Seasonal Affective Disorder

The Partnership for International Vaccine Initiatives' (PIVI) new data published in "Vaccine" provides foundation for best practices in influenza policy development and its role in pandemic readiness ATLANTA, Oct. 15, 2024 /PRNewswire/ -- The Partnership for International Vaccine Initiatives (PIVI), an Atlanta-based global health initiative that is a key program of The Task Force for Global Health (TFGH), has released a series of new research papers in Vaccine showing that countries with strong seasonal influenza programs had the necessary infrastructure that enabled them to better weather the COVID-19 pandemic. The series of 13 papers with data from 16 countries and global partners published in this month's Vaccine supplement provide important insights towards strengthening influenza vaccination programs worldwide as global health experts navigate the post-pandemic climate and prepare for the next impending global health crisis. The World Health Organization reports there are approximately one billion cases of seasonal influenza annually, including three to five million cases of severe illness that cause up to 650,000 respiratory deaths each year. Continue Reading New research shows countries with strong seasonal influenza programs enabled them to better weather COVID-19 pandemic. Post this Seasonal influenza vaccination programs play a critical role in reducing a country's disease burden. Through these annual vaccine programs, countries strengthen their health systems and bolster their capacity to respond swiftly and effectively to future pandemics and emerging health threats. The Partnership for International Vaccine Initiatives (PIVI), a program of the Task Force for Global Health, is dedicated to building robust respiratory vaccination programs worldwide. "As the world responds to novel and ongoing global health crises including expanded mpox outbreaks, the avian influenza A (H5N1) outbreaks in the U.S. and recurrent Ebola outbreaks, the utility of influenza vaccination programs as a mechanism to foster the capabilities of national vaccine responses are increasingly apparent and vital," said Dr. Joseph Bresee, leads the Partnership for International Vaccine Initiatives and several other teams within The Task Force for Global Health. Key learnings published in Vaccine include: New data from two reviews of Kenya's pediatric influenza vaccination program comparing year-round versus campaign approaches that provide lessons for countries with year-round influenza circulation for establishing influenza vaccination programs. Data from the COVID-19 pandemic vaccine response that demonstrates the value of adult influenza programs, including health worker vaccination, in improving national pandemic vaccine responses. These new data add to experiences from the 2009 influenza pandemic, strengthening the argument for influenza vaccination programs as a pandemic readiness tool. Focusing attention on creating health worker vaccination programs as a method, not only for pandemic vaccine preparedness, but as a key avenue to increase vaccine recommendation and acceptance among high risk groups. Progress in vaccination and delivery systems is underscored by data from the last decade. Research found that low- and middle-income countries are better positioned to combat future endemics and pandemics due to the concerted collaborative effort amongst PIVI and its partners. "The influenza program in Albania helped our COVID response, supporting service delivery, training of healthcare workers, as well as prioritization of risk groups. Having these pieces already in place with influenza allowed for a stronger and more efficient COVID vaccination program," said Dr. Silvia Bino, Director, Control of Infectious Diseases Department at the Institute of Public Health in Albania and a long-time PIVI partner. PIVI was founded in 2013 to help protect communities from the annual impact of influenza while building the vaccine delivery systems critical for endemics and pandemics. These programs supported efficient distribution of the COVID-19 vaccine in 2020 and as a result, the CDC partnered with The Task Force for Global Health to create the COVID-19 Vaccine Implementation Program (CoVIP). In addition, PIVI works with World Health Organization and its regional offices to help countries prepare for influenza and other respiratory pandemic threats by supporting efforts to control and prevent seasonal illness through ongoing, organized support of Ministries of Health throughout the world, with a primary focus on low- and middle-income country outreach. EDITOR'S NOTE: The digital media kit for PIVI can be found here. Please courtesy the "Partnership for International Vaccine Initiatives" with usage. About the Partnership for International Vaccine Initiatives (PIVI) The Partnership for International Vaccine Initiatives (PIVI) is a key program of The Task Force for Global Health and sits within its Respiratory Virus Prevention and Preparedness unit. A public/private program, PIVI works in partnership with the US Centers for Disease Control and Prevention (CDC), Ministries of Health, corporate partners, and others to create sustainable respiratory virus vaccination programs in low- and middle-income countries. PIVI has worked with 30 countries with the mission of reducing the global disease burden from influenza and other