RG7667 / Roche - LARVOL DELTA

Resolution of unexpected pregnancy-related findings in a rat embryofetal development and toxicokinetic study of monoclonal antibodies specific for hCMV. (PubMed, Birth Defects Res) - "The results of the Pivotal study confirmed the lack of overt toxicity, teratogenicity, or effects on litter size and viability when human or humanized monoclonal antibodies that lack an endogenous target are administered IV to rats during pregnancy. With these additional data, we concluded that the unexpected pathology findings in the Pilot study were not specific to RG7667, but rather highlight some clinical pathology and macroscopic/microscopic findings that can occur during pregnancy in rats."

Journal • Preclinical

Pharmacokinetics and exposure-response analysis of RG7667, a combination of two anti-cytomegalovirus monoclonal antibodies, in a Phase 2a randomized trial to prevent cytomegalovirus infection in high-risk kidney transplant recipients. (PubMed, Antimicrob Agents Chemother) - P2; "MCMV5322A and MCMV3068A exhibited expected IgG1 PK profiles in high-risk kidney transplant recipients, consistent with earlier RG7667 PK behavior in healthy subjects. Higher drug exposure was associated with better anti-CMV pharmacological activity. ClinicalTrials.gov, NCT01753167."

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