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NAVEX Enhances Communication with AI-Driven Translations

NAVEX Global

NAVEX, the leader in integrated risk and compliance management software, announces the launch of a new NAVEX One platform shared service: dynamic machine translations. This first-to-market addition in the governance, risk and compliance (GRC) space will empower organizations operating across different countries to overcome language barriers, enabling accurate risk and compliance-related communication between employees, third parties and program administrators. NAVEX understands the challenges organizations face in maintaining accurate communication when dealing with sensitive data arising from risk and compliance tasks. Many organizations struggle with language barriers, hindering effective collaboration. With varying language skills among responders, the potential for misunderstandings and misinterpretations can be detrimental to decision-making and compliance efforts – especially in time-sensitive cases. "NAVEX is pioneering the future of machine translations within the GRC space, directly tackling the complexities of multilingual communication," stated A.G. Lambert, chief product officer at NAVEX. "The integration of secure machine translation into NAVEX One makes it simple for GRC professionals to translate disclosures, assessments, and responses, leading to better communication and faster resolution." The introduction of dynamic machine translations addresses these issues and improves communication efficiency. With advanced artificial intelligence technology, this shared service allows end users to translate directly from the NAVEX One user interface. How machine translations work In the past, administrators encountered the repetitive task of manually copying text, relying on external translation tools, and then painstakingly inputting the translations to proceed with their workflow. However, with the introduction of the machine translations shared service built on Amazon Web Services (AWS), administrators are now equipped to address important matters promptly and efficiently, leading to quicker resolution rates. Moreover, administrators can assess third-party entities proficiently, regardless of the languages they speak or the answers they provide. The user-friendly NAVEX One interface makes translating disclosures, evaluations, and responses easy, promoting smooth communication and understanding. "By relying on the broadest and deepest set of cloud services on AWS, including Amazon Translate, NAVEX is able to use machine translations within the governance, risk and compliance space, directly tackling the complexities of multilingual communication,” stated Venky Nagapudi, Senior Product Management Leader, Amazon Translate, AWS. “The work between NAVEX and AWS makes it easy to translate disclosures, assessments, and responses, leading to better communication and faster resolution." Key benefits of NAVEX One machine translations include: Multilingual support: The system supports 75 languages, facilitating seamless communication with stakeholders worldwide. Accurate and reliable: Powered by advanced neural network technology, the feature ensures precise translation of critical information. Streamlined workflow: The translation functionality integrates seamlessly into existing GRC workflows, saving time and effort for administrators and responders. Cost-effective translations: Organizations can deliver faster results and decrease operational costs by reducing the need for external translation services. Data privacy: Advanced technical and physical measures, including encryption at rest and in transit, are used to prevent unauthorized access or sharing of content. Incorporating a dynamic machine translation service highlights NAVEX's continued commitment to fostering innovative solutions throughout the NAVEX One platform. By seamlessly integrating artificial intelligence and machine learning capabilities, NAVEX continues to empower companies to overcome language obstacles, promoting cross-cultural teamwork and elevating the effectiveness of GRC processes. As NAVEX continues to leverage AI and ML, it cements its position as a leader in cutting-edge technology within the GRC space. The NAVEX One GRC – Information System Multilingual Machine Translation marks a bold stride in NAVEX’s innovative journey following the recent launch of the NAVEX Compliance Assistant. NAVEX's unwavering commitment to AI/ML innovation propels the governance, risk, and compliance landscape into a new era. By harnessing the power of AI, NAVEX is reshaping the compliance landscape, streamlining intricate processes, and automating tasks. This first-to-market shared service accelerates and enhances compliance initiatives while fostering clarity across your organization. Navigate the future of compliance with your AI-powered ally, simplifying employee compliance in ways that redefine ease and efficiency. For more information, visit the NAVEX One Platform. And read our blog. NAVEX is trusted by thousands of customers worldwide to help them achieve the business outcomes that matter most. As the global leader in integrated risk and compliance management software and services, we deliver solutions through the NAVEX One platform, the industry’s most comprehensive governance, risk and compliance (GRC) information system. For more information, visit NAVEX.com and our blog. Follow us on Twitter and LinkedIn. Contact Details Scott Levesque +1 617-388-5773 scott.levesque@navex.com Company Website https://www.navex.com

August 22, 2023 08:00 AM Eastern Daylight Time

News Release

Cybin Inc protects IP with granting of 2nd US Patent for its deuterated analog programs

Cybin Inc.

