DAT

ST. LOUIS, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that beginning Friday, April 5, 2024, Ioflupane I 123 Injection will be available for Friday patient administration in the US. This additional day of production allows customers to access the product and capitalize on early morning availability on a day not previously available from Curium. Ioflupane I 123 Injection is a radioactive diagnostic agent indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). Customers may begin ordering for Friday patient use immediately for administration on and after April 5, 2024. This expansion in capacity should help address a growing need for SPECT brain imaging. Approximately 90,000 people in the US each year are diagnosed with Parkinson’s1 and nearly 1.24 million will be diagnosed by 20302. Additionally, one in four patients with dementia suffers from DLB, making it the second most common form of degenerative dementia after Alzheimer’s Disease3. The clinical signs and symptoms of DLB can be atypical and overlap with other forms of dementia, leading to up to 70% of patients with DLB being misdiagnosed, often as having Alzheimer’s Disease4. Robert Burke, North American Senior Vice President of Commercial at Curium, commented: “Curium’s expanded capacity on Fridays will allow our customers and their patients greater scheduling flexibility. Our customers have asked for this expansion and Curium is thrilled to be able to satisfy this request. We look forward to launching Friday patient use on April 5.” About Ioflupane I 123 Injection INDICATION AND USE Ioflupane I 123 is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). Important Risk Information CONTRAINDICATIONS Ioflupane I 123 Injection is contraindicated in patients with known serious hypersensitivity to Ioflupane I 123. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions, including dyspnea, edema, rash, erythema, and pruritus, have been reported following Ioflupane I 123 Injection administration. Thyroid Accumulation: The Ioflupane I 123 Injection may contain up to 6% of free iodide (iodine-123). Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia. To decrease thyroid accumulation of I-123, block the thyroid gland before administration of Ioflupane I 123 Injection. Radiation Risk: Ioflupane I 123 Injection emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients. ADVERSE REACTIONS In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness of mild to moderate severity were reported. In postmarketing experience, hypersensitivity reactions and injection-site pain have been reported. DRUG INTERACTIONS Drugs that bind to the dopamine transporter with high affinity may interfere with the Ioflupane I 123 Injection image. The impact of dopamine agonists and antagonists on Ioflupane I 123 Injection imaging results has not been established. USE IN SPECIFIC POPULATIONS Pregnancy: Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of a thyroid blocking agent is recommended before the use of Ioflupane I 123 Injection in a pregnant woman. All radiopharmaceuticals have potential to cause fetal harm. There are no available data on Ioflupane I 123 Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Advise pregnant women of the potential risks of fetal exposure to radiation with the administration of Ioflupane I 123 Injection. Lactation: Iodine 123 (I 123), the radionuclide in Ioflupane I 123 Injection, is present in human milk. There is no information on the effects on breastfed infants or on milk. Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for at least 6 days after Ioflupane I 123 Injection administration to minimize radiation exposure to a breastfeeding infant. Pediatric Use: The safety and efficacy of Ioflupane I 123 Injection have not been established in pediatric patients. Geriatric Use: There were no differences in responses between elderly patients and younger patients that would require a dose adjustment observed in the parkinsonian syndrome studies. Renal Impairment: Ioflupane I 123 Injection is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and altered Ioflupane I 123 Injection images. OVERDOSAGE The risks of overdose relate predominantly to increased radiation exposure, with the long-term risk for neoplasia. In case of overdosage of radioactivity, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient. Please see full Prescribing Information by clicking here or visit References: 1 Willis AW, Roberts E, Beck JC, et al. “Incidence of Parkinson disease in North America.” NPJ Parkinsons Disease. 2022;8:170. 2 Marras C, Beck JC, Bower JH, et al. “Prevalence of Parkinson’s disease across North America.” NPJ Parkinsons Disease. 2018;4:21. doi:10.1038/s41531-018-0058-0 3 Barker, Warren W, Luis, Cheryl A, Kashuba A, et al. “Relative frequencies of Alzheimer disease, Lewy body, vascular and frontotemporal dementia, and hippocampal sclerosis in the State of Florida Brain Bank.” Alzheimer Disease and Associated Disorders vol. 16,4 (2002): 203-12. doi:10.1097/00002093-200210000-00001 4 Warr L, Walker Z. “Identification of biomarkers in Lewy-body disorders.” Quarterly Journal of Nuclear Med Mol Imaging; 2012; 56: 39-54 About Curium Curium is a world leader in nuclear medicine. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit curiumpharma.com. For more information about this press release, please contact Ross Bethell ross.bethell@curiumpharma.com or +44.7827.833.176.

