Clinical Trial News

Sumitomo Heavy Industries, Ltd. signed an agreement with National Cancer Center Japan, STELLA PHARMA CORPORATION, and Cancer Intelligence Care Systems, Inc. for Phase-I/II basket trials of the boron neutron capture therapy system (BNCT) for unresectable and recurrent thoracic malignant solid tumors. This is the first BNCT clinical trial covering several types of thoracic cancer, aiming to shorten development periods and offer optimal therapy options through FBPA-PET imaging before treatment.

Unicycive Therapeutics submits NDA to FDA for Oxylanthanum Carbonate (OLC) to treat hyperphosphatemia in CKD dialysis patients, aiming for a best-in-class therapy with reduced pill burden.

The VA Health Care System developed a phase II/III RCT for oligometastatic prostate cancer, addressing challenges in study development/conduct and adapting the trial to include de novo OMPC patients and up to 10 metastases.

GnRH-a suppresses estrogen and endometrial hyperplasia, inhibits endometrial cancer cell growth. AIs reduce estrogen levels, treating hyperplasia and early cancer. LNG-IUD treats menorrhagia and prevents hyperplasia. Systemic progestogen therapy treats hormone-sensitive hyperplasia and tumors but has low compliance due to adverse effects. Adverse events are managed according to clinical practice guidelines. Trial treatment discontinuation criteria include participant refusal, study cancellation, protocol violation, lack of remission, severe adverse events, and physician judgment. Long-term follow-up is conducted, with statistical analysis using SPSS, focusing on complete response rates, pregnancy outcomes, and adverse events. Data management ensures quality, security, and storage. Results will be published in medical journals.

The third phase of India's first indigenous dengue vaccine, 'DengiAll', has started at Kalinga Institute of Medical Sciences (KIMS). This trial aims to evaluate the efficacy of the tetravalent dengue vaccine developed by Panacea Biotec in collaboration with the Indian Council of Medical Research (ICMR). KIMS is the only hospital in Odisha selected for the Phase 3 trial, which involves 18 other sites across India. The trial commenced with the involvement of key personnel from KIMS and Panacea Biotec, aiming to recruit over 500 participants in Bhubaneswar.

Nxera Pharma received $35m from Neurocrine Biosciences after positive Phase II trial data of NBI-568 in schizophrenia, potentially leading to $2.6bn total and $202m in sales by 2030. The trial met primary endpoint with a 20mg dose significantly reducing symptoms, advancing to Phase III in 2025. Current treatments have significant side effects, driving demand for new medications targeting both positive and negative schizophrenia symptoms.

The RAPIDxAI trial found that an AI-based clinical decision support tool did not improve 6-month CV outcomes in patients with elevated hs-cTn but enhanced rates of evidence-based care without increasing adverse events.

Iovance Biotherapeutics' MDA-TIL trial terminated due to lack of efficacy, leading to drops in Phase Transition Success Rates (PTSR) in various cancers. Sention Therapeutics' ST-1891 and Armata Pharmaceuticals' APPA-02 trials completed successfully in hypothyroidism and bronchiectasis, respectively, boosting their PTSRs. Karyopharm Therapeutics' Xpovio trial in metastatic melanoma and Worg Pharmaceuticals Hangzhou's WP-1302 trial in Graves' disease were terminated, affecting their PTSRs negatively.

Medtronic shared long-term results from its global EV-ICD pivotal trial at the 2024 ESC Congress, showing sustained safety and effectiveness of the Aurora EV-ICD system, which delivers defibrillation and pacing therapies without transvenous risks. The trial, involving 356 patients across 46 sites, reported high success rates for ATP and shock therapies, low complication rates, and improved patient quality of life.

Sanofi's tolebrutinib met its key goal in a Phase 3 MS study, potentially leading to regulatory approval, though not all patients saw benefits. The positive result boosts investor confidence in Sanofi's R&D capabilities.