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Clinical Trial News

Nexcella Completes Pre-IND Meeting with FDA for NXC-201 in Multiple Myeloma and AL Amyloidosis

  • Nexcella, a subsidiary of Immix Biopharma, completed a Pre-IND meeting with the FDA regarding NXC-201 for AL amyloidosis and multiple myeloma.
  • The FDA reviewed Nexcella's pre-IND package, offering guidance on clinical data, manufacturing plans, and the Phase 1b/2 study protocol for NXC-201.
  • Nexcella plans to submit an IND application to the FDA for a Phase 1b/2 trial of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis.
  • NXC-201 has demonstrated promising response rates in early trials, with Nexcella aiming to submit data to the FDA after treating a specific number of patients.

NXC-201 (formerly HBI0101) Multiple Myeloma

NCT04720313Active, Not RecruitingPhase 1
Hadassah Medical Organization
Posted 1/1/2021

Approved Anti-Obesity Medications in 2022: A Comprehensive Overview

The article provides an in-depth look at the current landscape of anti-obesity medications (AOMs) approved for long-term weight management, highlighting the importance of pharmacotherapy in treating obesity, especially for individuals with a BMI of 25 kg/m2 or higher who have not achieved weight loss through non-pharmacological treatments. It covers the updated obesity pharmacotherapy guidelines recommended by the Korean Society for the Study of Obesity (KSSO), the currently available AOMs in Korea, and upcoming and potential future AOMs undergoing clinical trials.

A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity

NCT05556512Active, Not RecruitingPhase 3
Eli Lilly and Company
Posted 10/11/2022

Moderna Submits FDA Application for Updated COVID-19 Vaccine Targeting XBB Variants

  • Moderna has submitted a regulatory application to the FDA for mRNA-1273.815, an updated monovalent COVID-19 vaccine specifically targeting XBB descendant lineage viruses.
  • The submission follows unanimous FDA advisory committee recommendations to update COVID vaccines to target the Omicron XBB lineage, which currently causes the majority of COVID infections in the United States.
  • Preliminary preclinical data demonstrated that the XBB.1.5 monovalent vaccine generates a robust immune response against current XBB variants of concern.
  • Moderna has built sufficient supply for fall vaccination season distribution, pending FDA authorization, while competitors Pfizer/BioNTech and Novavax are also developing similar XBB-targeting vaccines.

FDA-Approved Cancer Drug Ruxolitinib Shows Promise for Treating Cardiac Arrhythmias

  • Researchers from Johns Hopkins University and University of Chicago discovered that ruxolitinib, an FDA-approved cancer and skin condition drug, effectively inhibits CaMKII protein kinase linked to cardiac arrhythmias.
  • The team developed a novel biosensor called CaMKAR to screen nearly 5,000 FDA-approved drugs, identifying five previously unknown CaMKII inhibitors with ruxolitinib being the most effective.
  • In mouse models, a 10-minute application of ruxolitinib prevented catecholaminergic polymorphic ventricular tachycardia and rescued atrial fibrillation without causing adverse cognitive effects.
  • The discovery could enable rapid clinical translation since ruxolitinib has already been proven safe in humans, potentially offering new treatment options for arrhythmia patients resistant to standard therapies.

Zanubrutinib, Obinutuzumab, and Venetoclax Triplet Achieves High uMRD Rates in CLL/SLL

  • A phase 2 trial (BOVen) showed that zanubrutinib plus obinutuzumab and venetoclax induced high rates of undetectable minimal residual disease (uMRD) in CLL/SLL patients.
  • 92% of patients achieved uMRD in both peripheral blood and bone marrow, leading to treatment discontinuation after a median of 10 months.
  • ΔMRD400, a measure of MRD kinetics, predicted early uMRD in bone marrow and shorter therapy duration, with 60% of patients achieving it.
  • The BOVen regimen was well-tolerated, with manageable adverse events, supporting an MRD-driven approach to treatment duration in CLL/SLL.

Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)

NCT03824483RecruitingPhase 2
Memorial Sloan Kettering Cancer Center
Posted 2/22/2019

Navigating Complex Validation Challenges in ATMP Analytical Methods: Key Considerations for Drug Development

  • Advanced Therapy Medicinal Products (ATMPs) face unique analytical method validation challenges due to inherent variability in starting materials, complex biological features, and limited batch availability.
  • Quality control testing methods for ATMPs can be categorized into three maturity levels: fully mature methods analogous to established biologics, common GMP QC release assays requiring adaptation, and novel techniques specific to complex molecules.
  • Regulatory compliance for ATMP analytical validation requires careful consideration of reference standards, product availability, and continuous dialogue with regulatory agencies throughout development.

Emerging Role of GLP-1 Agonists in Obesity

GLP-1 agonists, initially developed for type 2 diabetes treatment, have shown significant efficacy in promoting weight loss in both preclinical and clinical studies. This review highlights the role of GLP-1 agonists in weight management, their pleiotropic effects, and their impact on hyperglycemia, insulin sensitivity, blood pressure, and cardio-metabolic and renal protection.

Sequana Medical Announces Positive Outcomes from North American Pivotal Alfapump Study (POSEIDON)

Sequana Medical has revealed additional data from its North American pivotal study, POSEIDON, showcasing the alfapump's effectiveness in controlling ascites, improving patients' quality of life, and demonstrating a favorable survival rate. The study, focusing on patients with recurrent or refractory ascites due to liver cirrhosis, also highlighted the device's safety profile and its potential to significantly reduce the need for therapeutic paracentesis.

CardioMEMS Implant Halves Hospital Admissions for Heart Failure Patients

  • A tiny CardioMEMS sensor implanted in the pulmonary artery significantly reduces hospital admissions for heart failure patients by 44%.
  • The device monitors blood pressure fluctuations, alerting doctors to changes before they escalate into serious health issues.
  • Patients transmit data daily via a specialized pillow, enabling proactive management and reducing the need for hospitalization.
  • Early trials show improved quality of life for patients, with hopes for broader NHS evaluation and availability.

FDA Extends Review of GSK's Momelotinib for Myelofibrosis

  • The FDA has delayed its decision on GSK's momelotinib, a potential treatment for myelofibrosis, to September 16 to review additional data.
  • Momelotinib, acquired through GSK's $2 billion purchase of Sierra Oncology, aims to alleviate symptoms like anemia and reduce transfusion needs in myelofibrosis patients.
  • The drug targets a different protein than existing JAK inhibitors like Jakafi, offering a potential new option for patients who don't respond well to current treatments.
  • Analysts speculate the additional data may support a broader use of momelotinib, although Jakafi is expected to remain the preferred first-line treatment.

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