New paper in The Lancet Neurology proposes the first iteration of a research framework for defining and staging Parkinson's disease (PD) based on biology, rather than clinical symptoms The framework defines PD based on the neuronal alpha-synuclein pathology that is a hallmark for the disease, building on the 2023 discovery of a biomarker that detects alpha-synuclein in living people Based on this new definition, the paper's authors propose a staging system — the neuronal alpha-synuclein disease integrated staging system (NSD-ISS) — that promises to be a research accelerator by improving the development of new drugs across the disease continuum, enabling clinical trials for disease prevention and clarifying regulatory review NEW YORK, Jan. 23, 2024 /PRNewswire/ -- Today, an international working group has proposed a new research framework — the neuronal alpha-synuclein disease integrated staging system (NSD-ISS) —that, for the first time, stages Parkinson's disease (PD) and defines it based on the disease's underlying biology. The paper, published in The Lancet Neurology, describes the framework, its applications, gaps in knowledge and future plans. The NSD-ISS framework is considered a milestone for the field, and a critical starting point — as more data is developed, its concepts and definitions are expected to evolve. The foundation of NSD-ISS defines Parkinson's by the presence of its hallmark pathology, neuronal alpha-synuclein (asyn), that can now be detected by reliable biomarkers, often before symptoms appear. By applying an objective approach to detecting PD and standardizing its tracking on a biological continuum, NSD-ISS represents a major leap into the new and emerging biological era of Parkinson's science. The new research framework stands to accelerate and increase the success of scientific discovery and therapeutic development at all stages of Parkinson's. And ultimately, a treatment that targets the biology of the disease — rather than just its symptoms — is the way to reach a cure. (A similar biological framework in Alzheimer's disease resulted in successful trials and new drug approvals, with the first drugs to slow Alzheimer's-related cognitive decline appearing in 2022 and 2023.) This landmark step forward was made possible by the breakthrough discovery of a test — validated in April 2023 by The Michael J. Fox Foundation's Parkinson's Progression Markers Initiative — capable of detecting the earliest believed pathology of PD even prior to the onset of any visible symptoms. The test, known as the alpha-synuclein seed amplification assay (αSyn-SAA), detects dysfunctional alpha-synuclein protein, one of the two biological hallmarks of PD alongside dopaminergic transport dysfunction, which can be visualized later in the disease process in the brain using DaTScan. Together, these two hallmarks serve as the basis for the NSD-ISS staging system. Key details include: The NSD-ISS integrates two core biomarkers: aggregated asyn (as currently detected by αSyn-SAA) and dopamine dysfunction (as currently measured by DaTScan dopamine transporter imaging in the brain). Stages one and two are based on these objective biomarkers, and stages three to six require these biomarkers and progressive motor and other nonmotor symptoms, such as REM sleep-behavior disorder, tremor, severe loss of smell, cognitive impairments and gait and balance problems. While disease occurs on a continuum and progression varies from person to person, defining discrete biological stages is critical to provide an objective framework for therapeutic development. Researchers are still investigating and refining the timeline for biological disease progression. "This new research framework promises to transform clinical trial design as we know it," said Diane Stephenson, PhD, executive director, Critical Path for Parkinson's Consortium, Critical Path Institute, and a coauthor on The Lancet Neurology paper. "This is how the field will meaningfully and tangibly achieve smarter and faster drug trials and treatments that can slow or halt disease progression, and perhaps one day, prevent the disease process from occurring altogether." Because the framework encompasses clinical syndromes for which dysfunctional asyn is the defining biological hallmark, it applies to — and stands to improve treatment for — both PD and dementia with Lewy Bodies (DLB). The NSD-ISS unifies PD and DLB along the same continuum of progression based on a standardized biological diagnosis. Framework Developed through Open Multistakeholder Collaboration There is widespread recognition that to achieve a paradigm shift in how PD is defined and staged, multiple diverse stakeholders need to come together and engage in open and transparent dialogue. As part of the effort, the framework's international working group hosted a multistakeholder discussion to collect input on the concepts for NSD-ISS from people and families living with PD, neuroscience and clinical leaders, industry experts, federal research funders (i.e., the National Institutes of Health), disease-focused nonprofit organizations and regulatory authorities (i.e., the Food and Drug Administration). A draft manuscript also was posted online for public comment. The process — which engaged more than 550 individuals and organizations from six continents — resulted in a framework informed by collective community input. "Inviting scientific discourse from a multitude of perspectives is a key principle and a shared value of every organization and individual in the working group effort," said Sohini Chowdhury, The Michael J. Fox Foundation's chief program officer and a coauthor on the paper. "This new research framework is the product of a diverse community of contributors, whose inputs have helped to align and harmonize this first meaningful step toward a shared tool for researchers and the biopharma industry." NSD-ISS Will Become a Research Accelerator for the Field The first iteration of the NSD-ISS framework is expected to play a transformative role in guiding development of therapies that affect disease progression