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Vivos One Step Closer To Transforming Cancer Treatment With FDA Application To Start Human Trials For Pioneering Injectable Brachytherapy Device

Vivos Inc.

By Meg Flippin, Benzinga In what could prove to be a transformational development in cancer treatment, Vivos (OTCQB: RDGL), the maker of the Radiogel™ Precision Radionuclide Therapy, submitted an application to the U.S. Food and Drug Administration (FDA) to initiate human clinical trials. The Investigational Device Exemption (IDE) application is an amendment addressing the FDA’s comments about the company’s previous application. Once it's granted approval, Vivos can begin testing its therapy on humans to treat solid metastatic tumors, particularly in lymph nodes associated with papillary thyroid cancer. How RadioGel Works RadioGel, a pioneering Yttrium-90-based injectable brachytherapy device, represents what the company says is a groundbreaking approach to cancer treatment. It is designed for patients who are either not eligible for surgery or have chosen not to undergo the procedure, particularly those with non-radioiodine avid disease and limited burden regional nodal disease. The therapy involves directly injecting a hydrogel containing Yttrium-90 phosphate microparticles into the tumor. This method allows for a more localized and potent radiation treatment compared to traditional external-beam radiation therapies. First Filing Since Breakthrough Device Designation The application marks Vivos’ first filing with the FDA since being granted FDA Breakthrough Device Designation for the Radiogel ™ Precision Radionuclide Therapy. The Breakthrough Devices Program by the FDA is designed to accelerate the development and review of innovative technologies that show potential for more effective treatment options. The program's support is instrumental in hastening patient access to promising medical advancements like RadioGel. The technology behind RadioGel allows for the safe delivery of higher doses necessary for treating non-resectable and radiation-resistant cancers. The product also boasts a short half-life, delivering over 90% of its therapeutic radiation within ten days. That will be welcome news to cancer sufferers, given other treatments can require up to six weeks for a full course of radiation therapy. Additionally, the outpatient nature of the RadioGel therapy means patients can return home without concerns about radiation exposure to family members. Vivos Is Ready Since receiving that status, Vivos said the communication with the FDA has improved further, which is important to ushering this treatment along. The IDE filing includes reports on two studies – RadioGel genotoxicity and the retention of RadioGel at the injection site in VX2 tumors in rabbits. Vivos said the IDE submission addressed the 63 FDA comments received in previous FDA correspondences. In some cases, the company repeated underlying testing to strengthen its answers with current data. “We are mindful that most of the twelve FDA reviewers have joined in the past two years and we anticipate they will have some comments after reviewing the extensive material in our filing, which we are prepared to address promptly,” said Dr. Michael Korenko, President and CEO of Vivos. “We are eager to secure the FDA’s IDE approval so that we can submit our plan to the Mayo Clinic's Independent Review Board (IRB) for clearance to initiate the first in human clinical trials. This is an exciting time for Vivos and we are committed to bringing a new treatment option to patients in the fight against challenging cancer types. Initially our collaboration with Mayo will be targeting solid metastatic tumors in lymph nodes associated with papillary thyroid cancer.” Vivos, in collaboration with the Mayo Clinic, is working hard to develop treatments to fight challenging cancer types, offering hope and potentially more effective treatment options to people around the globe. The IDE application puts it one step closer to realizing that dream. Featured photo by National Cancer Institute on Unsplash. Vivos Inc. has developed a Yttrium-90-based injectable Precision Radionuclide Therapy brachytherapy device to treat solid tumors in animals (IsoPet®) and humans (RadioGel™). Using the company's proprietary hydrogel technology, brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows the safe delivery of higher doses needed for treating non-resectable and radiation-resistant cancers. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Michael K. Korenko info@vivosinc.com Company Website http://www.vivosincusa.com

July 02, 2024 09:00 AM Eastern Daylight Time

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AmeriLife Expands Wealth Distribution Portfolio with Acquisition of WerksGroup

