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Posted on: 11/23/2004


Optimal Catheter Placement and Prediction of Drug Distribution is
Focus of NeoPharm Sponsored Clinical Study
LAKE FOREST, Illinois – November 22, 2004 – NeoPharm, Inc. (Nasdaq: NEOL) announced that new and updated Phase I/II trial data for its tumor-targeting compound IL13-PE38QQR were presented by John H. Sampson, MD, PhD, Associate Professor of Surgery and Assistant Professor of Pathology at Duke University on November 20th at the 9th Annual Meeting of the Society for Neuro-Oncology, held from November 18-21 in Toronto, Canada. The oral presentation was entitled “Convection-Enhanced Delivery of IL13-PE38QQR in Malignant Glioma: Comparison of Observed and Predicted Drug Distribution.”

“We are pleased with the results of this Phase I study,” said Gregory P. Young, NeoPharm’s President and Chief Executive Officer. “Optimizing catheter positioning in the Company’s ongoing Phase III PRECISE Trial will help to maximize the efficacy of IL13-PE38QQR when administered to patients with recurrent glioblastoma multiforme (GBM).”

Dr. Sampson’s clinical study was based on observations to date from NeoPharm’s other Phase I/II IL13-PE38QQR clinical trials indicating an increase in median survival is associated with optimal (70.3 weeks) vs. sub-optimal (41.4 weeks) catheter placement in the peritumoral setting. The median survival for this same patient population, according to publications of clinical studies with other treatments, is 20-26 weeks.

Although not designed to be an efficacy study, the Dr. Sampson’s study was designed to assess the effect of catheter positioning on drug distribution using a radioactive labeled iodine human serum albumin (123I-HSA) as a surrogate imaging tracer. This study also examined the predictive value of computer software in assessing drug distribution.

In a previous poster presentation at the American Association of Neurological Surgeons (AANS) meeting in May of this year, Dr. Sampson compared the distribution of the drug when catheters were positioned according to the guidelines used in the PRECISE trial to the distribution of the drug when the positioning of the catheters did not meet these criteria. The drug distribution was assessed using radiologic imaging, including spectroscopy and MRI scans. At the SNO meeting, Dr. Sampson updated these results and also showed how using computer software could potentially help surgeons better position catheters.

“The findings from this imaging study have helped to advance our understanding of how to administer agents such as IL13-PE38QQR by CED,” commented John Sampson, MD, PhD, Associate Professor of Surgery and Assistant Professor of Pathology at Duke University. “The study findings also support the catheter positioning guidelines being used in the IL13-PE38QQR PRECISE Study.”

IL13-PE38QQR has received orphan drug designation in Europe and the U.S., and fast track drug development program status from the U.S. Food and Drug Administration (FDA). NeoPharm's IL13-PE38QQR development program was also selected to participate in the FDA Continuous Marketing Application Pilot 2 Program. Currently, IL13-PE38QQR is the subject of the ongoing Phase III “PRECISE” clinical trial ( in patients with recurrent GBM.

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

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 initiation, progress and outcomes of clinical trials of the Company’s drug product candidates, including, but not limited to, IL13-PE38QQR and the 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, regulatory approval, production and marketing of the Company's drug and non-drug compounds, including, but not limited to, IL13-PE38QQR and the PRECISE Trial, uncertainty regarding the availability of third party production capacity, uncertainty regarding the outcome of damage claims made by or against the Company, the Company’s ability to cut back on 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 and non-drug compounds, including, but not limited to IL13-PE38QQR, that could slow or prevent products coming to market, uncertainty regarding the Company's ability to market its drug and non-drug products directly or through independent distributors, the uncertainty of patent protection for the Company's intellectual property or trade secrets, including, but not limited to IL13-PE38QQR, 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

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