NeoPharm (Nasdaq:NEOL) today announced that it has received notification that the Company's Phase III PRECISE trial has reached the criterion for the first futility analysis (50 deaths). As a result, the PRECISE trial independent Data Monitoring Committee will, at its next periodic clinical safety review meeting, currently scheduled for late June, also review the first futility analysis, analyze and review the data to date, and thereafter provide its recommendation to the Company.
The PRECISE trial has two futility analyses, the first at 50 deaths, and the second at 100 deaths. The futility analyses are used to assess whether the PRECISE trial is on target to meet its primary endpoint of a 50% improvement in median survival over the Gliadel(R) Wafer.
Enrollment in the PRECISE trial will continue uninterrupted. As of April 30, 2005, 174 patients were enrolled in the trial. The Company provides monthly enrollment data on the PRECISE trial at www.precisetrial.com.
About NeoPharm, Inc.
NeoPharm, Inc., based in Lake Forest, Illinois, is a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative cancer drugs for therapeutic applications. The Company has a portfolio of cancer compounds in various stages of development. Additional information can be obtained by visiting NeoPharm's Website at www.neophrm.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," "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, but not limited to clinical trials including cintredekin besudotox, future patient survival in and the Company's ongoing Phase I studies and PRECISE trial, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in financing, development, testing, obtaining regulatory approval, production and marketing of the Company's drug and non-drug compounds, including, but not limited to, cintredekin besudotox, uncertainty regarding the availability of third party production capacity, 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, directly or through independent distributors, the uncertainty of patent protection for the Company's intellectual property or trade secrets, 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 reports on Form 10-K and quarterly reports on Forms 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.
CONTACT: NeoPharm, Inc.
Paul Arndt, 847-295-8678 x 215
SOURCE: NeoPharm, Inc.