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Clinical Trial News

OrsoBio Secures $67M for Obesity Drugs, Vor Bio's AML Therapy Shows Promise, and More

  • OrsoBio, backed by Eli Lilly, raised $67 million to advance its portfolio of weight loss medicines targeting different mechanisms than GLP-1 therapies.
  • Vor Bio's experimental AML therapy, trem-cel, demonstrated successful engraftment and protection against Mylotarg toxicity in a Phase 1 trial.
  • Boehringer Ingelheim plans to advance its geographic atrophy drug into Phase 2 trials after positive Phase 1 safety data.
  • Novartis has licensed a capsid from Voyager Therapeutics to develop a gene therapy for a rare neurological disease, expanding their collaboration.

Travoprost Intracameral Implant Shows Sustained IOP Reduction in Glaucoma Patients

  • A travoprost intracameral implant demonstrated non-inferiority in reducing intraocular pressure (IOP) compared to timolol eye drops over 12 months in glaucoma patients.
  • The implant provided a sustained IOP reduction, with a favorable safety profile observed throughout the study period.
  • The study suggests the travoprost implant as a potential alternative to topical medications for managing open-angle glaucoma or ocular hypertension.
  • The implant is placed nasally into the trabecular meshwork and sclera, offering a novel approach to IOP control.

Iterum's Oral Sulopenem Faces FDA Decision Amidst Antibiotic Resistance Concerns

  • Iterum Therapeutics' oral sulopenem, an antibiotic for uncomplicated urinary tract infections (uUTIs), awaits an FDA decision by October 25.
  • An FDA advisory committee acknowledged oral sulopenem as an important treatment option, particularly for multi-drug resistant pathogens.
  • Concerns remain about potential misuse and the need for antibiotic stewardship to prevent further antimicrobial resistance.
  • Post-marketing surveillance and clear labeling are crucial to ensure responsible prescription and limit off-label use of oral sulopenem.

Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women

NCT05584657CompletedPhase 3
Iterum Therapeutics, International Limited
Posted 10/18/2022

Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women

NCT03354598CompletedPhase 3
Iterum Therapeutics, International Limited
Posted 8/1/2018

Subcutaneous Rituximab Shows Similar Efficacy, Lower Cost in Non-Hodgkin Lymphoma

  • A meta-analysis of 7 studies showed subcutaneous rituximab had similar efficacy to intravenous rituximab in non-Hodgkin lymphoma patients.
  • The analysis found no significant difference in grade 3 or higher adverse events between subcutaneous and intravenous rituximab.
  • Subcutaneous rituximab was associated with lower total costs, pharmacy technique costs, and administration costs compared to intravenous rituximab.
  • Subcutaneous rituximab also demonstrated a lower total process time, suggesting increased efficiency in administration.

Advanced Treatment Strategies Show Promise in Improving PTCL Patient Outcomes

  • Current PTCL patients face challenging 5-year survival rates of 25-35%, prompting researchers to explore personalized treatment approaches including histologic-based therapy and MRD testing.
  • Novel therapies including HDAC inhibitors and PI3K inhibitors have shown promising response rates, with PI3K inhibitors achieving 50% response rates and 33% complete response rates in PTCL patients.
  • Integration of advanced imaging techniques, MRD testing via T-cell receptor sequencing, and histologic-specific treatments are emerging as key strategies for improving patient outcomes in PTCL management.

Minimal Residual Disease in Peripheral T-cell Lymphoma

NCT03297697Completed
Washington University School of Medicine
Posted 7/31/2017

Donor Human Milk Significantly Reduces Necrotizing Enterocolitis Risk in Premature Infants

  • A meta-analysis of 12 trials reveals that donor human milk (DHM) significantly reduces the risk of necrotizing enterocolitis (NEC) in very preterm or very low-birth-weight (VLBW) infants.
  • The study indicates that DHM reduces the risk of NEC by approximately half compared to formula feeding in this vulnerable population.
  • Evidence suggests DHM has little to no effect on late-onset invasive infection or all-cause mortality before hospital discharge in preterm infants.
  • These findings support the use of DHM when sufficient maternal milk is unavailable, highlighting its potential to improve outcomes for preterm infants.

Assessing the Clinical Impact of Drug-Drug Interactions: A Focus on Colchicine and COVID-19

  • A recent study in JAMA Network Open evaluated drug-drug interactions (DDIs) involving colchicine in COVID-19 patients, utilizing data from the COLCORONA trial.
  • The analysis found no significant increase in adverse events or hospitalization/death risk due to potential DDIs with colchicine in COVID-19 patients.
  • The study highlights the challenge of translating theoretical DDIs into real-world clinical harms, emphasizing the need for robust screening and testing methods.
  • Conservative prescribing practices and vigilance regarding potential adverse effects remain crucial in managing DDIs, considering over-the-counter medicines and supplements.

AcuraStem Awarded $4 Million CIRM Grant to Advance UNC13A-Targeted Therapy for ALS and FTD

  • AcuraStem receives a $4 million grant from CIRM to support its UNC13A-targeted therapeutic program for ALS and FTD.
  • The funding will advance the development of antisense oligonucleotides (ASOs) designed to restore UNC13A function disrupted by TDP-43 pathology.
  • AcuraStem's iNeuroRx platform facilitates the identification and testing of ASOs to address genetic expression dysfunction in ALS and FTD.
  • The company's previous ASO for the PIKFYVE enzyme was licensed to Takeda Pharmaceuticals and is currently in clinical trials.

FDA Grants Priority Review and Breakthrough Therapy Designation to Imfinzi for SCLC and Approves Neoadjuvant/Adjuvant Use in NSCLC

  • The FDA has granted priority review to Imfinzi for limited-stage small cell lung cancer (SCLC), potentially expediting its availability to patients.
  • Imfinzi also received Breakthrough Therapy designation from the FDA for SCLC, highlighting its potential to significantly improve outcomes.
  • The FDA approved Imfinzi for neoadjuvant/adjuvant treatment of resectable non-small cell lung cancer (NSCLC), expanding its clinical application.
  • These regulatory actions underscore Imfinzi's growing role in treating both SCLC and NSCLC, addressing critical needs in lung cancer therapy.

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.
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