NeoPharm must submit more data to FDA before beginning cancer drug trial

By Angela McDaniels

Seattle, Feb. 9 - NeoPharm Inc. has been informed by the Food and Drug Administration that the agency needs more data before it can approve the company's request to begin a 100-patient trial of LEP-ETU (Liposomal Paclitaxel Easy to Use) comparing the drug's efficacy with that of Taxol for the treatment of cancer.

More specifically, the agency has requested data to establish bioequivalence between LEP-ETU and Taxol, according to a company news release.

As a result of the request, the trial will now begin in the second quarter of this year, at the earliest.

LEP-ETU is the company's NeoLipid liposomal formulation of widely used cancer drug Taxol (paclitaxel).

The company said that Taxol's common side effects include nausea, vomiting, hair loss and nerve and muscle pain. In addition, Taxol cannot be introduced into the body unless it is first formulated in a mixture of castor oil and ethanol, which can lead to another set of debilitating side effects including hypersensitivity reactions.

NeoLipid technology eliminates the need for castor oil. As a result, LEP-ETU may overcome many of the current limitations of Taxol and may limit the adverse side effects, the company said.

NeoPharm is a biopharmaceutical company based in Waukegan, Ill., that researches, develops and commercializes cancer drugs.

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