Cybin Inc CEO Doug Drysdale joined Steve Darling from Proactive to share news the US Patent and Trademark Office has granted another patent to a deuterated psilocybin analog within the company's CYB003 investigational drug program. This patent is expected to provide exclusivity until 2041 and encompasses composition of matter claims for deuterated tryptamines. These claims support various programs within Cybin, including CYB003, a deuterated psilocybin analog, and CYB004, a deuterated dimethyltryptamine. The patent also covers methods of treating major depressive disorder and treatment-resistant depression. Drysdale explained that CYB003 is a proprietary deuterated psilocybin analog developed for the potential treatment of major depressive disorder. The deuterated structure of CYB003 aims to optimize its therapeutic profile, including rapid onset of effect, shorter treatment duration, and efficacy at lower doses. Currently, CYB003 is undergoing Phase 2 clinical trials involving participants with moderate to severe MDD. Additionally, Drysdale mentioned CYB004, an investigational deuterated dimethyltryptamine program targeted for the potential treatment of Generalized Anxiety Disorder. This program is in Phase 1, with dosing underway as part of the CYB004-E clinical trial evaluating intravenous DMT and CYB004 in healthy volunteers. Cybin Inc anticipates releasing topline Phase 2 efficacy data for CYB003 in MDD and Phase 1 data from the CYB004-E study in the third or fourth quarter of 2023. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 21, 2023 01:40 PM Eastern Daylight Time

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News Release

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Coya Therapeutics

Coya Therapeutics CEO Dr Howard Berman joined Steve Darling from Proactive to share news regarding the company's recent financial results and developments. Notably, Coya Therapeutics presented positive outcomes from a proof-of-concept clinical study involving low-dose interleukin-2 (ld IL-2) in patients with Amyotrophic Lateral Sclerosis (ALS) during the second quarter. The study revealed several encouraging findings, including enhanced Treg (T-regulatory cell) function during treatment, a halt in disease progression at the 24-week mark, and minimal decline at 48 weeks. Additionally, the treatment appeared to be well-tolerated by the patients. These promising results were presented at the 2023 Muscular Dystrophy Association Conference. Coya Therapeutics also shared the results from an open-label clinical study involving ld IL-2 in patients with mild to moderate Alzheimer's Disease. During the four-month treatment period, the therapy enhanced Treg function and numbers, showed good tolerability, and resulted in a statistically significant improvement in mean MMSE scores compared to baseline. These findings are significant for potential Alzheimer's Disease treatments. Dr Berman expressed the company's belief in the potential of their proof-of-concept clinical data and revealed plans for a pre-IND (Investigational New Drug) meeting with the FDA in the upcoming fall of 2023. The company aims to have its IND application for a phase 2 trial accepted by the FDA in early 2023, with the optimism of commencing the trial soon after acceptance. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 21, 2023 01:31 PM Eastern Daylight Time

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News Release

Tonix Pharmaceuticals begins Phase 1 trial of TNX-1500 in healthy participants

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr Seth Lederman joined Steve Darling from Proactive to announce the company has initiated a Phase 1 clinical study involving TNX-1500 in healthy volunteers, focusing on single ascending dose escalation. The primary objectives of this study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous TNX-1500. TNX-1500 is a pharmaceutical product under development for the prevention of kidney transplant rejection, as well as other potential indications related to transplantation and autoimmune disorders. Lederman highlighted that recent animal studies have shown promising results, indicating that TNX-1500 has the potential to prevent organ rejection and maintain graft function, either as a standalone treatment or when combined with other drugs. The Phase 1 study will involve the evaluation of eligible participants over a 120-day period after dosing, with a target enrollment of 36 participants. The initiation of this Phase 1 study is a crucial step towards supporting the dosing regimen for an upcoming Phase 2 trial involving kidney transplant recipients. Tonix Pharmaceuticals is optimistic about TNX-1500's potential to improve long-term graft survival with reduced toxicity compared to current immunosuppressive treatments. Additionally, the company believes that TNX-1500 could address various indications, including autoimmune diseases beyond transplantation. Contact Details Proactive Studio +1 604-688-8158 na-editorial@proactiveinvestors.com

