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NEOPHARM, Inc. today announced that it has filed an investigational new drug application with the FDA for a novel, proprietary liposomal delivery system of docetaxel, the active ingredient of Taxotere(R) (docetaxel), for the treatment of patients with locally advanced or metastatic solid tumor after failure of prior chemotherapy
WAUKEGAN, IL, USA | January 2, 2008 | NEOPHARM, Inc. (NASDAQ:NEOL) today announced that it has filed an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for a novel, proprietary liposomal delivery system of docetaxel, the active ingredient of Taxotere(R) (docetaxel), for the treatment of patients with locally advanced or metastatic solid tumor after failure of prior chemotherapy.
"This filing is a notable milestone in the advancement of our NeoLipid platform, which I believe reflects our commitment to progressing our portfolio, while concurrently optimizing the Company's cost structure," commented Mr. Laurence Birch, President and Chief Executive Officer of NEOPHARM Inc. "In August 2007, we announced our drug development timeline, and the IND for LE-DT is the first step in achieving that plan. We are on track and are now in a position to further our portfolio in 2008 and are optimistic for what the coming year should bring."
Assuming FDA acceptance of the IND application, NEOPHARM intends to enter a Phase I clinical study to assess the maximum tolerated (MTD) dose and dose limiting toxicity (DLT) of Liposome Entrapped Docetaxel for Injection (LE-DT) in approximately 30 patients. Additionally, NEOPHARM will use this Phase I study to evaluate the pharmacokinetics of LE-DT therapy and any anti-tumor effects of LE-DT.
Pre-clinical data suggests that LE-DT may improve the safety profile of docetaxel, eliminate the risk of hypersensitivity reactions, maximize the therapeutic benefit, minimize side effect, and overall exhibit a better efficacy profile.
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 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 including, but not limited to LE-DT, drug candidate pathways, including the acceptance of the IND by the FDA 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 including, but not limited to LE-DT, in order to conserve its cash resources, the ability of the Company to procure additional future sources of financing, 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, 2006, as 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.
SOURCE: NEOPHARM, Inc. |
