Vitro Biopharma Receives FDA Authorization to Conduct a Clinical Trial Using AlloRx Stem Cells(R) to Treat Pitt Hopkins Syndrome, a rare form of Autism - Seite 2

Dr. Caroline Mosessian, Ph.D., DRSc., FACMPE, FACHE, Chief of Regulatory Affairs, said: "I am excited for the opportunity to work with my FDA colleagues who authorized Vitro Biopharma to proceed with this IND. This allows us to collaborate with physicians and parents as a cohesive team in addressing the unmet needs of patients with PTHS."

Dr. Jessica Duis, MD, Head of Pitt Hopkins Syndrome Center of Excellence, Children's Hospital, CU Anschutz Medical Center and PI of the PTHS clinical trial said: "Currently, treatment for Pitt Hopkins syndrome is supportive and often falls short of making the impact we hope for the children and adults with PTHS. This approval allows us to move forward to study the safety and efficacy of AlloRx stem cells with the potential to meet a huge need for individuals with PTHS. I am excited to partner with families and Vitro Biopharma to conduct this pivotal trial."

ABOUT VITRO BIOPHARMA
Vitro Biopharma is a clinical-stage biotechnology company focused on developing novel and proprietary best-in-class natural regenerative products. Vitro is currently focused on autoimmune disorders and inflammatory disease processes. Vitro develops and commercializes adult stem cell technology for applications in stem cell research and drug development for the treatment of a vast variety of diseases and conditions. The company's innovative and proprietary technology platform manufactures umbilical cord derived stem cells, AlloRx Stem Cells®, used in regenerative clinics to treat a variety of disease indications.

AlloRx Stem Cells® have been previously used in various clinical studies that showed safety with minimal to no adverse events. Strong evidence of efficacy have been reported by patients and clinicians in these clinical studies. Vitro Biopharma has a proprietary and scalable manufacturing platform to provide stem cell therapies to treat critically ill Coronavirus patients and other conditions including Alzheimer's, autism, multiple sclerosis osteoarthritis, Crohn's disease, and numerous medical conditions that are under-treated by the current standard of care. Our cGMP manufacturing is CLIA, ISO9001, ISO13485 certified, and we are FDA registered.