NORTHWELL HEALTH
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Established
- 1997-01-01
- Employees
- -
- Market Cap
- -
- Website
- https://www.northwell.edu/
NeOnc Technologies Partners with CBCC Global Research to Accelerate Brain Cancer Clinical Trials in India
• NeOnc Technologies has formed a strategic partnership with CBCC Global Research to expand its clinical trial network to 30 FDA-compliant research sites across India, focusing on neuro-oncology treatments.
• The collaboration will initially focus on the NEO100-01 Phase 2a trial for Glioblastoma (GBM), evaluating an intranasal ultra-purified perillyl alcohol therapy targeting IDH1 mutations in Grade 3 and 4 tumors.
• NeOnc aims to complete Phase 2 enrollment this year with results expected 6-8 months later, potentially accelerating the development timeline for novel brain cancer therapies while reaching a more diverse patient population.
Feinstein Institutes Pioneers Precision Vagus Nerve Stimulation with $3M NIH Grant
• The Feinstein Institutes for Medical Research has received a $3 million NIH grant to develop advanced vagus nerve stimulation techniques in collaboration with imec, focusing on precise fiber targeting.
• Dr. Stavros Zanos's team has developed a novel "interferential stimulation" method that selectively activates specific nerve fibers, potentially minimizing side effects while maximizing therapeutic benefits.
• The research could transform treatments for inflammatory conditions including rheumatoid arthritis, inflammatory bowel disease, and heart failure by enabling personalized bioelectronic medicine approaches.
New York Man Becomes First in State to Be Cured of Sickle Cell Disease with Lyfgenia Gene Therapy
• 21-year-old Sebastien Beauzile has been successfully treated for sickle cell disease at Cohen Children's Medical Center using Bluebird Bio's Lyfgenia gene therapy, becoming the first New Yorker to receive this breakthrough treatment.
• The FDA-approved therapy works by extracting the patient's blood stem cells, genetically modifying them to produce functional hemoglobin, and reinfusing them after chemotherapy, effectively curing the disease rather than just managing symptoms.
• After suffering from severe pain rated "10 out of 10" since infancy, Beauzile is now symptom-free, calling the treatment "like a second birthday," and plans to pursue a medical career to help others with the condition.
Novel Therapies Transform Rheumatology Landscape in Early 2025
• FDA regulatory actions in Q1 2025 include approval of Celltrion's denosumab biosimilars and Fast Track designation for CAR-T therapies targeting lupus, expanding treatment options for autoimmune conditions.
• Breakthrough clinical data from the REGENCY trial demonstrates obinutuzumab's superior efficacy in lupus nephritis, while rosnilimab shows historic response rates in rheumatoid arthritis patients.
• Novel approaches for difficult-to-treat conditions emerge with SAP-001 showing "best-in-class" results for refractory gout and transcranial magnetic stimulation providing sustained pain relief for fibromyalgia.
Gazyva Shows Significant Improvement in Lupus Nephritis Treatment: Phase III REGENCY Trial Results
• Genentech's Phase III REGENCY trial demonstrates that Gazyva plus standard therapy achieved 46.4% complete renal response in lupus nephritis patients compared to 33.1% with standard therapy alone.
• The study, published in NEJM, showed clinically meaningful improvements in complement levels and reductions in anti-dsDNA markers, indicating reduced disease activity and inflammation.
• Results were consistent across all patient subgroups, including those with Class IV lupus nephritis and higher baseline proteinuria levels, while maintaining Gazyva's established safety profile.
Clinical Trials Should Be Viewed as Standard Care Option, Not Last Resort, Experts Emphasize
• Leading oncologists at Northwell Health advocate for integrating clinical trials into standard care pathways, emphasizing their role as crucial treatment options rather than last resorts.
• Dr. Richard Carvajal, Deputy Physician-in-Chief at Northwell Health Cancer Institute, stresses that clinical trials access is essential for advancing cancer treatment until cure rates improve significantly.
• Healthcare experts call for enhanced education among medical providers and patients to normalize clinical trials as part of routine treatment discussions and decision-making processes.
PET-Adapted Radiation Therapy Fails to Improve Outcomes in Stage III NSCLC
• A phase II trial (NRG-RTOG1106/ECOG-ACRIN 6697) investigated whether midtreatment FDG-PET/CT-guided adaptive radiation therapy (RT) could improve outcomes in stage III non-small cell lung cancer (NSCLC).
• The study found that adaptive RT, involving dose escalation to residual metabolically active areas, was safe and feasible but did not significantly improve freedom from locoregional progression compared to standard RT.
