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Clinical Trial News

Ultimovacs Discontinues Patient Recruitment in Phase II Lungvac Trial for NSCLC

  • Ultimovacs ASA halts patient recruitment for the LUNGVAC trial due to slow enrollment attributed to evolving NSCLC treatment options.
  • The Phase II trial investigated UV1 cancer vaccine combined with checkpoint inhibitors (cemiplimab or pembrolizumab) as first-line NSCLC treatment.
  • Data from the 31 enrolled patients will be analyzed, with topline results expected in the first half of 2025.
  • Ultimovacs continues to advance UV1 in ovarian cancer through the DOVACC trial and explore a novel drug conjugation platform.

Efficacy and Safety of Anti-PD-1/PD-L1 Treatment +/- UV1 Vaccination in Patients With Non-small Cell Lung Cancer

NCT05344209RecruitingPhase 2
Vestre Viken Hospital Trust
Posted 8/12/2022

Cancer Clinical Trials Inappropriately Exclude Patients with Duffy-Null Phenotype

  • A recent study reveals that many cancer clinical trials exclude individuals with the Duffy-null phenotype, a trait common in people of African and Middle Eastern descent.
  • The exclusion is due to lower neutrophil counts in Duffy-null individuals, which are misinterpreted as a sign of increased infection risk during cancer treatment.
  • Researchers recommend that clinical trials adjust neutrophil count criteria to include Duffy-null individuals and avoid inappropriate dose reductions.
  • Addressing this inequity could improve clinical trial representation and treatment outcomes for diverse populations.

Casgevy Faces Hurdles to Profitability Despite Landmark Approval for Sickle Cell Disease

  • CRISPR Therapeutics and Vertex Pharmaceuticals' Casgevy, the first CRISPR-Cas9 gene editing therapy approved for sickle cell disease, faces a slow rollout due to complex patient preparation processes.
  • Reimbursement challenges, particularly with Medicaid and Medicare, and the high list price of $2.2 million, complicate access to Casgevy.
  • Fertility treatment coverage for patients undergoing Casgevy is a significant hurdle, with ongoing disputes between Vertex and the U.S. Department of Health and Human Services.
  • Despite these challenges, analysts remain optimistic about Casgevy's potential, with peak sales estimated at $3.6 billion, highlighting its importance as a pioneering gene editing therapy.

UAB Launches ADAPT Trial: Adaptive Treatment for Early Smoking Cessation Relapse

  • The University of Alabama at Birmingham (UAB) has initiated the ADAPT clinical trial, focusing on adaptive treatment strategies for individuals experiencing early relapse after attempting to quit smoking.
  • The study offers participants the opportunity to try varenicline, a prescription medication for smoking cessation, or nicotine replacement therapies like patches and lozenges.
  • ADAPT is a fully remote study involving online screening and eight contacts over six months, aiming to provide accessible support for smoking cessation.
  • Eligible participants will receive compensation for their involvement in the study, which seeks to improve the effectiveness of interventions for preventing smoking relapse.

Johnson & Johnson's Rybrevant and Lazcluze Combination Shows Reduced Infusion Reactions in NSCLC Trial

  • Phase II SKIPPirr study shows that prophylactic dexamethasone significantly reduces infusion-related reactions (IRRs) associated with Rybrevant and Lazcluze in NSCLC patients.
  • The IRR rate decreased to 22.5% with the dexamethasone regimen, compared to a historical rate of 67.4% with standard management, enhancing patient treatment experience.
  • The combination of Rybrevant and Lazcluze, along with dexamethasone, demonstrated a safety profile consistent with previous studies, with no Grade 3 or higher IRR events reported.
  • All infusion-related reactions were Grade 1 or 2, and no hospitalizations were required, suggesting improved tolerability with the new prophylactic approach.

Sotatercept Approved in Europe for Pulmonary Arterial Hypertension

  • Sotatercept (Winrevair; Merck) has received European Commission approval for pulmonary arterial hypertension (PAH) in adult patients with WHO Functional Class II-III.
  • The approval marks sotatercept as the first activin signaling inhibitor therapy approved in Europe for PAH, based on the Phase 3 STELLAR trial.
  • Sotatercept, administered via subcutaneous injection every three weeks, significantly improved exercise capacity and reduced the risk of clinical worsening or death.
  • Common adverse reactions included headache, epistaxis, and rash, but the drug's safety profile was consistent with previous studies.

Merck's Gardasil 9 Shows Positive Phase 3 Results in Japanese Males

• Merck's Gardasil 9 demonstrated efficacy in preventing HPV-related anogenital persistent infection in Japanese males aged 16-26 in a Phase 3 trial. • The trial met its primary endpoint, showing a reduction in the combined incidence of anogenital persistent infection caused by 9 HPV types compared to placebo. • Merck plans to submit these data to regulatory authorities in Japan and other countries to support licensure for use in males. • An ongoing Phase 3 trial is evaluating Gardasil 9's efficacy in preventing HPV oral persistent infection to support effectiveness against HPV-related oropharyngeal cancers.

Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)

NCT04199689Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 2/27/2020

Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)

NCT04635423Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 11/30/2020

Entero Therapeutics to License AI-Powered Clinical Trial Compliance Tech from Data Vault

  • Entero Therapeutics will license Data Vault's QOLPOM and FotoDigm platforms to enhance clinical trial compliance, particularly for its Phase 3 latiglutenase trial.
  • The technology employs machine learning and machine vision to improve remote patient monitoring and data collection in clinical trials.
  • Entero plans to customize the software for gastrointestinal trials and explore commercial applications for other pharma companies.
  • The deal hinges on Entero securing strategic investments, with Data Vault assisting in this effort, to fund the technology's customization and implementation.

DCGI Suspends Approval for Entod Pharma's PresVu Eye Drops Amidst Overselling Concerns

  • The Drugs Controller General of India (DCGI) has suspended Entod Pharmaceuticals' PresVu eye drops approval due to concerns of overselling its benefits.
  • The regulator found the company was promoting the eye drops as a way to reduce the need for reading glasses, a claim not approved by the DCGI.
  • Entod Pharma intends to challenge the suspension in court, asserting that their claims were based on clinical trial results and DCGI approval for presbyopia treatment.
  • Ophthalmologists have raised concerns about the long-term safety and potential side effects of pilocarpine, the active ingredient in PresVu, for presbyopia treatment.

Indies Pharma Secures FDA Approval for Generic Regadenoson, Targeting $400M Market

  • Indies Pharma Jamaica has received FDA approval for its generic drug, Regadenoson, marking a historic milestone as the first Jamaican company to achieve this feat.
  • The approval unlocks access to a substantial US$400 million market, positioning Indies Pharma among the top players in the United States for this medication.
  • Generic Regadenoson is bioequivalent to Astellas Pharma's Lexiscan, offering a cost-effective alternative for patients undergoing cardiac stress tests.
  • Indies Pharma anticipates significant revenue growth, projecting a potential doubling of sales and aiming for $2-3 billion in revenue by FY2025.

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