ContraFect : DSMB Observes No Clinical Adverse Safety Signals With CF-301

(RTTNews) - ContraFect Corp.(CFRX, CFRXW) announced the Phase 1, first-in-human study of CF-301 has concluded. The independent data safety monitoring board or DSMB reviewed safety, tolerability, and pharmacokinetic data from healthy volunteers dosed in all of the planned cohorts. The DSMB observed no clinical adverse safety signals associated with CF-301 in the study.

"This is a major milestone for CF-301, a first-in-class, first-in-field biologic agent targeting Staph infections, including MRSA," said Julia P. Gregory, ContraFect's Chief Executive Officer.

The company said it is excited to have achieved its objectives for this Phase 1 study, and it will now continue preparations and discussions with regulatory agencies for its next study of CF-301 which is anticipated to be conducted in patients with Staph bloodstream infections including endocarditis.

The CF-301 Phase 1 study was a randomized, double-blind, placebo-controlled, single escalating dose study in healthy volunteers in the United States to evaluate safety, tolerability, and pharmacokinetics.