Clinical Trial News

Invion's partner RMW Cho Group completed a Phase II prostate cancer trial using INV043, showing a solid safety profile and promising efficacy signals. 40% of participants responded positively, with 10% showing complete regression. INV043, employing next-gen photodynamic technology, aims to offer an effective, less invasive treatment for prostate cancer.

Raj Chovatiya discusses promising HS treatments at Maui Derm NP+PA Fall 2024, highlighting bimekizumab, secukinumab, and nanobodies. Secukinumab's approval by the FDA was based on SUNSHINE and SUNRISE trials, showing superiority over placebo.

Post-op Keytruda doubles cancer-free time for high-risk bladder cancer patients with muscle invasion, extending average cancer-free survival to nearly 30 months, with significant benefits for PD-L1-positive tumors.

ImCheck Therapeutics announced that the FDA granted Fast Track designation to ICT01, a humanized anti-butyrophilin 3A monoclonal antibody, in combination with azacitidine and venetoclax for treating AML patients unfit for induction chemotherapy. The designation is based on encouraging results from the Phase 1/2a EVICTION study, which evaluated ICT01 in relapsed/refractory hematological malignancies.

EA3163 trial findings show neoadjuvant chemotherapy may improve organ preservation in T3/T4a NPNSCC, though not statistically significant. SP rates were 57% vs 18% for neoadjuvant vs surgery alone, and 50% vs 15% including T4b cases. Challenges include slow enrollment and proximity of tumors to critical structures.

Merit Medical's WRAPSODY endoprosthesis showed 89.9% primary patency at six months in AVF patients, 27% higher than PTA. The WAVE trial, under FDA IDE, supports PMA application for U.S. commercial use.

Nicox's partner, Ocumension Therapeutics, has received approval for ZERVIATE® for ocular itching in China, adding a royalty revenue stream for Nicox. Ocumension forecasts peak sales over $100 million annually within 7 years.

Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis; MANDARA trial showed nearly 60% of patients achieved remission and 41% fully stopped taking oral corticosteroids.

Sensorion reports first patient treated in SENS-501 Audiogene study, on-track for first cohort recruitment by year-end 2024. Final data from SENS-401 Phase 2a study in cochlear implantation preservation to be presented at WCA on September 20, 2024. Preliminary efficacy and safety data of SENS-401 Phase 2a in Cisplatin-Induced Ototoxicity also to be presented at WCA. Cash on-hand of €87m supports operations into end of 2025.

Poolbeg Pharma reports £10.1m cash balance as of 30 June 2024, with independent research indicating a potential $10 billion market for POLB 001, an oral preventative therapy for cancer immunotherapy-induced Cytokine Release Syndrome (CRS). The company also signed an exclusive 12-month option agreement for tPTX, a treatment for Behçet’s Disease, and is preparing for a GLP-1R clinical trial expected to commence in late 2024. Poolbeg continues to engage with partners for its AI-led infectious-disease programs and has onboarded several former Amryt Pharma executives.