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Clinical Trial News

Johnson & Johnson and Karolinska Institutet Celebrate Decade of Collaboration Advancing Medical Innovations

• The ten-year partnership between Johnson & Johnson Innovative Medicine and Karolinska Institutet has yielded significant scientific advances across nine disease areas, with researchers working side by side since 2015.
• Over 150 researchers have participated in the collaboration, producing more than 30 scientific papers and 50 presentations at international conferences, focusing on critical medical needs in oncology, neurology, immunology, and ophthalmology.
• The partnership exemplifies successful innovation through academic-industry collaboration, with both organizations now exploring new opportunities to develop innovative therapies for complex conditions like Alzheimer's disease and cancer.

AB Science Secures Chinese Patent for Masitinib in COVID-19 Treatment Until 2041

• AB Science has received a Chinese patent for its lead compound masitinib to treat COVID-19, providing intellectual property protection until April 2041.
• The patent is supported by preclinical data published in Science showing masitinib acts as a broad antiviral agent against SARS-CoV-2, with efficacy maintained against variants of concern.
• Recent positive Phase 2 study results confirm masitinib's anti-inflammatory activity in COVID-19 by controlling activated macrophages and mast cells, positioning it as a potential treatment for future pandemics.

Astellas to Present New Long-Term Survival Data for Cancer Therapies at ASCO 2025

• Astellas will showcase 16 abstracts at the 2025 ASCO Annual Meeting, including two oral presentations highlighting long-term survival data for its oncology portfolio.
• New post-hoc analyses will feature five-year overall survival data for XTANDI (enzalutamide) in metastatic hormone-sensitive prostate cancer and exploratory analyses for PADCEV (enfortumab vedotin) in urothelial cancer.
• The presentations underscore Astellas' commitment to delivering meaningful clinical outcomes for patients with advanced prostate and bladder cancers through innovative treatment approaches.

Evolving Treatment Landscape for Metastatic Hormone-Sensitive Prostate Cancer: Beyond ADT Monotherapy

• Current 2025 guidelines for metastatic hormone-sensitive prostate cancer (mHSPC) recommend androgen deprivation therapy (ADT) with intensification, marking a significant shift from ADT monotherapy.
• Multiple evidence-based intensification options including abiraterone, darolutamide, and docetaxel have demonstrated survival benefits and delayed disease progression in key clinical trials such as ARANOTE, ARASENS, and TITAN.
• Treatment selection can now be tailored based on individual patient characteristics and preferences, with all intensification approaches showing superior outcomes compared to ADT alone.

EMA Designates Allopurinol as First Orphan Drug for Marfan Syndrome

• The European Medicines Agency has designated allopurinol as the first orphan drug for Marfan syndrome, a rare connective tissue disease affecting approximately 7 in 100,000 people in the European Union.
• Researchers from the University of Barcelona, IDIBAPS, and CIBERER have demonstrated allopurinol's potential to halt and prevent aortic aneurysms in animal models, with international clinical trials in patients planned for the future.
• This repurposing of allopurinol, currently used for gout treatment, represents a significant advancement for Marfan syndrome patients who currently have no curative options beyond limited palliative treatments and high-risk surgical interventions.

Scientific Breakthrough Reveals How Alpha1H Targets Bladder Cancer Cells

• Hamlet BioPharma and Lund University researchers have discovered that Alpha1H, a bladder cancer drug candidate, targets the endoplasmic reticulum in tumor cells, causing it to collapse like a net around toxic components.
• The mechanism explains Alpha1H's ability to kill cancer cells while sparing healthy tissue, as it prevents leakage of harmful substances from dying tumor cells into surrounding areas.
• This breakthrough provides scientific validation for Alpha1H's efficacy and safety profile, strengthening its market position and potential applications in treating the 600,000 people affected by bladder cancer annually.

Protagenic and Phytanix Merge to Form Neuroactive Biopharmaceutical Company with Obesity Drug in Development

• Protagenic Therapeutics and Phytanix Bio have completed an all-stock business combination to form Phytanix, Inc., creating a pipeline of six drug candidates focused on stress-related and CNS disorders.
• The merged company's portfolio includes a proprietary cannabinoid-based molecule targeting obesity and metabolic disorders, potentially competing in the lucrative GLP-1 agonist market.
• The combined entity brings together clinical and preclinical assets with significant milestones expected in the next 18 months, leveraging expertise from team members who previously worked on approved cannabinoid medications.

DexTech Medical Secures European Patent for OsteoDex GMP Manufacturing Until 2045

• DexTech Medical has received European patent approval for the GMP manufacturing process of OsteoDex, their lead candidate for treating castration-resistant prostate cancer.
• The newly granted patent extends market exclusivity until 2045, significantly strengthening the company's position in ongoing partnership and licensing negotiations.
• This patent approval represents a critical milestone for the continued clinical development of OsteoDex following its completed Phase 2 trials.

Taiwan Approves Chugai's PiaSky as First Subcutaneous Treatment for Paroxysmal Nocturnal Hemoglobinuria

• Taiwan FDA has granted orphan drug approval for PiaSky, making it the first subcutaneous treatment for paroxysmal nocturnal hemoglobinuria (PNH) available in Taiwan for patients 13 years and older.
• PiaSky, developed with Chugai's proprietary Recycling Antibody technology, allows for convenient subcutaneous administration every 4 weeks, significantly reducing treatment burden compared to existing biweekly intravenous options.
• The approval was based on positive results from three Phase III clinical trials, including COMMODORE 2, which demonstrated efficacy in transfusion avoidance and control of hemolysis compared to eculizumab.

Massalia Therapeutics Launches with Seed Funding to Target Fibrosis-Neoplasm-Neovascularization Interface

• Massalia Therapeutics has launched as a biotechnology spin-off from Aix-Marseille University's C2VN Institute, backed by seed financing to develop its novel SANF factor therapeutic platform.
• The company's proprietary SANF (Soluble Angiogenic Neoplastic and Fibrotic) factor targets the critical intersection of fibrosis, neoplasm, and neovascularization, representing a potential paradigm shift in treatment approaches.
• With preclinical testing complete, Massalia plans to begin first-in-human trials within six months and advance toward IND-enabling studies, leveraging 20 years of research by co-founders Dr. Marcel Blot-Chabaud and Professor Nathalie Bardin.
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