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Graft Polymer eager to push on after signing fresh manufacturing agreement

Graft Polymer (UK) PLC

Graft Polymer (UK) PLC (LSE:GPL) independent non-executive director Alex Brooks speaks to Thomas Warner from Proactive after the polymer modification company announced the signing of a manufacturing agreement with an undisclosed Israeli pharmaceutical partner to produce a patented blood-clotting powder at its GraftBio facility in Slovenia. The product, designed to stimulate blood coagulation, holds versatile applications in wound care and surgical procedures. Brooks explains that Graft Polymer's expertise in polymer knowledge and complex manufacturing processes makes them a natural choice to produce the powder. He expresses optimism that such self-emulsifying nano emulsion products could become a revenue generator. While the main focus remains on their core activities, this segment holds potential strategic importance. Brooks also draws attention to the importance of Graft Polymer's Slovenian manufacturing facility to being able to fulfil orders of this type reliably and at scale. He says that Graft is "excited about the potential to really help our customers really achieve whatever product performance characteristics they're looking for." Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 23, 2023 08:00 AM Eastern Daylight Time

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Atossa Therapeutics backing Endoxifen in the fight against breast cancer

Atossa Therapeutics Inc

Atossa Therapeutics (NASDAQ:ATOS) President & CEO Dr. Steven Quay joins Thomas Warner from Proactive to speak about the latest developments in his and the clinical-stage biopharma company's fight against breast cancer. Dr. Quay gives an overview of ongoing clinical trials centered around their innovative drug, oral Endoxifen. The drug combines oestrogen receptor degradation, suppression, and PKC beta inhibition to combat breast cancer. The trials are conducted at different stages of breast cancer management. One focus is on breast cancer prevention, specifically targeting high mammographic breast density, a significant risk factor. Dr. Quay emphasises the link between density and cancer risk, noting the potential for changing mammograms' readability and reducing future risk. He goes on to talk about a trial of Endoxifen during what is known as the neoadjuvant window, the period between diagnosis and initial treatment, which is aimed at rapidly reducing tumour activity after diagnosis. These trials, held at Mayo Clinic and UCSF, test the drug's impact on oestrogen-driven cancers, where current treatments often fall short. Additionally, the CEO discussed Atossa's broader motivations, underscoring breast cancer's prevalence and the immense impact it has on individuals and society. He goes on to discuss the company's financial position. with approximately $99.4 million on the balance sheet as of Q2, enabling continued research and development. Dr. Quay also reveals research collaborations at Weill Cornell Medical Centre targeting triple-negative breast cancer, a particularly aggressive form. These efforts seek to transform it into a more treatable type, potentially revolutionising treatment options. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 23, 2023 08:00 AM Eastern Daylight Time

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BiVictriX Therapeutics passes "exciting milestone" with US patent for BVX001

BiVictriX Therapeutics PLC

BiVictriX Therapeutics PLC (AIM:BVX, OTC:BVTXF) founder and CEO Tiffany Thorn speaks to Thomas Warner from Proactive after announcing that the UK-based drug discovery and development company has been granted a patent for its primary cancer treatment BVX001 by the United States Patent and Trademark Office (USPTO). Thorn describes the granting of the US patent as an "exciting milestone" for the business and explains that the patent marks a significant achievement for the company as it encompasses broad claims, unlike the typical narrow specifications for antibody therapeutics. She highlights that BiVictriX's approach allows for more extensive intellectual property protection. The company's global focus is evident, with patent prosecution spanning eight jurisdictions, including Japan, a pivotal market. A Notice of Allowance has been received from the Japanese patent office that showcases even broader protection than the US grant. Thorn also discusses a recent £2.1mln fundraise and an intensification of business development efforts, including participation in an upcoming partnering conference. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 23, 2023 06:43 AM Eastern Daylight Time

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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

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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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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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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

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