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Implantica's RefluxStop Device Shows Strong Two-Year Results in GERD

  • Implantica's RefluxStop device demonstrated a 90.9% improvement in the quality of life for patients with gastro-oesophageal reflux disease (GORD).
  • A retrospective analysis showed that 96.4% of patients discontinued regular proton pump inhibitor (PPI) medication after RefluxStop implantation.
  • The study, involving 158 patients in Germany, highlights RefluxStop's potential to offer durable benefits for GORD, even in complex cases.
  • RefluxStop aims to reconstruct the anti-reflux barrier, offering a different approach compared to existing technologies like Johnson & Johnson's Linx system.

Recombinant Factor 7A Shows Promise in Halting Brain Bleeds After Stroke

  • A global study is underway to evaluate Recombinant Factor 7A's efficacy in stopping brain bleeds following a stroke, potentially improving patient outcomes.
  • The trial focuses on administering the drug within the first few hours of stroke onset, when it is believed to have the greatest impact.
  • Mobile stroke units are being utilized to expedite treatment, aiming to administer the drug within a critical two-hour window.
  • The FDA has granted permission for "exception from informed consent" to facilitate rapid treatment in eligible patients.

Alteogen Seeks Approval for Aflibercept Biosimilar ALT-L9 in Korea

  • Alteogen has applied for marketing authorization in Korea for ALT-L9, a biosimilar of aflibercept (Eylea®), marking a significant step in expanding treatment options for retinal diseases.
  • A Phase 3 study conducted across 12 countries demonstrated that ALT-L9 met its primary endpoint, establishing therapeutic equivalence to the reference product, Eylea®.
  • Alteogen's subsidiary, Altos Biologics, previously submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for ALT-L9, with potential approval expected in 2025.

TAR-200 Plus Cetrelimab Shows Promise in Muscle-Invasive Bladder Cancer

  • Interim analysis of the SunRISe-4 study reveals that TAR-200 combined with cetrelimab demonstrates a 42% pathologic complete response rate in patients with muscle-invasive bladder cancer.
  • The combination therapy also achieved a 60% pathologic objective response rate, indicating a significant reduction in tumor size or elimination of the tumor.
  • Cetrelimab monotherapy showed a 23% pathologic complete response rate and a 36% pathologic objective response rate in the same patient population.
  • The TAR-200 and cetrelimab combination presented a manageable safety profile, suggesting it could be a viable neoadjuvant treatment option.

A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder

NCT04919512Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 7/7/2022

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

NCT04640623Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 12/18/2020

Oral Gildeuretinol Acetate Fails to Meet Primary Endpoint in Phase 3 Geographic Atrophy Trial

  • Alkeus Pharmaceuticals' oral gildeuretinol acetate (ALK-001) did not meet the primary endpoint of reducing geographic atrophy (GA) lesion growth rate in the SAGA phase 3 study.
  • The SAGA study enrolled 198 patients with GA secondary to age-related macular degeneration, assessing GA lesion growth over 24 months.
  • Gildeuretinol showed a 0.25 mm²/year reduction in GA lesion growth compared to placebo, considered "clinically meaningful" by Alkeus, and significantly reduced low luminance visual acuity loss (p = 0.03).
  • Alkeus plans to discuss the SAGA data with regulatory agencies to determine the best path forward for gildeuretinol, a deuterated vitamin A analog.

PlaqueTec and RxCelerate Collaborate on Novel Drug Discovery for Coronary Artery Disease

  • PlaqueTec and RxCelerate successfully completed a collaboration to assess small molecules against a novel target in coronary artery disease (CAD).
  • RxCelerate developed a bespoke cell-based assay to test small molecules predicted to bind PlaqueTec's candidate target.
  • The collaboration characterized lead compounds, demonstrating the assay's value in PlaqueTec's CAD endotyping mission.
  • Further collaboration is planned to investigate additional lead compounds and targets identified in PlaqueTec's BIOPATTERN trial.

TiNivo-2 Trial: Nivolumab Fails to Improve Outcomes in Advanced RCC After Prior ICI Therapy

  • The Phase 3 TiNivo-2 trial evaluated tivozanib plus nivolumab versus tivozanib alone in patients with renal cell carcinoma (RCC) who progressed on prior immune checkpoint inhibitor (ICI) therapy.
  • The study found no significant difference in progression-free survival (PFS), overall survival (OS), or response rate between the combination and tivozanib monotherapy arms.
  • These results, along with previous data, suggest that re-challenging with an ICI in metastatic RCC should be approached with caution, except in specific scenarios like long duration from prior ICI.
  • The combination arm used a lower dose of tivozanib due to hypertension concerns, which may have impacted the results.

Kesimpta Demonstrates Sustained Efficacy in Relapsing Multiple Sclerosis

  • Kesimpta (ofatumumab) shows promise in reducing disability progression and disease activity in patients with relapsing multiple sclerosis (RMS) based on ALITHIOS and OLIKOS trial data.
  • Treatment-naïve RMS patients on continuous Kesimpta were more likely to avoid six-month confirmed disability worsening compared to those switching from Aubagio (83.4% vs. 76.3%).
  • The OLIKOS trial found no new gadolinium-enhancing T1 lesions at 12 months in clinically stable RMS patients switching from IV anti-CD20 therapy to Kesimpta.
  • Continuous Kesimpta led to fewer disability worsening events and a greater likelihood of being progression-free, especially when initiated early in the disease course.

FDA Grants Orphan Drug Designation to CF33-hNIS for Cholangiocarcinoma

  • The FDA has granted orphan drug designation to CF33-hNIS (Vaxinia) for treating cholangiocarcinoma, a rare cancer with limited therapeutic options.
  • CF33-hNIS, an oncolytic virotherapy, is being investigated in the phase 1 MAST trial as a monotherapy and in combination with pembrolizumab for advanced solid tumors.
  • Early data from the MAST trial showed promising results, including an objective response rate of 14% and a disease control rate of 86% in monotherapy arm.
  • The orphan drug designation provides Imugene with incentives such as tax credits and market exclusivity to support the development of CF33-hNIS.

A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors

NCT05346484RecruitingPhase 1
Imugene Limited
Posted 5/17/2022

NIH-Funded Study to Investigate Type 1 Diabetes' Impact on Children's Brain Development

  • A nationwide longitudinal study, funded by a $2.7 million NIH grant, will explore the effects of type 1 diabetes on brain development in children.
  • The multi-site study will involve 12 research centers across the U.S. and recruit over 1,000 children newly diagnosed with type 1 diabetes.
  • Researchers aim to identify factors that may accelerate or mitigate the risk of brain-related complications in children with type 1 diabetes.
  • The study will use fMRI and collect data on academic performance, memory, attention, and neurobehavioral health to refine clinical guidelines.

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