NeoPharm, Inc. (NASDAQ: NEOL) announced that it has enrolled its first patients in its multi-center open-label, Phase II clinical trial of Liposomal Paclitaxel (LEP-ETU) for efficacy and safety in patients with Metastatic Breast Cancer. In pre-clinical and Phase I clinical data, LEP-ETU demonstrated a reduced side-effect profile, particularly peripheral neuropathy, as well as the potential for increased dosage and greater efficacy over Taxol®, the standard care for many tumors, principally breast and ovarian cancer.
NeoPharm has developed this liposomal formulation of paclitaxel in an effort to improve the safety profile of the currently marketed paclitaxel formulations by eliminating other toxic excipients, such as Cremophor® and ethanol, which must be co-administered to help decrease unwanted side effects.
Mr. Laurence Birch, President and Chief Executive Officer of NeoPharm Inc. commented, "We are pleased to announce the commencement of our Phase II trial for LEP-ETU. Our NeoLipid™ technology has enabled us to develop a formulation that we hope will eliminate the need for the use of Cremophor® and ethanol when administering paclitaxel. We believe LEP-ETU may present an opportunity for reduced side effects including peripheral neuropathy, hypersensitivity reactions, nausea, vomiting, and hair loss, as well as ease of use for patients suffering from multiple forms of cancer."
Mr. Birch continued, "The Company's re-entry into the clinic shows the significant strides that we have made over the last year with our drug candidate portfolio. With a number of structural changes to our operations, as well as a successful evaluation of NeoPharm's drug product pipeline and intellectual property, we are now in a position to capitalize on the compounds we have developed to date."
The Phase II open-label, multicenter outpatient study is designed to evaluate the anti-tumor effect and safety/tolerability of LEP-ETU in metastatic breast cancer. The study will target enrolling 35 patients in five centers with histologically or cytologically confirmed diagnosis of invasive adenocarcinoma originating in the breast. The primary objective of this Phase II trial will be to assess the Overall Response Rate of patients with metastatic breast cancer after treatment with a dose of 275 mg/m2 LEP-ETU administered over 90 minutes, with secondary objectives to evaluate the Progression-Free Survival (PFS) of patients treated with LEP-ETU and the safety of LEP-ETU, in particular peripheral neuropathy.
About NeoPharm, Inc.
NeoPharm, Inc., based in Waukegan, Illinois, is a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative cancer drugs for therapeutic applications. Additional information, including ongoing clinical trials, can be obtained by visiting NeoPharm's Web site at NeoPharm.
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 LEP-ETU, 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, LEP-ETU, 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, LEP-ETU, 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, LEP-ETU, 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 for. 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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