August 21, 2023 01:18 PM Eastern Daylight Time

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Immunic CEO hails "great day" after completing IMU-838 phase 2 trial enrolment

Immunic Inc

Immunic Inc (NASDAQ:IMUX) President and CEO Dr Daniel Vitt speaks to Thomas Warner from Proactive after the biotechnology company announced the completion of the enrolment of its phase 2 CALLIPER trial of lead asset vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS). Dr Vitt explains that 467 patients have been enrolled across various sub-indications including primary progressive, secondary active, and non-active secondary progressive MS. He calls it a "great day for the programme." The trial aims to assess the efficacy of IMU-838 and Dr. Vitt highlights the focus on biomarkers, particularly the neurofilament light chain (NFL), a protein indicative of active disease. Anticipated next steps include an interim analysis set for release this fall, which will examine biomarker benefits for different sub-indications. Dr. Vitt also reflects on what he considers a successful 2023 so far, with positive data emerging from Immunic's colitis maintenance and IMU-856 celiac disease programs. Contact Details Proactive United States +1 347-449-0879 action@proactiveinvestors.com

August 21, 2023 08:00 AM Eastern Daylight Time

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PathAI Announces Commercial Availability of AISight™ Digital Pathology Image Management System to Power the Next Generation of Pathology Labs

PathAI

PathAI, a global leader in AI-powered pathology, today announced the commercial launch of its AISight TM digital pathology image management system (IMS) for anatomic pathology laboratories. 1 The launch comes at a time when the pathology space is increasingly transitioning to digitally-enabled reads and recognizing the utility of AI and machine learning to enhance quality control, standardize diagnoses, and quantitate biomarkers. AISight is a cloud-based platform that enables efficient, end-to-end digital pathology workflows. AISight provides best-in-class image and case management, ingestion, and viewing while seamlessly enabling access and deployment of AI applications. AISight can also be integrated bidirectionally with laboratory information systems for streamlined workflow adoption. Anatomic pathology laboratories of all sizes and specialties – including health systems, reference laboratories, independent pathology labs, and academic medical centers – may utilize AISight. 1 “We are thrilled to make the AISight Image Management System available to labs globally. We’ve been honing this platform with input from hundreds of pathologists from dozens of institutions, and this launch underpins all of the work PathAI does to support pathologists, biopharma partners, and the academic research community,” said Dr. Andy Beck, M.D. Ph.D., chief executive officer and co-founder of PathAI. “Expanding the feature set to support pathology workflows as an IMS for anatomic pathologist laboratories is a natural progression for PathAI as we strive to meet our mission of improving patient outcomes with AI-powered pathology.” This announcement builds on prior progress as PathAI’s solutions increasingly support digital pathology workflows. In March of this year, PathAI announced the Early Access Program for AISight, and the 12 leading anatomic pathology laboratories that began trialing the platform. Subsequently, PathAI announced the availability of its first 5 algorithm products through the platform including AIM-PD-L1 algorithms across 4 indications, and the AIM-HER2 Breast Cancer algorithm. 2 In addition to AISight for research use, PathAI also has a regulated platform, AISight™ Dx, that has 510(k) clearance for primary digital diagnosis in the US and is CE-marked in the EU. “We have been overwhelmed with the positive feedback from pathologists, lab directors, operators, and administrators who have trialed AISight and we’re excited to make it available at scale,” said Eric Walk, M.D., F.C.A.P., chief medical officer at PathAI. “AISight provides a one-stop shop for digital pathology case management that is flexible for multiple use cases given its interoperability and configurability. We will continue iterating on new and improved features as we listen to our users and release updates as they become available.” To learn more about AISight IMS, register for our upcoming webinar, visit our website, or meet with our team at upcoming conferences including ECP, CAP, and PathVisions. 1 AISight™ is for research use only. Not for clinical use in diagnostic procedures. 2 AIM-PD-L1™ and AIM-HER2™are research use only. Not for clinical use in diagnostic procedures. 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 diagnostic 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 patient 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/

