MedPath

Clinical Trial News

Simvastatin Fails to Reduce Disability Progression in Phase 3 MS-STAT2 Trial for Secondary Progressive Multiple Sclerosis

  • The MS-STAT2 trial, a phase 3 study, evaluated simvastatin's effectiveness in slowing disability progression in patients with non-active secondary progressive multiple sclerosis (SPMS).
  • Results showed simvastatin did not significantly reduce disability progression compared to placebo over a 48-month period (HR 1.13, 95% CI 0.91-1.39, P = 0.26).
  • While simvastatin was safe and well-tolerated, the trial's primary and secondary outcomes did not demonstrate a benefit for SPMS, despite promising phase 2 results.
  • Researchers emphasize the trial's value in understanding progressive MS and enabling future large-scale clinical trials for emerging treatments.

Multiple Sclerosis-Simvastatin Trial 2

NCT03387670Active, Not RecruitingPhase 3
University College, London
Posted 3/28/2018

Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis

NCT00647348CompletedPhase 2
Imperial College London
Posted 1/1/2008

UAMS Awarded $2.2 Million Grant to Investigate Efferocytosis in Retinopathy

  • The University of Arkansas for Medical Sciences (UAMS) has received a $2.2 million grant from the National Eye Institute (NEI).
  • The grant will fund research into how modulating the immune response through efferocytosis can benefit patients with retinopathy.
  • Dr. Abdel Fouda's lab will lead the study, exploring methods to enhance myeloid cell-mediated efferocytosis in treating retinopathy.
  • The research aims to develop new therapies for ischemic and trauma-induced retinopathy by understanding efferocytosis' role.

REDUCE-AMI Trial Re-evaluates Beta-Blocker Use Post-Myocardial Infarction

  • The REDUCE-AMI trial found no significant benefit in long-term beta-blocker treatment for patients with acute myocardial infarction (AMI) and preserved left ventricular ejection fraction (LVEF).
  • The study challenges current guidelines that widely recommend beta-blocker use post-AMI, regardless of LVEF, prompting a re-evaluation of treatment strategies.
  • Experts suggest a tailored approach to beta-blocker use, considering individual patient profiles, comorbidities, and potential side effects, especially in those with preserved LVEF.
  • The trial may lead to changes in clinical practice, with clinicians potentially reducing beta-blocker prescriptions in patients with preserved LVEF and no other indications.

CD Biopharma's CD-001 Receives FDA Clearance for Phase 1 Trial in Oncology

• CD Biopharma's CD-001, a bispecific fusion protein, has been cleared by the FDA for a Phase 1 clinical trial. • CD-001 targets PD-1-positive, CD8-positive T cells using an anti-PD-1 antibody and an engineered IL-21 mutant. • The Phase 1 trial will assess CD-001 as a potential treatment for solid tumors and hematologic malignancies. • Preclinical studies have demonstrated CD-001's effectiveness in mouse tumor models with good tolerance in non-human primates.

myeloMATCH Launches Precision Medicine Trial for Myeloid Cancers

  • The NIH has initiated myeloMATCH, a precision medicine trial, to match AML and MDS patients with treatments based on their cancer's genetic profile.
  • The trial employs rapid genetic testing (within 72 hours) to assign patients to targeted sub-studies or standard treatment, aiming to personalize therapy.
  • myeloMATCH will re-evaluate patients and transfer them to subsequent trials based on genomic data to target residual disease effectively.
  • The initiative includes over 140 clinical sites across the US and Canada, with plans to enroll thousands of patients and expand sub-studies.

Additional BCG Shows High Response Rates in BCG-Exposed and BCG-Unresponsive NMIBC

  • A study at MD Anderson Cancer Center evaluated additional BCG treatment in NMIBC patients, showing high response rates in both BCG-exposed and BCG-unresponsive groups.
  • In BCG-exposed patients, additional BCG resulted in a 79% complete response rate, with a median duration of response of 169 months.
  • For BCG-unresponsive patients, 75% remained disease-free after additional BCG, with a median duration of response of 83 months.
  • The findings suggest additional BCG should be considered as a control arm in clinical trials for BCG-exposed NMIBC patients.

Cybin's Phase 3 Trial of CYB003 for Major Depressive Disorder Faces Delay

  • Cybin Inc. has delayed the start of its Phase 3 clinical trial for CYB003, a potential treatment for Major Depressive Disorder (MDD), missing its late summer 2024 target.
  • The company completed site selection for the Phase 3 trial across the U.S. and Europe, but patient enrollment has not yet commenced.
  • Phase 2 results of CYB003 showed rapid improvement in depression symptoms and a 75% remission rate four months after two doses in the 16mg group, with 12-month data expected in early Q4 2024.
  • Cybin held a Type B meeting with the FDA, incorporating elements to address methodological issues like functional unblinding in the Phase 3 trial design.

Greenwood Genetic Center Appoints Dr. Michael Lyons to Lead Precision Medicine Initiative

  • Dr. Michael Lyons has been appointed as the Ravenel Boykin Curry chair in translational genomics and therapeutics at Greenwood Genetic Center (GGC).
  • Lyons will spearhead the Precision Medicine Initiative at GGC, focusing on translating research discoveries into improved patient care.
  • His role includes overseeing the Genomic Discovery Program and providing leadership for clinical trials aimed at enhancing existing treatments.
  • Dr. Lyons, board-certified in pediatrics and medical genetics, will contribute to GGC's clinical, diagnostic, research, and educational endeavors.

Novo Nordisk's Oral CB1 Blocker Monlunabant Fails in Phase II Obesity Trial

  • Novo Nordisk's oral CB1 receptor blocker, monlunabant, failed to demonstrate significant weight loss in a Phase II obesity trial at 16 weeks.
  • The trial was further impacted by neuropsychiatric adverse events, raising concerns about the drug's safety profile.
  • This setback increases pressure on Novo Nordisk to seek external partnerships or acquisitions to maintain its leading position in the oral obesity therapy market.
  • The failure casts doubt on CB1 as a viable target for obesity treatment, despite initial enthusiasm.

Iomab-B Demonstrates Durable Remission in Phase 3 SIERRA Trial for Relapsed/Refractory AML

  • The Phase 3 SIERRA trial demonstrated that Iomab-B achieved a statistically significant durable Complete Remission (dCR) rate of 22% compared to 0% in the control arm for relapsed/refractory AML patients.
  • Event-Free Survival (EFS), a secondary endpoint, was significantly improved with Iomab-B, showing a Hazard Ratio of 0.22 (p < 0.0001), indicating a substantial reduction in the risk of events.
  • While overall survival (OS) was not met due to a high crossover rate, subgroup analyses showed improved survival in patients with TP53 mutations and those aged 65 and above.
  • Actinium Pharmaceuticals is seeking a strategic partner to conduct an additional Phase 3 trial to demonstrate overall survival benefit, as requested by the FDA for potential BLA filing.

Trending News

1

FDA Approves Streamlined Access for Bristol Myers Squibb CAR T Cell Therapies

a day ago
2

Vor Bio Secures Global Rights to Telitacicept in $4+ Billion Deal with RemeGen

3 days ago
3

UCB's Fenfluramine Achieves Positive Phase 3 Results in Ultra-Rare CDKL5 Deficiency Disorder

a day ago
4

Percheron Therapeutics Acquires Phase II-Ready Anti-VISTA Cancer Immunotherapy HMBD-002 in $290M Deal

3 days ago
5

ProFound Therapeutics Partners with Novartis in $775M Cardiovascular Drug Discovery Deal

2 days ago
6

Lipocine Initiates Phase 3 Trial for Oral Brexanolone in Postpartum Depression

2 days ago
7

China Approves First Once-Daily Nebulized LAMA for COPD, Triggering $7.5M Milestone for Theravance

2 days ago
8

DBV Technologies Initiates COMFORT Toddlers Phase 3 Study for Viaskin Peanut Patch in Young Children

3 days ago
9

FDA Approves Gamifant as First Treatment for Macrophage Activation Syndrome in Still's Disease

16 hours ago
10

Cellarity Initiates Phase 1 Trial of CLY-124, First-in-Class Oral Therapy for Sickle Cell Disease

2 days ago
Subscribe Icon

Daily Pharma Insights

Get curated, high-impact pharmaceutical news delivered to your inbox every morning.

  • Critical clinical trial updates & results
  • Regulatory approvals & strategic partnerships
  • Market access decisions & commercial developments
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy