News Hub | News Direct

Healthcare

Addiction Biotech Cannabis Genetics Healthcare Medical Devices Pharmaceutical Science Veterinary
Article thumbnail 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

Video
Article thumbnail News Release

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

Video
Article thumbnail News Release

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

Article thumbnail News Release

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

Article thumbnail News Release

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

Video
Article thumbnail News Release

Roquefort Therapeutics seeks to lock in future value with anti-cancer therapeutic patents

Roquefort Therapeutics PLC

Roquefort Therapeutics PLC (LSE:ROQ, OTCQB:ROQAF) chief executive Ajan Reginald speaks to Thomas Warner from Proactive after announcing the successful filing of a global patent for its anti-cancer therapeutics. Once approved, the international phase PCT (patent treaty cooperation) patent would cover the invention of Roquefort’s RNA oligonucleotide and mRNA therapeutics in over 155 countries, the company said in a statement. Reginald highlights the significant strides made recently by the likes of Moderna, BioNTech, and Merck in employing mRNA effectively against cancer. Roquefort's own promising results were unveiled in June, demonstrating what Reginald calls the cancer-killing potential of their mRNA and RNA oligonucleotide therapies for breast and liver cancers. The global patent covers their proprietary composition, securing their position in a competitive landscape. Reginald emphasises the importance of capturing value through patents, with a view to making the company's offerings enticing for potential partnerships or acquisitions. He explains that "by patenting [the treatments] we're making sure we own that future potential once its realised." Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 15, 2023 09:03 AM Eastern Daylight Time

Video
Article thumbnail News Release

MGC Pharmaceuticals to "move forward and speak to the FDA"

MGC Pharmaceuticals Ltd

MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) CEO and managing director Roby Zomer speaks to Thomas Warner from Proactive after the Europe-based plant-inspired medicine company announced the successful completion of a Pre-clinical Chronic Toxicology Evaluation of its immuno-modulation treatment CimetrA. The study was undertaken on 32 domestic swine, that received a study treatment (three dosages groups of CimetrA® and Placebo) for 14 days. Zomer describes the positive results from the trial as the "final piece of the puzzle" and says that MGC can now "move forward and speak to the FDA" about getting the treatment approved. The CEO expresses optimism that the alignment of safety and efficacy results will facilitate a smooth interaction with the FDA and says he hopes to file in early 2024. Zomer says that the results from the trial mean that "we have a quite straightforward line to speak to the FDA, and take [CimetrA] to the big league and get it approved in America. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 15, 2023 03:37 AM Eastern Daylight Time

Video
Article thumbnail News Release

A Leap in Ionization Prediction: ACD/Labs Unveils Groundbreaking Version of Modeling Software at ACS Fall 2023

ACD/Labs

Version 2023 of the Classic pK a calculator in Percepta® includes a significantly expanded training set for improved prediction accuracy, broader chemical applicability; and algorithmic changes that deliver impressive speed enhancements to this industry-leading software. 26 years after the release of their first ionization predictor, ACD/Labs, an informatics company that develops and commercializes software in support of R&D, today announces the release of their latest version of molecular property calculators on the Percepta Platform. Andrew Anderson, Vice President of Innovation and Informatics Strategy at ACD/Labs says, “Metaphorically speaking, data is the 'heartbeat' of chemistry R&D, generated during either physical experimentation or in silico calculation. In an age where research groups are looking to harness the power of data in artificial intelligence and machine learning frameworks, prediction reliability is one of the most important success determinants. Our new version of Percepta pK a exemplifies our commitment to enabling reliable, data-driven R&D. Many molecules under investigation in R&D labs are susceptible to ionization. Knowing 'when and where' is of paramount importance since the same chemical might behave differently under different conditions. Reliable and accurate predictions not only help computational scientists develop accurate SAR models; these predictions also help scientists account for the ionization properties of molecules during their 'design, make, test' cycles. Finally, accurate descriptor prediction will empower data scientists with reliable insights for the 'next crop' of ground-breaking innovation activity. We're proud to support our large user community with this important new release.” Ionization—frequently expressed as the acid dissociation constant for molecules with ionizable centers, or pK a —is a fundamental property that affects the behavior of chemical compounds in environmental, pharmaceutical, agrochemical, and other fields. It plays a crucial role in defining other properties like lipophilicity (log D ), aqueous solubility, toxicity (hERG), and helps with understanding the chemical reactivity of molecular entities. In biopharma, it is used to model more complex ADME behaviors such as absorption, bioavailability, and clearance, and to develop delivery systems and formulations for new drug entities. pK a values are used by researchers to understand and modulate the behavior of molecules in biological and environmental systems, and to successfully apply separation technology such as chromatography. Furthermore, predictive software is an integral part of green chemistry initiatives and sustainable practices, providing a reliable alternative to physical experiments. “This new release is a shining example of our continued commitment to excellence,” said Andrius Sazonovas, Head of Percepta Software Development at ACD/Labs. “Since the introduction of our first ionization predictor in 1997; my colleagues and I have overseen the improvements to our computational software and have worked on numerous customer projects to apply our modeling methodology to proprietary datasets at innovative chemistry-driven organizations. In our tests of Percepta version 2023, we saw a 5–10 fold increase in the speed of calculation of pK a for various datasets. Significant improvement was also observed for prediction accuracy. While this varies for different datasets, 120% improvement was noted for a set of ~370 novel pharmaceutical compounds with ~600 pK a values in a recent collaborative project. This release truly represents the next generation of pK a prediction from ACD/Labs, with respect to performance, reliability, and speed.” For more information about in silico predictions available from ACD/Labs, meet our team at Booth 933 in the ACS exhibition hall or visit acdlabs.com/percepta. ACD/Labs is a leading provider of scientific software for R&D. We help customers in >94 countries around the world assemble digitized analytical, structural, and molecular information for effective decision-making, problem solving, and product lifecycle control. Our enterprise technologies enable automation of molecular characterization and facilitate chemically intelligent knowledge management. ACD/Labs provides worldwide sales and support and brings decades of experience and success helping organizations innovate and create efficiencies in their workflows. For more information, please visit www.acdlabs.com. Follow us on Twitter and LinkedIn. Contact Details ACD/Labs Sanji Bhal +1 416-368-3435 media@acdlabs.com Racepoint Global Allison Matthews +1 617-624-3248 amatthews@racepointglobal.com Company Website https://www.acdlabs.com/

August 14, 2023 12:00 PM Eastern Daylight Time

Article thumbnail News Release

Experts encourage including HPV vaccine in back-to-school preparation for kids

YourUpdateTV

Every year, nearly than 40,000 men and women are diagnosed with a cancer caused by human papillomavirus (HPV) and about 14 million people, including teens, become infected with HPV each year. Recently, Heather Brandt, PhD, the Director of the HPV Cancer Prevention Program at St. Jude Children’s Research Hospital, conducted a satellite media tour to increase awareness and education about the importance of HPV vaccination in preventing HPV-related cancers. Dr. Brandt is urging parents and caregivers to include HPV vaccination in their child’s back-to-school immunizations. A video accompanying this announcement is available at: https://youtu.be/36xZsO3L3U4 There are several good reasons to immunize children against HPV as early as possible. HPV vaccination is recommended for males and females ages 9-26. HPV vaccination is encouraged to be completed by the 13th birthday, well before the potential for exposure to HPV, which is why Dr. Brandt is encouraging including HPV vaccination as part of a child’s back-to-school preparation. HPV can cause six different types of cancers: cervical, vaginal, vulvar, oral, anal and penile. One of the biggest misconceptions is that HPV only affects women, which is false. Men can also be diagnosed with HPV and carry the virus, which is why HPV vaccination is encouraged for both females and males. It is important that parents know which vaccines are recommended for their children and why. This allows for parents to have a thorough discussion with their child's health care provider and can avoid surprises and last-minute decision-making on vaccines. For more information go to stjude.org/hpv. ------------------------------------------------------------------------- BIO: Heather M. Brandt, PhD, is the Director of the HPV Cancer Prevention Program at St. Jude Children’s Research Hospital. Dr. Brandt, a social and behavioral scientist, focuses on working with stakeholders to prevent and control cancer by using evidence-based interventions through innovative, partnered approaches. About the HPV Cancer Prevention Program Launched in 2021, the HPV Cancer Prevention Program at St. Jude Children’s Research Hospital has set out to increase awareness and education about the importance of HPV vaccination in preventing HPV-related cancers. As the only NCI-designated Comprehensive Cancer Center dedicated solely to children, St. Jude Children’s Research Hospital has an important role and responsibility in increasing HPV vaccination rates locally, regionally, and nationally. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

August 14, 2023 11:13 AM Eastern Daylight Time

Video
1 ... 5253545556 ... 195