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The Promise Of Psilocybin When It Comes To Mental Health, And How COMPASS Pathways (NASDAQ: CMPS) Is Advancing It

COMPASS Pathways

By Faith Ashmore, Benzinga Recent advancements in understanding mental health and the brain have allowed us to identify possible commonalities between different mental health conditions. One of the shared experiences among patients with conditions like treatment-resistant depression (TRD), bipolar II disorder and PTSD is the inability to move on and the presence of repetitive thoughts or ruminations. These thoughts can be persistent, counterproductive and even self-destructive. Patients often describe feeling disconnected from the world including friends and family. Although our ability to measure brain activity in humans is limited, doctors can use magnetic resonance imaging (MRI) to observe blood flow, which is closely linked to brain activity. When there is an increase in blood flow in a specific area, it indicates increased local activity, particularly at synapses. The brain is a highly energy-demanding organ, and different parts of the brain tend to fire together as modules rather than operating as completely independent entities. These modules control various functions such as vision, sensory/motor control of movement, the emotions, attention and even a default mode network associated with rumination and internal dialogues. This default mode network is where patients may experience the persistent and intrusive self-critical voice in their minds. In a number of mental health conditions, these functional modules appear to be more connected within and less between each other compared to individuals without the condition. Understanding the commonalities revealed by human imaging studies across conditions offers valuable insights for rethinking treatment approaches and providing proper care, especially for patients with unmet needs. This is why the world of psychedelics is especially promising when it comes to mental health care. Drugs producing psychedelic experiences have shown promise in treating mental health conditions, perhaps by disrupting the connectivity of functional modules altered in depression, anxiety, and other conditions. For example, by reducing activity in the default mode network, it has been suggested that these drugs may also help individuals break negative thought patterns and ruminations. Animal studies suggest that they may help in promoting neuroplasticity and repairing neural circuits, which may lead to improved and sustained mental health outcomes in some patients. This potential is exciting and more research is needed to understand how psychedelics may be used. COMPASS Pathways’ (NASDAQ: CMPS) innovative approach has received FDA Breakthrough Therapy designation in the U.S. and Innovative Licensing and Access Pathway designation in the U.K. for their investigational COMP360 psilocybin in TRD. Moreover, in late 2021, COMPASS Pathways announced the completion of a randomized, controlled double-blind phase 2b study of investigational COMP360 psilocybin treatment involving 233 patients with TRD in 22 sites across Europe and North America. While the company is currently focusing on TRD, it is also researching PTSD and anorexia nervosa, in part because of neurological similarities. Companies like COMPASS Pathways are working to develop interventions that address these common factors and support patients on their path toward improved mental well-being. For patients who have found no relief with current medications, this would be meaningful progress. Company BioCOMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP 360 psilocybin therapy in TRD, the largest randomised, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also conducting phase 2 clinical studies of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Stephen Schultz stephen.schultz@compasspathways.com

October 12, 2023 09:15 AM Eastern Daylight Time

Josephine Antonellis and Julie Harris, Ph.D., Named to New Roles at Cure Alzheimer’s Fund

Alzheimer’s Disease Research Foundation

Cure Alzheimer’s Fund announces Josephine (Jo) Antonellis has been named Chief Financial Officer (CFO) and Julie Harris, Ph.D., has been named Executive Vice President, Research Management for the nonprofit organization. As CFO, Antonellis will be responsible for the financial management of the nonprofit organization, including leadership of the accounting and financial teams. She will be a member of the management committee and report directly to Meg Smith, Chief Executive Officer. “We are fortunate to have a person with Jo’s depth and breadth of experience to lead our financial operations,” said Smith. “Jo has played a key role as our Controller and I expect she will move seamlessly into the CFO role, ensuring continuity of all our financial operations.” Antonellis joined Cure Alzheimer’s Fund in 2021 as Controller. She came to the organization with more than 25 years of diverse accounting experience, including responsibility for accounting operations and human resource functions. She started her career as an auditor for Arthur Andersen, where she became a licensed CPA. She holds a B.S. in accounting from Bentley University. Harris will be responsible for research management and funding for Cure Alzheimer’s Fund in her new role. She will bring new ideas and perspectives to managing the research portfolio, and partner with the scientific community to further the nonprofit’s mission to eradicate Alzheimer’s disease. “When we hired Julie, I knew that her deep experience as a scientist and as the central leader of large scientific teams and projects meant that she would be an immediate contributor to our research program,” said Smith. “Julie has also shown us all that she is a natural ambassador for our science, our scientists and our organization.” Prior to joining CureAlz, Harris was vice president of preclinical biology at Cajal Neuroscience, a biotech startup focused on identifying novel therapies for neurodegenerative diseases. Before that, she spent 10 years at the Allen Institute for Brain Science, where her team was responsible for employing whole brain microscopy and transcriptomics in Alzheimer’s mouse models to characterize molecular, cellular and circuit patterns of disease. Harris received a B.S. in zoology from Michigan State University and a Ph.D. in neurobiology and behavior from the University of Washington. She trained as a postdoctoral fellow at the Gladstone Institute of Neurological Disease in San Francisco. Since its founding in 2004, Cure Alzheimer’s Fund has provided grants to more than 750 of the world’s leading researchers and contributed more than $175 million to research. Its funded initiatives have been responsible for many key breakthroughs in understanding the causes and pathology of Alzheimer’s disease. Cure Alzheimer’s Fund has received a 4-star rating for 12 consecutive years from Charity Navigator. With 100% of funds raised going to support research, Cure Alzheimer’s Fund has been able to provide grants to many of the best scientific minds in the field of Alzheimer’s research. For more information, please visit https://www.CureAlz.org/. Contact Details Cure Alzheimer's Fund Barbara Chambers +1 978-417-9890 bchambers@curealz.org

