Brain Injuries, Traumatic

Pilot study reveals early evidence of efficacy of a pharmacologic treatment for concussion, as patients experienced faster symptom reduction and return to physical activity PHILADELPHIA, March 19, 2024 /PRNewswire/ -- In the first clinical trial of a targeted pharmacologic therapeutic for mild traumatic brain injury in pediatric patients, scientists from the Minds Matter Concussion Frontier Program at Children's Hospital of Philadelphia (CHOP) have found preliminary evidence that adolescents and young adults with concussion who take a specific formulation of branched chain amino acid (BCAA) supplements after injury experience faster symptom reduction and return to physical activity. The findings were published online by the Journal of Neurotrauma. More than 2 million concussions occur in the youth and adolescent population in the United States each year. The mainstay of treatment remains symptom management with temporary modification of cognitive and physical activity and over the counter medication. Although active rehabilitation strategies have shown promise for improving recovery time, including aerobic, vestibular, and vision interventions, these can be time and labor intensive. To date, no targeted pharmacologic intervention to improve clinical outcomes in concussion has been evaluated in humans. Animal model studies of mild to moderate traumatic brain injury, which have been led by the study's senior author, Akiva S. Cohen, PhD, Professor of Neuroscience in the Department of Anesthesiology and Critical Care Medicine at CHOP and a research professor of Anesthesiology and Critical Care at the Perelman School of Medicine of the University of Pennsylvania, have shown that supplementation with a specific formulation of three BCAAs – leucine, isoleucine and valine – improve neurocognitive function. However, prior to this study, no human studies involving adolescents and young adults have assessed the potential benefits of this formulation of BCAAs as a specific treatment to aid in concussion recovery. "The goal of this pilot study was to determine, among several different doses, whether our specific formulation of BCAAs could accelerate recovery – faster reduction in symptoms and return to baseline physical activity," Cohen said. "Based on our work in animal models, we expected that our specific formulation of BCAA supplementation would result in a more rapid resolution in symptom burden and improved physical activity levels which are key measures of recovery from a concussion." The scientists conducted a pilot, double-blind, randomized controlled trial of participants between the ages of 12-30 years who presented with concussion to outpatient clinics, urgent care and emergency departments across the CHOP Network between June of 2014 and December of 2020. Individual participants were divided into five groups consisting of a placebo arm and different treatment arms of 15 g, 30 g, 45 g and 54 g doses of a specific formulation of BCAAs. The participants were followed for a period of 21 days after enrollment. Participants were assessed with daily computerized neurocognitive tests, reported symptom score, physical and cognitive activity, treatment compliance and adverse events. A total of 38 participants had analyzable data after study completion. The study found that there was a significant reduction in and faster resolution of the total symptom score in a dose-dependent fashion with the specific formulation of BCAA supplementation, with a significant decrease in total symptoms across the study; for every 500 g of the treatment consumed, the total symptom score, on a scale of 0-54 (with 0 representing no symptoms), dropped 4 points. Similar significant improvements were seen in a faster return to physical activity, with an increase of 0.5 on a 0-5 scale of physical activity for each 500 g of the defined BCAA supplement consumed. The treatment was very well tolerated; no serious adverse events were reported in the study, and there were no differences in mild adverse events between the placebo and treatment groups. "Our results demonstrate that our specific formulation of BCAA supplementation is a highly promising treatment that addresses the underlying mechanism driving concussion symptoms in order to accelerate recovery and improve outcomes," said the study's first author Daniel Corwin, MD, MSCE, Assistant Professor of Pediatrics and Emergency Department Lead of the Minds Matter Concussion Frontier Program at CHOP. "While a larger study is needed to confirm the formulation's efficacy before routine use of BCAA supplementation should be recommended, we are extremely encouraged by these preliminary findings, the first trial to demonstrate that a targeted pharmacologic using a specific formulation of BCAAs may be useful as a treatment for youth and young adult concussion." This study was supported by The Dana Foundation, with additional support provided by Children's Hospital of Philadelphia Frontier Program, the National Institute of Neurological Disorders and Stroke of the National Institutes of Health award number K23NS128275-01, Veterans Affairs Clinical Science and Research Department Merit Award #I01 CX002022, Oregon Aging and Disability Resource Connection, National Institutes of Health grant P30 AG066518, and VA Rehabilitation Research and Development Career Development Award #1K2 RX002947. Corwin et al, "Head Injury Treatment with HEalthy and Advanced Dietary Supplements (HIT HEADS): A pilot randomized controlled trial of the