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Clinical Trial News

EORTC and Medidata Extend Partnership to Enhance Oncology Clinical Trials

  • The European Organisation for Research and Treatment of Cancer (EORTC) has extended its partnership with Medidata for four years.
  • The collaboration aims to improve patient access to oncology clinical trials and accelerate the delivery of new treatments.
  • EORTC is leveraging 13 Medidata solutions to streamline data management and enhance patient engagement in clinical trials.
  • The partnership will explore joint research and data collaboration with Medidata AI to improve cancer care standards.

Bria-IMT Shows Promise in Metastatic Breast Cancer, Including Brain Metastasis

  • Bria-IMT, combined with checkpoint inhibitors, demonstrates encouraging antitumor activity, including complete resolution of brain metastasis in a breast cancer patient.
  • Patients treated with Bria-IMT in phase 1/2 trials showed a median overall survival of 15.6 months, exceeding historical data for similar patient populations.
  • The Bria-IMT regimen is under evaluation in the pivotal phase 3 BRIA-ABC trial for advanced metastatic breast cancer, with interim results expected in the second half of 2025.

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

Combination Study of SV-BR-1-GM With Retifanlimab

NCT03328026Enrolling by InvitationPhase 1
BriaCell Therapeutics Corporation
Posted 3/16/2018

GLP-1 Receptor Agonists Spearhead Obesity Treatment Advancements

  • Semaglutide (WEGOVY) marked the resurgence of GLP-1R agonists for obesity treatment, gaining FDA approval in June 2021 and achieving blockbuster status with $7.73 billion in sales by 2023.
  • Tirzepatide (ZEPBOUND), a GIPR/GLP-1R co-agonist, and setmelanotide (IMCIVREE), an MC4R agonist, have expanded the therapeutic landscape for obesity, addressing different mechanisms of action.
  • Obesity, a chronic disease affecting millions globally, heightens the risk of type 2 diabetes, heart disease, and certain cancers, emphasizing the need for safe and effective anti-obesity medications.

Tirzepatide (Mounjaro) Approved in Australia for Weight Management in Comorbid Adults

  • Australia's TGA has approved tirzepatide (Mounjaro) for chronic weight management in adults with obesity or overweight with comorbidities, alongside diet and exercise.
  • The approval expands Mounjaro's indication beyond type 2 diabetes, offering a new treatment option for eligible patients seeking weight loss and maintenance.
  • Supply of tirzepatide vials remains limited until August next year, but Eli Lilly Australia is transitioning to multi-use KwikPens to improve availability.
  • Experts emphasize that tirzepatide should be part of a multidisciplinary approach, including lifestyle advice and support from healthcare professionals.

Basking Biosciences Initiates Phase II Trial of BB-031 for Acute Ischemic Stroke

  • Basking Biosciences has dosed the first subject in its Phase II RAISE trial evaluating BB-031 for acute ischemic stroke (AIS).
  • The trial is a multicenter, randomized, placebo-controlled, double-blinded study assessing safety, tolerability, and preliminary efficacy of BB-031.
  • The study will enroll 156 patients within 24 hours of stroke onset and monitor them over 90 days for radiological outcomes.
  • BB-031, an RNA aptamer targeting von Willebrand Factor (vWF), aims to provide a rapid-onset, reversible thrombolytic option for stroke patients.

Incendia Therapeutics Initiates Phase Ic Trial of PRTH-101 for Advanced Solid Tumors

  • Incendia Therapeutics has dosed the first patient in a Phase Ic trial of PRTH-101, a novel DDR1 inhibitor, for advanced or metastatic solid tumors.
  • The open-label study will evaluate PRTH-101's safety, tolerability, and anti-tumor activity as a monotherapy and in combination with pembrolizumab.
  • The trial aims to enroll up to 270 patients in the US and will determine optimal dosing for future Phase II clinical programs.
  • The study will also investigate DDR1 and related proteins as potential biomarkers for patient response to PRTH-101 treatment.

China Streamlines Local Manufacturing for Foreign Pharmaceuticals

  • China is enhancing its regulatory framework to encourage local pharmaceutical manufacturing, particularly for drugs already approved as imports.
  • New regulations prioritize the review and approval of locally manufactured originator drugs, potentially shortening the approval timeline to 130 days.
  • Foreign companies can now transfer drug production to domestic Chinese entities, provided manufacturing processes remain consistent with original standards.
  • Challenges persist regarding intellectual property protection and regulatory compliance during technology transfer and local manufacturing.

Akebia Prepares Vafseo Launch for Dialysis Patients, Seeks Expansion to Pre-Dialysis Market

  • Akebia Therapeutics is set to launch Vafseo (vadadustat) in January 2025 for anemia treatment in dialysis patients, following its FDA approval in March.
  • The company plans to re-engage with the FDA to explore Vafseo's potential use in pre-dialysis chronic kidney disease (CKD) patients.
  • Akebia aims to present data from the Phase 3 PRO2TECT trial to support the drug's efficacy and safety in the pre-dialysis population, addressing an unmet medical need.
  • Company anticipates feedback from the FDA by the end of the year regarding further testing and approval pathways for the pre-dialysis market.

Fentanyl Vaccine Shows Promise in Preclinical Studies, Faces Hurdles in Addiction Treatment

  • A novel fentanyl vaccine has demonstrated promising results in rat models by blocking the drug's euphoric effects and reducing its impact on vital signs.
  • The vaccine works by stimulating the production of antibodies that prevent fentanyl from crossing the blood-brain barrier and activating mu opioid receptors.
  • Clinical trials for drug dependency vaccines have had limited success, highlighting the need for comprehensive treatment approaches that address underlying psycho-social issues.
  • Experts caution that a fentanyl vaccine is unlikely to be a standalone solution and should be integrated with psychotherapy and other support systems to tackle addiction effectively.

EU Clinical Trial Regulation Aims for Harmonization and Oversight

  • The EU Clinical Trial Regulation aims to harmonize clinical trial requirements, timelines, and procedures across 27 member states.
  • The previous clinical trials directive resulted in 27 different national laws, leading to inconsistent quality and oversight.
  • The new regulation seeks to create a unified framework for multistage trials, ensuring consistent standards and timelines across the EU.
  • This harmonization aims to improve oversight and streamline the clinical trial process within the European Union.

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