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Clinical Trial News

OcuDyne's OPTiC System Shows Promise in Geographic Atrophy Pilot Study

  • OcuDyne's OPTiC System pilot study demonstrates procedural feasibility for ophthalmic artery angioplasty in treating vascular lesions linked to geographic atrophy.
  • The study showed subjective visual function improvement in BCVA, MNRead acuity, and reading speed, alongside objective evidence of visual function preservation.
  • No device-related adverse effects were reported, with ocular adverse events being transient and resolving without treatment.
  • OcuDyne plans to develop further data to support regulatory approval pathways for the OPTiC System following positive trial results.

FDA Approves Eli Lilly's Ebglyss for Eczema Treatment

  • Eli Lilly's Ebglyss (lebrikizumab) has received FDA approval for treating moderate-to-severe atopic dermatitis (eczema).
  • Clinical trials showed that 38% of patients achieved clear or almost-clear skin with Ebglyss at 16 weeks, compared to 12% with placebo.
  • Ebglyss offers a new treatment option for individuals whose eczema is not adequately controlled with topical therapies.

Aclarubicin Shows Promise as Less Toxic Chemotherapy for Childhood Cancers

  • Aclarubicin, an anthracycline chemotherapy not currently available in the U.S., is showing promise as a less toxic alternative to existing treatments for childhood cancers.
  • Preclinical studies indicate that aclarubicin effectively kills cancer cells while minimizing long-term side effects such as heart problems and secondary cancers.
  • Researchers at Seattle Children's are planning clinical trials to evaluate aclarubicin's safety and efficacy, potentially importing the drug from China for testing.
  • Aclarubicin's unique mechanism of action, primarily damaging chromatin rather than DNA, may reduce cardiotoxic effects compared to drugs like doxorubicin.

FDA Updates Veozah Label with Warning for Rare but Serious Liver Injury

  • The FDA has issued a warning for Veozah (fezolinetant) regarding rare but serious liver injury in patients using the drug for hot flashes due to menopause.
  • The updated label includes recommendations for increased frequency of liver blood testing during treatment, specifically monthly for the first two months.
  • Patients are advised to immediately stop Veozah and contact their healthcare provider if they experience signs and symptoms of liver injury.
  • The FDA's decision was prompted by a postmarketing report of a patient exhibiting elevated liver blood test values and liver injury symptoms after approximately 40 days of treatment.

Taletrectinib Shows Promise in ROS1-Positive NSCLC: Nuvation Bio Announces Positive Phase 2 Data

  • Taletrectinib demonstrated an 89% tumor shrinkage rate in TKI-naïve patients with ROS1-positive NSCLC, showcasing its high efficacy.
  • The drug achieved a median duration of response of 44 months and progression-free survival of 46 months in TKI-naïve patients.
  • Taletrectinib exhibited a favorable safety profile with a low incidence of neurologic treatment-emergent adverse events.
  • Nuvation Bio plans to submit an NDA to the FDA in Q4 2024, aiming for a U.S. launch in 2025.

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

NCT04919811RecruitingPhase 2
Nuvation Bio Inc.
Posted 9/1/2021

A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene

NCT04395677Active, Not RecruitingPhase 2
AnHeart Therapeutics Inc.
Posted 7/7/2020

CAR T-cell Therapy Demonstrates Superior Overall Survival Compared to Bispecific Antibody in Multiple Myeloma

  • A real-world study comparing CAR T-cell therapies (ide-cel and cilta-cel) to the bispecific antibody teclistamab in multiple myeloma patients showed improved overall survival with CAR T.
  • The CAR T cohort experienced a lower mortality rate (20%) compared to the teclistamab cohort (30%) after one year of follow-up, with a hazard ratio of 0.62 (95% CI, 0.38-0.99).
  • While CAR T therapy was associated with a higher risk of cytokine release syndrome (CRS), no significant differences in neurotoxicity were observed between the two treatment approaches.
  • The study suggests that upfront BCMA-targeted CAR T-cell therapy may improve survival outcomes, especially in older, transplant-ineligible patients with multiple myeloma.

Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma

NCT03430011CompletedPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 2/1/2018

Immunocore and Bristol Myers Squibb Collaborate on Phase 3 Trial for Advanced Cutaneous Melanoma

• Immunocore partners with Bristol Myers Squibb to evaluate IMC-F106C plus nivolumab in a Phase 3 trial for advanced cutaneous melanoma. • IMC-F106C is an ImmTAC bispecific TCR candidate designed to target and destroy diseased cells by harnessing the body's immune system. • Immunocore's pipeline includes clinical-stage programs like IMC-I109V for Hepatitis B Virus (HBV) and PRAME ImmTAC candidates targeting solid tumors. • KIMMTRAK® (tebentafusp-tebn), Immunocore's approved TCR therapy, is available for metastatic uveal melanoma in multiple regions.

Luvelta Plus Bevacizumab Shows Promise in Late-Stage Ovarian Cancer

  • Sutro Biopharma's Luvelta, combined with bevacizumab, achieved a 56% objective response rate at the recommended Phase 2 dose in late-stage ovarian cancer patients.
  • The combination therapy demonstrated a 35% overall response rate, irrespective of Folate Receptor-α (FRα) expression or prior bevacizumab treatment.
  • An additional 23 patients have been enrolled in the expansion phase at the recommended dose, with initial data expected in the first half of 2025.
  • The combination showed no new safety signals compared to either agent alone, with neutropenia being the most common adverse event.

Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody Drug Conjugate in Ovarian & Endometrial Cancers

NCT03748186CompletedPhase 1
Sutro Biopharma, Inc.
Posted 2/1/2019

A Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With Bevacizumab in Epithelial Ovarian Cancer

NCT05200364RecruitingPhase 1
Sutro Biopharma, Inc.
Posted 3/22/2022

Study to Investigate Luveltamab Tazevibulin in Adults with Advanced or Metastatic Non-small Cell Lung Cancer

NCT06555263RecruitingPhase 2
Sutro Biopharma, Inc.
Posted 8/21/2024

REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1

NCT05870748RecruitingPhase 2
Sutro Biopharma, Inc.
Posted 7/12/2023

Acrivon's ACR-368 Shows Promise in Endometrial Cancer, ACR-2316 Advances to Clinic

  • Acrivon Therapeutics reported a 62.5% confirmed overall response rate in OncoSignature-positive endometrial cancer patients treated with ACR-368 in a Phase 2 trial.
  • The study demonstrated statistically significant segregation of responders based on the OncoSignature biomarker (p = 0.009), with a median duration of response not yet reached.
  • The FDA cleared the IND for ACR-2316, a dual WEE1/PKMYT1 inhibitor, with first-in-human dosing anticipated in Q4 2024.
  • Acrivon's AP3 Interactome platform continues to generate insights for drug development and patient selection, validating its precision medicine approach.

Insights into Long COVID's Neurological Impact, MS Progression, and SCN8A-Related Disorders

  • Recent data underscores the growing concerns regarding the neurological impact of Long COVID on previously infected individuals.
  • Smoldering disease in multiple sclerosis broadens the scope beyond traditional measures, impacting disease progression independent of relapsing activity.
  • A new tool helps assess the likelihood of transitioning to secondary progressive multiple sclerosis, aiding timely treatment decisions.
  • A recent paper captures information on the estimated frequency, severity, and prognosis of comorbidities in SCN8A-related disorder phenotypes.

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