Clinical Trial News

A phase II clinical trial assesses mycophenolate mofetil's efficacy and safety in 27 patients with high-grade locally advanced or metastatic osteosarcoma. Primary endpoint: progression-free survival at 16 weeks. Secondary endpoints include overall survival, response rate, safety, pharmacokinetics, biomarkers, pain score, and quality of life.

China approved clinical testing for a COVID-19 vaccine developed by Chen Wei's team, deemed effective and safe in pre-trial testing. Chen Wei, a PLA academician, specializes in biological and chemical protection and has been researching the virus since January 26 in Wuhan.

Sodium phenylbutyrate-taurursodiol slowed ALS functional decline (-1.24 vs. -1.66 points/month on ALSFRS-R) over 24 weeks compared to placebo, with no significant differences in secondary outcomes. Adverse events were mainly gastrointestinal. Larger trials are needed for further efficacy and safety evaluation.

A U.S. COVID-19 patient was treated with remdesivir, marking the first such treatment in the U.S. A clinical trial has begun, with the first participant being a quarantined American from the Diamond Princess. Remdesivir's effectiveness remains uncertain without comparative data. Health officials urge public preparation for significant disruptions due to COVID-19 spread.

A federal judge ruled that government agencies misinterpreted a law requiring clinical trial data publication, creating a 10-year data gap. Now, universities, drug companies, and device manufacturers must release unpublished data from trials for unapproved drugs and devices, enhancing public access to trial results.

Recent studies and FDA approvals have marked significant progress in cancer treatment, including advancements in immunotherapy, targeted therapies, and the exploration of new drug combinations for various cancer types.

Ensifentrine, a novel inhaled dual phosphodiesterase 3 and 4 inhibitor, showed significant improvements in lung function and COPD symptoms in Phase 2b trials, offering potential as a first-in-class therapy combining bronchodilator and anti-inflammatory effects.

Network meta-analysis found no significant differences in efficacy and toxicity among PARPi regimens for BRCA-mutated ovarian cancer. ASCO value framework showed similar clinical benefits and toxicity, but higher costs for combined therapies. Upfront PARPi regimens are less toxic than relapse treatments. Cost-effectiveness should guide regimen choice.

The RESMAIN study, evaluating resminostat for advanced-stage CTCL maintenance, continues without protocol changes after a positive DSMB safety review. Enrollment increased to 190 patients to expedite unblinding, with results expected by mid-2021. Yakult Honsha discontinued a Phase II study in Japan, with no financial impact on 4SC.

A NYU study found that a single psilocybin dose with psychotherapy significantly improves emotional and existential distress in cancer patients, with effects lasting nearly five years. The treatment showed sustained reductions in anxiety, depression, and improved quality of life, offering a promising approach for cancer-related psychological care.