AmeriLife

AmeriLife Group, LLC (“AmeriLife”), a national leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions, announced today a strategic partnership with WerksGroup, LLC and its primary business line, MyFedRetirementWerks, helping Federal Employees optimize their retirement and benefit options. This partnership will enhance the retirement and life insurance guidance available to federal employees, offering a more comprehensive range of solutions to help them achieve their long-term financial goals. Per the agreement, the terms of the deal were not disclosed. “Our company began with a simple phrase: ‘One big purpose,’” said Richard and Karen Wolfe, principals of WerksGroup, LLC. “We believe that financial guidance is more than just selling products. It is the pursuit of helping clients create and implement a plan to achieve their long-term life goals. Partnering with AmeriLife strengthens that mission, broadens our reach, and merges our core values seamlessly.” With over 60 years of combined retirement planning and life insurance expertise, WerksGroup, LLC has built its business on the idea that relationships are more important than sales. As such, the company has focused on nurturing a client base of those who serve the American people, including employees of the U.S. Postal Service, the Department of Veteran Affairs, the Central Intelligence Agency, and various other federal agencies and departments. “Our success and this partnership would not have been possible without the dedication of our management team and minority partners, Patrick Shehan from our sales division in the postal and federal market, and Mark Ross, who was critical in expanding our annuity market. Their contributions were exemplary in bringing our vision to fruition and building WerksGroup into a great organization,” added Richard and Karen. As part of AmeriLife Wealth Group, WerksGroup will gain access to a best-in-class platform that delivers efficiency, value, and access to diverse resources and services to increase their productivity and grow their bottom line. “We are immensely impressed with Richard and Karen and their dedication and expertise while growing WerksGroup,” said AmeriLife Chief Distribution Officer of Wealth Distribution Mike Vietri. “Their exceptional work in the life insurance and annuity sectors has played a pivotal role in ensuring the retirement comfort of their federal employee clients. We are excited to integrate their strengths into our portfolio and continue building on their success.” About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as the leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For over 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers through a distribution network of over 300,000 insurance agents, financial professionals, and over 100 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com and follow AmeriLife on Facebook and LinkedIn. About WerksGroup, LLC Founded on a simple yet profound principle, WerksGroup, LLC is committed to assisting clients nationwide in preparing for their immediate needs and future aspirations. With over 60 years of combined expertise in retirement and life insurance, our team understands that trustworthy financial guidance involves more than just offering products—it requires a deep, comprehensive understanding of each client's financial, familial, and estate planning goals. Contact Details Media Inquiries Jeff Maldonado media@amerilife.com Partnership Inquiries Patrick Nichols corporatedevelopment@amerilife.com Company Website https://amerilife.com/

July 01, 2024 09:00 AM Eastern Daylight Time

Shedding Light on Cystic Fibrosis

YourUpdateTV

Cystic fibrosis (CF) is a rare, progressive, and genetic disease that currently affects about 40,000 people in the United States. CF is the result of a defective gene, inherited from each parent, and the disease can impact people of all races and ethnicities. Recently, KC White, Board Chair of the Cystic Fibrosis Foundation, participated in a nationwide satellite media tour to discuss the disease, her personal journey, and how the Foundation is helping progress care and treatment options. A video accompanying this announcement is available at: https://youtu.be/8wj8u0JEqLU CF is a life-shortening disease that prevents our bodies from clearing mucus. This can lead to lung infections, poor nutrition, lung disease, and a host of unique challenges that can impact every aspect of a person’s life. When it was first discovered, it was considered a fatal pediatric disease. But due to transformative advancements in treatments and high-quality care, the life-expectancy for someone born with CF today is 56. While that number is climbing there is still a long way to go and unfortunately, not all people with CF equally benefit from this progress. KC White was elected chair of the Cystic Fibrosis Foundation’s Board of Trustees in 2022 after serving on the Board since 2005. Diagnosed with cystic fibrosis at age 3, White has been a committed volunteer and inspiring advocate for the Foundation since childhood and is the first person with CF to serve as board chair. When she was diagnosed, she wasn’t expected to live past high school age, but her family refused to accept that fate, which prompted their dedication to the Foundation’s work. Because of recent treatments known as modulators, about 90% of the CF population (including KC) experienced an incredible transformation in their health. With this though, comes navigating unplanned challenges including careers, finances, family, and more. In addition to fueling the research, particularly in genetic therapies, that will lead to transformative treatments for the entire CF population, the CF Foundation works to support the CF community in all aspects of their lives through support programs and fostering connection opportunities. The CF Foundation is committed to finding a cure and providing all people with CF the opportunity to lead long, fulfilling lives. The Foundation is aggressively funding research and drug development, advancing high-quality, specialized care, and partnering with and advocating for the CF community. For more information, visit CFF.ORG About KC White KC White was elected chair of the Cystic Fibrosis Foundation’s Board of Trustees in 2022 after serving on the Board since 2005. Diagnosed with cystic fibrosis at age 3, White has been a committed volunteer and inspiring advocate for the Foundation since childhood, speaking at her first Foundation event when she was only 9 years old. She is the first person with CF to serve as board chair. White received her Master of Applied Positive Psychology from the University of Pennsylvania in 2022 and currently serves as an assistant instructor in the program. She is also the Head Varsity Women’s Lacrosse coach for the Chagrin Falls, Ohio, Tigers. She and her husband, Justin, have one son, Mac. About the Cystic Fibrosis Foundation The Cystic Fibrosis Foundation is a donor-supported nonprofit organization leading the relentless pursuit of a cure for cystic fibrosis. The Foundation is committed to providing all people with CF the opportunity to lead long, fulfilling lives by funding research and drug development, advancing high-quality, specialized care, and partnering with and advocating for the CF community. The Foundation funds more CF research than any other organization, and nearly every CF drug available today was made possible because of Foundation support. The organization supports and accredits a national network of over 130 CF care centers recognized by the National Institutes of Health as a model of care for a chronic disease. Also, the Foundation manages support programs and fosters connection opportunities for the CF community. Based in Bethesda, Md., the Foundation’s impact is made possible by the work of nearly 70 local chapters across the country. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

