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Clinical Trial News

UCSD and Hyundai Bio to Evaluate Xafty for Long COVID Treatment

  • UC San Diego and Hyundai Bioscience will collaborate on an investigator-initiated trial to assess Xafty, a niclosamide-based antiviral, for treating Long COVID.
  • Xafty has shown promise in Phase 2 trials by improving symptoms faster than existing treatments, especially in high-risk COVID-19 patients.
  • Preclinical studies suggest Xafty may alleviate Long COVID symptoms through anti-inflammatory and neuroprotective mechanisms, including dopamine production.
  • The trial aims to confirm niclosamide's potential to address the complex symptoms of Long COVID, offering a new treatment option for affected individuals.

Triplet Therapy Shows Promise in Advanced Chronic Myeloid Leukemia

  • A novel triplet regimen of decitabine, venetoclax, and ponatinib achieved bone marrow remission in 80% of advanced-phase CML patients.
  • The Phase II trial included patients with accelerated or myeloid blast-phase CML and Philadelphia chromosome-positive AML.
  • The combination therapy showed efficacy even in patients with prior therapies and high-risk cytogenetic or molecular features.
  • The observed side effects were consistent with previous studies of the individual drugs, including neutropenia, rash, and nausea.

Bristol Myers Squibb Initiates Two Phase I Trials Testing Novel Therapies for Advanced Solid Tumors and Relapsed/Refractory Lymphomas

Oncology
  • Bristol Myers Squibb has launched two Phase I clinical trials evaluating experimental therapies BMS-986408 for advanced solid tumors and BMS-986458 for relapsed/refractory non-Hodgkin lymphoma.
  • The BMS-986408 study targets patients with histologically confirmed, advanced, unresectable or metastatic solid malignancies who have exhausted existing treatment options.
  • The BMS-986458 trial focuses on patients with relapsed/refractory DLBCL and follicular lymphoma who have received at least two prior lines of therapy.
  • Both studies exclude patients with autoimmune diseases and require specific performance status criteria for enrollment.

UpFrontPSMA Trial: Lutetium-PSMA Plus Docetaxel Shows Promise in Metastatic Hormone-Sensitive Prostate Cancer

  • The UpFrontPSMA trial demonstrated that adding lutetium-PSMA to docetaxel significantly improved undetectable PSA rates at 48 weeks in mHSPC patients.
  • The study also showed improvements in key secondary endpoints like PSA progression-free survival and freedom from castration resistance with the lutetium-PSMA combination.
  • Treatment with lutetium-PSMA did not increase overall toxicity or negatively impact quality of life, suggesting a potential role in mHSPC management.
  • The ongoing PSMAddition Phase III trial will further evaluate lutetium-PSMA's utility in mHSPC, potentially changing the standard of care.

In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy

NCT04343885Active, Not RecruitingPhase 2
Peter MacCallum Cancer Centre, Australia
Posted 4/21/2020

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC

NCT04720157Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 6/9/2021

Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer

NCT00309985Active, Not RecruitingPhase 3
ECOG-ACRIN Cancer Research Group
Posted 9/26/2006

AI-Powered Saliva Test Offers Personalized Epilepsy Management

  • Oregon State University researchers are developing an AI-driven saliva test to optimize anti-epileptic drug (AED) dosing for epilepsy patients.
  • The device aims to provide rapid, at-home monitoring of AED levels, overcoming the limitations of traditional blood tests.
  • The AI component will help to interpret complex saliva composition and personalize drug dosages based on individual patient needs and reported side effects.
  • The system will wirelessly transmit data to doctors, enabling timely adjustments to medication and improved seizure control.

FDA Approves Keytruda for First-Line Treatment of Malignant Pleural Mesothelioma

  • The FDA has approved Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy as a first-line treatment for unresectable advanced or metastatic malignant pleural mesothelioma.
  • The approval was based on the Phase 2/3 KEYNOTE-483 trial, which demonstrated a statistically significant improvement in overall survival compared to chemotherapy alone.
  • Patients receiving Keytruda plus chemotherapy had a median overall survival of 17.3 months, compared to 16.1 months for those receiving chemotherapy alone, reducing the risk of death by 21%.
  • The Keytruda regimen also showed significant improvements in progression-free survival and overall response rate, offering a new treatment option for this aggressive cancer.

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

NCT04223856Active, Not RecruitingPhase 3
Astellas Pharma Global Development, Inc.
Posted 3/30/2020

Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma

NCT02784171CompletedPhase 2
Canadian Cancer Trials Group
Posted 11/11/2016

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

NCT03765918Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 12/17/2018

Kincell to Manufacture Cell Therapy for Clinical Trials in New Partnership

  • Kincell has entered a two-year contract to produce a formulated cell product for an undisclosed client's clinical trial, leveraging its Gainesville, Florida facility.
  • The agreement encompasses technology transfer and GMP manufacturing, with Kincell aiming for a production rate of two to four doses per month for the client.
  • This partnership marks one of several planned for Kincell's Gainesville facility, which is equipped with advanced infrastructure to support cell therapy manufacturing.
  • Kincell continues to expand its CDMO capabilities through strategic partnerships and facility acquisitions to meet the growing demand for cell and gene therapies.

Trishula Therapeutics' TTX-030 Shows Promise in Phase I Pancreatic Cancer Trial

  • Trishula Therapeutics reported positive Phase I results for TTX-030, an anti-CD39 antibody, in first-line metastatic pancreatic cancer treatment.
  • The study combined TTX-030 with gemcitabine/nab-paclitaxel, with or without budigalimab, demonstrating a 30% objective response rate.
  • Patients with high HLA-DQ expression experienced a 46% ORR, 9.6-month progression-free survival, and 21.9-month overall survival.
  • A global Phase II trial, ELTIVATE, is underway to further assess TTX-030 in metastatic pancreatic adenocarcinoma, with results expected in 2026.

Microbot Medical Completes Trial for LIBERTY Surgical Robot, Eyes FDA Submission

  • Microbot Medical has concluded its ACCESS-PVI clinical trial for the LIBERTY endovascular surgical robot, with plans to submit a 510(k) application to the FDA by the end of 2024.
  • The LIBERTY system aims to improve endovascular procedures by reducing the need for bulky equipment and minimizing radiation exposure for physicians.
  • The company is accelerating its commercialization strategy, including hiring a seasoned healthcare executive, in anticipation of FDA clearance expected in Q2 2025.
  • Clinical data from the ACCESS-PVI trial will be presented at a medical conference in early 2025, showcasing the performance and safety of the LIBERTY system.

Health Canada Grants Priority Review to Biogen's Omaveloxolone for Friedreich's Ataxia

  • Health Canada has accepted Biogen's New Drug Submission for omaveloxolone under priority review for treating Friedreich's ataxia in patients aged 16 and older.
  • Omaveloxolone, a once-daily oral medication, could become the first disease-specific treatment option available for this rare and debilitating neuromuscular condition.
  • The submission is supported by data from the MOXIe Part 2 trial, which demonstrated significant improvements in mFARS scores compared to placebo at 48 weeks.
  • A regulatory decision from Health Canada regarding the approval of omaveloxolone is anticipated in early 2025, offering hope for Canadian patients with Friedreich's ataxia.

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