tolerability, safety, and efficacy of branched chain amino acids (BCAAs) in the treatment of concussion in adolescents and young adults." J Neurotrama. Online March 12, 2024. DOI: 10.1089/neu.2023.0433. About Children's Hospital of Philadelphia: A non-profit, charitable organization, Children's Hospital of Philadelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals, and pioneering major research initiatives, the hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country. The institution has a well-established history of providing advanced pediatric care close to home through its CHOP Care Network, which includes more than 50 primary care practices, specialty care and surgical centers, urgent care centers, and community hospital alliances throughout Pennsylvania and New Jersey, as well as the Middleman Family Pavilion and its dedicated pediatric emergency department in King of Prussia. In addition, its unique family-centered care and public service programs have brought Children's Hospital of Philadelphia recognition as a leading advocate for children and adolescents. For more information, visit . Contact: Ben Leach Children's Hospital of Philadelphia (609) 634-7906 [email protected] SOURCE Children's Hospital of Philadelphia

The innovative food-as-medicine platform will help support eligible North Carolinians with serious mental health needs transitioning from institutional care settings to independent living. STAMFORD, Conn., March 19, 2024 /PRNewswire/ -- Alliance Health, a North Carolina-based behavioral health care services managed care company, announced today that it has entered into a strategic partnership with NourishedRx, a digital health and nutrition company based in Stamford, Connecticut, to support eligible members enrolled in North Carolina's Transitions to Community Living (TCL) program. The new partnership will enable Alliance Health to better serve TCL program members transitioning from institutional care settings into community living by providing them with nutritious home-delivered food and associated nutritional support services. Continue Reading Alliance Health "Access to quality food and nutrition is an indispensable component of well-being and has a measurable impact on physical and mental health, including loneliness and depression," said Lauren Driscoll, NourishedRx Founder and CEO. "When combined with coaching, education, and social support, such services catalyze confidence in self-care and self-efficacy that is foundational to successful independent living." The TCL program supports eligible North Carolina adults living with serious mental illness who chose to live outside institutional care settings. Eligible members may have mental health disorders, substance abuse disorders, intellectual/developmental disabilities, or traumatic brain injuries. The TCL program combines affordable housing with intensive, coordinated services, including case management, peer support, and community integration support, to help program participants live and thrive in their communities. Currently, Alliance Health supports over 1,000 households through the TCL program. The partnership's goals are to positively impact tenancy and independent living, improve participants' nutrition security, support health equity, and improve self-reported health outcomes. "In NourishedRx, we've identified a partner with a proven track record of working successfully with vulnerable populations at scale, and a team and platform that can deliver the results we want to see in this innovative program," said Ann Oshel, SVP of Community Health and Well Being, of Alliance Health. "We're excited to engage with NourishedRx in our effort to improve the health and lives of North Carolinians in need of these services." About Alliance Health Alliance Health is the managed care organization for publicly funded behavioral health care services for the people of Cumberland, Durham, Johnston, Harnett, Orange, and Wake counties in central North Carolina as well as Mecklenburg County. Currently, Alliance works with a network of over 4,000 private providers to serve the needs of almost 190,000 Medicaid-eligible and state-funded individuals among a population of over 3.5M. On July 1, 2024, Alliance will begin operating as a Tailored Plan as part of North Carolina's Medicaid transformation. In that role, Alliance will manage all the health care needs – physical, behavioral, and pharmaceutical – for individuals with severe mental illnesses, substance use disorders, or long-term care needs, including intellectual/developmental disability and traumatic brain injury. About NourishedRx NourishedRx is on a mission to eradicate poor diet and nutrition insecurity as top drivers of death, disease, and disparities. Founded in 2019, NourishedRx is a digital health and nutrition company that helps people live healthier lives and supports health equity. Leveraging the connective power of food, NourishedRx partners with healthcare organizations to nourish their most vulnerable members, build health relationships, and support lasting dietary behavior change. Visit Media Contact: Cathy Giandurco [email protected] SOURCE NourishedRx

