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Clinical Trial News

PolyActiva Initiates US Phase 2b Trial for Six-Month Biodegradable Glaucoma Implant PA5108

  • PolyActiva has enrolled the first US patient in a Phase 2b clinical trial evaluating PA5108, a biodegradable ocular micro implant designed to deliver sustained intraocular pressure control for up to six months.
  • The rod-shaped implant uses the company's proprietary PREZIA™ technology platform to provide zero-order drug release of latanoprost acid and complete biodegradation without leaving residual material in the eye.
  • Previous Phase 2a results in Australia demonstrated statistically significant IOP reductions from baseline at weeks 12, 21, 33, and 42, with successful repeat dosing capability after six months.
  • The Phase 2b study will enroll approximately 75 patients across 12 US sites to assess safety and efficacy of redosing PA5108 at two dose levels compared to topical latanoprost therapy.

Insmed Reports Strong Q2 2025 Results with ARIKAYCE Growth and Brensocatib Approval Pending

Drug Approval
  • Insmed achieved $107.4 million in ARIKAYCE revenue for Q2 2025, representing 19% growth compared to the same quarter in 2024, with growth across all geographic regions.
  • The company's brensocatib NDA for bronchiectasis remains on track with a PDUFA target action date of August 12, 2025, following FDA Priority Review designation.
  • TPIP program advances with positive Phase 2b PAH study results that surpassed expectations, with Phase 3 studies planned for PH-ILD in H2 2025 and PAH in early 2026.
  • The company maintains 2025 global ARIKAYCE revenue guidance of $405-425 million, reflecting double-digit growth, while holding $1.9 billion in cash and marketable securities.

Experimental Dendritic Cell Therapy Shows Promise for Glioblastoma in Phase 1 Trial

  • A phase 1 clinical trial of DOC1021 (dubondencel), an individualized dendritic cell therapy, demonstrated positive immune responses and improved survival in 16 newly diagnosed glioblastoma patients.
  • The treatment creates a personalized vaccine from each patient's tumor tissue to train the immune system to attack cancer cells, including those that evade surgical removal.
  • Researchers observed tumor disappearance on MRIs in some patients, an unprecedented outcome for glioblastoma where survival rates have remained unchanged for 20 years.
  • Diakonos Oncology has initiated a phase 2 trial of DOC1021 at 20 sites nationwide following the encouraging safety and efficacy results.

Standard BioTools' SomaScan Platform Selected for Singapore's Landmark 100,000-Sample Precision Medicine Study

Precision Medicine
  • Standard BioTools' SomaScan 11K Assay was selected by Singapore's PRECISE-SG100K initiative to analyze 100,000 plasma samples in one of the world's largest population health research studies.
  • The collaboration aims to transform precision medicine by discovering novel genetic associations and biomarkers through comprehensive proteomics analysis of Singapore's multi-ethnic population.
  • This partnership reinforces SomaScan's leadership in population proteomics, with the platform now being used in more than 30 biobank studies worldwide totaling nearly 160,000 samples this year alone.

Samson Clinical Initiates Phase III Trial of Sublingual Minoxidil for Male Pattern Hair Loss

  • Samson Clinical has successfully randomized the first patient in its Phase III clinical trial (SAM-002) evaluating sublingual minoxidil for androgenetic alopecia in men.
  • The multicentre, randomized, controlled study will assess safety and efficacy using a 1:1 randomization to sublingual minoxidil or placebo across Australian clinical sites.
  • Male pattern hair loss affects up to 80% of men during their lifetime and significantly impacts self-esteem and quality of life beyond visible symptoms.
  • The sublingual formulation aims to provide a more convenient and usable alternative to existing therapies for this leading cause of hair loss.

