MedPath

Clinical Trial News

FDA Clears AI-Powered Brain Mapping Tool for Personalized Neuromodulation Therapies

  • Turing Medical's Bullsai Identify, an AI-driven platform, has received FDA clearance for creating personalized brain maps used in neuromodulation therapies.
  • The platform analyzes advanced MRI data to map individual brain structures, aiming to improve the precision and efficacy of treatments like deep brain stimulation (DBS).
  • Bullsai Identify helps doctors target specific brain regions, potentially reducing side effects and enhancing clinical outcomes for neurological conditions.
  • This clearance marks a step toward accessible precision medicine in neurological care, offering tailored neuromodulation strategies based on individual brain anatomy.

TriClip TEER Shows Sustained Benefits in Tricuspid Regurgitation at 3 Years

  • Transcatheter edge-to-edge repair (TEER) using Abbott's TriClip device significantly reduces tricuspid regurgitation (TR) to moderate or less in 79% of patients.
  • The reduction in TR observed after one year with TriClip was sustained at three years, indicating long-term efficacy of the treatment.
  • Patients treated with TriClip experienced a notable improvement in quality of life, with a decrease in NYHA class III/IV heart failure symptoms from 76% to 19%.
  • The major adverse event rate remained minimal over the three-year follow-up, reinforcing the favorable safety profile of the TriClip TEER procedure.

First Patient Dosed in Phase 1 Trial of Novel SIGLEC10 Inhibitor ONC-841 for Solid Tumors

  • A patient at Norton Cancer Institute received the first dose of ONC-841, a novel SIGLEC10 inhibitor, in a Phase 1 clinical trial.
  • The Phase 1 trial (NCT06352359) aims to evaluate the safety, side effects, and dosing of ONC-841 in patients with advanced/metastatic solid tumors.
  • ONC-841, developed by OncoC4 Inc., represents a new approach to cancer treatment by targeting the SIGLEC10 immune checkpoint.
  • The trial is enrolling patients with various types of advanced solid tumors to assess the drug's potential to reduce tumor size and slow disease progression.

Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors

NCT06352359RecruitingPhase 1
OncoC4, Inc.
Posted 8/23/2024

Nirsevimab Shows Promise in Preventing RSV in Infants and Immunocompromised Children

  • Nirsevimab, a long-acting monoclonal antibody, demonstrates safety and efficacy in preventing RSV in infants, as shown in studies published in Pediatrics.
  • A study in immunocompromised children aged 24 months and under found nirsevimab to be well-tolerated, with serum concentrations supportive of efficacy.
  • In Spain, universal RSV prevention with nirsevimab for newborns up to 6 months was associated with a 63.1% reduction in bronchiolitis-related hospital admissions.
  • Wastewater surveillance shows a strong correlation between viral concentrations and positive community respiratory tests for flu viruses, RSV, and SARS-CoV-2.

MMJ BioPharma Sues DEA Over Delays to Cannabis Research for MS and Huntington's

  • MMJ BioPharma Cultivation is suing the DEA, alleging significant delays in processing its application to grow marijuana for pharmaceutical research.
  • The company claims DEA delays have hindered clinical trials for cannabis-based treatments for Multiple Sclerosis and Huntington's Disease.
  • MMJ argues the DEA's administrative law judge process is biased and violates their right to a fair trial, impacting investment and research timelines.
  • The lawsuit raises constitutional questions and could have broader implications for cannabis research and federal cannabis policy amid rescheduling efforts.

Novel Chemotherapy-Free Regimens Show Promise in Mantle Cell Lymphoma

  • A phase 1/2 trial (NCT05861050) is evaluating glofitamab-gxbm, venetoclax, lenalidomide, and obinutuzumab for high-risk mantle cell lymphoma (MCL), including cases with TP53 mutations or complex karyotypes.
  • Another phase 1 trial (NCT03523975) is investigating venetoclax, lenalidomide, and rituximab as a frontline treatment for standard-risk MCL, offering a chemotherapy-free approach.
  • Nemtabrutinib combined with rituximab is also under investigation for MCL, with trials focusing on both frontline and relapsed settings to improve patient outcomes.
  • Studies in relapsed MCL are exploring CAR T-cell therapy and bispecific antibodies like glofitimab, potentially offering new therapeutic options and improved survival rates.

Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

NCT03523975RecruitingPhase 1
City of Hope Medical Center
Posted 12/24/2018

Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma

NCT05861050RecruitingPhase 1
City of Hope Medical Center
Posted 8/10/2023

Real-World Data Confirms Predictors of Exceptional Response to HER2-Targeted Therapy in Metastatic Breast Cancer

  • Analysis of real-world data from Dana-Farber's EMBRACE program and the French ESME database reveals that 25-28% of HER2-positive metastatic breast cancer patients are exceptional responders to first-line anti-HER2 therapy.
  • Strong HER2 expression, de novo metastatic disease, and treatment with trastuzumab, pertuzumab, and chemotherapy (triplet regimen) are identified as predictors of exceptional response.
  • Genetic analysis of tumor samples identifies PIK3CA and MYC mutations as potential markers associated with poor response to HER2-targeted therapy.
  • Clinical trials are planned to explore intensifying therapy for predicted conventional responders and to investigate the possibility of safely stopping treatment for exceptional responders.

FDA Panel Rejects Ocaliva's Full Approval for Primary Biliary Cholangitis

  • An FDA advisory committee voted against full approval of obeticholic acid (Ocaliva) for primary biliary cholangitis (PBC) due to insufficient evidence of clinical benefit.
  • The COBALT trial, intended to confirm Ocaliva's efficacy, failed to demonstrate a significant reduction in liver transplantation, death, or liver-related outcomes.
  • Safety concerns, including trends of excess liver transplants and death in patients taking Ocaliva, further contributed to the panel's negative recommendation.
  • The FDA will make a final decision by October 15, with the possibility of Ocaliva being pulled from the market, following a similar revocation in Europe.

Tarlatamab (Imdelltra) Receives Accelerated FDA Approval for Relapsed Small-Cell Lung Cancer

  • The FDA granted accelerated approval to tarlatamab (Imdelltra) for relapsed small-cell lung cancer (SCLC) post-platinum-based chemotherapy, offering a novel treatment option.
  • Tarlatamab, a bispecific T-cell engager, demonstrated promising early efficacy, leading to its accelerated approval while Phase 3 confirmatory trials are ongoing.
  • Nurse navigators play a crucial role in supporting SCLC patients during clinical trials, addressing mistrust and logistical challenges to improve enrollment and retention.
  • Early involvement of investigators in study design and sponsor receptiveness to feedback are critical for successful clinical trial experiences, as seen with Amgen's approach to the Imdelltra trials.

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

NCT05740566Active, Not RecruitingPhase 3
Amgen
Posted 5/31/2023

Withings' Sleep Rx Mat Receives FDA 510(k) Clearance for OSA Diagnosis Assistance

  • The FDA has granted 510(k) clearance to Withings' Sleep Rx Mat, a device designed to aid in the diagnosis of sleep apnea in adults.
  • The under-mattress mat tracks sleep, breathing, and cardiovascular activity, providing users with a sleep quality score and detailed sleep data.
  • The device uses pneumatic, sound, and motion sensors to monitor respiratory rate, heart rate, sleep cycles, snoring, and breathing disturbances.
  • Withings' VP, Antoine Robillard, highlights the potential for Sleep Rx to improve OSA diagnosis and reduce the economic burden of undiagnosed sleep apnea.

Trending News

1

Eli Lilly Acquires Verve Therapeutics for $1.3 Billion to Advance One-Time Gene Editing Treatments for Cardiovascular Disease

6 days ago
2

Eli Lilly Acquires Gene-Editing Biotech Verve Therapeutics for $1.3 Billion to Expand Cholesterol Treatment Pipeline

6 days ago
3

AbbVie's VERONA Trial for High-Risk Myelodysplastic Syndrome Fails to Meet Primary Survival Endpoint

7 days ago
4

FDA Approves CSL's ANDEMBRY for Hereditary Angioedema Prevention with Novel Factor XIIa Targeting

6 days ago
5

FDA Approves Tafasitamab Triple Combination for Relapsed/Refractory Follicular Lymphoma

4 days ago
6

AbbVie's Atogepant Demonstrates Superior Tolerability and Efficacy Over Topiramate in Phase 3 Migraine Prevention Trial

5 days ago
7

D&D Pharmatech's DD01 Shows Rapid Liver Fat Reduction in MASH Phase 2 Trial, Matching Competitor Results in Quarter of the Time

7 days ago
8

Draig Therapeutics Emerges from Stealth with $140M to Advance Novel Neuropsychiatric Therapies

5 days ago
9

Single Psilocybin Dose Provides Two-Year Depression Relief in Cancer Patients

7 days ago
10

Lundbeck's Eptinezumab Shows Strong Efficacy in Asian Chronic Migraine Patients in Phase III SUNRISE Trial

2 days ago
Subscribe Icon

Daily Pharma Insights

Get curated, high-impact pharmaceutical news delivered to your inbox every morning.

  • Critical clinical trial updates & results
  • Regulatory approvals & strategic partnerships
  • Market access decisions & commercial developments
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy