NeoPharm Submits Application for a Multicenter, Open-Label, Phase II Study of LE-DT for Locally Advanced or Metastatic Pancreatic Cancer Patients as a Frontline Treatment

October 27, 2009 8:30 AM EDT

LAKE BLUFF, Ill.--(BUSINESS WIRE)-- 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(R), 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."

About NeoPharm, Inc.

NeoPharm, Inc., based in Lake Bluff, Illinois, is a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative cancer and other drugs for therapeutic applications. Additional information, including ongoing clinical trials, can be obtained by visiting NeoPharm's Web site at www.NeoPharm.com.

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "projects," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to, any statements relating to the Company's drug development programs, the initiation, progress, and outcomes of clinical trials of the Company's drug product candidates including, but not limited to LE-DT, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, risks and uncertainties relating to difficulties or delays that may arise in the development, testing, regulatory approval, production, and marketing of the Company's drug and non-drug compounds, including, but not limited to, LE-DT, the Company's possible need to reduce its funding of certain of its development projects in order to conserve its cash resources, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug product candidates, including, but not limited to, LE-DT, that could slow or prevent products coming to market, uncertainty regarding the Company's ability to commercialize any of its drug product candidates, including, but not limited to, LE-DT, and other risks of the type previously detailed from time to time in filings the Company formerly made with the Securities and Exchange Commission ("SEC"). Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release. At the Company's request, the Company's obligation to file reports with the SEC was suspended effective February 12, 2009. For the foregoing reasons, you should not rely on these forward-looking statements or our previously filed SEC reports as a prediction of actual future results.

    Source: NeoPharm, Inc.

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