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Clinical Trial News

FDA Faces Pressure to Act on Cassava Sciences' Alzheimer's Drug Simufilam Amidst Misleading Claims

  • The FDA is under increasing scrutiny regarding Cassava Sciences' Alzheimer's drug candidate, simufilam, following allegations of misleading claims.
  • The Securities and Exchange Commission (SEC) has already charged Cassava and two former executives with making misleading statements about simufilam.
  • The FDA acknowledges its responsibility to protect the safety and rights of clinical trial participants, but has not confirmed or denied any specific investigation into Cassava.
  • Concerns persist regarding the drug's efficacy and the potential for vulnerable Alzheimer's patients to be misled during ongoing Phase 3 trials.

TerraPower Isotopes Commercially Produces Actinium-225 for Targeted Cancer Therapies

  • TerraPower Isotopes is now producing Actinium-225 at commercial scale, ensuring a consistent supply for global pharmaceutical companies developing targeted cancer treatments.
  • The Actinium-225 produced is being utilized in human clinical trials for radiopharmaceuticals, marking a significant step forward in cancer therapy development.
  • TerraPower Isotopes employs a natural decay method to produce highly pure Actinium-225, minimizing isotopic impurities and enhancing the efficiency of the process.
  • The company collaborates with the U.S. Department of Energy to harvest Actinium-225 from thorium-229 decay, creating a secure supply chain for this crucial isotope.

PBM Reform Urgently Needed as Drug Pricing Crisis Deepens, Industry Analysis Shows

  • National polling reveals over 80% of Americans find prescription drug costs excessive, while only 25% understand the role of Pharmacy Benefit Managers in drug pricing inflation.
  • The three largest PBMs now control 80% of U.S. prescriptions, creating a monopolistic environment that has led to the closure of over 300 independent pharmacies in the past year.
  • Bipartisan legislation aimed at increasing transparency and curbing anti-competitive practices by PBMs has stalled, despite mounting evidence of their role in driving up healthcare costs.

Deltacel Shows Promising Efficacy in Metastatic NSCLC in Phase 1/2 Trial

  • Deltacel (KB-GDT-01), an allogeneic gamma delta T-cell therapy, demonstrated a 27% reduction in tumor size in a patient with stage IV metastatic NSCLC at 10 months.
  • The patient in the Deltacel-01 trial experienced progression-free survival of 10 months with no adverse effects observed, indicating a favorable safety profile.
  • Interim data from five evaluable patients showed an average PFS of 4.8 months, with no dose-limiting toxicities reported among patients completing the Deltacel course.
  • Kiromic BioPharma anticipates further data from the Deltacel-01 trial in October 2024, potentially reinforcing Deltacel's therapeutic promise.

Safety Study for a Gamma Delta T Cell Product Used with Low Dose Radiotherapy in Patients with Locally Advanced or Metastatic NSCLC or Solid Tumors with Bone Metastases

NCT06069570RecruitingPhase 1
Kiromic BioPharma Inc.
Posted 11/7/2023

EXACT Therapeutics Presents ACTIVATE Trial Data at CMR Symposium

  • EXACT Therapeutics will present data from the ACTIVATE Phase 1 trial at the Contrast Media Research (CMR) Symposium 2024 in Oslo.
  • The presentation will focus on Acoustic Cluster Therapy (ACT) in patients with liver metastases of colorectal origin.
  • ACT, a targeted drug delivery platform, uses ultrasound to enhance the effects of co-administered therapeutic agents.
  • The ACT platform is being tested in oncology and has shown potential across multiple therapeutic areas, including CNS and immunotherapy.

WuXi AppTec Predicts Shift from Antibodies to Peptides in Radiopharmaceutical Development

• WuXi AppTec's VP Dr. Dave Madge highlights potential transition from antibody-based to peptide-based radiotherapeutics, citing advantages in tissue penetration and reduced toxicity.
• Major pharmaceutical companies including Bristol Myers Squibb, Novartis, and Eli Lilly have made significant investments in radiopharmaceuticals, with deals ranging from $1.4B to $4.2B.
• WuXi AppTec expands peptide manufacturing capacity with two new facilities in China, responding to growing global demand despite potential challenges from US BIOSECURE Act.

Halda Therapeutics Appoints Christian Schade as CEO to Spearhead Clinical-Stage Development

  • Halda Therapeutics has appointed Christian Schade as President and CEO to lead the company through its next phase of clinical development.
  • Schade brings over 20 years of experience in the pharmaceutical and biotech industries, including leading companies through clinical stages and value-creating transactions.
  • Halda's lead RIPTAC therapeutic is on track to begin clinical trials in the first half of 2025, targeting prostate and breast cancer.
  • The company's RIPTAC platform aims to develop targeted oral cancer therapies to improve outcomes for cancer patients.

AI Reveals Trial Planning Flaws and Diversity Gaps in Clinical Research

• Lokavant's AI analysis highlights how trial planning decisions can unintentionally skew conclusions, impacting the reliability of study results. • Eligibility criteria in cancer studies are excluding individuals of African or Middle Eastern descent due to the Duffy-null phenotype. • AI and ML are being leveraged to address diversity issues in trial participation, aiming for more inclusive and representative research. • A large Phase 3 treatment trial for Graves’ disease is pending launch, marking a significant step in addressing this autoimmune disorder.

Ipilimumab and Nivolumab Show Promise in Treating Rare Desmoid Tumors

  • A Phase II basket trial evaluated the efficacy of dual anti-CTLA-4 and anti-PD-1 blockade with ipilimumab and nivolumab in patients with desmoid tumors.
  • The study reported an overall response rate of 18.8% and a clinical benefit rate of 62.5% among the treated patients.
  • Median progression-free survival was 19.4 months, suggesting a potential new treatment option for individuals with desmoid tumors.

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