Latest news with #Neurosurgery
Yahoo
3 hours ago
- Business
- Yahoo
FG001 clinical data in High-Grade Glioma is now published in Neurosurgery
KØBENHAVN, DK / / June 10, 2025 / FluoGuide A/S (STO:FLUO) - Copenhagen, Denmark - FluoGuide A/S ("FluoGuide" or the "Company"), a clinical-stage biotech company focused on precision cancer surgery, is pleased to announce its compelling phase I clinical data with FG001 has been published in Neurosurgery. The data is the first-in-human result of its proprietary near-infrared (NIR) optical imaging agent, FG001, in patients with malignant glioma undergoing surgery. The article, published in the prestigious journal Neurosurgery, which targets neurosurgeons, is entitled "Novel uPAR-targeting optical imaging agent ICG-Glu-Glu-AE105 (FG001) for visualization of malignant glioma during surgery: First-in-human study in 35 brain cancer patients" and identified with doi:10 1227/neu.0000000000003542, available here: link. "We are very pleased with the publication of the results from this first-in-human study that shows FG001 not only enables safe and targeted tumor identification including in the transition zone, being the tissue between the cancer and normal tissue which constitutesthe biggest challenge for the surgeon treating high-grade glioma - where the agent continued to produce visible fluorescence." said Morten Albrechtsen, CEO of FluoGuide; "FG001 has the potential to redefine how surgeons approach brain tumor resection" Next clinical step and regulatory pathFollowing the successful completion of this phase I study, FluoGuide is obtaining FDA regulatory advice prior to initiate the U.S. clinical trial supporting approval of FG001 guiding surgery of patients with High Grade Glioma. FluoGuide anticipates feedback from ongoing regulatory interactions over the summer. "I am pleased to see the first result of FG001 in patients with malignant glioma published" says Jane Skjøth-Rasmussen, MD, PhD, Chief Physician in the Department of Neurosurgery at Rigshospitalet, Copenhagen, Denmark and Principal Investigator of the trial and the author of the publication, and continues: "The data demonstrates FG001 to be well tolerated and shows a promise for guiding surgery of malignant glioma." In an editorial comment published together with the article Professor Pierre A. Robe, Chair of Neurosurgical Oncology at the University Medical Center (UMC) concludes: "Altogether, the results reported here are a welcome and exciting addition to the brain tumor neurosurgical community." Please refer to the published article for the full commentary. Glioblastoma is among the most aggressive and lethal forms of brain cancer, with a crucial need for tools that enable maximal tumor resection while preserving healthy brain tissue. FG001 lights up cancer, enabling surgeons to perform more precise surgeries. It is an novel imaging agent that targets the urokinase-type plasminogen activator receptor (uPAR), a protein highly expressed in tumor tissue but largely absent from normal brain cells. Key results from the phase I studyThe result is from the first clinical trial with FG001 in patients with High Grade Glioma and is an open-label, single-center phase I trial involving 35 patients, and FG001 was administered intravenously prior to brain surgery. A dose of 36 mg administered 12-19 hours before surgery provided optimal tumor visualization. The tumor-to-background fluorescence ratio (TBR) was relevant for all image system tested (>1.5) and up to 2.7 (TBR mean) and 3.6 (TBR max). Notably, FG001 achieved a sensitivity of 79% and a specificity of 100% in identifying malignant tissue confirmed by histopathology. Compared with the imaging agent 5-ALA, FG001 was observed to provide clearer delineation in deeper tissue layers due to its NIR fluorescence properties, with no observed false positives. FG001's safety profile was equally promising, with only few (4) mild drug-related adverse events linked to the drug. It was observed that unlike 5-ALA, no FG001-related nausea or vomiting was reported in patients receiving evening doses, underscoring FG001s favorable tolerability. High precision in the transition zoneThe transition zone, being the tissue between the tumor and the normal tissue, is of special attention to neurosurgeons as it is where they must make the difficult decisions between removing tissue that may be cancer and risking disabling