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Clinical Trial News

FDA Clears Advanced UroNav System for Precision Focal Therapy in Prostate Cancer

  • The FDA has granted 510(k) clearance to an updated version of the Philips UroNav System, featuring advanced annotation workflow for enhanced precision in minimally invasive prostate cancer focal therapy procedures.
  • The platform integrates pre-procedural MRI imaging with real-time intra-procedural ultrasound to provide clinicians with comprehensive visualization of target areas during treatment.
  • The system works in tandem with DynaCAD Urology to support focal therapy planning, delivery, and review, allowing urologists to edit prostate segmentation and add targets as needed.
  • Clinical experts highlight the platform's potential to personalize therapy with greater accuracy while sparing patients unnecessary side effects of traditional treatments.

Stem Cell Therapy Shows Promise for Fertility Restoration in Women with Ovarian Failure

  • A retrospective study of 145 women found that Stem Cell Regenera treatment achieved oocyte activation in nearly 70% of participants with ovarian failure conditions.
  • The therapy resulted in spontaneous pregnancy in 7% of participants and pregnancy through IVF in 14% of treated women.
  • The treatment protocol successfully mobilized CD34+ stem cells in all participants without severe adverse effects, with most experiencing only mild symptoms.
  • Results suggest the combination of G-CSF stem cell mobilization and platelet-rich plasma injection may offer new hope for women with diminished ovarian reserve, poor ovarian response, or premature ovarian insufficiency.

UC Davis Researchers Develop Gene Therapy to Reactivate Silent Genes in Rett Syndrome

Rare Disease
  • UC Davis Health scientists led by Sanchita Bhatnagar have developed a novel gene therapy that reactivates silenced healthy genes in Rett syndrome by targeting microRNA-106a.
  • The therapy uses a DNA-based "sponge" molecule delivered via gene therapy vector to block miR-106a, allowing dormant healthy MECP2 genes to become active again.
  • In female mouse models of Rett syndrome, treated animals showed longer survival, improved movement and cognition, and significant improvements in breathing irregularities.
  • The approach could potentially treat other X-linked genetic conditions and represents a promising therapeutic strategy for a disorder that currently has no cure.

Legacy Healthcare's Cinainu Shows Sustained Hair Regrowth in Pediatric Alopecia Areata Phase 2/3 Trial

  • Legacy Healthcare's topical botanical drug Cinainu demonstrated significant efficacy in treating moderate to severe alopecia areata in children and adolescents, with 47.6% of patients achieving substantial hair regrowth by week 48.
  • The RAAINBOW Phase 2/3 trial showed Cinainu's benefits persisted even after treatment discontinuation, with no immunosuppression-related adverse events reported in the treatment group.
  • Results published in the British Journal of Dermatology represent the first successful treatment for pediatric alopecia areata that maintains efficacy without triggering disease relapse upon discontinuation.

Flatiron Health Triples Global Oncology Research Network, Expanding Real-World Data Access Across Three Countries

AIPrecision Medicine
  • Flatiron Health's international oncology research network has tripled in size over the past year, now encompassing more than 30 partnerships across the UK, Germany, and Japan.
  • The expansion brings Flatiron's total patient database above 5 million records, with new partnerships including major academic medical centers and national cancer centers in each country.
  • The company established Flatiron FORUM, a global consortium addressing data transportability challenges to support multinational cancer research and regulatory decisions.
  • Seven research studies using multinational real-world data have been completed within the past two years, demonstrating the platform's capability for cross-country cohort analyses.

UCSF Chemists Overcome Solubility Issues in Next-Generation Malaria Drug Through Molecular Redesign

  • UCSF researchers successfully modified the molecular structure of artefenomel, a promising malaria drug that failed clinical trials due to poor solubility, by reducing its symmetry to improve dissolution properties.
  • The redesigned compound maintains equal potency against malaria parasites while showing superior effectiveness against artemisinin-resistant strains compared to current standard treatments.
  • This breakthrough addresses a critical need as artemisinin resistance spreads from Southeast Asia to Africa, where 95% of malaria cases and deaths occur among the 600,000 annual fatalities.
  • The optimized molecule can be easily formulated into pills and combined with other anti-malarial drugs, potentially enabling single-dose treatment regimens.

AI-Guided Drug LP-284 Achieves Complete Response in Treatment-Resistant Lymphoma Patient

AIOrphan Drug
  • Lantern Pharma's LP-284 achieved complete metabolic response in a heavily pretreated diffuse large B-cell lymphoma patient after just two treatment cycles.
  • The 41-year-old patient had previously failed three aggressive treatment regimens including CAR-T therapy and bispecific antibody therapy over 18 months.
  • LP-284 was developed using Lantern's RADR® AI platform in under three years at approximately $3 million, demonstrating computational efficiency in drug development.
  • The synthetic lethal therapy targets cancer cells with DNA damage repair deficiencies while preserving healthy tissue function.

Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients with Relapsed or Refractory Lymphomas and Solid Tumors

NCT06132503RecruitingPhase 1
Lantern Pharma Inc.
Posted 1/3/2023

Long-Acting Anti-TSLP Antibody HBM9378/WIN378 Enters Global Phase 2 Trial for Asthma Treatment

Monoclonal Antibody
  • Windward Bio has initiated the global Phase 2 POLARIS trial evaluating HBM9378/WIN378, a long-acting anti-TSLP monoclonal antibody for asthma treatment, with initial data expected in mid-2026.
  • The fully human antibody targets thymic stromal lymphopoietin (TSLP) and has been engineered for extended half-life with potential twice-yearly dosing, addressing the need for more effective long-acting treatments.
  • HBM9378/WIN378 demonstrated extended half-life, low antidrug antibody incidence, and good safety profile in Phase 1 trials, with additional COPD clinical programs planned for 2026.
  • The therapy represents a collaborative effort between Harbour BioMed and Kelun-Biotech, with Windward Bio holding exclusive global licensing rights outside Greater China and select Asian countries.

NeuroOne Receives USPTO Patent Approval for Novel Neural Probe Manufacturing Technology

  • NeuroOne Medical Technologies Corporation received a notice of allowance from the U.S. Patent and Trademark Office for a strategic patent covering novel methods of making neural probe devices.
  • The patent titled "Methods for Making Probe Devices and Related Devices" protects specific manufacturing steps for probe component arrangement and electrode contact material deposition.
  • This approval strengthens NeuroOne's intellectual property portfolio, which now includes 17 issued and pending patents covering thin-film electrode technologies for neurological applications.
  • The company develops minimally invasive solutions for treating epilepsy, Parkinson's disease, dystonia, essential tremors, and chronic pain conditions.

Former Poseida CEO Kristin Yarema Named to Lead Ikena-Inmagene Merger as Companies Advance Anti-OX40 Therapy

Monoclonal Antibody
  • Ikena Oncology and Inmagene Biopharmaceuticals have appointed former Poseida Therapeutics CEO Kristin Yarema to lead the merged company ImageneBio following their anticipated July 2025 closing.
  • The merger includes a concurrent $75 million private placement and will focus on advancing IMG-007, an anti-OX40 monoclonal antibody that recently completed Phase 2a trials in atopic dermatitis and alopecia areata.
  • IMG-007 demonstrated sustained clinical activity with a 34.7-day half-life in subcutaneous formulation, supporting potential for infrequent dosing in immunological and inflammatory diseases.

A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

NCT07037901RecruitingPhase 2
Inmagene LLC
Posted 6/17/2025

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