August 17, 2023 10:00 AM Eastern Daylight Time

G MEDICAL INNOVATIONS WILL PROVIDE SERVICES TO VETERANS AND MILITARY PERSONNEL BY PARTNERING WITH RESILIENT SUPPORT SERVICES

G-Medical Innovations Holdings Ltd

Rehovot, Israel, August 17 th, 2023 – G Medical Innovations Holdings Ltd. (Nasdaq: GMVD) (“G Medical Innovations”), an industry innovator in comprehensive remote patient monitoring solutions, today announced that its wholly-owned subsidiary, G Medical Innovations USA, Inc., has entered into an agreement with Resilient Support Services Inc. (“RSS”) to expand the health care and remote patient monitoring capabilities to U.S. veterans and military personnel. RSS is a Service-Disabled Veteran-Owned Business that partners with U.S. federal agencies and private sector businesses that are concerned with improving the medical care of veterans and the military community. G Medical Innovations’ innovative technology will help federal agencies and military personnel to better monitor and diagnose new onset cardiovascular symptoms as part of a growing need in virtual care. This will allow full access to near real-time patient information which will also be analyzed by certified cardiac monitoring technicians through G Medical Innovations’ own independent diagnostic testing facility. Available to both adult and pediatric patients, this cloud-based monitoring system includes a small, water-resistant monitor that patients will receive by mail or in person. Patient’s symptoms can then be monitored in near real-time from the comfort of their home. Those who experience unusual arrhythmias or other monitored symptoms receive immediate communication from providers, enabling greater access to care and, in some cases, earlier diagnoses of serious medical conditions. The use of the G Medical Prizma device will allow for state-of-the-art remote patient monitoring (RPM) in the comfort of their home. This care experience platform ensures that patients remain connected with their care teams through next-generation devices to improve clinical decision-making. The patients will be able to download the G Medical app and receive a digital health kit to measure biometric data in one single device. “We are excited to have G Medical Innovations provide their powerful technology and 31 test kits to those serving our country in veteran affairs and all military branches here and abroad. Innovations like this will help protect and improve the care of our veterans and military serving soldiers, now and into the future,” explained Robert Domenici, Lieutenant Colonel (USA Ret.) President and CEO, RSS Inc. “We are delighted to say that we could not find a better partner to serve veterans affairs and all military branches than RSS Inc. G Medical is committed to providing the highest level of care and service to our veterans and military personnel,” said Dr. Yacov Geva, Chief Executive Officer and Founder of G Medical Innovations. About G Medical Innovations G Medical Innovations is a healthcare company engaged in the development of next generation mHealth and telemedicine solutions and monitoring service platforms. The Company’s solutions and services can empower consumers, patients, and providers to better monitor, manage and improve clinical and personal health outcomes, especially for those who suffer from cardiovascular disease, pulmonary disease, and diabetes. The Company’s current product lines consist of its Prizma medical device, a clinical-grade device that can transform almost any smartphone into a medical monitoring device, enabling both healthcare providers and individuals to monitor, manage and share a wide range of vital signs and biometric indicators; its Extended Holter and Monitoring Cardiac Telemetry Patch services, utilizing multi-channel patient-worn biosensors with algorithms, to generate real time analysis and transmission that captures electrocardiography data continuously, including QT syndrome prolongation detection. In addition, the Company is developing its wireless vital signs monitoring system, which is expected to provide full, continuous, and real-time monitoring of a wide range of vital signs and biometrics. Its monitoring services include provision of independent diagnostic testing facility monitoring services and private monitoring services. For more information about G Medical innovations, visit https://gmedinnovations.com/. About Resilient Support Services Resilient Support Services Inc. (RSS Inc.) is an experienced multi-faceted certified service-disabled veteran-owned business providing strategic advisory services to companies looking to navigate, identify and capitalize on the vast procurement complexities and opportunities within the federal, state, local government and the commercial sectors. The company has a wide-array of health/safety, defense, industrial supply and construction products and service offerings available to its government and commercial clients within the US and abroad. