NeoPharma submits a Phase II protocol to the FDA for its liposome entrapped docetaxel study

Oct 27 2009

NeoPharm, Inc. (Other OTC: NEOL.PK) today announced that it has submitted a Phase II protocol to the FDA for the study of liposome entrapped docetaxel (LE-DT), a novel, proprietary liposomal delivery system of docetaxel, the active ingredient of Taxotere^®, for locally advanced or metastatic pancreatic cancer patients.

“As we have noted in the past, the preliminary results from our Phase I trial have been encouraging. As a result, we have submitted a Phase II protocol to the FDA to further evaluate the efficacy of LE-DT in pancreatic cancer patients with locally advanced disease or metastasis,” commented Mr. Laurence Birch, President and Chief Executive Officer of NeoPharm Inc. “We believe this submission is yet another example of our commitment to progressing our drug product candidates through development.”

Dr. Aquilur Rahman, Chief Scientific Officer, Emeritus, commented “We have been impressed with LE-DT data in the Phase I trial. The open-label, Phase II study is designed to determine antitumor effect of LE-DT, Progression Free Survival and Overall Survival along with a number of biologic markers such as CA-19-9, SPARC expression which are related to the response of the disease. In addition, we will be evaluating the quality of life in these patients with metastatic disease. If the study is approved, NeoPharm anticipates enrolling 40 patients in this Phase II trial at three-to-four locations in US and Europe.”