Written by Jan Shultis
Sugar Land, Texas, 1 NOV 2024: Hope Biosciences, a clinical-stage biotechnology company that manufactures mesenchymal stem cell therapeutics through proprietary technology unprecedented in its ability to create repeatable treatments, 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).
Hope Biosciences is this week represented at the KoNECT International Conference in Seoul, Korea, where results of this trial will be presented on the final day of a three-day program that annually draws more than 1,300 biotechnology researchers from around the world.
“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 through multidimensional quality of life measures that combine general and MS-specific points related to fatigue, physical and cognitive function, sexual impairment, pain, energy, mobility, level of disability, and other considerations,” elaborates Donna Chang, Chief Executive Officer, Hope Biosciences. “The results of this trial are groundbreaking for multiple sclerosis. These results 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. We believe that this positive response will translate in other autoimmune diseases in the near future.”
This Phase II clinical trial (NCT05116540) is a balanced randomized, double-blind, single center study that brought 24 participants to Hope Biosciences Research Foundation, the clinical trial site, for six intravenous infusions over the course of 32 weeks. End of study was 52 weeks. A single infusion in the treatment group consists of 200 million stem cells, which means that twelve patients in that group received approximately 1.2 billion stem cells in sum. The trial is the first globally to administer pure mesenchymal stem cells, an adult stem cell harvested from fat, to MS patients in such high quantities over repeat treatments.
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).
More than 2 million people worldwide and about 400,000 people in the United States suffer from MS, a condition in which the immune system attacks a protective sheath around nerve fibers, called “myelin.” As myelin deteriorates, the brain and spinal cord are affected. Symptoms are diverse, depending on which nerves are damaged and to what degree. Developmental timelines also vary widely, ranging from periods of remission to loss of ability to walk. Typically diagnosed in the 30’s and 40’s, MS disproportionately affects women. Economically, MS is second only to heart failure in fiscal burden, with an estimated cost of nearly $5 million over the course of a lifetime.
Headquartered in Sugar Land, Texas, United States and now in its eighth year of operation, to date MSCs cultured at Hope Biosciences have been used or are in use in FDA-authorized clinical trials in the U.S. encompassing COVID-19 prevention and treatment, “Long Haul” COVID, Parkinson’s Disease, multiple sclerosis (MS), traumatic brain injury, and Alzheimer’s Disease. Expanded access protocols include nervous system conditions such as amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), cerebral palsy, spinal cord injury, ataxia, drug-resistant epilepsy, polyneuropathy, and muscular dystrophy; as well as immune conditions such as lupus; chronic musculoskeletal pain, severe osteoarthritis, and psoriatic arthritis; pancreatic and breast cancers; stroke; and palliative care.
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