MedPath

Clinical Trial News

New Zealand Launches World's First Clinical Trial Testing THC-CBD Combination for Canine Osteoarthritis

  • Hale Animal Health is conducting the first regulated clinical trial testing a THC-CBD liquid formulation for osteoarthritis pain management in over 100 dogs across New Zealand.
  • The six-week study aims to provide pain relief comparable to current anti-inflammatory medications but without the common side effects of digestive upset and liver or kidney damage.
  • Trial data will support regulatory applications to New Zealand's ACVM and eventually the FDA, with plans to register the product as a veterinary medicine in New Zealand, Australia, and the United States.
  • Eligible dogs receive free veterinary care including physical exams, X-rays, and blood screening, with the liquid treatment administered daily based on body weight.

Advanced Mycosis Fungoides Treatment Requires Strategic Sequencing of HDAC Inhibitors and Targeted Therapies

Targeted Therapy
  • Advanced mycosis fungoides with nodal involvement requires systemic approaches adapted from peripheral T-cell lymphoma management, as standard skin-directed therapies provide limited benefit in this setting.
  • CTCL patients typically require 50% dose reductions compared to systemic T-cell lymphoma protocols due to enhanced treatment sensitivity and altered tumor cell metabolism.
  • HDAC inhibitors including romidapsin and vorinostat demonstrate efficacy in patients with both peripheral blood and nodal involvement, while mogamalizumab shows particular effectiveness in circulating disease.
  • Chronic use of single-agent chemotherapy introduces unique toxicity considerations, with gemcitabine carrying risks of hemolytic uremic syndrome after continuous use for over a year.

Alafair Biosciences Initiates Multi-Center Study of VersaWrap Hydrogel Device for Achilles Tendon Repair

  • Alafair Biosciences has enrolled the first patient in the B.R.A.A.D study, a multi-center controlled case series evaluating VersaWrap for Achilles tendon repair at UC Davis Foot and Ankle Orthopaedics Clinic.
  • The study aims to assess VersaWrap's ability to reduce postoperative complications such as tendon tethering, addressing limitations of traditional surgical repair techniques including long healing times and scar tissue formation.
  • VersaWrap is an FDA-cleared bioresorbable device comprising hyaluronic acid and alginate that provides tissue protection and can be delivered as either a sheet or flowable gel.

CDC's Reconstituted Vaccine Advisory Panel Votes to Eliminate Thimerosal from All Flu Vaccines

Monoclonal Antibody
  • The newly appointed Advisory Committee on Immunization Practices (ACIP) voted 5-1 to recommend thimerosal-free influenza vaccines for all age groups, despite the preservative being present in only 6% of U.S. flu vaccines.
  • Committee members expressed concerns that restricting thimerosal-containing vaccines could reduce vaccine access, particularly in global markets where multi-dose vials are more cost-effective.
  • The panel also approved RSV prevention recommendations, voting 5-2 to recommend clesrovimab for infants under 8 months during their first RSV season.
  • Public health experts criticized the committee's focus on thimerosal as scientifically unfounded, noting the preservative was already removed from pediatric vaccines over 20 years ago.

DBV Technologies Initiates COMFORT Toddlers Phase 3 Study for Viaskin Peanut Patch in Young Children

  • DBV Technologies has begun screening the first subject in its COMFORT Toddlers Phase 3 supplemental safety study, evaluating the Viaskin Peanut patch 250 μg in peanut-allergic children ages 1-3 years old.
  • The double-blind, placebo-controlled study will enroll approximately 480 subjects across 80-90 centers in the U.S., Canada, Australia, UK and Europe over six months with an optional 18-month extension.
  • Data from COMFORT Toddlers is designed to supplement the completed Phase 3 EPITOPE study and support a Biologics License Application submission to the FDA anticipated in the second half of 2026 under the Accelerated Approval Pathway.

