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news.Lpath has reported that the FDA, after review of the company's December 2007 investigational new drug submittal, has allowed the administration of Asonep into human cancer patients in a Phase I clinical trial.
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Lpath will soon begin dosing patients in the first clinical study ever performed involving an antibody that inhibits a bioactive lipid. Lpath plans a multi-center Phase I open-label, single-arm, dose escalation trial in the US. Investigators will assess the safety and tolerability of the intravenous infusion of Asonep in patients with refractory advance solid tumors. Other endpoints include Asonep’s pharmacokinetics, pharmacodynamics, and immunogenicity, as well as exploration of the molecule’s mechanism of action. Doses will be given for a four-week period, with an option for an additional four weeks of therapy if disease improvement or stabilization is observed.
Asonep is a humanized monoclonal antibody that neutralizes Sphingosine-1-Phosphate (S1P), a bioactive lipid that stimulates tumor cell migration, invasion, and survival, while also promoting in vivo angiogenesis.
William Garland, vice president of drug development at Lpath, said: “We anticipate Asonep will be shown to be safe in human cancer patients at dose levels that we believe will be efficacious.”