SARASOTA, Fla.--(BUSINESS WIRE)-- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced it has appointed Dr. James “Jim” Kelly, Neurologist, as its Chief Medical Officer, to oversee its upcoming Phase II clinical trial. Oragenics’ lead drug candidate, ONP-002 is combined with its intranasal device intended for the treatment of mild Traumatic Brain Injury (TBI), aka concussion. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. A 40-patient Phase I study was completed and showed the drug to be safe and well-tolerated. In the recent past, Dr. Kelly served as the Executive Director of the Marcus Institute for Brain Health (MIBH) and Professor of Neurology at the University of Colorado Anschutz Medical Campus in Aurora, Colorado. The MIBH specialized treatment program is funded by the Marcus Foundation to care for US military veterans with persistent symptoms of TBI. Dr. Kelly was also National Director of the Avalon Action Alliance TBI Programs for which the MIBH serves as the clinical coordinating center. “I am excited to join Oragenics as its Chief Medical Officer at such an important and pivotal time in the drug development process. I have been involved with the drug for many years now and look forward to testing the drug and showing it can improve patient outcomes in our upcoming Phase II clinical trials,” said Dr. Kelly. Prior to these recent positions, Dr. Kelly was the Director of the National Intrepid Center of Excellence (NICoE) at Walter Reed National Military Medical Center in Bethesda, MD. As its founding Director, he led the creation of an innovative interdisciplinary team of healthcare professionals who blended high-tech diagnosis and treatment with complementary and alternative medical interventions in a holistic, integrative approach to the care of US military personnel with the complex combination of TBI and psychological conditions, such as post-traumatic stress, depression, and anxiety. In this role, Dr. Kelly was frequently called upon by leaders of the Military Health System at the Pentagon, the US Congress, the Department of Veterans Affairs, and numerous military facilities in the continental US and abroad. Dr. Kelly has interacted with the FDA and clinical trials for brain injury throughout his esteemed career. He is a strong advocate for treatments in the acute phase of brain injury and understands the value of protecting the brain early on from inflammation, swelling and oxidative stress to gain better clinical outcomes. “We are fortunate to have such an esteemed neurologist as Dr. Kelly join our team in this important role at Oragenics. Dr. Kelly is recognized as a leading expert in concussion and other brain injuries and we are fortunate to have him lead our drug trials going forward. We are currently completing the drug manufacturing and formulation at GMP facilities to ensure the integrity of the drug before and during the trials, and we look forward to completing this work in the short-term and getting the Phase II trial underway,” stated Michael Redmond, President of Oragenics. In preclinical animal models, the drug has been shown to acutely improve molecular and behavioral outcomes following brain injury. In addition, intranasal delivery of the drug as a nanoparticle has been shown to enhance brain exposure and metabolism in animals. “Our Phase I human study has shown ONP-002 to be well tolerated in humans. Our mission now is to show that the ONP-002 brain protective mechanisms in animals translates to humans. Our Phase II study is designed to establish time to first dose, relationships between drug application and blood biomarkers, and the evaluation of clinical endpoints to determine improved in patient outcomes, ” said Dr. Kelly. Concussion is an unmet medical need. There is an estimated 69 million concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents, and contact sports. Other neurological disorders including Alzheimer’s Disease, Parkinson’s Disease and Chronic Traumatic Encephalopathy (CTE) have been linked to concussion. Post concussion syndrome is linked to long term disability and occurs in as high as 20% of concussed patients. Forward-Looking Statements This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the ability of the Company to timely and successfully undertake the Phase II clinical trial using its novel drug - device combination for the treatment of mild Traumatic Brain Injury. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words "believe," "expect," "anticipate," "intend," "estimate," "project" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: the Company’s ability to advance the development of its product candidates, including the neurology assets, under the timelines and in accord with the milestones it projects; the Company’s ability to retain its key employees and independent contractors necessary to continue to develop its product candidates and in particular ONP-002 and the availability of those key employees and independent contractors; the Company’s ability to raise capital and obtain funding, non-dilutive or otherwise, for the development of its product candidates; the Company’s expectations as to the outcome of the Phase II clinical trial and the potential benefits, activity, effectiveness and safety of its product candidates including as to administration, transmission, manufacturing, storage and distribution; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth is as of the date hereof unless otherwise indicated. You should consider these factors in evaluating the forward-looking statements included and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law. Released March 18, 2024 View source version on businesswire.com: Contacts Oragenics, Inc. Janet Huffman, Chief Financial Officer 813-286-7900 jhuffman@oragenics.com LHA Investor Relations Tirth T. Patel 212-201-6614 tpatel@lhai.com Source: Oragenics, Inc. View this news release online at: