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Clinical Trial News

Nanoparticle Therapy Shows Promise in Shrinking Pancreatic Tumors in Mice

  • Researchers at UMass Chan Medical School have developed a nanoparticle therapy that effectively shrinks pancreatic tumors in mice, offering a potential new approach for this deadly cancer.
  • In preclinical trials, the nanoparticle treatment led to significant tumor reduction in eight out of ten mice, with two mice remaining tumor-free for an extended period.
  • The nanoparticles are designed to evade detection in the bloodstream, allowing for more targeted delivery to tumors and activation of the immune system.
  • The research team hopes to advance this therapy to human trials, particularly for patients with late-stage pancreatic cancer who have not responded to conventional treatments.

Verastem Oncology Appoints John Hayslip as Chief Medical Officer

  • Verastem Oncology has appointed John Hayslip, M.D., a seasoned oncologist, as its new Chief Medical Officer to spearhead clinical and medical strategies.
  • Dr. Hayslip will oversee the development programs for avutometinib, including the Phase 3 RAMP 301 clinical trial, and advance other pipeline assets.
  • This appointment follows the departure of Louis J. Denis, M.D., marking a strategic shift in Verastem Oncology's leadership to drive forward its oncology drug development efforts.

Gemcitabine Shows Comparable Efficacy to Mitomycin C in Non-Muscle Invasive Bladder Cancer

  • A randomized phase II trial compared intravesical gemcitabine to mitomycin C after resection of non-muscle invasive bladder cancer (NMIBC).
  • Recurrence rates and time to recurrence were similar between gemcitabine and mitomycin C groups after one year of follow-up.
  • Gemcitabine instillation was slightly less costly than mitomycin C, with comparable adverse event profiles observed in both groups.
  • These findings suggest gemcitabine as a potential alternative to mitomycin C for immediate post-resection instillation in NMIBC.

QL1706 Bifunctional Antibody Shows Promise in Advanced Hepatocellular Carcinoma

  • A Phase II study of QL1706, a bifunctional antibody, shows encouraging response rates and progression-free survival in advanced hepatocellular carcinoma (HCC).
  • QL1706-containing arms demonstrated numerically higher response rates compared to the control arm (sintilimab and bevacizumab), approaching 35-36%.
  • The triplet combination of QL1706 with chemotherapy (CAPOX) and bevacizumab was selected for further evaluation in a Phase III randomized study.
  • The safety profile, particularly regarding immune-related adverse events, requires further investigation to determine the benefit over standard checkpoint inhibitor blockade.

Extended Estrogen Suppression in Breast Cancer Shows No Increased Risk of Coronary Artery Calcification

  • A new study indicates that extended use of aromatase inhibitors in postmenopausal breast cancer patients does not elevate the risk of coronary artery calcification.
  • The research addresses concerns about the cardiovascular side effects of hormonal therapy, a standard treatment post-surgery for breast cancer.
  • Findings suggest that longer aromatase inhibitor use is safe regarding coronary artery calcification, offering reassurance for preventing breast cancer recurrence.
  • The study identifies low hemoglobin as a novel risk factor for coronary artery calcification in postmenopausal women undergoing aromatase inhibitor therapy.

EVOLVE Clinical Trial Significantly Reduces Radiation Time for Throat Cancer Patients

  • The EVOLVE clinical trial at Sanford Health investigates reduced-intensity treatment for throat cancer, aiming to lessen side effects.
  • The trial protocol uses a lower radiation dose delivered in 20 fractions over 10 days, compared to the standard 30 fractions over six weeks.
  • Preliminary results indicate that the reduced radiation schedule maintains efficacy while decreasing common side effects like swallowing difficulties and dry mouth.
  • One patient's experience highlights the trial's success, showing cancer remission and a return to normal activities post-treatment.

FDA Issues Notice of Violation for Misleading Migraine Drug Ad Featuring Serena Williams

  • The FDA's OPDP issued a Notice of Violation for a migraine drug ad that overstated the speed and certainty of pain relief, with only up to 22% of patients achieving pain freedom within two hours in trials.
  • The advertisement, featuring Serena Williams, misleadingly suggested complete migraine pain elimination after a single dose, despite clinical trials showing 78-81% of patients not achieving this.
  • The FDA found that the ad's visual presentation, showing Williams' quick recovery, amplified the misleading claims about the drug's efficacy, raising concerns about promotional material accuracy.
  • The OPDP's scrutiny highlights the importance of precise language and data accuracy in pharmaceutical advertising, especially regarding efficacy claims and celebrity endorsements.

FDA Updates Clinical Trial Guidance and ASCA Program

  • The FDA has released updated guidance on clinical trial diversity, emphasizing the inclusion of underrepresented populations to improve data applicability.
  • New guidances were issued under the Accreditation Scheme for Conformity Assessment (ASCA) program, streamlining medical device evaluations.
  • These updates aim to enhance regulatory efficiency and ensure clinical trials reflect the demographic diversity of affected patient populations.

FDA Approves New Therapies and Expands Indications in Gastroenterology

  • The FDA approved Gilead’s Livdelzi for primary biliary cholangitis treatment, offering a new option for patients inadequately responding to or intolerant of UDCA.
  • Skyrizi gained FDA approval for moderate to severe ulcerative colitis, marking it as the first IL-23 inhibitor approved for both UC and Crohn’s disease.
  • Tremfya was approved for moderately to severely active ulcerative colitis, joining Skyrizi in the increasingly competitive UC treatment landscape.
  • The FDA granted breakthrough therapy designation to plozasiran for familial chylomicronemia syndrome, potentially reducing triglycerides and associated risks.

Acelyrin to Proceed Directly to Phase 3 Trials for Thyrotropin Eye Disease Treatment

  • Acelyrin is advancing directly to Phase 3 clinical trials for its investigational treatment for Thyroid Eye Disease (TED), bypassing Phase 2 trials.
  • This decision is based on promising early data and aims to expedite the development process for patients with significant unmet needs.
  • The company's strategic move reflects confidence in the drug's potential efficacy and safety profile in treating TED.
  • Acelyrin's approach could potentially accelerate the availability of a new therapeutic option for individuals suffering from TED.

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