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Clinical Trial News

New Study Raises Safety Concerns About Fecal Microbiota Transplants

  • A new study published June 6, 2025, warns that fecal microbiota transplants may introduce microbes that hijack the host environment, potentially creating new health risks.
  • Research conducted on mice, human tissue samples, and seven volunteers found that transplanted microbes "terraform" the entire intestinal tract rather than staying in their original regions.
  • The study suggests that mismatches between donor fecal matter and recipient gut environments could have unintended consequences on immune and metabolic function.
  • Researchers propose omni microbial transplantation (OMT) as a safer alternative, using targeted microbes matched to specific intestinal regions.

UConn Researchers Develop Novel Nanoparticle-mRNA Vaccine Platform for Infectious Bronchitis Virus in Poultry

  • University of Connecticut researchers have developed a protein-based nanoparticle platform that significantly enhances mRNA vaccine stability and effectiveness against Infectious Bronchitis Virus in chickens.
  • The innovative vaccine demonstrated a 1000-fold increase in antibody titers compared to unvaccinated controls, addressing critical limitations of current live attenuated and killed virus vaccines.
  • The nanoparticle system uses modified bovine serum albumin to protect mRNA from degradation, potentially eliminating cold chain storage requirements that challenge farm-based vaccine distribution.
  • Beyond poultry applications, the modular platform technology could accelerate mRNA vaccine development for emerging diseases by allowing rapid incorporation of new genetic sequences.

Pharmacist-Led Interventions Generate $9 Million in Cancer Care Cost Savings Through Remote Clinical Reviews

  • Clinical review pharmacists at The US Oncology Network identified 1,271 cost-saving interventions across 5,600 patients, with 1,180 accepted interventions generating nearly $9 million in total cost of care reductions.
  • The initiative focused on six primary strategies including pembrolizumab dose banding, monoclonal antibody dose rounding, and biosimilar therapeutic interchange, with drug costs representing 63% of patient total cost of care.
  • Each clinical review pharmacist position cost approximately $25,000 but delivered significant financial returns while streamlining medication protocols and saving provider time in value-based care models.
  • Research from University of California San Diego revealed that 9% of inpatient chemotherapy treatments were due to transportation or housing barriers, resulting in over $7 million in potentially avoidable hospital costs over five years.

ACIP Members Face Termination as RFK Jr.'s Vaccine Policy Changes Spark Institutional Upheaval

  • Four members of the CDC's Advisory Committee on Immunization Practices have received termination notices as special government employees, raising concerns about potential political interference in vaccine policy oversight.
  • The terminations follow the resignation of ACIP co-lead Lakshmi Panagiotakopoulos, who stepped down after HHS Secretary Robert F. Kennedy Jr. bypassed traditional protocols to change COVID-19 vaccine recommendations without committee input.
  • Industry analysts had previously warned that Kennedy could "restack" the ACIP panel with members aligned with anti-vaccine rhetoric to redirect public health policies.
  • The institutional changes are occurring amid a leadership vacuum at the CDC, with no confirmed director in place since February and Trump's new nominee still awaiting a confirmation hearing.

High Placebo Response Rates Challenge Lupus Drug Development as Researchers Develop New Trial Strategies

  • High placebo response rates of approximately 40% in systemic lupus erythematosus trials are obscuring the true efficacy of investigational biologics, as patients continue receiving powerful background medications like glucocorticoids and hydroxychloroquine.
  • Researchers have identified four core strategies to address the "placebo problem," including stabilizing background therapy, applying central expert review, controlling rescue therapy, and acknowledging evolving standard-of-care treatments.
  • New trial design innovations include enriching study populations with high-disease-activity patients, employing more stringent sustained endpoints, and implementing adaptive features to better detect drug efficacy signals.
  • Clinical practice approaches now focus on realistic patient expectations for biologics like belimumab and anifrolumab, emphasizing gradual benefit timelines of 3-4 months and steroid-sparing goals rather than miracle cures.

Mission Bio Secures Funding to Advance Single-Cell Tri-Omics Platform for Cancer Drug Development

  • Mission Bio completed equity financing led by Ally Bridge Group to accelerate commercial growth and advance its Tapestri Platform's single-cell tri-omics capabilities for cancer research.
  • The company launched its industry-first Single-Cell Genotype and Targeted Gene Expression assay, enabling simultaneous profiling of DNA and RNA from over 10,000 single cells to address clinical trial failures.
  • The funding will support commercial expansion, development of tri-omics capabilities combining DNA, RNA, and protein analysis, and accelerated clinical adoption across multiple cancer segments including multiple myeloma and CAR-T therapies.

First Ascent Biomedical Partners with Fight Colorectal Cancer for $350,000 Precision Medicine Study

  • First Ascent Biomedical and Fight Colorectal Cancer have launched a $350,000 prospective feasibility study to advance precision oncology for colorectal cancer patients using xDRIVE tumor profiling technology.
  • The study will enroll 25 patients with metastatic colorectal cancer in Minnesota, integrating functional drug testing, genetic analysis, and artificial intelligence to provide personalized treatment insights.
  • Led by gastrointestinal cancer specialist Dr. Hao Xie and principal investigator Dr. Noah Berlow, the study aims to complete enrollment within nine months and deliver actionable data to oncologists.
  • The collaboration represents a strategic focus on enhancing care for patients with limited treatment options through advanced research and rapid, individualized tumor profiling.

Church & Dwight Recalls Zicam and Orajel Nasal Swabs Due to Fungal Contamination Risk

  • Church & Dwight Co., Inc. has issued a voluntary nationwide recall of all lots within expiry of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs due to potential fungal contamination in cotton swab components.
  • The contaminated swabs pose significant health risks including serious and life-threatening blood infections, particularly for children and individuals with compromised immune systems or underlying medical conditions.
  • No serious adverse events have been reported to date, but consumers are advised to stop using the products immediately and contact the company for full refunds.
  • The recall affects products distributed nationwide in the United States and Puerto Rico, while other Zicam and Orajel products remain unaffected by this safety action.

Neoadjuvant Immunotherapy Plus Chemotherapy Improves Long-Term Survival in Operable NSCLC

  • Adding immunotherapy to chemotherapy before surgery for patients with operable non-small cell lung cancer improved long-term survival overall compared with chemotherapy alone.
  • The clinical trial results were published June 2 in The New England Journal of Medicine and presented at the annual meeting of the American Society of Clinical Oncology.
  • This neoadjuvant approach represents a significant advancement in the treatment of operable NSCLC, offering patients better long-term outcomes through preoperative combination therapy.

Powers Health Partners with Profound Research to Establish Clinical Research Center in Northwest Indiana

  • Powers Health announces a strategic partnership with Profound Research to launch a clinical research center, initially focusing on cardiology, gastroenterology, and neurology specialties.
  • The collaboration will embed clinical research operations at select Powers Health locations, allowing patients to participate in trials directly through their trusted physicians.
  • This partnership aims to remove barriers to clinical trial access and accelerate care options for the Northwest Indiana community.
  • The first studies are expected to begin enrolling patients this summer, with plans for expansion into additional specialties and locations.

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