by: Stimulating new approaches to develop and test therapies targeting relevant biology across the disease continuum, which could lead to precision treatments for people at every stage of disease. Enabling clinical trials even prior to symptom onset though biomarker-based disease detection. These trials could ultimately lead to therapies that prevent the onset of clinical symptoms. Providing academic researchers, industry investigators and regulators a consistent and uniform definition for each disease stage so that molecular investigations and clinical trial outcomes can be objectively assessed, standardized and compared efficiently. "Our shared hope is that this new framework will foster innovation in clinical development, making trials more efficient and streamlining regulatory review. In short, the NSD-ISS is a research accelerator. And it is expected to evolve with accumulating scientific knowledge," said Tanya Simuni, MD, lead author on the paper, professor of neurology and director of the Parkinson's Disease Movement Disorders Center at Northwestern University. "The success that the Alzheimer's field has had with its biological framework provides the inspiration and motivation to achieve similar accelerated timelines in Parkinson's. Ten years from now, we hope we will look back and say this framework was the key that finally opened the door to next-generation treatments in Parkinson's." As Simuni and her coauthors note in The Lancet Neurology paper, the framework offers an actionable proposal to researchers and industry creating a new path for efficient clinical trials, but at present, it is not intended for use in routine clinical care. The paper includes acknowledgement that data supporting concepts of the NSD-ISS framework have emerged largely from the Foundation's landmark PPMI study. Major funding for PPMI comes from Aligning Science Across Parkinson's (ASAP) (), a coordinated research initiative focused on accelerating the pace of discovery and informing the path to a cure for PD. ASAP support is enabling a seismic expansion of PPMI to increase recruitment efforts and remote testing for those at-risk for PD as well as expanding assay development efforts to enable breakthroughs such as the alpha-synuclein seed amplification assay. PPMI is additionally funded by a consortium of more than 40 biotech and pharmaceutical firms providing financial and in-kind support, and by tens of thousands of individual donors to The Michael J. Fox Foundation. Heralded as "the study that's changing everything" about how Parkinson's is diagnosed, managed and treated, PPMI and its data are made possible by the more than 2,000 in-clinic and 40,000 online research volunteers with and without Parkinson's disease. "It's still early, but this framework will have an immediate impact in terms of how we're designing clinical protocols and optimizing research that can lead to better treatments that patients are waiting for," said Peter DiBiaso, MHSA, a coauthor on the paper, a drug development professional, and member of MJFF's Patient Council who was diagnosed with PD at 49. "We know there's a lot of work to be done, but this is the most important first step the field can take together to rapidly advance breakthroughs for patients and families." About The Michael J. Fox Foundation for Parkinson's Research (MJFF) As the world's largest nonprofit funder of Parkinson's research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson's disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson's patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding $1.75 billion in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson's research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; creates a robust open-access data set and biosample library to speed scientific breakthroughs and treatment with its landmark clinical study, PPMI; increases the flow of participants into Parkinson's disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson's awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world. For more information, visit us at , Facebook or Twitter. SOURCE The Michael J. Fox Foundation for Parkinson's Research

The option agreement grants NLS Pharmaceutics Ltd. the exclusive option to in-license all of Aexon Labs' assets for the potential treatment of narcolepsy and other neuro-degenerative disorders, and all future indications Exclusive option agreement accesses global rights to multiple highly selective Orexin-1 / Orexin-2 receptor agonists, unique compounds designed for specificity, acting multiple pathways involved in the pathophysiology of narcolepsy and other central disorders of hypersomnolence Additional targets include Cathepsin-H inhibition, sigma-1 receptor agonist, DAT and NET reuptake inhibition, addressing neurotransmission, neuroprotection and neuroinflammation First patent application filed at the end of 2022 for orexin receptors agonists for treating or preventing neurological diseases and psychiatric disorders including narcolepsy NLS continues to strengthen its neuroscience pipeline in sleep medicine with a unique and holistic approach to central disorders of hypersomnolence and neurodegenerative disorders franchise ZÜRICH, SWITZERLAND / ACCESSWIRE / December 1, 2023 / NLS Pharmaceutics Ltd. (NASDAQ:NLSP)(NASDAQ:NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system ("CNS") disorders, today announced that NLS has entered into an exclusive worldwide option agreement with Aexon Labs, Inc., a privately held U.S. company ("Aexon Labs"), under which NLS may acquire global development and commercialization rights to Aexon Labs' Dual Orexin Receptor Agonists platform, new molecular entities, highly selective dual oral orexin-1 and orexin-2 receptor agonists (OX1R and OX2R) with potential applications in the treatment of narcolepsy and idiopathic hypersomnia, as well as neuro-degenerative disorders such as Parkinson's and Alzheimer's disease. This option agreement represents a potentially leading next-generation, first-in-class, oral, dual orexin receptor agonist (AEX-2) that is expected to address