October 12, 2023 06:53 AM Eastern Daylight Time

News Release

Vivos Therapeutics secures Middle East-North Africa distribution deal and Stanford study

Vivos Therapeutics

Vivos Therapeutics CEO Kirk Huntsman joined Steve Darling from Proactive to share an exciting development for the company. Vivos has just entered into an exclusive distribution agreement with NOUM DMCC, a Dubai-based company with a strong focus on diagnostic testing and the distribution of treatment products for healthcare providers and hospital networks specializing in obstructive sleep apnea patients across the Middle East-North Africa (MENA) region. Huntsman elaborated on the significance of this partnership, highlighting how it addresses the growing demand for effective treatment alternatives to Continuous Positive Airway Pressure (CPAP) for individuals suffering from obstructive sleep apnea. With this agreement, NOUM has been granted exclusive distribution rights for Vivos' innovative products and services in several key countries in the MENA region. This list includes Saudi Arabia, the United Arab Emirates, Qatar, Kuwait, Bahrain, Oman, Jordan, Lebanon, and Palestine. A noteworthy aspect of this collaboration is that NOUM will promptly initiate the process of seeking regulatory approvals for Vivos' medical devices within the respective countries. These approval timelines are expected to vary, ranging from a few weeks to several months, contingent upon the specific regulatory requirements of each nation. Huntsman also revealed to Proactive that the company's flagship daytime-nighttime appliance or DNA will undergo a clinical trial at Stanford Medicine. The trial's protocol has been finalized, and participant enrollment is slated to commence in early 2024. In this clinical trial, individuals diagnosed with moderate to severe obstructive sleep apnea will be randomly assigned to one of two groups for treatment: either using Vivos' innovative DNA appliance or a traditional CPAP machine. The trial will closely monitor and assess the participants' condition through sleep studies conducted before and after the treatment course, using in-lab polysomnography to measure changes in the patients' apnea-hypopnea index. This clinical trial represents a significant milestone for Huntsman and Vivos as it provides an opportunity to validate the efficacy of their DNA appliance in addressing OSA, a serious and widespread sleep disorder. Contact Details Proactive Investors +1 347-449-0879 na-editorial@proactiveinvestors.com

October 11, 2023 01:47 PM Eastern Daylight Time

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News Release

BioHarvest Sciences announces Health Canada has approved VINIA Sales in Canada

BioHarvest Sciences Inc.

BioHarvest Sciences CEO Ilan Sobel joined Steve Darling from Proactive to share news Health Canada has granted BioHarvest Sciences a Canadian product license through Health Canada's Natural and Non-Prescription Health Products Directorate. Sobel explained that this newly acquired license now authorizes the company to sell VINIA in Canada, a pivotal step in their growth plan. VINIA stands as a groundbreaking product developed using BioHarvest's innovative Botanical Synthesis platform. It contains a rich assortment of polyphenols, including Piceid Resveratrol, with each daily 400mg capsule equivalent to the polyphenol content found in 1,000 grapes. VINIA is a potent nutraceutical, and its clinical efficacy has been demonstrated in significantly increasing arterial dilation. Following the launch in Canada, BioHarvest Sciences has ambitious expansion plans, with a keen eye on the immense potential of the Chinese health supplement market, which is valued at a staggering US$40 billion. This move into the Chinese market represents a significant opportunity for the company to further establish its presence and offer the benefits of VINIA to a broader global audience. In summary, the Canadian product license from Health Canada marks a crucial milestone for BioHarvest Sciences, enabling them to introduce their innovative product, VINIA, to the Canadian market and beyond. This achievement aligns seamlessly with the company's growth strategy, offering the potential for improved health and well-being to a wider consumer base, while also paving the way for expansion into one of the world's largest health supplement markets in China. Contact Details Proactive Investors Canada +1 604-688-8158 na-editorial@proactiveinvestors.com

