NeoPharm, a biopharmaceutical company, has submitted a Phase II protocol to the FDA for the study of liposome entrapped docetaxel, a novel, liposomal delivery system of docetaxel, the active ingredient of Taxotere, in hormone refractory metastatic prostate cancer patients.
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Laurence Birch, president and CEO of NeoPharm, said: “The preliminary results from our Phase I trial, which has not yet concluded, have been encouraging. As a result, we plan to evaluate the efficacy of liposome entrapped docetaxel in prostate cancer patients who have failed radiation and hormonal treatment and we have submitted a Phase II protocol for such a study to the FDA.
“While FDA approval is needed before commencing patient enrollment, we believe this submission is yet another example of our commitment to progressing our drug product candidates through development.”
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