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KOELIS Announces Positive Interim Results from VIOLETTE Trial on Targeted Microwave Ablation for Prostate Cancer

  • The VIOLETTE trial, a multicenter Phase II study, evaluates KOELIS' OBT-Fusion technology for targeted microwave ablation (TMA) in prostate cancer.
  • Interim results from the first 37 patients show that TMA, guided by the Koelis Trinity system, effectively covers tumors with minimal impact on urinary or sexual function.
  • The study reported a median pain level of 0/10 post-procedure, with all patients recovering spontaneous micturition and being discharged the same day.
  • These early findings suggest that image-guided, needle-based TMA could be a safe and efficient management option for selected prostate cancer patients.

Efficacy Assessment of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer

NCT04582656Unknown StatusNot Applicable
Koelis
Posted 2/11/2021

Ultromics' EchoGo® Amyloidosis Receives FDA Clearance for Cardiac Amyloidosis Detection

  • Ultromics' EchoGo® Amyloidosis, an AI-based software, has received FDA clearance for early detection of Cardiac Amyloidosis, a frequently underdiagnosed cause of heart failure.
  • The device, part of the EchoGo® platform, requires only a single echocardiographic clip, reducing the need for extensive clinical information compared to current diagnostic methods.
  • EchoGo® Amyloidosis demonstrated high sensitivity (84.5%) and specificity (89.7%) in detecting Cardiac Amyloidosis in individuals aged 65 and older with heart failure.
  • Developed with support from Janssen and Pfizer, EchoGo® Amyloidosis aims to improve diagnostic accuracy and enable timely access to appropriate treatment for patients.

Puma Biotechnology Initiates Phase 2 Trial of Alisertib for HR+/HER2- Metastatic Breast Cancer

• Puma Biotechnology has begun a Phase 2 trial (ALISCA™-Breast1) to evaluate alisertib combined with endocrine therapy for hormone receptor-positive, HER2-negative metastatic breast cancer. • The trial will enroll up to 150 patients who have previously received CDK 4/6 inhibitors and at least two prior endocrine therapies, with initial data expected in 2025. • The primary objective is to determine the optimal dose of alisertib, with endpoints including objective response rate, duration of response, and progression-free survival. • Puma plans to discuss potential FDA approval pathways following the trial, with a future Phase 3 trial potentially comparing alisertib plus endocrine therapy to placebo plus endocrine therapy.

Evaluating how well and how safely Alisertib works with hormone therapy in treating patients with breast cancer that has come back or spread (hormone receptor positive, HER2 negative

2024-511497-79-00RecruitingPhase 2
Puma Biotechnology Inc.
Posted 11/19/2024

Northwell Health Joins RenovoRx's Phase III Trial for Pancreatic Cancer

  • Northwell Health Cancer Institute enrolls patients in RenovoRx's Phase III TIGeR-PaC trial for locally advanced pancreatic cancer (LAPC).
  • The trial assesses RenovoRx's TAMP therapy, comparing intra-arterial gemcitabine delivery via RenovoCath to standard intravenous chemotherapy.
  • RenovoRx anticipates completing patient enrollment in the TIGeR-PaC study during the first half of 2025.
  • The TAMP platform offers a novel approach that could potentially improve the risk-benefit profile compared to standard systemic chemotherapy.

EMA Implements Strategy to Expedite Drug Approvals in the EU

  • The EMA is implementing changes to streamline drug approval processes in the EU to address delays affecting patients and businesses.
  • In 2023, only 35% of marketing authorization applications (MAAs) were submitted on time, highlighting the need for improved predictability.
  • The EMA plans to enhance submission predictability and regulatory preparedness through intensified pre-submission interactions and revised Letters of Intent.
  • The agency aims to refine submission predictability by monitoring the impact of these measures and addressing recurring issues systematically.

Ascendis Pharma's Yorvipath Commercially Available in the US, Offering New Hope for Hypoparathyroidism

  • Ascendis Pharma has launched Yorvipath (palopegteriparatide) in the US, the first FDA-approved treatment for hypoparathyroidism in adults.
  • Yorvipath is a once-daily prodrug of parathyroid hormone, designed to provide continuous exposure to active PTH over 24 hours.
  • Ascendis has established a dedicated support program to assist patients with clinical education, access, and injection training.
  • Clinical trials demonstrated that 93% of YORVIPATH-treated patients achieved independence from both active vitamin D and therapeutic doses of elemental calcium.

Puma Biotechnology Initiates Phase II Trial of Alisertib for HR+/HER2- Metastatic Breast Cancer

• Puma Biotechnology has commenced the ALISCA™-Breast1 Phase II trial to evaluate alisertib combined with endocrine therapy for HR+/HER2- metastatic breast cancer. • The trial aims to determine the optimal dose of alisertib in combination with endocrine therapy, enrolling up to 150 patients in a randomized 1:1:1 design. • The primary endpoints include objective response rate, duration of response, disease control rate, progression-free survival, and overall survival. • Puma plans to engage with global regulatory agencies regarding the design of a pivotal Phase III trial based on the outcomes of the Phase II trial.

Evaluating how well and how safely Alisertib works with hormone therapy in treating patients with breast cancer that has come back or spread (hormone receptor positive, HER2 negative

2024-511497-79-00RecruitingPhase 2
Puma Biotechnology Inc.
Posted 11/19/2024

IVC Filter Safety Data Transparency Questioned in New Analysis

  • A recent analysis highlights concerns regarding the safety data of inferior vena cava (IVC) filters, devices implanted to prevent blood clots.
  • The analysis points to potential flaws in the clinical trial design that may have obscured critical safety issues with the IVC filter.
  • Lack of transparency from both the FDA and device manufacturers regarding safety data raises concerns about patient safety and informed consent.

BioVie's Bezisterim to Enter Phase 2 Trial for Long COVID Treatment

  • BioVie Inc. will present the design of its Phase 2 trial of bezisterim for Long COVID at the Demystifying Long COVID International Conference.
  • The Phase 2 study is a double-blind, randomized, placebo-controlled, multicenter trial involving approximately 200 patients.
  • Bezisterim's efficacy in reducing neurocognitive symptoms associated with Long COVID will be evaluated over a 3-month treatment period.
  • The trial is fully funded by a $13.1 million grant from the U.S. Department of Defense.

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