October 11, 2023 01:37 PM Eastern Daylight Time

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Cardiol Therapeutics releases positive study results of subcutaneously administered cannabidiol

Cardiol Therapeutics

Cardiol Therapeutics CEO David Elsley joined Steve Darling from Proactive with news the company has unveiled highly promising study results from international research, which showcased the remarkable potential of subcutaneously administered cannabidiol, the active pharmaceutical ingredient found in Cardiol's groundbreaking CRD-38 subcutaneous formulation. In this study, it was revealed that the application of subcutaneous cannabidiol effectively curtailed the upward trajectory of both body weight and heart weight, while also preventing undesirable increases in crucial cardiac inflammatory and remodelling markers. This research was conducted in a meticulously designed model of heart failure with preserved ejection fraction, noteworthy for its ability to accurately replicate the comorbidities commonly associated with this condition, such as hypertension, obesity, and metabolic dysfunction. Elsley emphasized the profound significance of these study findings, particularly focusing on the unique pre-clinical model employed. This model, meticulously crafted to mimic the conditions experienced by patients suffering from heart failure with preserved ejection fraction, serves as an essential tool in understanding the complex interplay of factors contributing to the disease. The results, which illuminated the multiple cardioprotective effects of subcutaneously administered cannabidiol, serve as a pivotal stepping stone towards the development and potential approval of CRD-38 as a groundbreaking treatment for heart failure. The collective body of evidence generated by this research provides strong support for the advancement of Cardiol Therapeutics' innovative therapeutic approach in combating this debilitating condition, offering hope and potential relief to countless individuals affected by heart failure with preserved ejection fraction. Contact Details Proactive Canada +1 604-688-8158 na-editorial@proactiveinvestors.com

October 11, 2023 01:05 PM Eastern Daylight Time

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News Release

Perimeter Medical Imaging AI shortlisted for grant funding under Biden Cancer Moonshot initiative

Perimeter Medical Imaging AI

Perimeter Medical Imaging AI CEO Adrian Mendes joined Proactive's Stephen Gunnion with news that the company has been shortlisted in a grant funding process sponsored by the Advanced Research Projects Agency for Health (ARPA-H) as part of its Precision Surgical Interventions (PSI) program. Mendes explained that the initiative aims to provide groundbreaking tools for surgeons to effectively remove cancer in a single operation. Perimeter's technology aligns perfectly with this goal, as they have been working on it for the past decade. Perimeter Medical Imaging AI utilizes a technology called OCT, which has been around for 30 years. However, it has developed wide-field OCT, enabling larger image capture crucial for examining excised tumors. The company's current S series device is already in use in several operating rooms, gathering user feedback. It is also conducting clinical trials for its next-gen B series device, integrating AI technology to enhance surgeon workflow. While the base OCT technology isn't new, the company's innovations and AI integration represent the latest advancements. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

October 11, 2023 01:02 PM Eastern Daylight Time

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PathAI Announces Research Presentations at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

