Hope Biosciences Opens First Phase I/II Stem Cell Trial for Brain Injury Treatment

“We are pleased to announce this study—the first Phase I/II trial to use HB-adMSCs for TBI/HIE—in partnership with our esteemed colleague, Charles Cox, Jr., M.D., and his team at UTHealth. The promise of cell therapy is so evident, but it has always been limited by the inability to provide enough cells to make a significant, lasting impact. This trial is novel in that it overcomes these limitations. Due to our proprietary technology, we can now create, on demand, virtually unlimited doses of autologous mesenchymal stem cells from a single tablespoon of a patient’s fat. This completely revolutionizes the way we can deal with chronic degenerative diseases while eliminating donor rejection and donor-to-donor variability,” said Donna Chang, President and CEO of Hope Biosciences.

There are currently no therapies that have shown clinical benefit in chronic TBI and Hope Biosciences is committed to changing this. Chronic neuroinflammation has been demonstrated after neurological injury for up to 13 years in patients after TBI and is associated with progressive white matter loss. HB-adMSCs are anticipated to provide immunomodulation to reduce chronic microglial activation as measured by [¹¹C]ER-176 uptake value measurements globally and in the thalamus. Overall results are anticipated to be a decrease in neuronal cell loss and improvements in neurocognitive outcomes (improvements in verbal response, motor function, and memory, that correlate to physical changes in the brain).

“We have focused our approach using cell therapy on patients with measurable microglial activation (neuroinflammation) as determined by advanced imaging techniques. We hope that this will inform us regarding the overarching strategy of targeting the neuroinflammatory response to injury using cell-based therapies,” said Dr. Charles S. Cox, Jr., George & Cynthia Mitchell Distinguished Chair in Neurosciences, Department Of Pediatric Surgery at McGovern Medical School at UTHealth. Cox is the director of the Program In Children’s Regenerative Medicine and Co-Director of the Memorial Hermann Red Duke Trauma Institute.

This Phase I/II study is a single arm, non-randomized study that is expected to enroll 24 participants. The study’s primary objective is to determine the safety and treatment effect of HB-adMSCs for treatment of sub-acute and chronic traumatic brain injury and hypoxic-ischemic encephalopathy (TBI/HIE). HB-adMSCs are administered via three intravenous infusions over a six-week period and follow-up evaluations at six months and one-year post-infusion. HB-adMSCs are autologous and have an established safety profile.

Hope Biosciences and UTHealth are now recruiting participants; for more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT04063215.

Hope Biosciences is actively offering clinical grade, stem cell banking for adults and newborns. For more information please visit https://www.hope.bio/banking

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About Hope Biosciences

Hope Biosciences is a clinical stage biotechnology company focused on developing novel cell-based therapeutics for acute and chronic injury and disease. Hope Bio’s core technology lies in stem cell culture and banking. Mesenchymal stem cells are isolated from approximately one tablespoon of a patient’s own fat tissue, purified, and cultured with Hope Bio’s proprietary culture media, HB-101. HB-adMSCs are expanded to multiple passages and released at Passage 4 for therapeutic use. Samples of each passage are banked in order to create a master cell bank for each patient, which will be used to make additional therapies in the future. HB-adMSCs have already been used as a safe and effective treatment in a Phase I/IIa clinical trial for Rheumatoid Arthritis and Individual Expanded Access IND for Parkinson’s disease, Cerebral Palsy, Spinal Cord Injury and Thrombotic Thrombocytopenic Purpura.

Forward Looking Statements

This press release includes forward-looking statements including, but not limited to, statements related to our current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ending December 31, 2019. The Company disclaims any intent or obligation to update these forward-looking statements.

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