Aura Biosciences said today that the FDA approved its Investigational New Drug Application for the company’s light-activated viral nanoparticle conjugates for the treatment of ocular melanoma. The federal watchdog’s approval allows Cambridge, Mass.-based Aura to move forward with initial clinical tests of AU-011. The Phase Ib open-label clinical trial, which is currently enrolling, is designed to […]
Clinical Trials
MediWound touts Phase II study
MediWound (NSDQ:MDWD) touted data from a phase II trial of its EscharEx topical biological drug for debridement of chronic and other hard-to-heal wounds. The data includes a follow-up period of 6 months from the last treatment to 3 months from wound closure. The randomized phase II trial enrolled 73 patients with a variety of chronic and […]
FDA OKs Medtronic trial for In.Pact Admiral DCB in renal disease
Medtronic (NYSE:MDT) said today that the FDA approved its investigational device exemption application for a study to evaluate its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease. The Fridley, Minn.-based company said that its study will compare its DCB to plain balloon angioplasty as a treatment for failing arteriovenous fistulas. The primary efficacy endpoint […]
Medtronic touts In.Pact Admiral drug-coated balloon data
Medtronic (NYSE:MDT) touted data for its In.Pact Admiral drug-coated balloon in patients with peripheral arterial disease. The company presented outcomes from its In.Pact Global study patient cohorts in Asia and Belgium, concluding that its DCB demonstrated consistent outcomes across patient populations. More than 96% of the 114-patient study group in Asia achieved positive outcomes, which […]
NantKwest launches clinical trial for natural killer cells
NantKwest Inc. (NSDQ:NK) said yesterday that the FDA approved an Investigational New Drug Application for its natural killer cell therapy phase I clinical study. The company is evaluating its genetically engineered, allogenic natural killer cell therapy in patients with cancer. The study, which NantKwest touts as the 1st of its kind, will determine the safety […]
J&J, Actelion still in talks despite Opsumit failure
Although Actelion (VTX:ATLN)’s Opsumit drug candidate missed its primary endpoint in a phase III trial for patients suffering from a deadly heart-lung condition, analysts reportedly concluded that the result is unlikely to have an impact on merger talks with Johnson & Johnson (NYSE:JNJ). The Swiss drugmaker’s trial involved 226 patients with Eisenmenger Syndrome, which causes untreated congenital heart […]
Study finds financial ties between researchers, industry associated with positive trial results
A study conducted by a team of U.S. researchers found that financial ties between researchers and the companies that make the drugs they are studying are independently associated with positive trial results. The team’s work was published in The BMJ this week. The study was observational, so the results can’t be used to draw concrete conclusions. But the […]
Celsion’s ThermoDox activated by ultrasound in pediatric cancer study
Celsion (NSDQ:CLSN) and Children’s National Health System are teaming up to tackle refractory solid tumors in pediatric patients using a heat-activated chemotherapy drug and noninvasive ultrasound. The Phase I clinical trial, which launched last November, is the 1st of its kind in the U.S. Lawrenceville, N.J.-based Celsion’s ThermoDox is a heat-activated liposomal doxorubicin. In combination with MRI, […]
Taris Biomedical closes enrollment in phase Ib trial for drug-device combo
Taris Biomedical said today that it closed initial enrollment in its phase Ib clinical trial following positive results. The study is evaluating the safety and efficacy of its drug-device combination product that releases gemcitabine continuously into the bladder for 7 days in patients with muscle invasive bladder cancer. Although the study was slated to enroll […]
Apligraf cell therapy changes genomic profile of chronic wound
Organogenesis Inc. said yesterday that its wound-healing cell therapy Apligraf is the 1st of its kind to significantly change the genomic profile of a treated chronic wound. The claim was supported by new research done at the University of Miami and published in the journal Science Translational Medicine. The team applied Apligraf to a chronic venous leg […]
