Clinical Trial News

A nationwide clinical trial shows improved health-related quality of life (QoL) for young Hodgkin lymphoma patients treated with an immuno-oncologic agent, with fewer negative effects than standard treatment. The study, using brief, paper-based QoL questionnaires, demonstrated high participation and is part of a broader effort to incorporate patient-reported outcomes into cancer treatment and drug approval processes.

QuantHealth, an AI-based clinical trial design company, has surpassed 100 successfully simulated trials with 85% accuracy, significantly improving ROI for pharmaceutical partners. Utilizing proprietary technology and patient-centric solutions, QuantHealth addresses trial failures, reducing study duration, trial subjects, and full-time employees, resulting in substantial financial returns. Accuracy outcomes exceeded national averages for Phase II and III, highlighting the power of AI-generated clinical trials.

The study examines the effects of cholecalciferol and Silymarin, alone or combined, on BPH-related LUTS. Results show significant improvements in IPSS, PV, PVR, and symptoms with combination therapy, though no significant change in PSA levels. This suggests potential therapeutic benefits for BPH-associated LUTS.

Emyria reports interim clinical results from its MDMA-assisted therapy for PTSD, showing improved outcomes for eight patients with moderate to severe PTSD. The program aims to recruit 70 patients.

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.

Longeveron Inc. announced a positive Type C meeting with the FDA, advancing Lomecel-B™ for HLHS treatment. ELPIS II trial may lead to BLA submission, following ELPIS I's success. Lomecel-B™, derived from MSCs, shows promise for cardiac regenerative therapy. HLHS affects 1,000 U.S. infants annually, with current treatments offering limited survival rates.

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.