WAUKEGAN, Ill.--(BUSINESS WIRE)--NEOPHARM, INC. (Nasdaq:NEOL) today announced that it has met with officials of the Office of Oncology of the FDA to discuss the Company’s clinical trial data from its Phase 3 PRECISE trial for use of Cintredekin Besudotox in the treatment of recurrent glioblastoma multiforme (GBM).
Following presentation of the data by the Study’s principal investigator, the Office of Oncology position was that an additional Phase 3 clinical trial for Cintredekin Besudotox in the treatment of GBM would be required before the FDA could accept the Company’s application for approval. However, the Office of Oncology did encourage the Company to maintain a dialogue with the Agency regarding the pathway forward.
The Company is disappointed with the Office of Oncology’s position, which, if implemented, would significantly delay the introduction of this therapy to GBM patients. The Company will consider its options to determine the best path forward and will communicate its plans when they are completed and approved by the Board of Directors.
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
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,” “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 program, including the Company’s ability to make a submission to the FDA for approval of CINTREDEKIN BESUDOTOX, and the initiation, progress and outcomes of clinical trials of the Company’s drug product candidates, including, but not limited to, possible future trials for CINTREDEKIN BESUDOTOX. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in financing, development, testing, regulatory approval, production, and marketing of the Company’s drug and non-drug compounds, including, but not limited to, the Company’s ability to develop CINTREDEKIN BESUDOTOX, uncertainty regarding the outcomes of ongoing or proposed discussions with the FDA, 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 and non-drug compounds, including, but not limited to, CINTREDEKIN BESUDOTOX, that could slow or prevent products coming to market, uncertainty regarding the Company’s ability to market its drug and non-drug products, including, but not limited to, CINTREDEKIN BESUDOTOX, 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 year ended December 31, 2006. 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.
Contacts NEOPHARM, INC. Susan Bomhack, 847-406-178
