HB-adMSCs(Hope Biosciences)

SUGAR LAND, TX, USA I October 31, 2024 I Houston-area clinical research organization Hope Biosciences Research Foundation (HBRF) today shares positive top-line results of a Phase II clinical trial to evaluate Hope Biosciences’ adipose‑derived autologous mesenchymal stem cell therapy (HB-adMSCs) for patients with mild to moderate relapsing remitting multiple sclerosis (MS), a disease currently considered incurable that affects more than 2 million people worldwide and approximately 400,000 in the U.S. The trial successfully met its primary endpoint, demonstrating statistically significant improvements in both physical and mental health for the treatment group compared to the placebo group. The Phase II clinical trial (NCT05116540) is a balanced randomized, double-blind, single center study that enrolled 24 participants, 12 in the treatment group and 12 in the placebo. The study mandated six intravenous infusions of 200 million stem cells over the course of 32 weeks, for a total of 1.2 billion cells. End of study was 52 weeks. The primary endpoint was the MS Quality of Life-54 Instrument, a multidimensional quality of life measure that combines general and MS-specific points related to fatigue, physical and cognitive function, sexual impairment, pain, energy, mobility, level of disability, and other considerations. At end of study, the HB-adMSC group showed a statistically significant improvement from baseline in their Physical Health Composite Scores (p<0.0001) compared to the placebo group (p<0.4856). The effect size between the groups was large (Cohen’s d=1.23), with a significant overall treatment difference (p=0.0002). The HB-adMSC group also exhibited a significant improvement from baseline in their Mental Health Composite Scores (p<0.0042) compared to the placebo group (p<0.5724). The effect size was substantial (Cohen’s d=0.85), with a statistically significant overall treatment difference (p=0.016). Treatment was safe and tolerable in both groups. Detailed analysis is now underway. “The results of this trial are groundbreaking for multiple sclerosis. They clearly demonstrate that high doses of fresh HB-adMSCs delivered on a regular schedule can result in consistent efficacy in a highly complex and variable condition like MS,” says Donna Chang, President, HBRF. “We believe that this positive response will translate in other autoimmune diseases in the near future.” This research was made possible in part by the generous support of The Robert and Janice McNair Foundation . Texas-based HBRF is a 501(c)(3) nonprofit organization administered by the Greater Houston Community Foundation. SOURCE: Hope Biosciences Research Foundation

SUGAR LAND, Texas--( BUSINESS WIRE )--A four-year, nearly $5 million clinical trial grant awarded to UTHealth Houston by the Department of Defense’s Office of Congressionally Directed Medical Research Programs (CDMRP) will evaluate if intravenously infused Hope Biosciences’ autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) reduce chronic neuroinflammatory response to severe traumatic brain injury (TBI). The award is a significant positive step toward developing treatment for a currently incurable condition that affects approximately 1.5 million Americans every year, killing 50,000 annually. The Centers for Disease Control reports an estimated 5.3 million people live with permanent TBI-related disability in the U.S. More than 460,000 military service members have been diagnosed with TBI since 2000. Donna Chang, CEO of Hope Biosciences, highlighted the significance of their technology, stating, “Our repeatable stem cell therapy offers scalability, affordability and rapid delivery over one’s lifetime. Complex conditions like TBI will require sustained and repeated treatment which Hope Biosciences can deliver, potentially benefiting both military and civilian populations.” Preliminary results from a prior Phase I/IIa, 24-patient study sponsored by Hope Biosciences at UTHealth (NCT04063215) were presented in May during the Cellular Therapies and Transfusion Medicine in Trauma and Critical Care (CTTACC) 2023 Conference in Scottsdale, Arizona. Repeated intravenous administration of HB-adMSCs demonstrated the potential of reducing chronic neuroinflammation. “The funding for the Department of Defense Congressionally Directed Medical Research Program Phase 2 trial is a strong step forward in the treatment of the chronic after-effects of traumatic brain injury,” says Charles S. Cox Jr., MD, the George and Cynthia Mitchell Distinguished Chair in Neurosciences and the Glassell Family Distinguished Chair in the Department of Pediatric Surgery with McGovern Medical School at UTHealth Houston, “and it is based upon solid results from the Phase 1 study in terms of safety and treatment signal.” This award constitutes the Department of Defense’s first support of UTHealth Houston’s and Hope Biosciences’ collaboration. “Receipt of federal funding for research using Hope Biosciences’ stem cells is a deeply personal occasion,” reflects Jan Shultis, a Naval Academy graduate who joined the team at Hope Biosciences after thirteen years in uniform. “TBI is part of my story, and that of scores of family members and friends who served. We’ve been waiting for a solution. Vital though research is, men and women with boots on the ground need access now to deployable technology that supports current and future needs. Hope’s scalable infrastructure, an unprecedented position in the cell therapy landscape, carries promise of real-world application not only for those serving today, but also for veterans living with injury.” The anticipated multi-center Phase II study is set to begin enrollment in September, pending approval by UTHealth Houston’s Institutional Review Board. Headquartered in Sugar Land, Texas and now in its seventh year of operation, to date MSCs cultured at Hope Biosciences have been used in more than 35 FDA-authorized clinical studies covering a wide range of conditions including chronic injury, degenerative diseases and autoimmune diseases. For more information about Hope Biosciences, visit hope.bio .