Analyses that focus both on baseline ALSFRS-R and ENCALS model categories suggest that efficacy measurements are impacted in participants with more severe disease. "These compelling analyses add to the positive momentum behind our ALS program, and we were pleased to have the opportunity to share them with the clinical community at this year's ALS ONE Research Symposium," said Stacy Lindborg, PhD, Executive Vice President and Chief Development Officer, Brainstorm Cell Therapeutics. "We are very encouraged by the observation that there appears to be a meaningful treatment effect in patients with less severe disease at baseline that is consistent when using baseline ALSFRS-R scores and the ENCALS model which incorporates additional important disease characteristics that have been shown to be predictive of survival time. We believe this is an important finding, especially since this effect was protected by randomization. Looking ahead, we are eager to share additional analyses from our Phase 3 trial with the clinical community through a peer reviewed publication and remain committed to pursuing the best and most expeditious path forward to bring NurOwn to patients with ALS."
BrainStorm reports Q3 EPS (15c), two estimates (20c) » 07:1811/1511/15/21
Cash, cash equivalents,…
Cash, cash equivalents, and short-term bank deposits were approximately $28M as of September 30, 2021, compared to approximately $35M on June 30, 2021. "We made strong progress towards our goal of advancing NurOwn in ALS and MS over the past months," said Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics. "Our productive discussions with leading clinical experts continue, and we continue to bring forward new evidence of NurOwn's effectiveness in the scientific domain, as highlighted by our recent NEALS presentation of Phase 3 ALS data showing that NurOwn drove significant changes in important neural biomarkers that could be used to predict treatment outcomes within the trial. The insights we have gained from these discussions have generated strong momentum in our pursuit of the best and most expeditious path forward to bring NurOwn to patients. We also strengthened our leadership team and increased our manufacturing capacity, supporting our readiness to provide broad patient access as we seek paths for potential regulatory approval. The devastating and progressive nature of ALS creates an urgent unmet need for patients, and one that we are fully committed to addressing through NurOwn's continued advancement."