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Clinical Trial News

Shuttle Pharma Expands Glioblastoma Trial with Ropidoxuridine, Boosting Enrollment Sites

  • Shuttle Pharma broadens its Phase 2 trial for Ropidoxuridine in glioblastoma, increasing the number of active enrollment sites to four.
  • The trial focuses on IDH wild-type, methylation-negative glioblastoma patients, who currently have limited treatment options and poor prognosis.
  • Ropidoxuridine, an orphan drug, is being tested as a radiation sensitizer, potentially improving survival rates compared to historical controls.
  • The study aims to determine the optimal dosage over 18-24 months, with initial enrollment of 40 patients and an additional 14 for statistical significance.

Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter

NCT06359379RecruitingPhase 2
Shuttle Pharmaceuticals, Inc.
Posted 9/2/2024

T2 Biosystems' T2Candida Panel Receives FDA Clearance for Pediatric Use

  • T2 Biosystems has secured FDA clearance to market its T2Candida Panel for pediatric patients, expanding its reach to over 200 children's hospitals in the U.S.
  • The T2Candida Panel is the only FDA-cleared diagnostic test capable of detecting sepsis-causing Candida species directly from blood within 3-5 hours.
  • Clinical studies demonstrate the T2Candida Panel's superior speed and sensitivity compared to traditional blood culture methods, enabling faster, targeted antifungal treatment.
  • The FDA clearance allows for improved patient outcomes and reduced healthcare costs through quicker diagnosis and treatment of invasive candidiasis in children.

Cabometyx Demonstrates Significant Efficacy in Advanced Neuroendocrine Tumors

  • The CABINET Phase III trial revealed that Cabometyx significantly reduced the risk of disease progression or death in advanced neuroendocrine tumors (NETs).
  • In pancreatic NETs, Cabometyx showed a 77% reduction in risk, with median progression-free survival (PFS) of 13.8 months compared to 4.4 months for placebo.
  • For extra-pancreatic NETs, Cabometyx reduced the risk by 62%, achieving a median PFS of 8.4 months versus 3.9 months for placebo.
  • Ipsen has submitted an extension of indication Marketing Authorization to the European Medicines Agency, aiming to expand treatment options for NETs.

Cipher Pharmaceuticals Faces Temporary Setback with Nail Fungus Treatment Data

  • Cipher Pharmaceuticals' partner, Moberg Pharma, reported weaker-than-expected clinical cure data from a North American Phase 3 study of MOB-015 for nail fungus.
  • Despite the setback, analysts maintain a positive outlook, citing strong mycological cure data from previous Phase 3 studies and existing European approvals.
  • The analyst anticipates Health Canada approval based on EMA approval precedent, projecting peak Canadian sales of US$17.4M by 2030.
  • The analyst believes the stock weakness is temporary and expects a recovery, maintaining a "Buy" rating with a target price of $17.00.

GSK and iTeos' Jemperli-Belrestotug Combo Shows Promise in NSCLC

  • GSK and iTeos' combination of Jemperli and belrestotug demonstrated a confirmed objective response rate of approximately 60% in NSCLC patients.
  • Circulating tumor DNA levels decreased significantly in patients receiving the combination therapy compared to Jemperli alone, indicating a deeper response.
  • The GALAXIES Lung-201 study showed manageable immune-related adverse events with the doublet therapy, supporting its potential for further development.
  • The ongoing GALAXIES Lung-301 study aims to advance the Jemperli-belrestotug combination toward registration for PD-L1 high NSCLC patients.

Enhanced TSOS Intervention Shows Promise for Trauma Survivors in Australia

  • Researchers in Australia assessed the feasibility of an enhanced TSOS intervention for trauma patients at risk of persistent PTSD and pain.
  • The study found the intervention was highly valued by participants and could be implemented cost-effectively within the Victorian trauma system.
  • Preliminary evidence suggests the intervention may reduce PTSD symptoms and pain-related disability, warranting further efficacy studies.
  • The study enrolled patients with complex clinical and social experiences, often excluded from traditional psychology-informed intervention trials.

Clene to Meet with FDA to Discuss CNM-Au8 for ALS

  • Clene Inc. will meet with the FDA before the end of November 2024 to discuss CNM-Au8's development for amyotrophic lateral sclerosis (ALS).
  • The FDA agreed to re-evaluate Clene's submission under the accelerated approval pathway after initial concerns regarding the briefing package.
  • Clene has accumulated over 700 patient-years of safety data for CNM-Au8, showing no significant safety concerns or trends.
  • No serious adverse events related to CNM-Au8 treatment have been identified by clinical trial investigators to date.

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