patients by removing more brain tissue than necessary. FG001 worked well in the transition zone where all 7 samples were correctly classified by FG001 whereas 5-ALA had 2 false negative. When the efficacy was calculated for transition zone only, then specificity, sensitivity, positive predictive value (PPV), and negative predictive value (NPV) were all 100% for FG001, whereas the numbers were 100%, 60%, 100%, and 50% for 5-ALA, respectively. For further information, please contact:Morten Albrechtsen, CEOFluoGuide A/SPhone: +45 24 25 62 66E-mail: ma@ Certified Adviser:Svensk Kapitalmarknadsgransking ABWebsite: About FluoGuideFluoGuide is a biotech company specializing in precision cancer surgery improving the outcome for cancer patients. The Company's lead product, FG001, a novel optical imaging agent that light up cancerous tissue to improve surgical precision in patients undergoing surgery. FluoGuide's products are expected to have a dual benefit - reducing both the frequency of local recurrence after surgery and reducing surgical complications. The improved precision will potentially increase the patients' chance of achieving a complete cure and lower healthcare costs. FG001 binds to the urokinase plasminogen activator receptor (uPAR) being extensively expressed by solid cancer. The photosensitizer therapy potential of FG001 could add a direct treatment effect of FG001 to further benefit for patients with cancer undergoing surgery. The Company has published strong results from phase II trials demonstrating the efficacy of FG001 in patients undergoing surgery to remove aggressive brain (high-grade glioma), head & neck (oral squamous cell carcinoma) and lung cancers (non-small cell lung cancer). FG001 has also been demonstrated very well tolerated across all patients. Based on this strong foundation, FluoGuide advances the development toward approval in aggressive brain cancer and head & neck cancer. FluoGuide is listed on Nasdaq First North Growth Market, Stockholm under the ticker "FLUO". Read more about FluoGuide and upcoming events on AttachmentsFG001 clinical data in High-Grade Glioma is now published in Neurosurgery SOURCE: FluoGuide A/S View the original press release on ACCESS Newswire
CNN
5 days ago
- Entertainment
- CNN
Morten Harket, lead singer of a-ha, has Parkinson's disease
Morten Harket has revealed he has Parkinson's disease. The singer of a-ha, the band behind the 1985 hit and innovatively animated music video 'Take On Me,' shared the news during an interview with the group's biographer. 'I've got no problem accepting the diagnosis,' Harket said. 'With time, I've taken to heart my 94-year-old father's attitude to the way the organism gradually surrenders: 'I use whatever works'.' Harket, 65, explained why he wanted to share his diagnosis publicly. 'Acknowledging the diagnosis wasn't a problem for me; it's my need for peace and quiet to work that has been stopping me. I'm trying the best I can to prevent my entire system from going into decline,' he said. 'It's a difficult balancing act between taking the medication and managing its side effects. There's so much to weigh up when you're emulating the masterful way the body handles every complex movement, or social matters and invitations, or day-to-day life in general.' According to Mayo Clinic, 'Parkinson's disease is a movement disorder of the nervous system that worsens over time.' Harket had 'advanced brain surgery' at the Mayo Clinic, which along with medication, 'have softened the impact of his symptoms,' the a-ha biographer, Jan Omdahl, wrote. 'In June 2024, Morten underwent a neurosurgical procedure in which electrodes were implanted deep inside the left side of his brain. These are connected to a small pacemaker-like device placed under the skin of the upper chest that sends electrical impulses through the electrodes into the brain,' Omdahl wrote. 'The method is called deep brain stimulation (DBS) and is among the most advanced treatments in neurology. The procedure had the desired effect: with the right electrical impulses now reaching Morten's brain, many of his physical symptoms practically vanished. In December 2024 he underwent a similar procedure on the right side of his brain, which was also successful.' Harket's voice, however, has been affected, he said. 'The problems with my voice are one of many grounds for uncertainty about my creative future,' Harket said.