respiratory viruses while improving national and global responses to pandemics and other epidemic threats. For more information visit . About The Task Force for Global Health The Task Force for Global Health, founded 40 years ago to advance health equity, works with partners in more than 150 countries to eliminate diseases, ensure access to vaccines and essential medicines, and strengthen health systems to protect populations. Expertise includes neglected tropical diseases and other infectious diseases; vaccine safety, distribution and access; and health systems strengthening, including supply chains for essential medicines, public health informatics for data to inform programs and policies, and training support for epidemiologists and laboratory systems to prevent and respond to outbreaks. COVID-19 activities have included helping 45 low- and middle-income countries roll out vaccines; informing vaccine safety guidelines; training epidemiologists in more than 100 countries on disease surveillance and response; distributing essential protection and treatment to hard-hit communities; advising on digital contact tracing; using existing health programs to ensure protection for vulnerable groups, such as those afflicted with other diseases; and leveraging existing supply chains for ongoing response. For more information, visit TaskForce.org and read this 2023 annual report. 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SAN FRANCISCO, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Adaptive Research, a clinical trial site organization dedicated to democratizing clinical trials, announced its participation in a groundbreaking decentralized study for Parkinsons’ Disease sponsored by PhotoPharmics Inc. California Movement Disorders Center, part of Adaptive Research’s network, will serve as a site for PhotoPharmics’ LIGHT-PD trial, testing the efficacy of Celeste® Specialized Phototherapy in treating Parkinson’s symptoms. Key Highlights: Decentralized trial design allows for remote monitoring through telehealth visitsDr. Kristin Andruska from Adaptive Research network to serve as investigatorStudy showcases the potential for community physicians to participate in advanced clinical trials "The decentralized approach of the LIGHT-PD trial is revolutionizing Parkinson's research," said study investigator Kristin Andruska, MD, PhD. "Using remote, home-based assessments, Adaptive Research can now include participants from a wide geography. This not only provides a more diverse patient population but also makes the trial accessible to those who might otherwise be unable to participate. It's an exciting step towards more inclusive clinical research." Deepak Behera, MD, CEO of Adaptive Research, added, "The at-home, telemedicine-based design of this trial aligns perfectly with Adaptive Research's vision for the future of clinical studies. It exemplifies our commitment to enhancing accessibility and convenience, enabling broader participation across diverse populations and geographies. Moreover, this study showcases how community physicians, when provided with the right support, can effectively contribute to cutting-edge, decentralized clinical trials." “LIGHT-PD will be the largest phototherapy trial of its kind and holds immense promise for those affected by Parkinson’s Disease and has received FDA Breakthrough Designation for its potential in improving PD symptoms. We welcome the California Movement Disorders Center and Adaptive Research to the ranks of movement disorder neurologists across the country who are enrolling and caring for trial participants,” said Dan Adams, CSO, PhotoPharmics, Inc. About the LIGHT-PD Trial The LIGHT-PD trial (Double-blind, Randomized Controlled Trial to Demonstrate Efficacy of Celeste® Specialized Phototherapy in Treating Symptoms of Parkinson’s Disease) is a placebo-controlled study that aims to demonstrate safety and significant improvement in motor and non-motor symptoms beyond current medical care in Parkinson’s Disease. Parkinson’s Disease occurs when the brain’s ability to regulate essential signaling for movement and other functions is compromised. Recent scientific discoveries suggest that the eyes play a crucial role in this signaling process. Celeste®, the device being tested, passively delivers specific wavelengths of light aimed to potentially restore retinal signaling, which may improve function and quality of life for those living with Parkinson’s Disease. About Adaptive Research Founded in 2020, Adaptive Research Inc. is revolutionizing the landscape of clinical trials. By offering full-service support to trial investigators, Adaptive Research connects Sponsors of potential life-saving investigational agents and medical devices with community physicians and their patients nationwide. Adaptive Research’s expert team functions as a virtual clinical trials office, managing administrative and regulatory responsibilities, and enabling physicians to focus on providing exceptional clinical judgement and care. For additional information, visit https://adaptiveresearch.com. About PhotoPharmics PhotoPharmics is a privately held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative disorders through the eyes. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms for seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007). Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patient’s lives by delivering safe and effective treatments. Learn more at www.photopharmics.com. Contacts:Inquiriesyour.partner@adaptiveresearch.com

