Hope Biosciences Receives FDA Approval to Commence First Stem Cell Clinical Trial for Protection Against COVID-19

Autologous Mesenchymal Stem Cells to Provide Immune Support Against COVID-19

HOUSTON--(BUSINESS WIRE)--Hope Biosciences, a clinical stage biotechnology company focused on developing cell-based therapeutics for acute and chronic disease, today announced that FDA has approved a Phase II clinical trial evaluating efficacy and safety of Hope Biosciences’ autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) to provide immune support against COVID-19. MSCs are well-known for their immunomodulatory and regenerative potential. In a recent Phase I/II clinical trial for Rheumatoid Arthritis, results appeared to show that HB-adMSCs were safe and effective in attenuating systemic inflammation. In COVID-19 patients, inflammation is a driving force behind disease progression, and it is critical to regulate the immune system as early as possible.

“This study will utilize our proprietary core technology to deliver high quality, pure mesenchymal stem cells with standardized doses and multiple treatments. Our novel technology allows us to overcome the burdens of traditional cell therapy, such as inability to make enough cells to make a significant impact. We can produce, on-demand, over 1,000 highly concentrated HB-adMSC treatments from a single tablespoon of the patient’s own fat tissue. Most people who have been severely affected by COVID-19 had preexisting conditions. We are pretreating participants who are at higher risk of developing severe COVID-19, with the belief that we can prepare their immune systems, giving them their best chance to fight the virus,” said Donna Chang, President and CEO of Hope Biosciences.

This Phase II study is a single arm, non-randomized study that is expected to enroll 75 participants that are either 50 years of age, have preexisting health conditions, or are at high-exposure risk. The study’s primary objective is to determine the efficacy of HB-adMSCs to prepare the immune system so that it is better able to fight the virus, should one become infected. We anticipate that this pretreatment will limit the progression and severity of COVID-19, ultimately keeping patients out of the hospital and off of mechanical ventilation. HB-adMSCs are administered via five intravenous infusions over a fourteen-week period and follow-up evaluations through 6 months. All participants will be monitored for changes in health status, including immune cell levels, inflammatory markers, and requirements for supplemental care or hospitalization.

This is the first of three New Drug Applications (INDs), related to COVID-19, that Hope Biosciences has filed with FDA. This initial protocol is specifically designed for patients who already have their own stem cells banked with Hope Biosciences. The next two protocols will utilize a donor cell source that will aim in protecting against COVID-19 for those at high risk (patients and frontline workers) and treating hospitalized patients.

“Our ultimate goal is to prevent anyone from needing mechanical ventilation. We believe that interceding early in the inflammatory process will give us the best possible outcome. Treating the disease is very important but if we have a chance to prevent the condition, we must explore all options. We appreciate the FDA’s willingness to take this groundbreaking approach at such a critical time for our nation,” said Donna Chang.

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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 Expanded Access INDs for Parkinson’s disease, Cerebral Palsy, Spinal Cord Injury, Pancreatic Cancer, and Thrombotic Thrombocytopenic Purpura.

This study is fully funded by the Hope Biosciences Stem Cell Research Foundation. Hope Biosciences Stem Cell Research Foundation is administered through the Greater Houston Community Foundation (GHCF). As one of the leading philanthropic grant makers, GHCF is proud to partner with donors to create a meaningful and long-lasting impact in our community.

If you would like to learn more about Hope Biosciences Stem Cell Research Foundation, please visit our website at www.hopebio.org