Clinical Trial News

AiViva Biopharma completed enrollment and dosing in a phase 1 trial of AIV007, a tyrosine kinase inhibitor for wet AMD and DME, administered via periocular injection. The trial, involving 18 participants, aims to evaluate safety over 6 months, with full results expected in Q1 2025.

Novo Nordisk registered a new clinical study to examine long-term effects of semaglutide on teens. Semaglutide, in drugs Ozempic and Wegovy, mimics a hormone regulating blood sugar and suppressing appetite. FDA approved Wegovy for teens in 2022, though some doctors are cautious due to lack of long-term data. The trial will monitor 500 teens over three years for weight loss maintenance and adverse effects.

JW Therapeutics' relma-cel (Carteyva) received NMPA approval for r/r MCL, becoming the first CAR-T therapy for this indication in China. The approval was based on a pivotal trial showing 81.36% best objective response rate and 67.80% best complete response rate among 59 evaluable patients. Relma-cel is also approved for r/r LBCL and FL, and is being explored for autoimmune diseases and SLE.

Cedars-Sinai Medical Center in LA added to Edelife Clinical Trial for XLHED, offering prenatal treatment for boys affected by x-linked hypohidrotic ectodermal dysplasia. This marks the second US location, aiming for 15-20 participants, with the trial also available in Europe. Led by Dr. Ophir Klein, the trial seeks to confirm the safety and efficacy of ER-004, a potential first-of-its-kind medicine for structural birth defects, with all associated expenses covered for participating families.

The Jablons' lab has advanced novel pan RAS and dual anti-PARP/anti-microtubule inhibitors in clinical trials, and is conducting an international trial for an early-stage lung cancer diagnostic assay. Ongoing basic research focuses on developmental pathways like WNT and Hippo signaling, with immuno-therapeutic approaches targeting these pathways. A 14 gene molecular assay for early-stage non-small cell lung cancer predicts prognosis and guides adjuvant therapy, saving thousands of patients. The lab also demonstrated aberrant Wnt signaling causing lung cancer and mesothelioma, developing an anti-Wnt2-ADC showing significant anti-tumor effects, with a Phase I trial upcoming.

A new clinical trial at the University of Calgary uses probenecid, a gout drug, to help with opioid withdrawal symptoms, based on research showing it reduces withdrawal in rodents by disrupting abnormal brain-spinal cord communication during withdrawal.

FDA approved afami-cel, a T-cell receptor therapy, for metastatic synovial sarcoma. It uses genetically engineered T cells to target MAGE-A4 protein in cancer cells, showing tumor shrinkage in 43% of patients with a median response duration of 6 months. Similar to CAR T-cell therapies, it addresses a high need for new treatments in this rare cancer.

A new nasal COVID-19 vaccine, CDO-7N-1, is ready for clinical trials, inducing robust mucosal and systemic responses with a single dose, offering protection against all major variants and stable at 4°C for seven months.

Harvard Apparatus Regenerative Technology secures $5M from a new investor to continue clinical trials for its organ regeneration technology, focusing on the HRGN Esophageal Implant for treating esophageal damage in cancer or injury patients, with potential expansion to pediatric cases.

Oculis halts Phase III trial of OCS-01 due to third-party error, but FDA accepts data from other trials for NDA submission in Q1 2025. OCS-01 is developed for post-op inflammation, pain, and DME.