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, G Medical Innovations is using forward-looking statements when it discusses the services and products to be provided by the Company to Resilient Support Services Inc and the potential benefits of G Medical Innovations’ technology and specifically the G Medical Prizma device to end users. Because such statements deal with future events and are based on the Company’s current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of G Medical Innovations could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in G Medical’s Innovations Annual Report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on May 16, 2023, and our other filings with the SEC, which are available on the SEC’s website, www.sec.gov. Except as otherwise required by law, G Medical Innovations 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. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Investor Relations Contact G Medical Innovations service@gmedinnovations.com G Medical Innovations Holdings Ltd. is a health care company engaged in the development of next generation mHealth and telemedicine solutions and monitoring service platforms. The Company’s solutions and services can empower consumers, patients, and providers to better monitor, manage and improve clinical and personal health outcomes, especially for those who suffer from cardiovascular disease, pulmonary disease, and diabetes. The Company’s current product lines consist of its Prizma medical device, a clinical-grade device that can transform almost any smartphone into a medical monitoring device, enabling both health care providers and individuals to monitor, manage and share a wide range of vital signs and biometric indicators; its Extended Holter and Monitoring Cardiac Telemetry Patch services, utilizing multi-channel patient-worn biosensors with algorithms, to generate real time analysis and transmission that captures electrocardiography data continuously, including QT syndrome prolongation detection. In addition, the Company is developing its wireless vital signs monitoring system, which is expected to provide full, continuous, and real-time monitoring of a wide range of vital signs and biometrics. Its monitoring services include provision of independent diagnostic testing facility monitoring services and private monitoring services. This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, G Medical Innovations is using forward-looking statements when it discusses: revenue growth and profitability in future periods; the launch of the Company’s CLIA lab in Austin, TX, the Company’s online store for its Prizma Monitoring Devices on Amazon Marketplace and the Company’s HTKs business and online stores; potential announcements with large homecare service companies and large distributors for devices and At Home Test Kits; and the Company’s plans to expand its line of monitoring products and services offered to patients, hospitals and clinics. Because such statements deal with future events and are based on the Company’s current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of G Medical Innovations could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties,, including those discussed under the heading “Risk Factors” in G Medical’s Innovations Annual Report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on May 16, 2023, and our other filings with the SEC, which are available on the SEC’s website, www.sec.gov. Except as otherwise required by law, G Medical Innovations 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. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Contact Details G Medical Innovations G Medical Innovations +972 8-958-4777 service@gmedinnovations.com Company Website https://gmedinnovations.com