June 28, 2024 12:45 PM Eastern Daylight Time

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Tiziana Life Sciences adds to treasury with $3.4 million in non-dilutive funding

Tiziana Life Sciences Ltd

Tiziana Life Sciences Ltd (NASDAQ:TLSA) chairman and CEO Gabriele Cerrone joined Proactive's Stephen Gunnion with more details of the company's recent advancements and news. Tiziana Life Sciences is developing a fully human CD3 monoclonal antibody, delivered intranasally, specifically targeting neurodegenerative diseases such as multiple sclerosis (MS) and Alzheimer's disease. Cerrone discussed the company's progress in MS treatments, highlighting its expanded access trial at Harvard University's Brigham and Women's Hospital. Notably, 70% of patients in the trial showed improvement in fatigue scores, while 80% experienced reduced brain inflammation. The company is also preparing to dose the first Alzheimer's patients in a new trial approved by the FDA. Furthermore, Tiziana Life Sciences is exploring the combination of its drug with GLP-1 antagonists to target obesity-related diseases. Cerrone shared the exciting news of securing $3.4 million in non-dilutive funding, emphasising its commitment to protecting shareholder investments. "We have seen extraordinary improvements in patients, and we are thrilled about the potential impact of our treatments on neurodegenerative diseases," he remarked. Visit Proactive's YouTube channel for more videos, and don't forget to give the video a like, subscribe to the channel, and enable notifications for future content. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

June 28, 2024 07:53 AM Eastern Daylight Time

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Flash Appoints Chris Donus as President

