GOLDEN, CO / ACCESSWIRE / November 17, 2021 / Vitro Biopharma, Inc. announced receipt of FDA authorization and clearance to enroll patients in its IND for a phase I-II, randomized, double-blind, placebo-controlled study of the safety and efficacy of therapeutic treatment with AlloRx Stem Cells® in children with Pitt Hopkins Syndrome (PTHS), a rare neurogenetic disorder that features autistic traits. PTHS results from genetic mutations/deletions of a key brain development gene, TCF4 (transcription factor 4) that controls neurogenesis. Affected children have distinctive facial features and experience moderate to severe intellectual disability, feeding difficulties, delays in reaching developmental milestones, impaired ability to speak, and can have recurrent seizures (40-50%), poor sleep, autistic features, maladaptive behaviors, and breathing pattern abnormalities (reported from age 3-7 years old). The disorder is overwhelming with prolonged episodes of crying and neuro-irritability often reported around 3 years of age. Gastrointestinal concerns are common. Management is symptomatic with early intervention, use of orthotics, anticonvulsive therapies, and psychotropic medications with disappointingly modest improvement. In addition, through the use of AlloRx Stem Cells® in adult populations for other indications, and in children with autism spectrum disorders, there is evidence that support the safety and efficacy of this product.
The FDA clearance of our IND opens an additional pathway to potentially gain FDA pre-market approval of AlloRx Stem Cells® through an Orphan Drug Designation. This is a type of accelerated FDA approval for qualified rare conditions. Our IND-authorized clinical study protocol design is a pivotal study design that when successfully completed could lead to FDA pre-market approval of AlloRx Stem Cells®. This is our second indication for AlloRx Stem Cell® therapy to have received FDA authorization to proceed to enroll patients.
"This is the next step for Vitro Biopharma's efforts in developing successful treatments in the neurologic and inflammatory space. We are excited to have received clearance for this IND, which will enable us to evaluate the safety and efficacy of AlloRx Stem Cells® in PTHS patients in the United States," said Dr. Jack Zamora, M.D., Chief Executive Officer of Vitro Biopharma, Inc. "We look forward to working with investigators to initiate the trial in the United States and meet the needs of patients with PTHS."
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.
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CONTACT:
Dr. Jack Zamora, MD
Chief Executive Officer Vitro Biopharma, Inc. (303) 999-2130 x 1
www.vitrobiopharma.com
SOURCE: Vitro Biopharma, Inc.