August 17, 2023 06:00 AM Eastern Daylight Time

The Mothers’ Milk Bank Welcomes New CEO to Advance the Organization’s Mission to Enhance the Availability and Use of Safe Donor Human Milk for All Babies

Mothers' Milk Bank

The Mothers’ Milk Bank (MMB ), a California-based nonprofit and a leading provider of certified, safe, pasteurized donor human milk to all babies, today announced the appointment of Jennifer Benito-Kowalski as the organization's new Chief Executive Officer. With extensive experience in the nonprofit sector and a genuine passion for the organization's mission, Benito-Kowalski brings a wealth of knowledge and leadership to MMB. As the CEO, Benito-Kowalski will work to expand awareness and bolster support for MMB's mission within the postnatal community and beyond, as the organization prepares to mark its 50th anniversary in 2024. Founded in 1974, Mothers’ Milk Bank is the oldest nonprofit operating milk bank in North America, serving the state of California and other states in the U.S., including Hawaii and Alaska. The Milk Bank distributes safe donor human milk to more than 80% of California's NICUs and other hospitals. The Milk bank is a charter member of the Human Milk Banking Association of North America (HMBANA). Milk banks affiliated with HMBANA are certified safe and have a substantial legacy of meeting the needs of all vulnerable babies. The Milk Bank distributes more than 900,000 ounces of human milk to hospitals and outpatient families across the U.S. "I am both honored and excited to join Mothers’ Milk Bank as CEO," said Benito-Kowalski. "This organization has an incredible legacy of providing life-saving nutrition to infants and supporting families during their most vulnerable moments. I am committed to building upon this strong foundation and working collaboratively with MMB’s dedicated team to expand our reach, deepen our impact, and ensure that every baby has access to the vital nutrition they need to thrive." The Board of Directors of the Mother’s Milk Bank selected Benito-Kowalski from a broad field of candidates to lead the organization into a new era of growth and innovation. With her visionary leadership and passion for making a difference, Benito-Kowalski will address the organization’s strategic goals, which include increasing donor outreach and expanding community partnerships to serve more babies and their families. "We are thrilled to welcome Jennifer Benito-Kowalski as our new CEO," said Katie Anderson, chair of the MMB Board of Directors "Jennifer’s extensive experience, passion, and proven leadership make her the ideal candidate to bring MMB to the next level. Under her direction, we are poised for a promising future providing more life-saving nutrition to infants and supporting families to thrive." For more information about Mother’s Milk Bank, its services, or how to support its mission, please visit MothersMilk.org About The Mothers’ Milk Bank The Mothers’ Milk Bank is a leading nonprofit organization based in San Jose, California, dedicated to providing certified, donated human milk to all babies. The organization collects, pasteurizes, and distributes safe human milk to hospitals and families in need, ensuring that infants receive the essential nutrition required for optimal health and development. With a commitment to improving the lives of babies, Mothers’ Milk Bank plays a vital role in supporting families and advancing neonatal care across California and beyond. Contact Details Mothers' Milk Bank Angelica Rojas +1 831-800-5358 angelica.rojas@mothersmilk.org Company Website https://www.mothersmilk.org

August 16, 2023 11:00 AM Pacific Daylight Time

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Tiziana Life Sciences gets FDA green light to investigate potential Alzheimer's treatment

Tiziana Life Sciences PLC

Tiziana Life Sciences Ltd (NASDAQ:TLSA) chief medical officer and chief operating officer Matthew Davis speaks to Thomas Warner from Proactive after announcing that Tiziana has received FDA clearance to investigate Foralumab as a potential treatment for Alzheimer's disease. Davis says that the news marks a significant milestone for both the company and for Alzheimer's treatment at large, going on to say that the drug will be assessed for efficacy in patients with existing FDA approvals and as a standalone therapy for mild to moderate Alzheimer's cases. The green light from the FDA comes after extensive groundwork, building on the success of Tiziana's work in multiple sclerosis. Davis highlights the wealth of patient safety data and preclinical evidence that bolstered the FDA's decision. Promising preclinical models indicated behavioural improvements in test animals. With the regulatory hurdle crossed, clinical trials are set to commence in collaboration with Brigham and Women's Hospital. Davis acknowledges the vast potential of the Alzheimer's market, which remains underserved. He emphasises the unique approach of Foralumab as the only fully human anti-CD3, which sets it apart from existing treatments. While precise timelines haven't been disclosed, Davis anticipates concrete developments within the next two quarters. He also assures audiences of Tiziana's continued commitment to multiple sclerosis research, with an investigator meeting and dosing of the first patient anticipated by year-end. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 15, 2023 09:28 AM Eastern Daylight Time

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Healthcare

NAVEX Enhances Communication with AI-Driven Translations

Cybin Inc protects IP with granting of 2nd US Patent for its deuterated analog programs

Headline

Tonix Pharmaceuticals begins Phase 1 trial of TNX-1500 in healthy participants

Immunic CEO hails "great day" after completing IMU-838 phase 2 trial enrolment

PathAI Announces Commercial Availability of AISight™ Digital Pathology Image Management System to Power the Next Generation of Pathology Labs

G MEDICAL INNOVATIONS WILL PROVIDE SERVICES TO VETERANS AND MILITARY PERSONNEL BY PARTNERING WITH RESILIENT SUPPORT SERVICES

The Mothers’ Milk Bank Welcomes New CEO to Advance the Organization’s Mission to Enhance the Availability and Use of Safe Donor Human Milk for All Babies

Tiziana Life Sciences gets FDA green light to investigate potential Alzheimer's treatment