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Clinical Trial News

BWC0977: A Novel Antibacterial Agent Shows Promise Against Multi-Drug Resistant Infections

  • BWC0977, a novel bacterial topoisomerase inhibitor, has demonstrated efficacy against multi-drug resistant pathogens, including strains resistant to fluoroquinolones and carbapenems.
  • The drug's unique mechanism of action targets a broad spectrum of bacteria, encompassing both Gram-positive and Gram-negative types, distinguishing it from traditional antibiotics.
  • Clinical trials have shown BWC0977 to be safe and well-tolerated in healthy volunteers, with ongoing development including an oral formulation to enhance patient accessibility.

A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of BWC0977 in Healthy Volunteers

NCT05088421CompletedPhase 1
Bugworks Research Inc.
Posted 11/5/2021

University of Hong Kong to Enhance AI Tool for Cardiovascular Disease Risk Prediction

  • The University of Hong Kong (HKU) is launching a recruitment round for its "Heartwise" study, aiming to enroll 3,000 patients.
  • The study seeks to improve the accuracy of the "P-Cardiac" tool, an AI-powered system for predicting cardiovascular disease risk.
  • "P-Cardiac" utilizes Asia's largest patient records database, encompassing 300,000 records from the Hospital Authority.
  • Researchers hope the improved tool will enhance cardiovascular disease risk assessment and personalize healthcare strategies.

Molecular Imaging Reveals Mechanism Behind BCG Resistance in Bladder Cancer, Leading to New Trial

  • A recent imaging study has elucidated the mechanisms behind BCG resistance in non-muscle invasive bladder cancer (NMIBC) by assessing gene and protein activity in tumor samples.
  • The study identified the upregulation of the immune checkpoint NKG2A in immune cells, suggesting a potential target for overcoming BCG resistance.
  • Findings from this research have directly led to the launch of the phase 2 ENHANCE trial (NCT06503614), which will test the combination of durvalumab and monalizumab.
  • The ENHANCE trial will enroll patients with BCG-unresponsive NMIBC, including carcinoma in situ and papillary tumors, with the goal of improving treatment outcomes.

A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer

NCT06503614RecruitingPhase 2
John Sfakianos
Posted 2/24/2025

FDA Approves Shield Blood Test for Colorectal Cancer Screening

  • The FDA has approved Shield, the first blood test for primary colorectal cancer screening, offering a less invasive option for average-risk adults.
  • Shield demonstrated high sensitivity in detecting existing colorectal cancers (83%) but lower sensitivity (13%) for precancerous polyps in a study of nearly 8,000 participants.
  • Experts emphasize the importance of follow-up colonoscopies after positive Shield test results to remove precancerous growths and prevent cancer deaths.
  • While Shield could increase screening rates, questions remain about its cost-effectiveness and long-term impact on reducing colorectal cancer incidence and mortality.

Whooping Cough Cases Surge in the U.S., Prompting Review of Vaccine Testing Methods

  • Pertussis cases in the U.S. have increased fivefold compared to last year, reaching the highest levels since 2014, indicating a return to pre-pandemic infection rates.
  • Current pertussis vaccines offer strong initial protection, but their effectiveness wanes after two to three years, contributing to the upward trend in infections despite high vaccination rates.
  • The FDA is considering the use of human challenge trials, where participants are intentionally infected, to accelerate the development and testing of more effective pertussis vaccines.
  • Experts are exploring if challenge trials can accurately measure vaccine efficacy, while acknowledging the need to refine these models to ensure they provide sufficient evidence for vaccine approval.

Moderna's mRNA Cancer Vaccine Shows Promising Early Results in Solid Tumors

  • Moderna's mRNA vaccine demonstrates encouraging early results in a trial targeting advanced solid cancers, enhancing the immune system's ability to recognize and kill cancerous cells.
  • The vaccine represents a personalized approach, potentially offering an 'off-the-shelf' solution for various cancer types based on individual tumor profiles.
  • Early trial data suggests the vaccine's capability to stimulate immune responses against cancer cells, marking a significant step forward in cancer immunotherapy.
  • This development highlights the potential of mRNA technology beyond infectious diseases, paving the way for innovative cancer treatments.

Canadian Men with Breast Cancer Face Barriers to Accessing Capivasertib

  • Health Canada has approved capivasertib (Truqap) for women with HR-positive, HER2-negative advanced breast cancer, but not for men due to limited male participation in clinical trials.
  • Men with breast cancer in Canada are facing challenges accessing capivasertib, despite clinical evidence suggesting its potential benefit and approvals in other regions like the US and EU.
  • Canadian oncologists argue that the biology of breast cancer is similar in men and women, advocating for broader access to treatments like capivasertib for male patients.
  • Patient advocates emphasize the importance of informed choices and equal access to potentially life-extending drugs, regardless of gender, urging Health Canada to reconsider its approval process.

VESPER Trial: BaSq Subtype Linked to Poorer Outcomes in Bladder Cancer

  • The VESPER trial's molecular subtyping analysis reveals the BaSq subtype (pure or mixed) is associated with decreased progression-free survival and overall survival in bladder cancer patients.
  • Patients in the neoadjuvant setting who received dose-dense MVAC chemotherapy showed significantly higher three-year progression-free survival compared to those receiving gemcitabine and cisplatin.
  • Extended follow-up of the VESPER trial demonstrated improved overall survival at 5 years in the dose-dense MVAC group versus the gemcitabine + cisplatin group within the neoadjuvant subgroup.
  • Further research is needed to understand the biological bases for mixed tumors and to improve prognosis for BaSq subtype tumors.

WHO Assesses India's Drug Regulatory Authority and Vaccine Manufacturing

  • The World Health Organization (WHO) has assessed India's Central Drugs Standard Control Organization (CDSCO), the nation's top drug regulator.
  • The evaluation aimed to determine the status of India's National Regulatory Authority (NRA) concerning drug regulation.
  • The assessment also included an evaluation of vaccine manufacturing practices within India, a major global vaccine producer.

Oncology Leaders Emphasize Cautious AI Implementation to Maintain Physician Trust

  • Rocky Mountain Cancer Centers' executive director warns that inaccurate AI outputs could damage physician confidence in the technology for months, emphasizing the need for careful implementation.
  • Healthcare leaders advocate for experimental demonstration projects to understand both AI capabilities and provider responses before widespread adoption in oncology practices.
  • Experts stress the importance of maintaining physician autonomy and accountability while integrating AI tools into cancer care workflows.

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