News
MRD Is Now the Endpoint That Matters: The EMN24 Is Kia Trial Just Proved It
2+ hour, 17+ min ago (721+ words) The Clinical Trial Vanguard MRD Is Now the Endpoint That Matters: The EMN24 Is Kia Trial Just Proved It Picture a protocol statistician in 2019, sitting across from a regulatory reviewer at a Type B meeting, arguing that measurable residual disease negativity…...
Fennec Pharma, U. of Arizona Cancer Center Announce Study
8+ hour, 13+ min ago (663+ words) Fennec Pharmaceuticals is backing a new investigator-sponsored Phase I/II trial at the University of Arizona Cancer Center evaluating intravenous sodium thiosulfate (PEDMARK) as an otoprotectant in adolescent and young adult (AYA) and adult patients with head and neck and…...
Nervgen's Successful FDA Meeting Sparks Phase 3 Trial Hope
8+ hour, 13+ min ago (668+ words) NVG-291 produced a mean 3. 7-point gain on GRASSP Quantitative Prehension at Week 12 in chronic tetraplegia versus 0. 4 points on placebo in the randomized Phase 1b/2a CONNECT SCI study, a 3. 3-point treatment difference that exceeded the 2-point minimally important difference. The effect persisted…...
ANI Pharma Publishes "New Day" Ophthalmology Trial Results
8+ hour, 14+ min ago (631+ words) Peer-reviewed publication of the randomized Phase 4 NEW DAY trial evaluating ILUVIEN (fluocinolone acetonide 0. 19 mg intravitreal implant) as baseline therapy for diabetic macular edema has appeared in Ophthalmology. The publication announcement did not include new efficacy or safety figures beyond prior…...
Pioneering gamma Core n VNS Study for PTSD Enrolls First Patient
8+ hour, 12+ min ago (657+ words) electro Core's gamma Core non-invasive vagus nerve stimulation device has entered PTSD clinical testing with the first eight of a planned 40 adults enrolled in a 12-week study at Acacia Clinics, run in collaboration with the Vagus Nerve Society. The trial's…...
Landmark Study Validates AI for Opioid Disorder Treatment
8+ hour, 12+ min ago (613+ words) A peer-reviewed study in PNAS reports that GATC-1021, an AI-identified small molecule modulating 5-HT2 A and 5-HT6 receptors, reduced fentanyl intake in preclinical models across sexes, increased markers of neuroplasticity in the prefrontal cortex (including thin dendritic spine density and Bdnf expression),…...
Basket Trials: FDA Guidance Gap & Adaptive Design
1+ day, 2+ hour ago (828+ words) clinicaltrialvanguard. com The Basket Trial Is the New Black " and the FDA Hasn't Caught Up Pull up the final Phase 1 report for Arrowhead Pharmaceuticals' zodasiran program, published in Nature Medicine in 2026. What you're looking at isn't a conventional dose-escalation study....
The FDA Just Opened a Door in Anal Cancer Trials " And Most Sponsors Don't Know It's There
2+ day, 2+ hour ago (733+ words) clinicaltrialvanguard. com The FDA Just Opened a Door in Anal Cancer Trials " And Most Sponsors Don't Know It's There Pull up the FDA's guidance on expedited programs for serious conditions " the 2014 document that most regulatory teams have bookmarked but few…...
Trethera & MGH Launch Clinical Trial for TRE-515 in ALS
2+ day, 7+ hour ago (692+ words) In Trethera's prior expanded access case, treatment with TRE-515 in an 87-year-old patient with advanced ALS was associated with a slowing of forced vital capacity decline from roughly 1. 2% per week pre-treatment to 0. 5% at three months and 0. 2% at 6. 5 months, with no…...
Minerva Screens First Patient in Phase 3 Schizophrenia Trial
2+ day, 7+ hour ago (594+ words) The Clinical Trial Vanguard Minerva Screens First Patient in Phase 3 Schizophrenia Trial Minerva Neurosciences has screened the first patient in MIN-101 C19, a global, confirmatory Phase 3 trial of roluperidone as monotherapy for the negative symptoms of schizophrenia. The study will randomize…...