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news.Lpath has initiated its first Phase I clinical trial by dosing a cancer patient with its lead drug candidate, Asonep, a monoclonal antibody targeting sphingosine-1-phosphate.
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Lpath’s Asonep Phase I trial is a dose-escalation study, with an initial dose of one milligram per kilogram of body weight (mg/kg) and subsequent doses of three, 10, 17, and 24mg/kg. Patients with solid tumors will be enrolled; and, assuming Asonep is well tolerated, each patient will receive a minimum of eight intravenous treatments at a specific dose level. After a maximum tolerated dose is established, Lpath will conduct a Phase Ib trial extension, whereby up to ten patients, likely with the same tumor type, will be treated.
Scott Pancoast, Lpath’s president and CEO, said: “The initiation of this human trial represents Lpath’s most significant milestone to date. With its multiple mechanisms of action, Asonep has the potential to take the treatment of cancer to the next level.”