Associated Press
5 days ago
- Business
- Associated Press
CNS Pharmaceuticals' Chief Medical Officer, Sandra Silberman, MD, PhD to Present at the 2025 Brain Tumor Biotech Summit
In person presentation today, Thursday, June 5th at 9:30 AM ET to discuss Company's lead program, TPI 287, in development for treatment of glioblastoma multiforme (GBM) HOUSTON, TX / ACCESS Newswire / June 5, 2025 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ('CNS' or the 'Company'), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that Sandra Silberman, M.D., Ph.D., Chief Medical Officer of CNS Pharmaceuticals, will present at the Lenox Hill Hospital, Department of Neurosurgery's Brain Tumor Biotech Summit being held on June 5, 2025 in New York, NY. Details of the presentation are as follows: Title: The Future and Promise of TPI 287- A Brain Penetrating Taxane with Documented Evidence of Efficacy Against Glioblastoma Date and Time: Thursday, June 5, 2025 at 9:30 AM ET As part of the presentation Dr. Silberman will discuss the Company's drug candidate, TPI 287. TPI 287 is an abeotaxane and has the same mechanism of action as other taxanes, e.g. paclitaxel (Taxol®) and docetaxel, in which it stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. While most taxanes are substrates for multi-drug resistant transporters, which maintain the blood brain barrier (BBB), TPI 287's clinical data suggest it has the potential to cross the BBB and treat CNS tumors. In a Phase 1 trial treating glioblastoma patients with TPI 287 in combination with bevacizumab (Avastin®), the efficacy data included 3 Complete Responses and 9 Partial Responses out of 23 evaluable patients. TPI 287 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of gliomas, pediatric neuroblastoma, and progressive supranuclear palsy. The 2025 Brain Tumor Biotech Summit brings together innovators in neuroscience and oncology with investors in the field of biotechnology and healthcare life science. The Conference's goal is to foster and encourage collaboration among our neuroscience colleagues and the biotechnology community to accelerate the development of new, life-saving therapies for patients with brain tumors and other Central Nervous System diseases. For more information about the 2025 Brain Tumor Biotech Summit, please visit the event website. About CNS Pharmaceuticals, Inc. CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The Company's drug candidate TPI 287 is an abeotaxane, which stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. The initial clinical efficacy data suggest TPI 287 has the potential to cross the blood-brain barrier and treat CNS tumors. TPI 287 also has been tested in over 350 patients in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of a range of diseases or conditions, including recurrent glioblastoma, recurrent neuroblastoma and medulloblastoma, advanced malignancies, progressive neoplastic disease, advanced unresectable pancreatic cancer, metastatic melanoma, and breast cancer metastatic to the brain. To date TPI 287 appears have both an excellent safety profile and high tolerability among patients. For more information, please visit and connect with the Company on X, Facebook, and LinkedIn. Forward-Looking Statements Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. . These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including market and other conditions and those discussed under Item 1A. 'Risk Factors' in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ('SEC') and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except as required by law. CONTACT: JTC Team, LLC Jenene Thomas 908.824.0775 [email protected] SOURCE: CNS Pharmaceuticals, Inc. press release
Yahoo
05-05-2025
- Business
- Yahoo
Why Integra LifeSciences (IART) Shares Are Getting Obliterated Today
Shares of medical device company Integra LifeSciences (NASDAQ:IART) fell 28.5% in the morning session after the company reported weak first-quarter 2025 results, which included a significant miss on full-year EPS guidance and the next quarter's revenue outlook. Segment results were mixed as key businesses like Neurosurgery and Tissue Technologies declined, pulled down by inventory issues and slower ordering patterns. Along with rising costs, margins and profit were dragged down as EBITDA and EPS both dropped, and cash flow was in the red. Even though management kept the full-year sales target, they had to cut their profit outlook due to tariff concerns. Overall, this quarter could have been better. The stock market overreacts to news, and big price drops can present good opportunities to buy high-quality stocks. Is now the time to buy Integra LifeSciences? Access our full analysis report here, it's free. Integra LifeSciences's shares are very volatile and have had 21 moves