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Clinical Trial News

Blue Lake and CyanVac's Intranasal COVID-19 Vaccine Shows Promise in Phase 2a Trial

  • Blue Lake and CyanVac reported positive Phase 2a clinical trial data for their intranasal COVID-19 vaccine candidate, CVXGA, demonstrating safety and efficacy.
  • The trial showed a 78% reduction in the risk of symptomatic COVID-19 infection in participants who received CVXGA compared to the placebo group.
  • CVXGA induced S-protein specific serum antibody responses in both younger (18-64 years) and older adults (65+ years), with good tolerability.
  • The PIV5-vectored vaccine showed no significant difference in adverse reactions compared to placebo, suggesting a safe and well-tolerated profile.

BrioHealth Solutions Initiates INNOVATE Trial for BrioVAD System in Advanced Heart Failure

  • BrioHealth Solutions has begun patient enrollment in the INNOVATE trial to assess the safety and effectiveness of the BrioVAD System.
  • The BrioVAD System features a fully magnetically suspended blood pump and uniquely engineered external components.
  • The INNOVATE trial is a randomized, controlled, multi-center study evaluating BrioVAD for advanced, refractory left ventricular heart failure.
  • The trial aims to determine if the BrioVAD System can reduce complications and improve the quality of life for heart failure patients.

RTI Surgical Initiates ADMIRE Study for Cortiva Allograft Dermis in Breast Reconstruction

  • RTI Surgical has enrolled the first patient in the ADMIRE study to evaluate Cortiva Allograft Dermis for implant-based breast reconstruction.
  • The ADMIRE study is a prospective, multi-center, dual-arm, non-randomized clinical trial involving 467 female patients undergoing two-stage breast reconstruction.
  • Cortiva ADM, processed with RTI’s Tutoplast Tissue Sterilization Process, is being investigated for its safety and effectiveness in pre-pectoral breast reconstruction.
  • The study aims to support RTI’s pre-market approval application, potentially setting new standards for improving patient outcomes and quality of life in breast reconstruction.

Targeted Therapies and Clinical Trials Transform Stage 4 EGFR Lung Cancer Treatment for Young Woman

  • A 35-year-old woman with stage 4 EGFR-mutated non-small cell lung cancer experienced tumor shrinkage and successful surgery due to targeted therapies and clinical trial options at MSK.
  • Molecular testing revealed an EGFR mutation, common in young, non-smoking women, guiding treatment decisions towards targeted therapies and clinical trials.
  • Treatment initially involved a clinical trial combining osimertinib with patritumab deruxtecan, later switched to osimertinib alone due to side effects, leading to tumor reduction and surgical removal.
  • Post-surgery, chemotherapy and continued osimertinib are being used to prevent recurrence after pathology revealed some cells were no longer responsive to EGFR drugs.

MIRASOL Trial Update: Mirvetuximab Soravtansine Shows Promise in Platinum-Resistant Ovarian Cancer

  • The Phase III MIRASOL trial evaluated mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer with high folate receptor-alpha (FRα) expression.
  • Mirvetuximab soravtansine demonstrated a statistically significant improvement in progression-free survival compared to chemotherapy in this patient population.
  • The study's findings suggest mirvetuximab soravtansine could become a valuable treatment option for patients with advanced ovarian cancer expressing high levels of FRα.
  • These results may lead to changes in the treatment paradigm for platinum-resistant ovarian cancer, offering a targeted therapy alternative to traditional chemotherapy.

Paxalisib, TTFields, and Proton Irradiation Show Promise in Neuro-oncology

• Paxalisib with radiation therapy showed intracranial responses in two-thirds of patients with PI3K-mutant brain metastases in a phase I study. • Tumor treating fields (TTFields) combined with standard therapy improved progression-free survival in newly diagnosed glioblastoma patients. • Proton craniospinal irradiation demonstrated encouraging overall survival in patients with leptomeningeal metastases, particularly those with breast and lung cancer.

Soylent Meal Replacement Improves Quality of Life in Head and Neck Cancer Patients Undergoing Chemoradiation

• A phase II study evaluated Soylent, a liquid meal replacement, in head and neck cancer patients undergoing chemoradiation to prevent malnutrition and maximize quality of life. • The study demonstrated high patient adherence to Soylent, with 94% of patients successfully transitioning to exclusive meal replacement after experiencing a 5% body weight loss. • The gastrostomy tube (G-tube) placement rate was low at 5%, indicating effective nutritional support with Soylent during cancer treatment. • Patient-reported quality of life, initially reduced during treatment, rebounded to exceed baseline levels within six months, suggesting long-term benefits of Soylent.

SEL-212 Demonstrates Improved Outcomes in Refractory Gout Patients

  • SEL-212, a novel two-component infusion therapy, significantly improved patient-reported outcomes in adults with refractory gout after three doses.
  • Further improvements in physical and mental health were observed with six doses of SEL-212, indicating a dose-dependent benefit for patients.
  • The DISSOLVE I and DISSOLVE II Phase 3 trials showed that SEL-212 enhances health-related quality of life, functional ability, and pain reduction.
  • These findings suggest SEL-212 could address the unmet needs of refractory gout patients who do not respond to conventional urate-lowering therapies.

Merck's Winrevair Shows Strong Efficacy in Severe Pulmonary Hypertension Trial

  • Merck's Winrevair, combined with background therapy, significantly improved outcomes in patients with severe pulmonary arterial hypertension (PAH).
  • The ZENITH trial was halted early due to Winrevair's overwhelming efficacy compared to placebo in reducing mortality and disease-related hospitalization.
  • Winrevair, acquired through the Acceleron acquisition, is projected to reach peak sales of $5 billion annually, driven by its impact on PAH treatment.
  • The drug's success in the ZENITH trial may broaden its application, pending further data and regulatory review.

Increased Water Intake Does Not Significantly Impact Health Outcomes: A Meta-Analysis of Randomized Trials

  • A meta-analysis of randomized controlled trials found that increased daily water intake did not significantly improve various health outcomes in adults.
  • The study included 12 trials with 1,758 participants, assessing effects on body weight, blood pressure, and other physiological measures.
  • Findings suggest that recommendations for increased water consumption may not be supported by robust clinical evidence for general health benefits.
  • Further research is needed to explore potential benefits in specific populations or for particular health conditions related to hydration.

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