Sanofi posts pediatric Hectorol results; USC germ cell trial data also reported

Sanofi had several clinical trial registry updates posted this week, including one completed study with results and two newly listed programs.

• Sanofi's Phase 3 trial of Hectorol (doxercalciferol) in pediatric chronic kidney disease patients with secondary hyperparathyroidism was terminated after being conducted to fulfill a post-marketing commitment, which FDA acknowledged as fulfilled.¹ The study enrolled 21 participants and compared oral Hectorol against Rocaltrol (calcitriol) capsules.¹
• A Phase 2 trial of gemcitabine, oxaliplatin, and paclitaxel in refractory germ cell carcinoma, sponsored by the University of Southern California with Sanofi as a collaborator, reported results after completion. The trial enrolled 30 participants receiving the three-drug combination², and posted tumor response data showing 29 out of 30 participants experienced serious adverse events.²
• Sanofi listed a new managed access program for venglustat in patients 12 and older with Type 3 Gaucher disease, intended to provide early access in response to unsolicited requests from healthcare providers, since no approved therapies for the CNS manifestations of the disease are currently available.³
• Sanofi is a collaborator on a new observational study led by the Icahn School of Medicine at Mount Sinai, not yet recruiting, that will enroll an estimated 200 participants with a pre-existing diagnosis of asthma⁴ to assess Type 2 inflammation biomarkers using a FeNO breath test.