> In an article published today in the journal Regenerative Medicine, it turns out that the federal clinical-trials database ClinicalTrials.gov has allowed 18 ostensible clinical trials of unregulated stem cell therapies, that patients must to pay to enroll, to go up on its site. The article argues that some stem cell clinics are using the site as a marketing tool, claiming that their unapproved meds could potentially help an array of patients. Author Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics and School of Public Health, says: “Absent meaningful changes, it seems likely that there will be more reports of patients harmed after paying for unapproved stem cell interventions that first came to their attention on ClinicalTrials.gov.” Regenerative Medicine article.
> Context Therapeutics has hired Erard Gilles M.D., M.Sc., as its new chief medical officer, leaving his former CMO role at Invivis Pharmaceuticals to join the biotech, which is focused on work for Sigma1-related diseases. Gilles will oversee clinical development while taking the lead of its clinical trial strategy. While at Invivis, he developed an anti-progestin therapy and biomarker that was later licensed by Arno Therapeutics. He has around 30 years in the industry, with stints at J&J and Roche, among others. Release.
> UroGen Pharma has seen its bank balance jump by $7.5 million after a biobucks pay out from partner Allergan. This comes after the pharma’s recent submission of an FDA IND app for RTGel, in combo with its Botox med, in overactive bladder disorder. “Our licensing agreement with Allergan for the use of our RTGel in combination with Botox continues to be productive with the recent achievement of this important IND submission,” said Ron Bentsur, CEO at UroGen. Statement.