Flash Parking

Flash, the leading end-to-end parking technology platform, today announced that Chris Donus, the current CFO, has been appointed president of the organization. In the newly established role, Donus will expand his focus on day-to-day operations, working closely with the leadership team to execute transformative strategies that include the expansion of Flash’s burgeoning digital demand network, EV charging and parking platform scale, and driving the company’s regionalized branch organization to deliver unmatched partner experiences. Dan Sharplin will continue in his role as Chairman and CEO, focusing on international growth, strategic transactions, and ecosystem partnerships. “This promotion reflects Chris’s exceptional leadership and expertise at this time of tremendous momentum for Flash as we rapidly scale our industry-leading parking and EV charging digital ecosystem," said Flash CEO Dan Sharplin. “In the next 24 months, we anticipate more transformation in the parking industry than we’ve seen in several decades prior. Chris has the relevant experience to ensure we execute on our priorities that allow us to drive this industry transformation.” “We are building a parking and EV charging ecosystem where a seamless driver experience benefits everyone,” said Donus. “There is an incredible amount of innovation and hard work being done across Flash to build the platform and partnerships that further our position as the leader in parking and EV Charging technology. I look forward to ensuring the value we create is incomparable in my role as President of Flash.” Before Flash, Donus served as COO and CFO at Wheel Health, a venture-backed telehealth platform developer designed to connect companies and clinicians to deliver virtual care. He also served in senior leadership roles at Lyft as VP and Business Unit leader of Express Drive, the customer-facing fleet line of business, generating over $400 million in rental revenue and over $2 billion in Lyft rides. Prior to that, he was president of Silvercar from 2015 to 2018 alongside roles as COO, from 2017 to 2018, and CFO from 2012 to 2015. He has also served in leadership roles at Freescale Semiconductor, Hertz Global Holding, and Lucent Technologies. About Flash Flash is a pioneering technology company bringing seamless parking and EV charging experiences to drivers through a first-of-its-kind digital ecosystem. Flash’s platform connects reservable parking and charging in the apps drivers use every day with garage, surface lot, event, and valet parking locations—connected and controlled via a cloud-based operating system with unrivaled intelligence. Customer-obsessed brands partner with Flash to deliver digital, easy-to-use, reliable, and increasingly frictionless experiences to drivers eager to pay for a solution that eliminates wasted time, excess emissions, and stress. The solution has arrived. Contact Details Razor Sharp PR Ray Young +1 512-694-6097 ray@razorsharppr.com Company Website https://www.flashparking.com/

June 27, 2024 10:00 AM Central Daylight Time

FeedSpot Recognizes Take Pride in Retirement Podcast as a Leading LGBTQ+ Voice for Pride Month 2024

Retirement.Radio

Retirement.Radio, a premier network dedicated to providing essential retirement planning information, announced today that its Take Pride in Retirement podcast has been recognized as a must-follow Pride-related podcast by FeedSpot, one of the web’s foremost aggregators of the “best of” across the internet. This recognition not only underscores the podcast’s commitment to sharing diverse voices and stories from the LGBTQ+ community but also highlights the importance of empowering and representing this community as it navigates its unique challenges during the golden years of retirement. “I am humbled and honored to receive this recognition,” said Matt McClure, founder and host of Take Pride in Retirement. “I started Take Pride in Retirement because I saw a need in my community for retirement planning, education, and assistance. Knowing that the podcast is reaching its intended audience and making a difference in their lives is extremely fulfilling.” The Take Pride in Retirement Podcast, a one-of-a-kind platform, focuses on financial issues relevant to the LGBTQ+ community. It has had the privilege of hosting distinguished guests such as Gabrielle Claiborne, Co-Founder and CEO of Transformation Journeys Worldwide, who has shared invaluable insights on the unique challenges the trans community faces in retirement planning. The podcast has also featured Katie Leikam, a licensed therapist, who has underscored the importance of living wills and estate plans for the LGBTQ+ community. These unique and insightful perspectives testify to the podcast's importance and relevance. Matt reiterates in every episode that the Take Pride in Retirement Podcast remains steadfast in its mission that everyone, regardless of their background, identity, or who they love, deserves a retirement they can be proud of. This commitment to diversity and inclusivity is at the heart of our podcast. It is a testament to our dedication to ensuring that all voices are heard, and all needs are met, making our audience feel valued and included. “The Retirement.Radio team is deeply committed to amplifying these crucial conversations on our radio shows and affiliated podcasts,” said Sam Davis, executive producer for Retirement.Radio. “Our unwavering mission is to provide essential information, ensuring that every senior citizen and retiree, regardless of their background or identity, has the information they need to navigate retirement confidently and clearly. This recognition by FeedSpot is a testament to our dedication to inclusivity and our ongoing efforts to serve all communities.” FeedSpot’s ranking of the Best Pride Podcasts results from a rigorous evaluation considering podcast popularity, content quality, update frequency, and audience engagement. This recognition places the Take Pride in Retirement podcast in an exclusive league of content creators leading the way in celebrating and advocating for LGBTQ+ rights and stories. Other podcasts are available through the Retirement.Radio Network, including the Peak Financial Freedom Hour, Retirement Results, Guaranteeing Your Retirement, and the Federal Retirement Show. For more information, visit TakePrideInRetirement.com and subscribe to the show wherever you listen to podcast. ### About Take Pride in Retirement Take Pride in Retirement is Retirement.Radio podcast dedicated to retirement planning solutions for the LGBTQ community. During uncertain economic times, the safety of your principal is critical to planning a successful retirement. Our goal is to help educate you about ways to protect your hard-earned money while experiencing market-like growth at the same time. LGBTQ people face unique challenges when planning for their retirement future. Everyone's situation differs from legal barriers to a potential lack of family support. Tune in each week as we explore these obstacles and give you tips on overcoming them so you can get on the road to success. For more information, visit TakePrideInRetirement.com and subscribe to the show wherever you listen to podcasts. About Retirement.Radio Retirement.Radio is dedicated to providing essential retirement planning information to listeners across the United States. Our licensed financial professionals and insurance agents host weekly radio shows and podcasts, offering expert advice on various topics, including smart tax planning, retirement income strategies, and health care planning. Retirement.Radio is powered by national insurance distribution and marketing leader AmeriLife and features wide-reaching and impactful broadcasts. Our commitment is to help listeners invest wisely, plan effectively, and achieve successful retirement outcomes. Contact Details Retirement.Radio Sam Davis sdavis@amerilife.com Company Website https://retirement.radio/

