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news.Neopharm has filed an investigational new drug application with the FDA for a novel, proprietary liposomal delivery system of docetaxel, the active ingredient of Taxotere, for the treatment of patients with locally advanced or metastatic solid tumor after failure of prior chemotherapy.
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Assuming FDA acceptance of the IND application, Neopharm intends to enter a Phase I clinical study to assess the maximum tolerated dose and dose limiting toxicity (DLT) of liposome entrapped Docetaxel for injection (LE-DT) in approximately 30 patients. Additionally, Neopharm will use this Phase I study to evaluate the pharmacokinetics of LE-DT therapy and any anti-tumor effects of LE-DT.
Laurence Birch, president and CEO of Neopharm, said: “This filing is a notable milestone in the advancement of our NeoLipid platform, which I believe reflects our commitment to progressing our portfolio, while concurrently optimizing the company’s cost structure.”