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news.Nereus Pharmaceuticals has announced that enrollment has begun in a Phase Ib study evaluating the vascular disrupting agent NPI-2358 in combination with standard chemotherapy in patients with non-small cell lung cancer.
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The open-label Phase Ib study will assess escalating doses of NPI-2358 in combination with docetaxel in patients with non-small cell lung cancer (NSCLC) who previously failed at least one chemotherapy regimen. This study follows on positive outcomes in a Phase I single-agent clinical trial assessing the safety, pharmacokinetics, pharmacodynamics and efficacy of NPI-2358 in various tumor types.
Upon successful completion of the Phase Ib trial and determination of the recommended doses for the combined agents, Nereus expects to advance NPI-2358 into an international randomized Phase II study of approximately 150 patients at 30 centers late in 2008. Nereus is also evaluating NPI-2358 in other solid tumor indications.
Kobi Sethna, president and CEO of Nereus, said: “Our clinical program for NPI-2358 holds promise in non-small cell lung cancer, a large market indication where novel compounds could make a significant impact on patients.”