• Secondary analyses revealed no significant differences in survival, progression-free survival, or grade 3 toxicities between the adaptive and standard RT arms.
• Researchers suggest future studies should focus on greater individualization of radiation dose selection and consider the risks of cumulative irradiation of circulating lymphocytes.
Feinstein Institutes to Explore Ghrelin for Radiation-Induced Gastrointestinal Syndrome with NIH Grant
• The Feinstein Institutes received a $2.9 million NIH grant to study ghrelin as a countermeasure for radiation-induced gastrointestinal syndrome (GI-ARS).
• The research will investigate how ghrelin protects the intestines from radiation damage and enhances survival rates after exposure.
• The study aims to understand ghrelin's role in intestinal stem cell recovery via the vagus nerve, potentially leading to a novel treatment for GI-ARS.
• Human ghrelin has a positive safety record so far and is easy to produce, making it a strong contender for widespread use in emergencies.
AI Advances Show Promise in Early Cancer Detection and Personalized Treatment Strategies
• AI technology is demonstrating breakthrough capabilities in early detection of challenging cancers like pancreatic and breast cancer, improving both sensitivity and specificity in medical image analysis.
• Advanced AI systems are now incorporating multiple factors including age, genetics, and lifestyle habits to create personalized cancer risk assessments and prevention strategies.
• Dr. Sanjay K. Juneja highlights AI's potential to enhance treatment selection by analyzing tissue samples and patient data, while emphasizing that AI complements rather than replaces physician expertise.
Mineralys Therapeutics' Lorundrostat Advances to Phase 2 for Obstructive Sleep Apnea and Hypertension
• Mineralys Therapeutics' lorundrostat receives FDA clearance for a Phase 2 trial targeting obstructive sleep apnea (OSA) in hypertensive patients.
• The trial aims to assess lorundrostat's efficacy in reducing upper airway obstruction and nocturnal hypertension in moderate-to-severe OSA.
• The Phase 2 study is set to commence in Q1 2025, evaluating 50mg of lorundrostat daily in approximately 40 participants.
• Mineralys' Explore-CKD Phase 2 trial, evaluating lorundrostat for hypertension in CKD patients with albuminuria, has completed enrollment.
ACCC Fall 2024: Innovations in Clinical Trial Access, Patient Care, and Treatment Authorization
• The Ohio State University Cancer Center's automated informatics program has achieved a 21.9% increase in biosimilar utilization while streamlining prior authorization processes, earning an Innovator Award at ACCC 2024.
• University of Kentucky's Markey Cancer Center is transforming clinical trial participation by addressing misconceptions and adapting terminology to build trust, particularly among marginalized communities.
• Community-based initiatives, including Cowell Family Cancer Center's bispecific antibody program and wellness initiatives at Fox Chase Cancer Center, are expanding access to advanced cancer treatments and support services.
RSV Vaccines Show Weaker Immune Response in Immunocompromised Older Adults
• A recent study reveals that older, immunocompromised adults exhibit a weaker antibody response to RSV vaccines compared to healthy individuals.
• The research indicates that approximately 40% of immunocompromised participants did not achieve seroconversion or meet neutralization thresholds post-RSV vaccination.
• An adjuvanted vaccine (Arexvy) showed a tendency to induce higher levels of RSV-neutralizing antibodies compared to a non-adjuvanted vaccine (Abrysvo) in this population.
• Further research is needed to optimize RSV vaccine strategies, including timing and selection, for immunocompromised individuals to enhance protection.
Pfizer Advances Ibuzatrelvir, a Novel Oral Antiviral, into Phase 3 Trial for COVID-19
• Pfizer has initiated a Phase 3 clinical trial to assess ibuzatrelvir, a new oral antiviral drug, for treating non-hospitalized, high-risk COVID-19 patients.
• Ibuzatrelvir, designed to be administered without ritonavir, aims to reduce drug-drug interactions and taste disturbances associated with current treatments like PAXLOVID.
• The trial will evaluate ibuzatrelvir's efficacy in reducing COVID-19-related hospitalizations, emergency department visits, and mortality over a 28-day period.
• This antiviral targets the SARS-CoV-2 Mpro protease, suggesting potential effectiveness against current and future variants of concern, similar to PAXLOVID.
HeartBeam Submits FDA Application for 12-Lead ECG Synthesis Software
• HeartBeam has submitted a 510(k) application to the FDA for its 12-lead ECG synthesis software, designed to assess various cardiac rhythms and arrhythmias.
• The submission is supported by data from the VALID-ECG pivotal study, involving 198 patients across five clinical sites, demonstrating clinical equivalence to standard ECGs.
• The software synthesizes signals from three directions into a 12-lead ECG, using a personalized transformation matrix, for convenient cardiac monitoring.
• Future advancements include AI-based classification algorithms and heart attack detection, aiming to reduce 'symptom to door' times for patients.
UCSF-led Study Advances Understanding and Treatment of Hidradenitis Suppurativa
The HS PROGRESS study, led by UC San Francisco, aims to improve the understanding and treatment of Hidradenitis Suppurativa (HS), a chronic inflammatory skin condition affecting 1% of Western populations. With recent funding from UCB, the study seeks to accelerate the development of new treatments by collecting comprehensive clinical and biological data from HS patients across 15 academic institutions.
Vagus Nerve Stimulation Shows Promise for Treatment-Resistant Depression
• A large-scale clinical trial reveals that vagus nerve stimulation (VNS) can significantly improve depressive symptoms, quality of life, and daily functioning in individuals with severe, treatment-resistant depression.
• The study, involving nearly 500 participants, showed that VNS therapy led to measurable improvements, even in patients who had previously failed multiple treatments.
• VNS delivers focused stimulation to mood-regulating brain regions and can be used alongside other treatments, offering sustained relief for those who do not fully respond to antidepressants or therapy.
• The RECOVER trial aims to provide data that could lead to health insurance coverage for VNS, making it more accessible for patients with treatment-resistant depression.
NGS and Targeted Therapies Improve Survival in HR+/HER2- Breast Cancer
• Next-generation sequencing (NGS) is crucial for personalizing treatment decisions in hormone receptor (HR)-positive, HER2-negative metastatic breast cancer, identifying actionable mutations like PIK3CA, AKT, and P10.
• The phase 3 INAVO120 trial demonstrated that inavolisib, a PI3K kinase inhibitor, combined with palbociclib and fulvestrant, significantly improved progression-free survival in patients with PIK3CA-mutated HR-positive, HER2-negative breast cancer.
• The CAPItello-291 trial showed that capivasertib plus fulvestrant led to longer progression-free survival, especially in patients with PI3K, AKT, or P10 alterations, with manageable adverse events.
• Antibody-drug conjugates like fam-trastuzumab deruxtecan-nxki and sacituzumab govitecan-hziy are promising for HER2-low breast cancer, necessitating further research to optimize their sequencing for maximum patient benefit.
Newer Epilepsy Medications During Pregnancy Show No Impact on Children's Neurodevelopment at Age 6
• A recent study indicates that newer anti-seizure medications, like lamotrigine and levetiracetam, pose no significant risk to children's language development when taken during pregnancy.
• The research followed 387 children up to age 6, assessing their verbal abilities and finding no difference between those exposed to the drugs in utero and those who were not.
• Findings suggest that controlling seizures with newer medications during pregnancy is a safe approach, contrasting with older medications like valproate, which have known risks.
• The study also highlights the potential benefits of folate supplementation during early pregnancy for improved cognitive and behavioral outcomes in children.
Vagus Nerve Stimulation Shows Promise as 'Neural Tourniquet' to Reduce Surgical Bleeding
• Researchers are developing a 'neural tourniquet' that uses vagus nerve stimulation to enhance blood clotting and reduce bleeding during surgery and postpartum.
• Electrical stimulation of the vagus nerve activates immune cells in the spleen, preparing platelets to respond more effectively to injuries and reduce blood loss.
• Clinical trials are underway to assess the efficacy of vagus nerve stimulation in healthy subjects, with preclinical data showing up to a 75% reduction in traumatic blood loss.
• This proactive approach could revolutionize surgical practices by preventing excessive bleeding, potentially decreasing maternal deaths and surgical complications.
Alpheus Medical's Sonodynamic Therapy Shows Promise in Recurrent High-Grade Gliomas
• Alpheus Medical announced positive Phase 1/2 trial results for its sonodynamic therapy (SDT) in recurrent high-grade gliomas, demonstrating a strong safety profile.
• The trial showed extended median overall survival (15.7 months) and progression-free survival (5.5 months) compared to historical data for this aggressive brain cancer.
• Alpheus's SDT combines low-intensity ultrasound with oral 5-aminolevulinic acid, offering a non-invasive treatment option that can be administered in an outpatient setting.
• A randomized, controlled trial is planned for 2025 to further evaluate the efficacy of Alpheus Medical's SDT platform in treating recurrent high-grade gliomas.
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