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Clinical Trial News

Arcturus Therapeutics Gains Momentum with Regulatory Approval and Clinical Advancements

  • Arcturus Therapeutics' Kostaive vaccine receives Japanese regulatory approval for updated JN.1 formulation, expected to generate $85 million in revenue.
  • The company's cystic fibrosis treatment, ARCT-032, advances to Phase 2 study after promising Phase 1/1b trial results.
  • Arcturus is awaiting European Medicines Agency (EMA) decision on Kostaive approval, anticipated in the third quarter of 2024.

Medical Marijuana Use Linked to Rapid Improvements in Quality of Life

  • A new study reveals that medical marijuana users experience rapid and significant improvements in health-related quality of life within the first three months of use.
  • Participants reported notable gains in pain reduction, increased energy levels, and enhanced emotional, social, and physical functioning.
  • The study, involving nearly 400 adults, highlights the potential benefits of medical marijuana for conditions like anxiety disorders and chronic pain.
  • Researchers emphasize the importance of understanding which patients may benefit most from specific cannabis therapies in the era of precision medicine.

Intensified Therapy Reverses Poor Prognosis in Prostate Cancer Patients with HSD3B1 Mutation

  • A new study identifies that intensified treatment with androgen deprivation therapy (ADT) plus enzalutamide improves survival for prostate cancer patients with the adrenal-permissive HSD3B1 allele.
  • The research, analyzing the ENZAMET trial, demonstrates that upfront treatment intensification can effectively block adrenal androgens, reversing the poorer prognosis typically associated with the HSD3B1 mutation.
  • Findings suggest that genetic analysis of HSD3B1 could help tailor more effective therapies for advanced prostate cancer, potentially reducing mortality and improving survival outcomes.
  • The discovery offers a significant step forward in understanding the genetics of advanced prostate cancer and focusing future clinical trials on targeted treatments.

Metformin Use Linked to Reduced Long COVID Risk in Diabetes Patients

  • A new study reveals that metformin, a common diabetes drug, may lower the risk of developing Long COVID or dying within six months of COVID-19 infection.
  • The research, analyzing data from nearly 76,000 Americans with type 2 diabetes, found a 13% to 21% reduction in Long COVID or death among metformin users.
  • Scientists speculate that metformin's protective effects may stem from its ability to reduce inflammation, decrease viral levels, and suppress disease-related protein formation.
  • The findings support earlier research suggesting metformin's potential benefits in preventing Long COVID, regardless of diabetes status.

Enfortumab Vedotin Plus Pembrolizumab Shows Consistent Benefits in Urothelial Carcinoma Regardless of Nectin-4 Levels

  • The combination of enfortumab vedotin and pembrolizumab demonstrates superior progression-free survival (PFS), overall survival (OS), and overall response rate (ORR) compared to chemotherapy in urothelial carcinoma.
  • An exploratory analysis of the EV-302 trial reveals that the benefits of enfortumab vedotin plus pembrolizumab are consistent across all Nectin-4 expression subgroups.
  • The study suggests that Nectin-4 expression levels do not significantly impact the efficacy of enfortumab vedotin plus pembrolizumab in treating locally advanced or metastatic urothelial carcinoma.
  • These findings further establish enfortumab vedotin plus pembrolizumab as a standard of care for first-line treatment, irrespective of PD-L1 or Nectin-4 expression.

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

NCT04223856Active, Not RecruitingPhase 3
Astellas Pharma Global Development, Inc.
Posted 3/30/2020

BCL2 Protein Identified as Potential Drug Target in Aggressive Prostate Cancer

  • Researchers have found that high levels of BCL2 protein are associated with more aggressive metastatic castration-resistant prostate cancer (mCRPC) and shorter overall survival.
  • The study suggests that patients with elevated BCL2 may respond less favorably to hormone therapies like enzalutamide and abiraterone, but may benefit from docetaxel.
  • A clinical trial is underway to evaluate the BCL2 inhibitor venetoclax in combination with enzalutamide for prostate cancer, offering a potential new treatment strategy.
  • Targeting the BCL2 family of proteins (BCL2, BCLXL, and MCL1) together showed the best anti-tumor response in lab studies, suggesting a future combination therapy approach.

Eli Lilly's Lutetium Zadavotide Guraxetan Shows Promise in Metastatic Castration-Resistant Prostate Cancer

• Eli Lilly's 177Lu-PNT2002 demonstrated efficacy in chemotherapy-naïve mCRPC patients progressing on ARPIs, with a median rPFS of 9.5 months, compared to 6 months for ARPIs. • The overall survival analysis showed a hazard ratio of 1.14, but adjusted for crossover, the HR was reduced to 0.68, suggesting a potential survival benefit. • 177Lu-PNT2002 offers a more patient-friendly dosing schedule compared to Novartis' Pluvicto, with lower dosage, longer intervals, and fewer cycles. • Despite negative OS results, the FDA may view 177Lu-PNT2002 favorably due to the high crossover rate, similar to Pluvicto's approval circumstances.

Tislelizumab Approved in Israel for Advanced Esophageal Squamous Cell Carcinoma

  • The Israeli Ministry of Health has approved tislelizumab (Tevimbra) as monotherapy for unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy.
  • Approval was based on the phase 3 RATIONALE 302 trial, which demonstrated a statistically significant improvement in overall survival (OS) compared to chemotherapy.
  • In the RATIONALE-302 trial, tislelizumab showed a median OS of 8.6 months versus 6.3 months with chemotherapy, with a hazard ratio of 0.70 (P = .0001).
  • This approval marks a significant step in providing a new treatment option for ESCC patients in Israel, potentially improving outcomes for this challenging malignancy.

A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03430843CompletedPhase 3
BeiGene
Posted 1/26/2018

Boehringer Ingelheim's Nintedanib Demonstrates Positive Phase III Results in Idiopathic Pulmonary Fibrosis

  • Boehringer Ingelheim's nintedanib has shown statistically significant results in a Phase III trial for treating idiopathic pulmonary fibrosis (IPF).
  • The trial marks the first successful Phase III outcome in IPF treatment in a decade, offering new hope for patients.
  • Nintedanib aims to slow disease progression, addressing a critical unmet need in IPF management and improving patient outcomes.

Oral Obesity Pill Race Heats Up with New Data from Novo, Roche, and Terns

• Novo Nordisk's oral amycretin demonstrated a 4% placebo-adjusted weight loss after four weeks, showing potential in glucose control and appetite regulation. • Roche's CT-996 led with a 6.1% placebo-adjusted weight loss but raised tolerability concerns due to high rates of gastrointestinal adverse events. • Terns Pharmaceuticals' TERN-601 achieved a 4.9% placebo-adjusted weight loss, with analysts noting a unique approach that could balance efficacy and tolerability.

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