TME Pharma Appoints Diede van den Ouden as New CEO to Advance Glioblastoma Drug Development

Oncology
  • TME Pharma shareholders unanimously approved the appointment of Diede van den Ouden as new CEO, succeeding Aram Mangasarian at the company's 2025 annual general meeting.
  • The leadership transition comes as TME Pharma has achieved significant clinical progress with NOX-A12 in glioblastoma, earning FDA fast track designation for the challenging brain cancer indication.
  • Van den Ouden, who is also a major shareholder, will focus on accelerating strategic initiatives for both NOX-A12 and NOX-E36 while securing funding and partnerships.
  • The company has strengthened its financial position with reduced cash burn and a secured 12-month runway as it advances multiple clinical programs targeting the tumor microenvironment.

Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients

NCT04121455Active, Not RecruitingPhase 1
TME Pharma AG
Posted 9/12/2019

Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer

NCT04901741Not Yet RecruitingPhase 2
TME Pharma AG
Posted 1/1/2026

Cellugy Secures €8.1 Million EU Funding to Scale Microplastic Alternative for Cosmetics Industry

  • Danish biotechnology company Cellugy has secured €8.1 million in EU LIFE Programme funding to accelerate commercialization of EcoFLEXY, a biofabricated cellulose-based rheology modifier designed to replace fossil-derived microplastics in cosmetics.
  • The BIOCARE4LIFE project aims to prevent the release of 259 tonnes of microplastics annually by project completion, with projections rising to 1,289 tonnes per year by 2034.
  • EcoFLEXY targets the €2.8 billion global rheology modifier market, where approximately 70% of products are still based on fossil, non-degradable ingredients that face increasing regulatory scrutiny under EU REACH regulations.
  • The four-year funding will support process optimization, commercial validation, and industrial scaling, with Cellugy planning to achieve significant sales within three to five years.

Metabolics Pharma's ENT-03 Shows Promise in Phase 1a Trial for Obesity and Type 2 Diabetes

  • Metabolics Pharma announced positive top-line results from a Phase 1a clinical trial of ENT-03, demonstrating safety and tolerability across all evaluated doses in obese and diabetic patients.
  • The novel centrally acting aminosterol showed positive trends for weight reduction and increased insulin sensitivity at higher doses, targeting brain circuits that regulate energy and metabolism.
  • ENT-03 works through Protein Tyrosine Phosphatase 1B (PTP1B) inhibitory activity and has shown additive effects when combined with GLP-1 agonists in animal models.
  • The company plans to initiate a Phase 1b study to evaluate dosing regimens in the second half of 2025, building on these encouraging first-in-human results.

£7.5 Million Longitude Prize Launches to Accelerate AI-Driven ALS Drug Discovery

AIDrug Discovery
  • The Longitude Prize on ALS has launched as a £7.5 million global challenge to incentivize AI-based approaches for drug discovery targeting amyotrophic lateral sclerosis, the most common form of motor neurone disease.
  • The competition will provide access to the largest collection of ALS patient data ever assembled, with 20 initial winners receiving £100,000 each in 2026 and a final £1 million grand prize awarded in 2031.
  • The prize is principally funded by the Motor Neurone Disease Association and aims to identify promising drug targets for a disease that currently has no long-term treatments or cure.
  • Teams will progress through multiple stages of validation, with the ultimate goal of identifying therapeutic targets with the strongest evidence of potential for treating ALS patients.

RayBiotech and Venebio Group Form Strategic Partnership to Accelerate Drug Development Through Integrated Proteomics and Regulatory Expertise

  • RayBiotech Life, Inc. and Venebio Group, LLC have entered into a Master Services Agreement to combine proteomics platforms with regulatory strategy expertise for drug and diagnostics development.
  • The collaboration integrates RayBiotech's biomarker discovery services and high-throughput protein arrays with Venebio's regulatory planning and clinical trial design capabilities.
  • The partnership aims to provide customized services from biomarker-driven trial design to clinical assay validation, helping life science companies navigate regulatory challenges more effectively.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.