We look forward to reporting our clinical results in the scientific literature and through corporate announcements.” “We are pleased that the U.S. On November 20, 2019, BrainStorm announced the publication of the Phase 2 results of NurOwn® in the peer-reviewed journal Neurology (Berry et al., 2019). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). - All Participants Enrolled in Phase 2 Progressive MS trial with Dosing to be Completed in Q4'20 *(A) A significant correlation between VEGF increase and MCP-1 decrease is shown in the CSF of the mesenchymal stem cell (MSC)–neurotrophic factor (NTF) cells treated group at visit six 2 weeks post-transplantation with no significant change in the placebo group. My response is that this criticism is premature, given that the study was designed to investigate the benefit of NurOwn after only a single dose. ; and the University of Massachusetts in Worcester, Mass. Of the various responder analyses conducted by the company, one of them looked for 100% improvement in slope post-treatment versus pre-treatment. The sponsor then has seven years during which time the sponsor must obtain full market approval through a biologics license application (BLA) or the Japanese equivalent thereof. Additionally, patients who have previously received a stem cell treatment, including NurOwn® in Phase 1 or 2, are excluded as the long-term impact of that factor is unknown. Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at      29,669,855 and 23,174,228 shares at June 30, 2020

"Results from the study underscore the importance of conducting a larger Phase 3 clinical trial that will build upon the data collected in our Phase 2 study. This presents the opportunity to potentially eliminate the 24 IM injections altogether. Epub 2015 May 1.Cochrane Database Syst Rev. offers eligible public information officers paid access to a reliable news release distribution service.EurekAlert! Humira® (adalimumab) is the best-selling drug in the world, with 2015 worldwide revenues of $14 billion. Patients were dosed weekly with 30 mg/kg eteplirsen (n=4), 50 mg/kg eteplirsen (n=4), or placebo for 24-weeks, after which the four placebo patients rolled over to the open-label portion of the study (Study 202) to receive 30 mg/kg eteplirsen (n=2) or 50 mg/kg eteplirsen (n=2). based on data from the HGB-204 and HGB-205 studies; however, the strategy for gaining approval to treat β0/β0 patients in the E.U. COVID-19 is an emerging, rapidly evolving situation. These data are exactly what is needed to move forward with the current Phase 3 testing Our Phase 3 study has recently reached full recruitment. The company may seek conditional approval in the E.U.

Sarepta currently has a market cap of $2 billion while BrainStorm's market cap is $50 million. Most therapeutic products used to treat serious diseases have the opposite effect, healthier patients see a benefit but those deemed "too far gone" are relegated to palliative care.The other interesting observation from the Phase 2 top-line data presentation (see the I've heard some investors question the utility of NurOwn because they mistakenly believe there is waning efficacy after the first months post-treatment. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Phase 2 results of NurOwn are published, and that the Phase 3 trial enrollment is now complete," said Dr. Neil Thakur, PhD, Executive Vice President for Mission Strategy at the ALS Association. Our Phase 3 study has recently reached full recruitment. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. 2017 Oct 26;28(7):725-738. doi: 10.1515/revneuro-2017-0018. Investor concerns over an imminent massive dilutive offering are misguided. has not been determined. Treatments that are only effective in a portion of a patient population can be very successful. Study 201 was a 24-week double-blind, placebo-controlled study of eteplirsen in 12 ambulatory boys with DMD. Bluebird has multiple shots on goal, including β-thal, SCD and CALD. For more information, visit BrainStorm's website at Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements.

In December 2016, Bayer AG and Versant Ventures Sweeping legislative changes are also making cell therapy plays more attractive. Name must be less than 100 characters The technology involves extraction of a patient's hematopoietic stem cells (HSCs) followed by the Bluebird is currently conducting two clinical trials with Lentiglobin: 1) A Phase 1/2 clinical trial in France for patients with β-thalassemia and SCD (Study HGB-205); 2) A Phase 1/2 clinical trial in the U.S., Australia, and Thailand for SCD (Study HGB-206).β-thalassemia is a serious, life-long disease with a number of potential complications.

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