greater than 5% over the last year. But moves this big are rare even for Integra LifeSciences and indicate this news significantly impacted the market's perception of the business. The biggest move we wrote about over the last year was 2 months ago when the stock gained 13.6% on the news that the company reported strong fourth quarter 2024 results that beat analysts' EPS and EBITDA expectations. On the other hand, its full-year revenue and EPS guidance fell short of Wall Street's estimates. The company expects continued demand for its portfolio but flagged potential headwinds, including intermittent product shipping holds. Overall, while this was a strong quarter with solid execution, cautious guidance suggests near-term uncertainty. Integra LifeSciences is down 45.8% since the beginning of the year, and at $12.48 per share, it is trading 60.8% below its 52-week high of $31.86 from June 2024. Investors who bought $1,000 worth of Integra LifeSciences's shares 5 years ago would now be looking at an investment worth $240.51. Here at StockStory, we certainly understand the potential of thematic investing. Diverse winners from Microsoft (MSFT) to Alphabet (GOOG), Coca-Cola (KO) to Monster Beverage (MNST) could all have been identified as promising growth stories with a megatrend driving the growth. So, in that spirit, we've identified a relatively under-the-radar profitable growth stock benefiting from the rise of AI, available to you FREE via this link. Sign in to access your portfolio
Associated Press
25-03-2025
- Health
- Associated Press
Karger Publishers Expands Open Access Portfolio for 2025 with Subscribe to Open
The Subscribe to Open pilot program marks its 3rd year at Karger Publishers. 3 journals met threshold to provide Open Access without Article Processing Charges 'It is exciting to explore the potential of Subscribe to Open to enable Open Access (OA) without are thrilled to make more journals OA without costs for readers or authors.' — Beth Bayley, Open Science Manager at Karger Publishers BASEL, SWITZERLAND, March 25, 2025 / / -- In the third year of the publisher's S2O pilot, the journal Developmental Neuroscience has again met its sustainability threshold, while the two new journals in the S2O pilot, European Addiction Research and Neurodegenerative Diseases, have also met their criteria for this Open Access model for 2025. Subscribe to Open refers to a publishing model in which a journal volume can become Open Access if it reaches a certain number of subscriptions or renewals in a given year. In the program's first year at Karger, the 2023 volumes for Developmental Neuroscience and Pediatric Neurosurgery met their targets for OA, while the 2024 and 2025 volumes of Pediatric Neurosurgery did not meet that threshold and are subscription-based, with a paid option to publish any paper as Open Access. Instead of charging authors an APC, publishing costs under S2O are sustained by subscriptions from libraries, leveraging existing funds and infrastructure. If subscriptions are renewed to a level that ensures the journals' sustainability, Karger converts that year's volume to Open Access, making it completely free of barriers to read, share and re-use under the terms of the Creative Commons Attribution license (CC BY). 'It is exciting to explore the potential of Subscribe to Open to enable OA without APCs,' states Beth Bayley, Open Science Manager at Karger Publishers. 'APCs are one of the greatest challenges to making life-changing information globally accessible, so we are thrilled to make more journals OA without costs for readers or authors.' With its 'Open for Open' approach, Karger continues to seek ways to publish more Open Access in a way that is sustainable and accessible for all stakeholders. For more information, please visit Subscribe to Open | Karger Publishers. About Karger Publishers Connecting people and science since 1890, Karger provides scientists, healthcare professionals, patients, and the broader public with reliable and tailored information in Health Sciences. Building upon a publishing portfolio of more than 100 reputable scholarly journals and the award-winning Fast Facts medical info series, Karger excels in medical education and omnichannel HCP engagement in multiple formats, including 3D animations, podcasts, AR/VR environments, and more. Academic institutions and both medical affairs and pharma marketing teams in the corporate space entrust Karger with their most demanding communication challenges. Independent and family-led in the fourth generation by Chairwoman Gabriella Karger, Switzerland-based Karger is present in 15 countries with a team of 200 dedicated professionals worldwide. For more information, please visit Christine Hohlbaum Hohlbaum PR & Social Media +49 177 8638661 Legal Disclaimer:
