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Clinical Trial News

LSU LCMC Health Cancer Center Spearheads Advances in Cancer Research and Equitable Care

  • The LSU LCMC Health Cancer Center is focusing on community-based research to address cancer treatment and prevention in Louisiana.
  • Clinical trials are essential for developing new cancer treatments, understanding medication toxicity, and improving patients' quality of life.
  • The Gulf South Clinical Trials Network expands access to cancer care, particularly for minority and underserved populations across multiple states.
  • LSU LCMC Health Cancer Center collaborates globally, addressing HIV-related cancer development and tailoring treatments to local community needs.

Senate Confronts Novo Nordisk Over Semaglutide Pricing, Demands U.S. Price Parity with Europe

  • Senate HELP Committee Chair Bernie Sanders challenges Novo Nordisk CEO over Ozempic and Wegovy pricing, highlighting that U.S. prices are up to nine times higher than in European countries.
  • Novo Nordisk CEO Lars Fruergaard Jorgensen defends pricing strategy, citing extensive drug development history and manufacturing investments, while pointing to PBM influence on final consumer costs.
  • The hearing revealed potential breakthrough as PBMs commit to maintaining drug access if list prices are reduced, leading to planned discussions between Novo Nordisk, PBMs, and Senate leadership.

Metformin Shows Promise in Slowing Organ Aging in Primate Study

  • A recent study on primates indicates that metformin, a common drug for type 2 diabetes, may slow the aging process in key organs.
  • The research found that monkeys treated with metformin experienced slower aging in their kidneys, lungs, skin, and brain.
  • The observed reduction in aging was significant, with some organs aging up to six years slower in the treatment group.
  • Researchers plan to conduct human trials to investigate whether metformin can replicate these anti-aging effects in people.

Psilocybin Shows Promise in Reducing Symptoms of Body Dysmorphic Disorder

  • A pilot study indicates that psilocybin significantly reduced symptoms in individuals with body dysmorphic disorder (BDD).
  • Brain scans revealed that psilocybin treatment increased connectivity between brain regions related to emotional processing and cognitive activity.
  • The improvement in BDD symptoms correlated with the strengthening of connections within brain networks, suggesting enhanced brain flexibility.
  • Further research with larger groups is necessary to confirm the effectiveness and long-term effects of psilocybin for treating BDD.

AlgoTx Completes Phase II Trial of ATX01 for Chemotherapy-Induced Peripheral Neuropathy

  • AlgoTx has announced the completion of the Last Patient Last Visit (LPLV) in its Phase II clinical trial, ACT, evaluating ATX01 for chemotherapy-induced peripheral neuropathy (CIPN).
  • The international, double-blind, placebo-controlled trial included 276 patients across more than 40 sites in multiple countries.
  • ATX01, a topical formulation of amitriptyline, targets nociceptive sodium channels to alleviate pain associated with CIPN, which currently lacks approved treatments.
  • The company anticipates sharing the ACT data in early 2025 and plans to expedite a Phase 3 trial for ATX01.

Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy)

NCT05593614Active, Not RecruitingPhase 2
AlgoTherapeutix
Posted 2/28/2023

Experts Discuss Treatment Strategies and Challenges in Managing Chronic GVHD After Stem Cell Transplantation

  • Leading transplant specialists highlight the critical importance of collaboration between transplant centers and referring physicians in managing chronic graft-versus-host disease (GVHD) patients.
  • The REACH3 trial data shows ruxolitinib's effectiveness in treating steroid-refractory chronic GVHD, though complete response rates remain relatively low, emphasizing the need for managing patient expectations.
  • Multiple treatment options including ruxolitinib, belumosudil, and extracorporeal photopheresis are available for chronic GVHD, with treatment selection influenced by factors such as disease severity, patient characteristics, and insurance coverage.

A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)

NCT03112603CompletedPhase 3
Incyte Corporation
Posted 6/29/2017

Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)

NCT02959944CompletedPhase 3
Pharmacyclics LLC.
Posted 5/11/2017

Evrysdi Approved in Japan for Pre-Symptomatic SMA and Infants Under 2 Months

  • Chugai's Evrysdi (risdiplam) gains approval in Japan for treating pre-symptomatic spinal muscular atrophy (SMA) and infants under two months of age.
  • The approval is based on Phase II RAINBOWFISH study results, demonstrating Evrysdi's efficacy and safety in pre-symptomatic SMA infants.
  • Evrysdi, an oral SMN2 splicing modifier, becomes the first oral treatment option available for SMA patients of all ages after birth in Japan.
  • This approval enables earlier intervention, potentially maximizing treatment benefits for SMA patients diagnosed through genetic testing.

A Study of Risdiplam in Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy

NCT03779334Active, Not RecruitingPhase 2
Hoffmann-La Roche
Posted 8/7/2019

Medicare Drug Price Negotiations Pose Complex Challenges for Community Oncology Practices

  • The Inflation Reduction Act's Medicare Drug Price Negotiation Program introduces significant administrative burdens for community oncology practices, requiring separate inventory management for MFP and non-MFP eligible patients.
  • Community practices face substantial financial pressures from delayed reimbursements under the retrospective effectuation model, with potential waiting periods of up to two months for drug cost reconciliation.
  • Healthcare experts express concerns about reduced pharmaceutical innovation and a projected 49.4% decrease in Medicare Part B add-on reimbursements, potentially threatening the sustainability of community oncology practices.

Alzheimer's Trials Need to Include People with Down Syndrome: Experts Advocate for Inclusive Research

  • People with Down syndrome (DS) are at high risk of early-onset Alzheimer's disease (AD), yet are often excluded from clinical trials, creating a gap in treatment evidence.
  • Researchers emphasize that including individuals with DS in AD trials is ethically imperative and scientifically valuable due to the genetic basis of DS-associated AD (DSAD).
  • Adapting trial designs to accommodate the unique needs of people with DS, such as intellectual disabilities and younger age, is crucial for successful and inclusive research.
  • AC Immune S.A. is conducting the ABATE study, testing an anti-amyloid immunotherapy in both individuals with DS and those with mild cognitive impairment, with completion expected in 2026.

GSK's Single-Vial, Fully Liquid Menveo Receives Positive CHMP Opinion for Meningococcal Disease Prevention

  • The European Medicines Agency's CHMP has recommended GSK's single-vial, fully liquid Menveo for active immunization against invasive meningococcal disease (IMD).
  • If approved, the new formulation will simplify vaccine administration by eliminating the need for reconstitution before use in individuals aged two years and older.
  • Phase IIb trials demonstrated comparable immunogenicity, tolerability, and safety to the existing lyophilized/liquid formulation, supporting the CHMP's positive opinion.
  • The European Commission's final decision regarding marketing authorization is anticipated by November 2024, potentially expanding access to this crucial vaccine.

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