June 26, 2024 11:00 AM Eastern Daylight Time

DentalPlans.com: Empowering Families To Live Healthier Lives Through Affordable And Flexible Dental Savings Plans

DentalPlans.com

By Mangeet Kaur Bouns, Benzinga Oral health plays a vital role in our daily lives, impacting our ability to speak, smile and eat comfortably. Maintaining good dental hygiene not only enhances our appearance and self-esteem but also significantly influences overall well-being. Research has linked poor oral health to serious health issues such as heart disease, respiratory infections, stroke, diabetes and certain cancers. Finding affordable dental care is crucial for families. Traditional insurance has long been the standard, but dental savings plans are a flexible, cost-effective alternative. DentalPlans.com, a leader in dental savings plans, has transformed access to dental care in the U.S. over the past 25 years, making it easier for families to access affordable dental care without sacrificing quality. Understanding The Differences: Traditional Insurance Vs. Dental Savings Plans Traditional dental insurance typically involves paying monthly premiums in exchange for coverage that includes a percentage of costs for various services. These plans often come with annual spending caps, deductibles and waiting periods, which can limit immediate access to certain treatments. Additionally, there may be exclusions for pre-existing conditions and network restrictions that confine patients to a specific group of providers. In contrast, the dental savings plans available on DentalPlans.com do away with these limitations. By offering membership-based access to discounted rates from a vast network of over 140,000 dentists and specialists, these plans provide substantial savings without deductibles or annual limits. Plan members can receive care for existing dental conditions and enjoy flexibility in choosing their providers nationwide. Simply show your membership card at the dentist to receive savings. No Limits, No Restrictions: A Key Advantage One of traditional insurance's most significant drawbacks is the cap on coverage. Annual limits for a PPO plan are typically between $1,000 and $1,500 and can be quickly exhausted, especially when you need major dental procedures like root canals or crowns, which can cost between $750 and $2,000 per tooth. Once these limits are reached, patients must cover the remaining costs out-of-pocket while continuing to pay their insurance premiums. The dental savings plans on DentalPlans.com eliminate these restrictions, allowing plan members to access necessary dental care without worrying about annual limits. This includes treatments for existing dental conditions. Families can see as many participating providers as needed–for any number of reasons – including virtually all treatments, from cleanings to braces to root canals and dental implants. Extensive Network With Flexibility And Inclusivity The dental savings plans on DentalPlans.com are accepted by over 140,000 dentists and specialists nationwide, including pediatric dentists, orthodontists and endodontists, so choosing a dental savings plan doesn’t sacrifice network size. This broad network ensures that all family dental needs are met. The company offers more than 25 dental plans from top healthcare brands like Cigna, Aetna, Careington, United Concordia and Dentegra, ensuring your family will find a plan that fits its needs and budget. Dental savings plans also provide the flexibility to switch plans. Whether your family needs preventive care, braces for a child, or a root canal for an adult, DentalPlans.com allows for a seamless transition between plans, maximizing savings and maintaining continuous care. Ease Of Use And Significant Savings DentalPlans.com simplifies getting dental care with dental savings plans, which are easy to use and activate quickly (within 1-3 business days of signup). There is no paperwork to navigate and plan members can immediately save with reduced rates at the time of treatment. This straightforward approach not only saves time but also provides peace of mind when it comes to managing dental expenses. Dental savings plan members report saving an average of 50%* on their dental care, highlighting the cost-effectiveness of dental savings plans. Whether you're traveling and need to visit a dentist or simply require regular dental services, DentalPlans.com ensures continuous, affordable care. DentalPlans.com Leads The Way In Providing Quality, Affordable Dental Care For Families While traditional dental insurance has its benefits, the dental savings plans from DentalPlans.com offer a compelling alternative or complement with distinct advantages, such as no annual limits, no restrictions on existing dental conditions, an extensive network of providers, flexibility, ease of use and significant savings. The company's innovative and customer-focused approach continues to drive it toward achieving dental care equality, ensuring that everyone has the opportunity to access high-quality dental services. As DentalPlans.com celebrates its 25th anniversary, its commitment to making dental care accessible and affordable for everyone remains unwavering. Visit DentalPlans.com to learn more about dental savings plans and see how much you can save today. Featured photo by MonkeyBusinessImages at Shutterstock DentalPlans.com, founded in 1999, is a leading online marketplace for dental savings plans in the U.S., helping more than a million people to affordably access quality healthcare services. Our mission is to empower consumers with the tools, information, and services that they need to live happier, healthier lives. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. *Discount Health Program consumer & provider surveys indicate average savings of 50%. Savings may vary by provider, location and plan. Sample savings are based on zip code 43614, actual costs and savings may vary service and geographical area. Contact Details Matthew Wong matthew.wong@wpromote.com Company Website https://www.dentalplans.com/

