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Clinical Trial News

CEL-SCI Raises $5.7M to Fund Pivotal Multikine Trial for Head and Neck Cancer

Orphan Drug
  • CEL-SCI Corporation completed a $5.7 million stock offering to fund its confirmatory Phase 3 trial for Multikine, a neoadjuvant immunotherapy targeting head and neck cancer patients with low PD-L1 expression.
  • The company faces severe liquidity constraints with only $1.93 million in cash as of Q1 2025 and quarterly burn rate of approximately $7 million, creating an urgent need for additional funding.
  • Multikine previously demonstrated a 73% five-year survival rate versus 45% for standard care in a specific patient subset, earning FDA Orphan Drug designation.
  • The confirmatory trial will enroll 212 patients and represents CEL-SCI's final opportunity to validate decades of research in neoadjuvant immunotherapy for head and neck cancer.

Profusa Goes Public on Nasdaq with Tissue-Integrating Biosensor Platform for Chronic Disease Management

  • Profusa, Inc. completed its business combination with NorthView Acquisition Corp. and began trading on Nasdaq under ticker "PFSA" on July 14, 2025.
  • The Berkeley-based company has developed tissue-integrating biosensors that can function for months and continuously monitor body chemistry for diabetes, critical limb ischemia, and peripheral arterial disease management.
  • The company raised $9 million through a secured convertible promissory note with up to $20 million available to support transaction costs and working capital needs.

Real-World Study Reveals Persistent Gaps in Molecular Testing and Targeted Therapy Implementation for AML and MDS

Targeted TherapyReal World Evidence
  • A five-year retrospective analysis of over 16,000 patients with AML and MDS found significant gaps in molecular testing implementation, with mean turnaround times of 14-16 days exceeding recommended guidelines.
  • Despite mutations being detected in 68% of AML patients and 72% of MDS patients, transition rates to targeted therapies remained suboptimal, particularly in older AML patients and across all MDS patient groups.
  • The study highlighted the need for streamlined approaches, including ultra-rapid NGS platforms, to improve guideline adherence and enhance patient outcomes in hematological malignancies.

SimBioSys Receives Third FDA Clearance for AI-Powered Breast Cancer Surgery Platform TumorSight Viz

AI
  • SimBioSys secured its third FDA 510(k) clearance for TumorSight Viz 1.3, an AI-powered platform that converts standard breast MRI into 3D visualizations for surgical planning in breast cancer care.
  • The latest version introduces industry-leading AI-driven segmentation accuracy, faster case processing that produces results in minutes, and streamlined workflow integration with PACS connectivity.
  • Clinical validation demonstrates strong concordance with radiologist annotations and consistent performance across more than 1,600 retrospective cases from over nine institutions.
  • The platform addresses the critical need for precision in breast cancer surgery, where re-excision rates remain above 20 percent and significant variability exists in surgical decisions among experienced providers.

CMS Proposes Medicare Coverage for Renal Denervation Devices to Treat Uncontrolled Hypertension

  • The Centers for Medicare and Medicaid Services has proposed national coverage for renal denervation procedures, marking a significant step toward expanding access to this innovative hypertension treatment.
  • Medtronic and Recor Medical received FDA approval for their renal denervation devices in late 2023, with Medtronic's Symplicity Spyral using radiofrequency energy and Recor's Paradise system utilizing ultrasound technology.
  • The proposed coverage could benefit over 18 million Americans with poorly controlled hypertension, potentially making renal denervation one of the largest growth drivers in recent medical device history.
  • The CMS proposal opens a second 30-day public comment period, with the majority of initial comments from physicians speaking positively about the treatment's clinical value.

Indian Regulators Reject Troikaa's Rapid IV Paracetamol Bolus Over Safety and Efficacy Concerns

Drug Approval
  • India's Subject Expert Committee (SEC) has rejected Troikaa Pharmaceuticals' proposal for a rapid intravenous paracetamol bolus formulation due to insufficient safety and efficacy data.
  • The proposed formulation would deliver paracetamol 1000 mg/4 ml as a 2-minute IV bolus, significantly faster than the standard 15-minute infusion currently used.
  • Regulators flagged the absence of commonly expected adverse events in Phase III trial data and questioned the clinical support for proposed indications.
  • The committee has requested additional studies and data before reconsidering approval for the concentrated paracetamol formulation.

Anthem Biosciences Raises Rs 1,016 Crore from Anchor Investors Ahead of Rs 3,395 Crore IPO

  • Anthem Biosciences successfully mobilized Rs 1,016 crore from 60 anchor investors at Rs 570 per share, the upper end of the price band.
  • The Bengaluru-based contract research and manufacturing organization will launch its Rs 3,395 crore IPO for public subscription from July 14-16.
  • The company operates as an integrated CRDMO spanning drug discovery, development and manufacturing, with specialization in fermentation-based active pharmaceutical ingredients.
  • Notable anchor investors include Abu Dhabi Investment Authority, Government Pension Fund Global, and major Indian mutual funds like HDFC and ICICI Prudential.

Photodynamic Therapy Shows Promise in Cancer Treatment with Global Market Expected to Reach $6 Billion by 2030

FDA Approval
  • The global photodynamic therapy market is projected to surpass $6 billion by 2030, driven by technological advances in LED-based light delivery systems and improved photosensitizer formulations.
  • Recent clinical developments include Sun Pharmaceutical's FDA-cleared BLU-U Blue Light PDT Illuminator and Biofrontera's successful Phase 3 study of Ameluz® for superficial basal cell carcinoma treatment.
  • Comprehensive meta-analysis evidence demonstrates PDT's effectiveness varies by cancer type, with strong benefits for cholangiocarcinoma when combined with stenting and superior cosmetic outcomes for skin cancers compared to traditional treatments.

AstraZeneca Initiates Real-World Study of Koselugo in Korean Patients to Fulfill Post-Approval Commitment

Real World Evidence
  • AstraZeneca is conducting a real-world treatment study to evaluate the safety and effectiveness of Koselugo (selumetinib) in Korean patients as part of a post-approval commitment requested by the Korean health authority.
  • The observational study uses a case-only model to monitor patients already receiving the MEK inhibitor treatment in routine clinical practice settings without intervention allocation or masking.
  • The study began on June 15, 2024, and aims to provide insights into Koselugo's real-world performance that could influence investor confidence and market dynamics in the MEK inhibitor space.

Real-World Data Successfully Integrated as External Control Arm in HER2+ Breast Cancer Trial

  • Researchers successfully demonstrated the feasibility of using real-world data to create an external control arm for a phase 2 trial of tucatinib plus liposomal doxorubicin in HER2-positive breast cancer patients.
  • The pilot study expanded an 8-patient phase 2 trial to a 40-patient simulated dataset and matched it with a 77-patient real-world control arm, achieving 82% successful matching.
  • Baseline characteristics were well-balanced between cohorts, with mean ages of 61.2 and 60.4 years respectively, and similar prior treatment distributions.
  • This approach could accelerate clinical development pipelines by enabling faster, evidence-driven decision-making for advancing to phase 3 studies.

Study of Tucatinib and Doxil in Participants with Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer

NCT05748834RecruitingPhase 2
SCRI Development Innovations, LLC
Posted 7/24/2023

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