Efficacy & Safety of Minoxidil SL Tablets in Men With AGA

NCT06924632RecruitingPhase 3
Samson Clinical Operations Pty Ltd
Posted 7/14/2025

FDA Grants Fast Track Designation to Birelentinib for Relapsed/Refractory CLL/SLL

  • The FDA has granted fast track designation to birelentinib (DZD8586), a first-in-class noncovalent LYN/BTK dual inhibitor, for treating adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
  • Pooled phase I/II study data demonstrated an 84.2% objective response rate in heavily pretreated CLL/SLL patients, with responses observed regardless of BTK resistance mutations including C481X variants.
  • The dual inhibitor mechanism addresses both BTK-dependent and BTK-independent resistance pathways, representing a potential breakthrough for patients who have failed multiple prior therapies including BTK and BCL-2 inhibitors.

DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

NCT05824585RecruitingPhase 1
Dizal Pharmaceuticals
Posted 5/15/2023

DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)

NCT06539182RecruitingPhase 2
Dizal Pharmaceuticals
Posted 4/29/2024

Revvity Launches pHSense Reagents to Accelerate GPCR and ADC Drug Development

Drug DiscoveryPrecision Medicine
  • Revvity has launched pHSense™ reagents, a breakthrough technology designed to advance internalization studies for G protein-coupled receptors (GPCRs) and antibody-drug conjugates (ADCs) in drug discovery.
  • The reagents combine pH-sensitive dye with time-resolved fluorescence readout to deliver robust kinetics and high signal-to-background ratios, even at low endogenous receptor expression levels.
  • pHSense reagents are designed for high-throughput, plate-based workflows and can help researchers accelerate preclinical development timelines while potentially reducing overall development costs.
  • The technology addresses critical limitations of current internalization assay technologies, including low throughput and suboptimal signal-to-noise ratios in drug development workflows.

Dana-Farber, Boston Children's Hospital, and Broad Clinical Labs Launch BrightSeq Initiative for Pediatric Cancer Genomics

Precision Medicine
  • Dana-Farber Cancer Institute, Boston Children's Hospital, and Broad Clinical Labs have formed BrightSeq, a collaborative initiative to develop clinical molecular testing assays specifically for pediatric cancers.
  • The initiative aims to provide CLIA-certified somatic whole exome sequencing and liquid biopsy testing for pediatric solid malignancies and sarcomas, addressing the urgent diagnostic needs in rare childhood cancers.
  • Each institution will contribute specialized expertise, with Boston Children's leading clinical interpretation, Broad Clinical Labs handling sequencing operations, and Dana-Farber driving patient engagement and research innovation.
  • The collaboration builds on foundational research demonstrating that circulating tumor DNA is a clinically meaningful biomarker for pediatric solid tumors, supporting the integration of liquid biopsy technologies into routine clinical care.

FDA Approves Tocilizumab-anoh Biosimilar for Cytokine Release Syndrome Treatment

Monoclonal AntibodyDrug Approval
  • The FDA approved tocilizumab-anoh (Avtozma) IV formulation on August 6, 2025, for treating cytokine release syndrome in patients aged 2 years and older.
  • This approval achieves full indication alignment between the biosimilar and its reference drug tocilizumab (Actemra), expanding access to high-quality biologics.
  • Cytokine release syndrome is a potentially life-threatening condition causing widespread inflammation and organ damage through excessive cytokine release.
  • The IV formulation is expected to be available in the United States on August 31, 2025, following a patent settlement agreement with Genentech.

A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis

NCT05489224CompletedPhase 3
Celltrion
Posted 9/14/2022

Oxaliplatin Shows Survival Benefit Only in Stage III Colorectal Cancer Patients Under 70 Years

  • A large Korean population-based study found oxaliplatin-based adjuvant chemotherapy significantly improved survival only in stage III colorectal cancer patients aged 70 years or younger, with no benefit observed in older patients.
  • Patients over 70 years receiving oxaliplatin experienced higher treatment discontinuation rates and no survival advantage, highlighting the need for age-specific treatment guidelines.
  • The study found no survival benefit from oxaliplatin in stage II colorectal cancer patients at any age, emphasizing the importance of refined risk stratification for treatment decisions.
  • Five-year overall survival rates were 84.8% versus 78.1% for oxaliplatin versus non-oxaliplatin groups in younger stage III patients, establishing 70 years as a potential age cutoff for treatment decisions.

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