TWO CLINICAL TRIALS, 85 BILLION STEM CELLS, AND A WHOLE LOT OF HOPE IN THE FIGHT AGAINST PARKINSON’S

Sugar Land, Texas 21 June 2021: In the months to come, Houston area biopharmaceutical company Hope Biosciences will culture more than 85 billion stem cells for the fight against Parkinson’s Disease, to be used in two FDA-authorized Phase II clinical trials.

Hope Biosciences cultures pure mesenchymal stem cells, a type of stem cell found in adult fat, to develop cell- based therapeutics for a variety of indications. Hope Bio is currently culturing cells for an FDA-authorized Phase II clinical trial run by Hope Biosciences Stem Cell Research Foundation (HBSCRF) to assess the efficacy and safety of multiple intravenous infusions of autologous adipose-derived mesenchymal stem cells in improving activities of daily living and quality of life in subjects with Parkinson’s Disease. In that study, twenty-four patients are randomized to receive six intravenous infusions of 200 million stem cells each, or approximately 1.2 billion cells total per patient.

Last week HBSCRF received FDA authorization for a second Phase II trial in Parkinson’s Disease, this time using allogeneic adipose-derived mesenchymal stem cells, also thought of as donor cells. In this trial 60 patients will be randomized to receive six intravenous infusions of 200 million stem cells each, bringing the total number of stem cells cultured for both trials to approximately 85 billion.

“Our patented technology not only solves a major challenge in cell therapy – repeatability – but our technological model is easily scalable,” explains CEO Donna Chang. “In 2020 we cultured a very high volume of cells for three FDA-authorized clinical trials for COVID, so we know we can produce healthy, fresh, viable cells in the quantities required for these Parkinson’s trials. At this volume research organizations can not only explore what happens when patients receive more stem cells, over a longer period of time, but can also begin to study what happens when patients receive their own cells versus donor cells. This type of research is only possible when the biopharmaceutical is reliable and consistent in quality, and when the cell manufacturer can dependably produce the quantities required for patients to experience significant results in chronic degenerative disease. Hope Bio is the first U.S.-based company to demonstrate these capabilities, and it is a privilege to support cutting-edge research.”

Team members in every role at Hope Biosciences feel connection to the patients who will eventually receive the fruits of their labors in the lab.

“I am proud to be here because our technology directly enables research that was previously impossible,” shares Julie Joo, Operations Manager and Hope Bio’s longest tenured employee. “Promising results will translate into advances in medical care that matter to every American, especially people with unmet needs. I can’t think of a better reason to keep working hard, every day.”

Participants in the Parkinson’s trial can be male or female, must be between 45-80 years of age, and must have been diagnosed with mild-to-moderate Parkinson’s at least two years prior to commencement. There is no cost to participate.

Hope Biosciences is the only clinical grade adult stem cell banking facility in the nation that banks both adults and newborns. Hope Biosciences executes clinical research through the Hope Biosciences Stem Cell Research Foundation (HBSCRF). To date, HBSCRF has obtained FDA authorization for 20 clinical studies in 11 disease areas. Clinical trial authorizations encompass COVID-19 prevention and treatment, Alzheimer's disease, traumatic brain injury (TBI), and Parkinson’s disease. Expanded access protocol authorizations include amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), severe osteoarthritis, complete and incomplete spinal cord injury, Cerebral Palsy, chronic musculoskeletal pain, and lupus. In its first year of operation HBSCRF administered nearly 100 billion cells at zero charge to patients. Hope Biosciences has also cultured stem cells used in research at UT Health at the Texas Medical Center.

Learn more about Hope Biosciences at hope.bio.

For patient trial information, please call (346) 900-0340.