June 26, 2024 08:45 AM Eastern Daylight Time

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BenevolentAI and AstraZeneca collaborate on new lupus target

BenevolentAI

BenevolentAI chief scientific officer Dr Anne Phelan speaks to Proactive's Stephen Gunnion about the addition of a novel systemic lupus erythematosus (SLE) target to AstraZeneca's discovery portfolio. Phelan discussed the collaboration between BenevolentAI and AstraZeneca, which began in 2019 focusing on idiopathic pulmonary fibrosis and chronic kidney disease and later expanded to include heart failure and lupus. She highlighted the benefits of this collaboration, stating, "We can really leverage the power of the interconnectivity of the data foundations to pull through potential target hypotheses irrespective of the disease." Phelan explained how BenevolentAI's data-driven approach, combined with AstraZeneca's disease expertise, facilitates the identification and validation of new therapeutic targets. She also provided insights into lupus, describing it as a debilitating autoimmune disease where the body's immune system attacks its own tissues, leading to chronic fatigue and damage to vital organs. The BenevolentAI platform's ability to handle complex data and generate explainable hypotheses is pivotal in identifying new therapeutic targets for such complex diseases. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

June 26, 2024 08:01 AM Eastern Daylight Time

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atai Life Sciences co-CEO says initial results from ELE-101 show promise in treating depression

atai Life Sciences

Atai Life Sciences co-founder and co-CEO Florian Brand discussed initial results from Beckley Psytech’s phase 1 trial of its patent-protected psilocin ELE-101 in patients with major depressive disorder. Brand explained that ELE-101 is an intravenous (IV) formulation of psilocin, the active metabolite of psilocybin, developed for depression treatment. The IV formulation aims to reduce treatment duration to two hours, compared to the longer sessions required by traditional psilocybin and LSD treatments. Phase one trials in healthy participants showed that ELE-101 was well tolerated with no serious safety concerns and had a predictable pharmacokinetic profile, supporting dose selection for phase two trials. Brand highlighted the commencement of phase 2 trials with the first patient already dosed. This study involves 6 to 12 patients, with data expected in the second half of this year. atai Life Sciences is optimistic about the shorter treatment duration, potentially making it more convenient for patients and less burdensome for the healthcare system. Additionally, Brand mentioned their involvement with Compass Pathways, which is developing psilocybin therapy, and noted the importance of the two-hour treatment paradigm established by the intranasal esketamine spray, Spravato. This paradigm could be leveraged for their other compounds, such as BPL-003 and DMT, also being developed for depression treatment. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

June 26, 2024 06:09 AM Eastern Daylight Time

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