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news.Pharmaceutical company EntreMed has presented encouraging interim Phase I pharmacokinetic results for its antimitotic agent, together with preclinical antitumor activity results in non-small cell lung cancer.
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Pharmacokinetic results demonstrate that once-a-day orally-administered antimitotic agent ENMD-1198 has good pharmacokinetic (PK) parameters in cancer patients participating in a Phase I clinical study. In the first four cohorts of the dose-escalation trial in advanced cancer patients, ENMD-1198 demonstrated dose proportional PK exposures across the range of 5-30mg/m2.
Preclinical results demonstrated a three-fold increase in survival compared to cisplatin. Approximately 80% of the ENMD-1198 treated models remained on study until tumor dissemination evaluation. ENMD-1198 also exerts antiangiogenic activity that further contributes to its overall antitumor effects, according to the company.
Mark Bray, vice president, research of EntreMed, said: “These data demonstrate that ENMD-1198 achieves predictable plasma drug levels after once-daily oral dosing in humans, consistent with prior preclinical results. The ENMD-1198 Phase I study continues in refractory solid tumor patients with a current dose level that is approaching the maximum tolerated dose in preclinical models without any ENMD-1198-related toxicity.”