SALT LAKE CITY--( BUSINESS WIRE )--PhotoPharmics, a leader in non-invasive phototherapy for neurological disorders, has reached a significant milestone in its ongoing FDA pivotal “Light for PD” trial for the Celeste therapeutic device. The first subject has successfully completed the full 6-month treatment course and clinical visits, marking an important step towards the successful completion of the trial and future FDA authorization of Celeste in treating Parkinson’s disease (PD). "We are thrilled to reach this milestone,” said Kent Savage, CEO of PhotoPharmics. "This marks significant progress for this groundbreaking study. While it is too early to know results, we are optimistic that the Celeste device can represent a significant advancement in treating Parkinson's." A Closer Look at the “Light for PD” Trial The “Light for PD” trial aims to demonstrate the safety and efficacy of Celeste, PhotoPharmics' non-invasive phototherapy device in treating PD, a neurodegenerative disease impacting over 11 million people globally. Celeste passively delivers specialized wavelengths of therapeutic light to neurons in the eye that signal areas of the brain responsible for sleep, wakefulness, mood and energy. Just as Parkinson’s medications boost damaged motor signaling in brain, Celeste’s specialized phototherapy stimulates the eye’s damaged photoreceptor signaling. PD results from the degeneration of dopamine-producing neurons, leading to symptoms like tremors, rigidity, and cognitive decline. Current treatments are largely pharmacological, but there is growing demand for non-invasive, non-pharmacological treatments for both motor and non-motor symptoms in PD. Celeste offers the potential to complement or enhance existing treatments. Subjects in the trial receive daily phototherapy sessions over a 6-month period. The study, conducted remotely across the U.S., will provide critical data on the device’s safety and efficacy. "Our focus has always been on improving the lives of Parkinson’s subjects,” added Dan Adams, Science Officer at PhotoPharmics. "We believe Celeste could address both the motor and non-motor symptoms of PD beyond current medical care, offering a simple, passive treatment option." Subject Demand Subject demand continues to outpace openings in the trial. PhotoPharmics looks to finalize enrollment before the end of the year and the company anticipates final data in late 2025. The data will guide the regulatory approval and reimbursement processes. "Our optimism stems from high levels of subject engagement and their adherence to the therapy," noted Savage. "There is a clear demand for novel treatments, and both clinicians and participants have responded positively." Subject and Clinician Perspectives Those participating in the trial have expressed hope about the therapy’s potential. "The ‘Light for PD’ treatment has given me renewed hope,” said a trial applicant. "It’s easy to use, and I’m optimistic about its benefits." Clinicians are also supportive. "The ‘Light for PD’ device represents a promising addition to Parkinson’s treatments,” said Savage. "We are hopeful this technology can provide an alternative for subjects who struggle with the side effects of traditional treatments." The Science Behind Phototherapy Phototherapy has been used successfully to treat conditions like seasonal affective disorder (SAD) and certain skin conditions. However, applying this therapy to neurological disorders like PD is relatively new. The Celeste device uses light to activate neural pathways that may alleviate symptoms of PD. "Phototherapy is an exciting approach to age-related neurological disorders,” explained Adams. "In addition to the damage that occurs in the brain, new discoveries show similar damage in the eye which normally works with the brain to regulate most physiological function. This is the first device that stimulates the eye’s non-visual photoreceptors which are damaged from neurodegeneration. We believe this will alleviate symptoms in a way that is drug-free and non-invasive." Unlike many pharmacological treatments, phototherapy is generally well-tolerated, with no serious adverse events reported in the trial so far. Next Steps and Future Outlook “Our goal is to make this therapy widely accessible,” said Savage. "We are working closely with regulatory authorities, payers, and providers to ensure the device reaches the market as quickly as possible." In the future, PhotoPharmics plans to explore additional applications for its phototherapy technology in other neurological and psychiatric conditions. Forward-Looking Statements: This press release contains forward-looking statements regarding the “Light for PD” trial. These statements are based on current expectations but are subject to risks and uncertainties. There is no guarantee of final outcomes or regulatory approval. About PhotoPharmics PhotoPharmics is a privately held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative disorders through the eyes. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms for seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007). Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in subject’s lives by delivering safe and effective treatments. Learn more at www.photopharmics.com .