NeoPharm Submits Application For A Multicenter, Open-Label, Phase II Study Of LE-DT For Castrate Resistant Prostate Cancer

Main Category: Prostate / Prostate Cancer
Also Included In: Cancer / Oncology;  Urology / Nephrology;  Clinical Trials / Drug Trials
Article Date: 13 Feb 2009 - 2:00 PDT

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NeoPharm, Inc. (NASDAQ: NEOL) 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®, in hormone refractory metastatic prostate cancer patients.

"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 LE-DT 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," commented Mr. Laurence Birch, President and Chief Executive Officer of NeoPharm Inc. "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."

Dr. Aquilur Rahman, Chief Scientific Adviser of NeoPharm commented, "We are pleased with the ongoing results from our Phase I trial of LE-DT. To that end, this open-label, Phase II study is designed to determine the antitumor effect on serum Prostate Specific Antigen (PSA) levels, disease response, progression free survival, and quality of life in patients with metastatic prostate cancer. We anticipate enrolling 40 patients in this Phase II trial at three locations".

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 http://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 detailed from time to time in filings the Company makes with the Securities and Exchange Commission including its annual report on Form 10-K for the calendar year ended December 31, 2007, as subsequently updated by the Company in its quarterly reports on Form 10-Q. 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. Accordingly, you should not rely on these forward-looking statements as a prediction of actual future results.

NeoPharm, Inc.

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