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Clinical Trial News

Pediatric Oncology Nurse Drives Immunotherapy Trials Forward for Relapsed Brain Tumors

  • Robin Dobbins, an oncology research nurse, supports pediatric immunotherapy trials led by Dr. Ted Johnson at Augusta University, focusing on relapsed brain tumors.
  • Dobbins ensures trial protocol adherence, manages tests, dispenses medication, monitors side effects, and reports findings, while providing compassionate support to families.
  • The immunotherapy program leverages ALSF's Travel For Care program to assist families traveling to Augusta, Georgia, for treatment, overcoming accessibility challenges.
  • Dr. Johnson's immunotherapy drug, Indoximod, is currently in Phase 2 trials, with Dobbins hopeful for advancement to Phase 3, bringing it closer to broader availability.

UAB Study Investigates Exercise and Glucose Effects on Heart Hormones in Healthy Adults

  • A cardiometabolic research study at UAB is exploring the impact of exercise and glucose on heart hormones in healthy adults aged 18 and older.
  • The study involves controlled meals, treadmill exercise, glucose tests, and collection of blood, urine, and genetic samples from participants.
  • Participants meeting eligibility criteria, including a BMI under 45 kg/m2 and no history of diabetes, heart, or kidney problems, are being recruited.
  • Qualified participants will receive $300 compensation for completing all study visits, with meals provided at no cost.

Lundbeck Initiates Phase I Trial of Lu AG09222 for Migraine Prevention

  • Lundbeck has commenced a Phase I clinical trial to evaluate Lu AG09222, a second-generation migraine drug, as a potential combination therapy for migraine prevention.
  • The trial aims to assess the safety, tolerability, and pharmacokinetic profile of Lu AG09222 when administered in combination with other migraine treatments.
  • Lu AG09222 represents Lundbeck's "most promising" candidate for migraine, reflecting the company's commitment to addressing this debilitating neurological condition.

A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

NCT06578585RecruitingPhase 1
H. Lundbeck A/S
Posted 9/13/2024

Precision Medicine and Clinical Trials Improve Breast Cancer Survivorship

• Breast cancer treatment has evolved, with precision medicine tailoring therapies to specific cancer types, improving survival rates. • Clinical trials, like the one at KU Cancer Center, play a crucial role in advancing treatment options for aggressive cancers such as HER2-positive breast cancer. • Early detection and innovative drugs have significantly contributed to increased survivorship and reduced disease stage at diagnosis. • Research now focuses on prevention strategies to stop precancerous cells from developing into cancer, further improving patient outcomes.

FDA Advisors Question Novel Oral Antibiotic Sulopenem for UTI Treatment

• FDA advisory committee members voiced concerns regarding the potential for antimicrobial resistance and misuse of sulopenem, a novel oral antibiotic for uncomplicated urinary tract infections (uUTIs). • Advisors emphasized the need for restricted use in patients with resistant organisms or those who have failed first-line therapies to mitigate the risk of off-label use and resistance amplification. • Clinical trial data showed sulopenem was non-inferior to amoxicillin/clavulanate in patients susceptible to the latter, but the sample size was insufficient to draw conclusions for resistant infections. • The FDA will consider the committee's discussion to decide on sulopenem's approval by October 25, with potential modifications to labeling to ensure appropriate use.

Autolus' Obe-cel Nears Potential FDA Approval for Adult B-cell ALL

  • Autolus Therapeutics anticipates a November 16, 2024 PDUFA date for obe-cel, a CAR-T cell therapy targeting relapsed/refractory adult B-cell acute lymphoblastic leukemia (B-ALL).
  • Phase 1b/2 FELIX study data showed a 78% overall response rate (CR/CRi) in patients treated with obe-cel, with a median overall survival of 23.8 months.
  • Obe-cel may offer advantages over existing therapies like Tecartus, potentially demonstrating a more favorable safety profile with lower rates of cytokine release syndrome and ICANS.
  • Autolus has a strong cash position and partnerships with BioNTech, Moderna, and Bristol Myers Squibb, supporting the potential commercial launch and further development of obe-cel.

Elutia Celebrates First Anniversary Marked by EluPro FDA Approval and Commercial Launch

  • Elutia Inc. celebrates its first anniversary following a strategic shift towards drug-eluting biologics, marked by rebranding and a new mission.
  • The company secured FDA approval for EluPro, the first Antibiotic-Eluting BioEnvelope, and successfully completed an FDA inspection of its manufacturing facility.
  • Elutia achieved significant milestones, including the first implantation of EluPro and a 20% growth in proprietary product sales.
  • Elutia's stock value increased by over 170% in its first year, reflecting strong performance and increased shareholder value.

Relay Therapeutics' RLY-2608 Shows Promise in PI3Kα-Mutated Breast Cancer

• Relay Therapeutics' RLY-2608, combined with fulvestrant, demonstrated a median progression-free survival of 9.2 months in pre-treated patients. • The ReDiscover trial data supports advancing RLY-2608 into a pivotal Phase 2 study in 2025 for metastatic breast cancer. • RLY-2608 exhibited a favorable tolerability profile, with few patients discontinuing treatment due to adverse events. • Relay Therapeutics plans to present updated data on lirafugratinib at the AACR-NCI-EORTC conference in October 2024.

GSK's Depemokimab Shows Promise in Reducing Severe Asthma Exacerbations

• Depemokimab significantly reduced severe asthma attacks by 54% compared to placebo in Phase 3 trials, offering a potential new treatment option. • The ultra-long-acting biologic showed a 72% reduction in exacerbations requiring hospitalization or emergency department visits, highlighting its clinical impact. • Administered just twice yearly, depemokimab could improve treatment adherence and provide sustained suppression of type 2 inflammation in severe asthma. • These findings, presented at the European Respiratory Society International Conference, support regulatory filings for depemokimab globally.

Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level

NCT04133909CompletedPhase 3
GlaxoSmithKline
Posted 10/30/2019

A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype

NCT04718103CompletedPhase 3
GlaxoSmithKline
Posted 2/4/2021

Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype

NCT04719832CompletedPhase 3
GlaxoSmithKline
Posted 3/17/2021

FDA Approves Digital Therapeutic for GAD, Updated Novavax COVID-19 Vaccine, and New Insulin Patch Pump

• The FDA cleared DaylightRX, the first digital therapeutic for generalized anxiety disorder (GAD), to be used as an adjunct to usual care for patients aged 22 years and older. • Novavax received emergency use authorization (EUA) from the FDA for its updated COVID-19 vaccine, NVX-CoV2705, for individuals aged 12 years and older. • Embecta gained FDA 510(k) clearance for its disposable insulin delivery system, designed for adults with type 1 and type 2 diabetes, featuring a 300-unit reservoir.

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