PathAI

PathAI, a global leader in AI-powered pathology, today announced it will present research on advances in artificial intelligence (AI) approaches through three posters at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on October 11-15 in Boston, Massachusetts, including one poster to be presented in partnership with Flare Therapeutics. The posters showcase how AI may improve the utility of complex and specialized modalities such as multiplexed immunohistochemistry and may enhance the utility of routine modalities, such as augmenting cellular resolution from H&E-stained images. The presentations underline the significant strides in AI that can enhance translational and clinical research applications. Spatially-resolved prediction of gene expression signatures in H&E whole slide images using additive multiple instance learning models (Poster B010) In this research, PathAI demonstrates the prediction of TGFβ-CAF gene expression signature levels in breast cancer from H&E images and links these levels to tumor microenvironment features using PathExplore, PathAI’s recently launched structured, standardized and scalable panel of human interpretable features (HIFs) offering unprecedented resolution of the tumor microenvironment (TME) from H&E whole-slide images. H&E staining is routine for cancer diagnosis but does not provide molecular information. This potentially limits its utility for molecular-targeted therapy development and selection. AI models augment the information that can be extracted from H&E staining, enhancing resolution of H&E data and increasing other applications such as associating spatial TME features with gene expression signatures. End-to-end additive multiple instance learning (aMIL) models developed and deployed by PathAI performed well at predicting TGFβ-CAF levels. Importantly, aMIL models link PathExplore HIFs to specific sub-regions within the TME, which allows for granular understanding of specific cellular contributions to various molecular predictions from H&E WSI. This poster adds to a series of PathAI achievements in predicting molecular phenotypes from digital pathology images, providing a means to harness complex biological signatures as clinical biomarkers for precision medicine. It will be presented by Chintan Parmar, manager of AI research at PathAI, on October 13 from 12:30-4 p.m. ET. Artificial intelligence (AI) analysis of histological images accurately identifies luminal subtype Urothelial Carcinomas characterized by high Peroxisome Proliferator-Activated Receptor Gamma (PPARG) expression (Poster B016) This research was completed in collaboration with Flare Therapeutics and highlights an AI-based model that identifies luminal subtype in Urothelial Carcinoma as a novel biomarker approach for its first-in-class clinical candidate FX-909. The poster will be presented by Stefan Kirov from Flare Therapeutics on October 13 from 12:30-4 p.m. ET. Machine-learning enabled quantification of colocalized multiplex IHC signals with spectral overlap (Poster B008) This poster demonstrates novel imaging and AI technology to accurately detect and quantify up to four co-localized antigens or stains from a single multiplex IHC slide. Multi-spectral imaging addresses the challenge of how to separate markers exhibiting both spectral and spatial overlap. Expression or staining of individual markers is identified in spectrally unmixed images and combined with information across all separate marker channels to create a “super annotation” co-expression map that is then used to train AI models. PathAI’s model utilizing super annotation demonstrated a significantly lower error rate in detecting co-expression of several markers such as ER, PR, and Ki67 compared to an commercially available method, which was consistent on two different scanners, Leica At2 and 3DHistech. These results may facilitate clinical utilization of higher-plex biomarkers, which could enable faster and more accurate co-expression measurement of various markers, promising cost and time savings by consolidating biomarker measurement to a single slide with automated scoring to assist pathologists. This poster will be presented by Waleed Tahir, pathology AI research scientist at PathAI, on October 13 from 12:30-4 p.m. ET. Learn More PathAI representatives will be on site at the conference for the poster presentations: Poster B008 October 13, 12:30-4:00 p.m. ET Presenter: Waleed Tahir, PathAI Poster B010 October 13, 12:30-4:00 p.m. ET Presenter: Chintan Parmar, PathAI Poster B016 (In partnership with Flare Therapeutics) October 13, 12:30-4:00 p.m. ET Presenter: Stefan Kirov, Flare Therapeutics If interested in meeting the PathAI team during or after the conference, contact the team via email at BD@pathai.com. About PathAI PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and laboratory use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of pathology samples to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. PathAI, which is headquartered in Boston, MA, and operates a CAP/CLIA-certified laboratory in Memphis, TN, is proud to have a team of 600+ innovative thinkers from around the globe. For more information, please visit www.pathai.com. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

October 11, 2023 10:00 AM Eastern Daylight Time

Immunic "super excited" about latest PMS trial data

Immunic Inc

Immunic Inc (NASDAQ:IMUX) President and CEO Dr Daniel Vitt speaks to Thomas Warner from Proactive after the biotechnology company announced encouraging interim data from its phase II CALLIPER trial assessing the potential of its treatment for progressive multiple sclerosis (PMS). Dr. Vitt expresses says he's "super excited" about the data, which he believes exceeded expectations. He adds that given the limited treatment options available for progressive MS, the company's findings are particularly significant. Immunic has observed a 22.4% reduction in the neurofilament light chain (NFL) biomarker, which correlates with better outcomes in preventing disability worsening in MS patients. This result was achieved with patients treated with 45 milligrams of their drug. The company has enrolled 467 patients in this 120-week phase two study, with final data expected around April 2025. Dr. Vitt also hints at upcoming updates from other programs as well as more news to come on a phase three clinical study. Contact Details Proactive United States +1 347-449-0879 action@proactiveinvestors.com

October 11, 2023 05:15 AM Eastern Daylight Time

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Trainee Human Rights Lawyer from Watford Launches Global Mental Health Campaign