high unmet medical needs and has shown promising results in pre-clinical in vitro assays. Aexon Labs has plans to initiate clinical development, including Phase 1 First-in-Human and Phase 1b Proof-of-Concept (POC) studies, as early as 2024. The transaction will be structured as an exclusive worldwide license for the development and commercialization by NLS of the Aexon Labs' compounds and their derivatives. Under the terms of the option agreement, NLS must exercise its option by no later than March 31, 2024. NLS will pay Aexon Labs an upfront payment of $30,000 for the option exclusivity, and $170,000 upon execution of the definitive agreement to exercise the option. In addition, Aexon Labs will receive 15% of all proceeds earned by NLS in any future sub-licensing agreements which include upfront payments, regulatory milestones, commercial milestones and royalties earned during the first three years of commercialization in the U.S. and in the EU. Royalties will be payable, on a country-by-country basis, from the date of first commercial sale of a product in a given country until the date of patent expiry or the entry of a generic version of the product in such country. NLS will be the sole party responsible for the design and execution of the research and development plan, for the conduct and management of the preclinical as well as clinical studies, and for the interactions with the U.S. Food and Drug Administration and/or any other regulatory agency. NLS will pay all costs associated with executing and completing those studies, as well as those associated with the preparation and submission of a new drug application. NLS will pay for all studies in all indications and regulatory filings in the U.S. as well as outside of the U.S. Eric Konofal, MD, PhD, who works under a part-time consulting agreement for NLS as its Chief Scientific Officer, is the president and founder of Aexon Labs, and owns 59% of Aexon Labs. Alexander Zwyer, Chief Executive Officer of NLS, owns 35% of Aexon Labs. Mr. Zwyer holds no board or executive position at Aexon Labs. Mr. Zwyer said, "I believe the potential acquisition of this novel and unique platform which consists of over 300 compounds, bridges the present to the future treatment of sleep disorders as well as other neuro-degenerative disorders. These new compounds, in addition to our current pipeline, including Mazindol ER for the treatment of narcolepsy, along with NLS-4 focused on idiopathic hypersomnia, long-COVID and chronic fatigue syndrome, and NLS-11, addressing Kleine-Levin Syndrome and neurodegenerative diseases will further complement and strengthen our hypersomnia franchise." Orexin receptor pathways play vital regulatory roles in many physiological processes and studies have shown that orexin receptor pathways are involved in pathological processes of neurological diseases such as narcolepsy, depression, ischemic stroke, drug addiction and Alzheimer's disease. About Narcolepsy Narcolepsy is a life-long sleep disorder caused by the autoimmune-mediated loss of 70,000-90,000 orexin-producing neurons in the hypothalamus, characterized by excessive daytime sleepiness, cataplexy and rapid eye movement sleep abnormalities, and is tightly associated with human leukocyte antigen HLA-DQB1*06:02. Other predisposing factors for narcolepsy are associations with a polymorphism in the T-cell receptor alpha and beta genes, whose products recognize antigens presented by human leukocyte antigens (HLA) molecules, and Cathepsin H (CTSH). About NLS Pharmaceutics Ltd. NLS is a global development-stage biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders who have unmet medical needs. Headquartered in Switzerland and founded in 2015, NLS is led by an experienced management team with a track record of developing and commercializing product candidates. For more information, please visit . About Aexon Labs, Inc. Aexon Labs is conducting leading edge research on new compounds to address unmet needs in neurodegenerative disorders, defined by the breakdown of neurons over time. Alzheimer's, Parkinson's, Huntington's, Narcolepsy and Amyotrophic Lateral Sclerosis are just a few examples of brain disorders that have no cure. Current treatments do not address the root cause of each disorder and often lack therapeutical effectiveness and safety for these neurological disorders. For more information, please visit . Safe Harbor Statement This press release contains expressed or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements when it discusses the potential benefits of NLS' and Aexon Labs' products, development plans and timing of studies, and the timing and the expected outcome of the option agreement. These forward-looking statements and their implications are based on the current expectations of the management of NLS only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; NLS may encounter delays or obstacles in launching and/or successfully completing its clinical trials; NLS' products may not be approved by regulatory agencies, NLS' technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; NLS may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with NLS' process; NLS' products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; NLS' patents may not be sufficient; NLS' products may harm recipients; changes in legislation may adversely impact NLS; inability to timely develop and introduce new technologies, products and applications; and loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of NLS to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, NLS undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting NLS is contained under the heading "Risk Factors" in NLS' annual report on Form 20-F for the year ended December 31, 2022 filed with the Securities and Exchange Commission (SEC), which is available on the SEC's website, and in subsequent filings made by NLS with the SEC. For additional information: Marianne Lambertson (investors & media) NLS Pharmaceutics Ltd. +1 239.682.8500 ml@nls-pharma.com SOURCE: NLS Pharmaceutics AG View source version on accesswire.com: