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Cholecalciferol and Silymarin Combination Shows Promise in Alleviating BPH-Related LUTS

  • A study reveals that combined cholecalciferol and silymarin significantly improve lower urinary tract symptoms (LUTS) in benign prostatic hyperplasia (BPH) patients with vitamin D deficiency.
  • Silymarin alone notably reduces IPSS, irritation, obstruction, and post-void residual volume in BPH patients with sufficient vitamin D levels.
  • Both cholecalciferol and silymarin independently and significantly impact post-void residual volume, IPSS, and obstruction, offering potential therapeutic benefits.
  • The combination therapy demonstrates a notable improvement in IPSS score, prostate volume, and post-void residual, suggesting a novel approach for managing BPH-associated LUTS.

Emyria's MDMA-Assisted Therapy Shows Promise in PTSD Interim Trial Results

  • Emyria's MDMA-assisted therapy program for PTSD demonstrates improved patient outcomes in an initial cohort of eight participants with moderate to severe symptoms.
  • The interim analysis revealed clinically and statistically significant improvements in PTSD symptoms and overall quality of life following active treatment.
  • The Australian company is progressing towards its recruitment goal of 70 patients, with five additional individuals currently enrolled and undergoing treatment.
  • These early findings suggest potential benefits for patients with limited relief from standard PTSD treatments, warranting further investigation.

National Cancer Center to Initiate Basket Trial of BNCT for Thoracic Malignancies

  • The National Cancer Center Japan will conduct a Phase I/II basket trial of Boron Neutron Capture Therapy (BNCT) for unresectable and recurrent thoracic malignant solid tumors.
  • This trial is the first of its kind to evaluate BNCT across multiple thoracic cancer types, aiming to expedite development by grouping cancers with shared organs at risk.
  • The study will assess the safety and efficacy of BNCT, along with the utility of [18F]F-BPA PET imaging in determining patient suitability for BNCT.
  • The collaboration involves Sumitomo Heavy Industries, STELLA PHARMA CORPORATION, and Cancer Intelligence Care Systems, with the trial period extending until October 2028.

Unicycive Submits NDA to FDA for Oxylanthanum Carbonate to Treat Hyperphosphatemia in CKD Patients on Dialysis

  • Unicycive Therapeutics has submitted an NDA to the FDA for Oxylanthanum Carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.
  • The NDA is supported by data from three clinical studies, multiple preclinical studies, and CMC specifications, seeking approval via the 505(b)(2) regulatory pathway.
  • OLC, a next-generation lanthanum-based phosphate binder, aims to reduce pill burden and improve patient compliance compared to existing treatments.
  • The FDA granted a waiver for the NDA application Prescription Drug User Fee Act (PDUFA) fees, resulting in significant savings of approximately $4 million.

Urticaria Emerges as Concern in Phase 1 Trial of HIV mRNA Vaccines

  • Seven percent of participants in a phase 1 trial of experimental HIV-1 mRNA vaccines developed urticaria, with four cases remaining unresolved after 12 months of follow-up.
  • The study evaluated three investigational HIV-1 trimer mRNA vaccines at different doses in 108 healthy volunteers, with most adverse events being mild to moderate in severity.
  • All participants who developed urticaria had previously received Moderna COVID-19 vaccines, suggesting a potential correlation that warrants further investigation in future mRNA vaccine development.

FDA Grants Fast Track Designations to Caribou Biosciences' CB-010 and CB-012 for Refractory SLE and AML

Caribou Biosciences has received Fast Track designations from the FDA for its CB-010 and CB-012 therapies, aimed at treating refractory systemic lupus erythematosus (SLE) and relapsed or refractory acute myeloid leukemia (r/r AML) respectively. These designations are intended to expedite the development and review processes for these promising treatments.

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)

NCT04637763RecruitingPhase 1
Caribou Biosciences, Inc.
Posted 5/26/2021

CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

NCT06128044TerminatedPhase 1
Caribou Biosciences, Inc.
Posted 2/8/2024

Longeveron Achieves FDA Alignment on Lomecel-B Pathway for Hypoplastic Left Heart Syndrome

  • Longeveron secured FDA agreement on key endpoints for its Phase 2b ELPIS II trial of Lomecel-B™ in Hypoplastic Left Heart Syndrome (HLHS).
  • The FDA indicated that a successful ELPIS II trial, meeting specific conditions, could support a Biological License Application (BLA) submission for Lomecel-B™.
  • Lomecel-B™ has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA for HLHS treatment.
  • ELPIS II builds upon positive results from ELPIS I, which demonstrated 100% transplant-free survival up to five years in treated children.

VA STARPORT Network Tackles Challenges in Oligometastatic Prostate Cancer Trial

  • The Veterans Affairs (VA) Health Care System is utilizing a clinical trial network to study metastasis-directed therapy for veterans with oligometastatic prostate cancer (OMPC).
  • Challenges in timely site activation were addressed through project management strategies to maximize efficiency in the study start-up process.
  • The trial protocol was amended to include de novo OMPC patients and expand the allowed metastases from five to ten, adapting to evolving clinical paradigms.
  • Initiatives were developed to maintain local study team engagement, fostering collaboration and adding value to the overall clinical program through study participation.

GnRH-a Plus Letrozole or LNG-IUD Compared to Progesterone for Atypical Endometrial Hyperplasia

  • A clinical trial is underway comparing GnRH-a plus letrozole or LNG-IUD to traditional progesterone treatment for atypical endometrial hyperplasia (AEH).
  • The study aims to assess the complete response rates of the combination therapies versus progesterone after 24 weeks of treatment.
  • Secondary endpoints include pregnancy rates, recurrence rates, and safety profiles, offering a comprehensive evaluation of treatment efficacy.
  • The trial incorporates rigorous data management and monitoring to ensure data quality and patient safety throughout the study.

Phase 3 Trial of India's First Indigenous Dengue Vaccine, 'DengiAll,' Commences

  • The Phase 3 clinical trial for 'DengiAll,' India's first indigenous tetravalent dengue vaccine developed by Panacea Biotec and ICMR, has begun at KIMS, Bhubaneswar.
  • The trial will assess the vaccine's efficacy against all four serotypes of the dengue virus, addressing a critical need in a country where dengue is prevalent.
  • KIMS is the only site in Odisha and one of 18 sites across India participating in the Phase 3 trial, aiming to recruit over 500 participants in Bhubaneswar.
  • Previous Phase 1 and 2 trials of DengiAll have shown promising results, paving the way for this late-stage trial to potentially license the vaccine.
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