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Relutrigine Shows Promise in Reducing Seizures in SCN2A/SCN8A-DEE Phase 2 Trial

  • Relutrigine demonstrated a 46% reduction in motor seizures in pediatric patients with SCN2A and SCN8A developmental and epileptic encephalopathies (DEE).
  • A significant 30% of patients treated with relutrigine achieved seizure freedom, indicating a potential breakthrough in managing these rare disorders.
  • Patients experienced notable improvements in alertness, behavior, and communication, suggesting broader benefits beyond seizure control.
  • Praxis Precision's relutrigine, a sodium channel modulator, targets overactive sodium channels caused by SCN2A and SCN8A mutations.

Novo Nordisk Initiates Phase III Trial for Cagrisema, a Wegovy Successor

  • Novo Nordisk has commenced a Phase III clinical trial evaluating cagrisema, a combination treatment aimed at succeeding their blockbuster weight loss drug, Wegovy.
  • Cagrisema combines cagrilintide, a novel amylin analogue, with semaglutide, the active ingredient in Wegovy, to potentially enhance weight management.
  • The trial will assess the efficacy and safety of cagrisema in a diverse patient population, building upon promising results from earlier phase studies.
  • This strategic move underscores Novo Nordisk's commitment to advancing obesity treatment options and maintaining its leadership in the weight management market.

Rhenium-186 Obisbemeda Shows Promise in Recurrent Glioblastoma Trial

  • Plus Therapeutics' ReSPECT-GBM Phase 1/2 trial update reveals Rhenium-186 Obisbemeda's favorable safety profile and potential efficacy in recurrent glioblastoma treatment.
  • The trial achieved a mean Phase 2 absorbed dose of 300 Gy, with 89% of patients exceeding the 100 Gy minimal dose threshold, indicating effective drug delivery.
  • A statistically significant reduction in tumor volume rate change was observed in patients receiving >100 Gy absorbed dose, suggesting tumor control with sufficient radiation coverage.
  • The ReSPECT-GBM trial has expanded to new sites, enhancing patient enrollment and accelerating the evaluation of Rhenium-186 Obisbemeda as a therapeutic option.

FDA Authorizes Expanded Access to Bria-IMT™ for Metastatic Breast Cancer Patients

  • The FDA has authorized BriaCell's Expanded Access Policy (EAP) for metastatic breast cancer, allowing patients access to Bria-IMT™ outside the Phase 3 trial.
  • The EAP, a condition of BriaCell's Fast Track designation, aims to provide novel treatment options for patients with unmet needs in breast cancer.
  • BriaCell's CEO highlights the FDA's recognition of Bria-IMT™'s safety and efficacy, offering hope for those battling this deadly disease.
  • The Bria-IMT™ regimen has demonstrated impressive survival and clinical benefits in heavily pretreated metastatic breast cancer patients.

Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.

NCT06072612RecruitingPhase 3
BriaCell Therapeutics Corporation
Posted 12/5/2023

Immutep's Efti Shows Promise in Neoadjuvant Soft Tissue Sarcoma Treatment

  • Immutep's EFTISARC-NEO Phase II trial evaluates eftilagimod alpha (efti) with radiotherapy and pembrolizumab in soft tissue sarcoma patients.
  • Initial data from the trial shows encouraging results, with deep responses observed in the majority of the first six patients.
  • The EFTISARC-NEO trial is the first to assess efti in a neoadjuvant setting, allowing for assessment of its impact on the tumor microenvironment.
  • The trial is being conducted at the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw and is funded by a Polish government grant.

Pembrolizumab in Combination with Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients with Soft Tissue Sarcoma - EFTISARC-NEO Trial

NCT06128863Active, Not RecruitingPhase 2
Maria Sklodowska-Curie National Research Institute of Oncology
Posted 7/17/2023

Accord BioPharma's Hercessi (trastuzumab-strf) Receives FDA Approval for 420mg Strength

• Accord BioPharma's Hercessi (trastuzumab-strf), a biosimilar to Herceptin, has received FDA approval for its 420mg strength, expanding treatment options for HER2-overexpressing cancers. • The approval includes indications for adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric or gastroesophageal junction adenocarcinoma. • Clinical data demonstrated Hercessi's similarity to Herceptin in efficacy, safety, and quality, supporting its use as a cost-effective alternative. • Accord BioPharma plans to commercially launch Hercessi in the U.S. in early 2025, adding to their growing portfolio of biosimilars aimed at reducing healthcare costs.

Biosyngen's BRG01 CAR-T Therapy Enters Phase II Trial for Nasopharyngeal Carcinoma After Promising Phase I Results

  • Biosyngen's BRG01, a novel CAR-T therapy targeting EBV antigens, has advanced to a pivotal Phase II trial for advanced nasopharyngeal carcinoma (NPC).
  • Phase I data revealed a 75% tumor reduction rate and progression-free survival exceeding six months in patients who had failed prior treatments.
  • The Phase I trial demonstrated a significant reduction in EBV viral load and a favorable safety profile with no dose-limiting toxicities or severe cytokine release syndrome.
  • BRG01 has received orphan drug and fast track designations from the FDA, highlighting its potential to address unmet needs in EBV-positive tumors.

MIRA Pharmaceuticals Advances Ketamir-2 Development for Neuropathic Pain

  • MIRA Pharmaceuticals has finalized the Phase 1 clinical trial design for Ketamir-2, an oral ketamine analog, with the trial slated to begin in early Q1 2025.
  • The company aims to file an Investigational New Drug (IND) application with the FDA in December 2024, supported by ongoing GLP toxicological studies.
  • MIRA prioritizes demonstrating clinical efficacy in humans by 2025, focusing on neuropathic pain and exploring potential applications in mental health disorders.
  • Drug product development of Ketamir-2 capsules has commenced in collaboration with Formulex to optimize oral bioavailability and patient convenience.

Satellos Bioscience Initiates Phase 1 Trial of SAT-3247 for Duchenne Muscular Dystrophy

  • Satellos Bioscience has dosed the first healthy volunteer in a Phase 1 clinical study of SAT-3247, an oral small molecule drug targeting AAK1.
  • The Phase 1 trial includes healthy volunteers to assess safety and pharmacokinetics, with initial data expected in Q4 2024.
  • A second component of the study, involving adult Duchenne muscular dystrophy (DMD) patients, is anticipated to begin in Q1 2025.
  • SAT-3247 aims to regenerate skeletal muscle in DMD patients, independent of dystrophin and genetic mutation status.

Telemedicine Study Accelerates for Pediatric Ear Conditions, Showing Promise for Reduced Wait Times

  • The ACCENTUATE study investigates telemedicine's feasibility for children with ear and hearing issues, potentially reducing waiting times and improving access to specialist care.
  • Researchers reached their recruitment target of 120 healthy volunteers in just one month, thanks to outstanding teamwork, accelerating the study's progress.
  • The study assesses children with glue ear and healthy volunteers using smartphone otoscopy, hearing tests, and middle ear pressure tests, reviewed remotely by ENT specialists.
  • Findings will inform a pilot teleotology service for children, with results shared with service users and the medical community, potentially transforming pediatric ENT care.

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