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***FOR IMMEDIATE RELEASE***
CONTACT:
Paul Arndt, Corporate Communications Manager
parndt@neophrm.com
847-295-8678 x 215
Ø Independent Data Monitoring Committee Recommends PRECISE Trial Continue as Planned
Ø 200th Patient Randomized In Study
Ø Projected Enrollment Completion By Year-End 2005 Reconfirmed
LAKE FOREST, Illinois – June 27, 2005 – NeoPharm, Inc. (Nasdaq: NEOL) today announced that the independent Data Monitoring Committee (“DMC”), responsible for overseeing the Company’s Phase III PRECISE trial, has met, analyzed, and reviewed the data for the trial’s first futility analysis, and has recommended to the Company that the PRECISE trial continue as planned.
The PRECISE trial has two futility analyses: the first at 50 deaths, and the second at 100 deaths. The futility analyses assess whether the PRECISE trial is progressing towards its primary endpoint of a statistically significant increase in overall patient survival between treatment groups at final analysis. The primary endpoint of the PRECISE study is designed to determine whether there is an improvement of at least 50% in median survival of patients with glioblastoma multiforme (“GBM”) resulting from treatment with the Company’s cintredekin besudotox (IL13-PE38QQR) over treatment with Gliadel® Wafer, the current primary treatment option. The study’s second futility analysis is currently projected by the Company for the fourth quarter of 2005.
The Company also announced that enrollment in the PRECISE trial is more than two-thirds complete. The PRECISE trial randomized its 200th patient in early June. If the Company enrolls an average of 15 patients per month between June and December 2005 it will meet its goal to fully enrolling 300 patients in the PRECISE trial by the end of 2005.
While PRECISE trial enrollment has been averaging 19 patients per month during 2005, the Company anticipates that enrollment may slow during the summer months due to the turnover in resident and fellowship training programs at academic medical centers (which comprise many of the PRECISE trial sites), medical community vacations, and the general seasonal slowdown in Europe in July and August. To keep enrollment as robust as possible during the summer months, the Company is working with the trial sites on staffing needs and patient referrals. The Company, however, continues to anticipate completion of PRECISE trial enrollment by the end of 2005.
Additionally, the Company reported that Sandeep Kunwar, MD, Assistant Professor of Neurosurgery at the University of California-San Francisco, and Principal Investigator of the Company’s PRECISE trial, recently spoke at the 13th World Congress of Neurological Surgery in Marrakesh, June 19-24, 2005, organized by the World Federation of Neurosurgical Societies and the Moroccan Society of Neurosurgery. Dr. Kunwar spoke on brain tumor therapy, new technologies, and procedures which featured cintredekin besudotox delivered via Convection Enhanced Delivery.
About PRECISE
PRECISE, an acronym for Phase III Randomized Evaluation of Convection Enhanced Delivery of IL13-PE38QQR with Survival Endpoint, is a randomized, controlled Phase III clinical trial. It is designed to compare overall survival, drug safety and quality of life of patients receiving cintredekin besudotox with patients receiving GLIADEL® Wafer in the treatment of first recurrent GBM following surgical tumor resection (removal). Patients are randomized so that 200 patients receive cintredekin besudotox via Convection Enhanced Delivery (CED) using catheters placed following the resection, and 100 patients receive GLIADEL® Wafer placed at the time of resection. Enrollment in PRECISE is expected to be completed in the fourth quarter of 2005.
About the Independent Data Monitoring Committee
The independent DMC is responsible for, among other things, assuring that study participants are not exposed to unnecessary or unreasonable risks and that the study is being conducted according to high ethical, regulatory, and scientific standards. The DMC will recommend that the study protocol be stopped, temporarily suspended or amended, as appropriate, if a result of data monitoring determines that a trial:
1) has answered the primary study question;
2) is futile or will not be able to reach a positive conclusion;
3) is not being conducted according to high standards; or
4) poses an unreasonable or unnecessary risk to study participants,
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 the PRECISE trial and other clinical studies involving cintredekin besudotox, future patient enrollment in the Company’s 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, 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.
Paul Arndt
Corporate Communications Manager
NeoPharm, Inc.
150 Field Drive, #195
Lake Forest, IL 60045
847-295-8678 x 215
847-295-8854 - Fax
parndt@neophrm.com