Renske Technologies

This World Mental Health Day, a British human rights lawyer is launching an ambitious campaign to reshape attitudes, policies, and access to mental healthcare across the globe. Mohammed Sbahuddin Rafiuddin, a 32-year-old trainee human rights lawyer from Watford, UK, is unveiling "Mohammed's Mental Health Campaign" - a pioneering initiative to have sound mental health universally recognized as a fundamental human right worldwide. Mohammed, who has battled severe mental illness for a decade and draws from his own harrowing experiences, aims to completely transform the narrative and policies surrounding mental health through this bold campaign. "My mission is to ensure no one battling mental illness ever feels alone or has to surrender their fight for a fulfilling life of sound mental health," Mohammed said. "Together, we can create a world where mental health is no longer stigmatized but treated with the same urgency as physical health." The World Health Organization estimates 1 in 8 people globally live with a mental disorder - nearly 1 billion worldwide. Mental illness is a leading cause of disability and lost economic opportunities. However, mental health remains chronically underfunded. Stigma prevents many from seeking help. Access to quality, affordable treatment remains out of reach for too many. Mohammed's solution is a massive cultural and policy shift: enshrining the right to mental health as a protected Human Right across the globe. The campaign's central goal is incorporating the right to sound mental health into legislation such as the UK's Human Rights Act and seeing it recognized internationally through groups like the United Nations. "If we can secure the right to mental health as we have done for rights like fair trials or freedom of speech, it will transform how governments approach funding mental health services and force real change in access to care," Mohammed explained. Increased Investment in Research and Treatment A key pillar is advocating for urgently increased investment in mental health research and treatment worldwide. "The lack of funding for mental health research and resources is unacceptable given the scale of this crisis," said Mohammed. "We need a massive injection of funding to develop better treatments and make high-quality care available to all." Greater Focus on Prevention and Early Intervention The campaign also calls for a greater focus on prevention and early intervention worldwide. This includes broader public awareness campaigns, more proactive screening, and expanding free and low-cost community mental health programs. "We know so much more about how to prevent mental illness and intervene early. We desperately need greater investment in public mental health initiatives to give people the education, tools and support they need before reaching crisis," Mohammed stated. Tackling Stigma and Normalizing Conversations Around Mental Health Mohammed also aims to tackle head-on the stigma that prevents so many from seeking help - especially in minority communities. "Within many Asian communities, mental illness is simply not discussed," Mohammed shared. "I want to normalize these conversations, break taboos, and allow people to get treatment without shame." Drawing from Personal Struggles to Inspire Others As part of launching the campaign, Mohammed is courageously sharing his own story of overcoming severe mental illness after being bedridden for 7 years, in hopes it will inspire others worldwide facing similar challenges. Mohammed's mental health crisis began while finishing his law degree, when he developed severe depression and anxiety that later spiraled into psychosis. He spent his 30th birthday in a mental health ward. At his worst, he was on 4 medications just to stay alive. After finally receiving appropriate treatment and support, Mohammed has recovered and completed his law qualifications. He now wants to help millions of others get their lives back too. "My own journey has given me the strength and passion to fight for a future where no one has to suffer in silence or feel hopeless," said Mohammed. "I want to help empower people worldwide to live mentally healthy, fulfilling lives." Ambitious Worldwide Campaign Gaining Support Mohammed has spent years raising awareness on mental health issues and working with organizations like Mind, Rethink Mental Illness, and the NHS as an Expert by Experience. Now his ambitious global campaign is gaining backing from mental health professionals, community leaders, and policymakers across sectors. "Mohammed's courageous work will open minds, save lives, and bring us closer to treating mental health as a basic human right for all," said Dr. Malik, a psychiatrist who treated Mohammed. "I fully support this campaign and hope it inspires global action." A Collective Mission for Mental Health This World Mental Health Day, Mohammed is calling on people worldwide to join him in this urgent mission. "I believe together we can reshape the global narrative around mental health and create real, positive change in access to care," Mohammed said. "We have a collective responsibility to speak up and make sure mental health is no longer ignored." Mohammed hopes this bold campaign will spark a movement, driving real policy changes that secure mental health rights and transform millions of lives. "We have come too far to allow those with mental illness to keep suffering in silence," he said. "The time for action is now." Contact Details Mohammed Sbahuddin Raﬁuddin Mohammed +44 7746 698754 mohammed@msrofficial.com Company Website https://www.msrofficial.com/

October 10, 2023 02:12 PM Eastern Daylight Time

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