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Clinical Trial News

Aga Khan University Hospital Launches Clinical Trial of KRAS Inhibitor GDC-6036 in Kenya

  • A new clinical trial in Kenya is evaluating Roche's GDC-6036, a novel drug targeting the KRAS gene, in cancer patients.
  • The trial aims to determine if GDC-6036 can effectively block the mutation of the KRAS gene into the KRAS G12C variant, which is implicated in various cancers.
  • The study emphasizes the importance of conducting clinical trials in Africa to develop therapies that are better suited to the genetic specifications of African populations.
  • The trial seeks to provide new treatment options for cancer patients and contribute to the advancement of precision oncology in the region.

Gene Editing Shows Promise for Usher Syndrome Treatment

  • Researchers are exploring gene editing techniques to address the underlying genetic mutations in Usher syndrome, a rare disorder causing hearing and vision loss.
  • An exon skipping strategy targeting the Ush2A gene, responsible for the most common form of Usher syndrome, has shown potential in preclinical studies.
  • Gene and cell therapies offer avenues for restoring hearing and vision, with gene therapy demonstrating success in other hearing and vision loss conditions.
  • Further research is needed to demonstrate treatment efficacy in mature animal models before clinical trials can be initiated for Usher syndrome patients.

GLP-1 Agonists Show Promise in Primary Prevention of Cardiovascular Events

  • GLP-1 drugs like Ozempic and Wegovy, traditionally used for diabetes and obesity, may significantly reduce cardiovascular disease risk.
  • A new study suggests GLP-1 drugs could prevent up to 34,000 strokes and heart attacks annually in the United States.
  • Research indicates GLP-1s could serve as primary prevention for heart attack and stroke in patients with obesity and mild to moderate CVD.
  • Further research is needed to validate these findings and address the challenges of widespread GLP-1 use for primary prevention.

Expert Dermatologist Outlines Key Diagnostic Criteria for Urticaria at Maui Derm Conference

  • Dr. Jason Hawkes emphasizes that urticaria should be viewed as a heterogeneous condition characterized by wheals lasting less than 24 hours or angioedema persisting up to 72 hours.
  • The expert highlights that mast cell degranulation, rather than T-cell activity, is the key pathophysiological mechanism underlying all types of urticaria, including acute, inducible, and chronic spontaneous forms.
  • Angioedema, involving deeper skin swelling, is identified as the primary driver of emergency care visits, with the condition requiring longer resolution time compared to typical hives.

Aspirin Efficacy Varies During Pregnancy, Suggesting Need for Dose Adjustment

  • A recent study in the American Journal of Obstetrics & Gynecology reveals that aspirin's effectiveness in pregnancy varies, impacting salicylic acid concentrations and platelet inhibition.
  • The study found an inverse relationship between BMI and peak aspirin concentration (Cmax), indicating obesity may affect drug absorption during pregnancy.
  • While aspirin reduced urinary thromboxane levels, these changes decreased in the third trimester, suggesting a potential need for dose adjustments as pregnancy progresses.
  • Researchers recommend considering aspirin dose modification during pregnancy to achieve optimal therapeutic response and improve outcomes.

FDA Approves New Therapies from Lilly, Novartis, Merck, J&J, and AstraZeneca

• Eli Lilly's Ebglyss secured FDA approval for treating moderate-to-severe atopic dermatitis in adults and children, offering significant skin clearance and itch relief. • Novartis' Kisqali gained approval for adjuvant treatment of early breast cancer, reducing recurrence risk by 28.5% when combined with an aromatase inhibitor. • Merck's Keytruda, combined with chemotherapy, received FDA approval for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM). • J&J's Rybrevant was approved for expanded use in advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions after EGFR TKI treatment.

Tyra Biosciences Initiates Phase 1/2 Trial of TYRA-300 in Metastatic Urothelial Carcinoma

• Tyra Biosciences has commenced its SURF301 Phase 1/2 clinical trial, dosing the first patient with TYRA-300, an oral FGFR3-selective inhibitor. • The SURF301 study will evaluate TYRA-300's safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with metastatic urothelial carcinoma. • TYRA-300 represents a novel, purpose-built therapy designed to overcome tumor resistance and improve outcomes in cancer patients with FGFR3 alterations. • The initiation of the SURF301 trial marks a significant milestone for Tyra Biosciences in advancing precision oncology treatments for urothelial carcinoma.

Vortioxetine Shows Promise in Glioblastoma Treatment by Targeting Tumor-Specific Vulnerabilities

  • A high-throughput drug screening identified vortioxetine, a neuroactive drug, as a potential treatment for glioblastoma, demonstrating anti-cancer activity in patient-derived cells.
  • Ex vivo drug testing revealed that vortioxetine selectively targets glioblastoma cells, reducing their viability while sparing other cell types, indicating a tumor-specific mechanism.
  • Mechanistic studies showed vortioxetine modulates calcium signaling and downregulates key genes involved in glioblastoma proliferation and survival, such as BTG1 and BTG2.
  • In vivo experiments in mice confirmed that vortioxetine can inhibit glioblastoma tumor growth, suggesting its potential as a novel therapeutic agent for this aggressive brain cancer.

Trabectedin Plus Ipilimumab and Nivolumab Shows Promise in Advanced Soft Tissue Sarcoma

  • A combination of trabectedin, ipilimumab, and nivolumab demonstrates potential as a safe and effective first-line treatment for advanced soft tissue sarcoma.
  • The SAINT study's phase 2 results showed an overall response rate of 24.7% and a disease control rate of 82.5% in previously untreated patients.
  • Median progression-free survival was 7.3 months, and median overall survival reached 32.0 months, indicating a clinically meaningful benefit.
  • Further randomized studies are recommended to confirm the superiority of this regimen compared to standard first-line therapies.

Third Harmonic Bio Appoints Geoff McDonough to Board of Directors, Advancing THB335 for Chronic Spontaneous Urticaria

  • Third Harmonic Bio appointed Geoff McDonough, M.D., to its Board of Directors, enhancing its leadership with extensive clinical and commercial experience.
  • The appointment supports the advancement of THB335, Third Harmonic Bio's lead product candidate, into clinical trials for chronic spontaneous urticaria.
  • Geoff McDonough's expertise and cultural alignment are expected to significantly benefit Third Harmonic Bio's strategic and operational initiatives.

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