Date: 2014-02-04
Type of information: Treatment of the first patient
phase: 1-2
Announcement: treatment of the first patient
Company: Sigma-Tau Pharmaceuticals (USA – MD)
Product: STP206 (Lactobacillus acidophilus and Bifidobacterium animalis subsp. Lactis)
Action
mechanism: live product. STP206 is a biologic agent comprised of live bacteria, which may be effective in preventing the occurrence of necrotizing enterocolitis. In 2009, Sigma Tau has signed a partnering agreement with Danisco BioActives for the development of this product.
Disease: prevention of necrotizing enterocolitis (NEC) in very low birth weight premature infants
Therapeutic area: Rare diseases - Inflammatory diseases
Country: USA
Trial
details: The study will be conducted in two parts. Part A will be a sequential dose escalation study to determine the safety and tolerability of two doses of STP206 versus control. Part B will evaluate safety and NEC preventive efficacy of STP206 in very low birth weight and extremely low birth weight neonates.(NCT01954017)
Latest
news: * On February 4, 2014, Sigma-Tau Pharmaceuticals announced that the first patient has been dosed as part of the Company’s Phase I/II multi-center, double-blind, randomized, placebo-controlled clinical trial for STP206, in development for the prevention of necrotizing enterocolitis (NEC) in very low birth weight premature infants.
