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NEOPHARM ANNOUNCES NEW CLINICAL TRIAL DATA FOR IL13-PE38QQR IN BRAIN CANCER


Posted on: 05/06/2004

NEOPHARM ANNOUNCES NEW CLINICAL TRIAL DATA FOR IL13-PE38QQR IN BRAIN CANCER

CONTACT:
Larry Kenyon, Chief Financial Officer Paul Arndt, Corporate Communications Manager
lkenyon@neophrm.com parndt@neophrm.com
847-295-8678 x 210 847-295-8678 x 215
Investors: Media:
Janet Dally, President Paula Waters, Vice-President
MontRidge, LLC Fleishman-Hillard 203-894-8038 312-751-3735


Data In Support of the PRECISE Trial Presented at the American Association of Neurological Surgeons (AANS) 72nd Annual Scientific Meeting

LAKE FOREST, Illinois – May 6, 2004 – NeoPharm (Nasdaq/NM: NEOL) today announced that additional Phase I/II clinical trial data in support of the Company’s Phase III PRECISE Trial study of IL13-PE38QQR, the Company’s novel tumor-targeting agent for glioblastoma multiforme, was presented at the American Association of Neurological Surgeons (AANS) 72nd Annual Scientific Meeting, held in Orlando, Florida, on May 1-6, 2004. Data from two studies were presented by Dr. Sandeep Kunwar of the University of California-San Francisco, in an oral presentation, and Dr. John Sampson of Duke University, in a poster presentation.

“We are encouraged that this data further supports our PRECISE Trial design, and are pleased to have contributed to progress in better understanding Convection-Enhanced Delivery of therapeutic agents such as IL13-PE38QQR in the treatment of brain tumors,” said James M. Hussey, NeoPharm’s President and Chief Executive Officer. “We are hopeful that IL13-PE38QQR, which is currently being studied in the Phase III PRECISE Trial, will be a treatment advance for those patients afflicted with glioblastoma multiforme, a deadly form of brain cancer.”

Oral Presentation – Abstract #710

On Monday, May 3, 2004, Dr. Kunwar, Assistant Professor in the Department of Neurological Surgery at the University of California-San Francisco, Principal Investigator of the PRECISE Trial study, and the recipient of the 2003 Ronald L. Bittner Award on Brain Tumor Research at AANS, delivered an oral presentation titled “Safety of Convection Enhanced Drug Delivery in Functional Human Tissue: Experience from Phase I Studies” In his presentation, Dr. Kunwar illustrated that Convection-Enhanced Delivery (CED) could be safely used in functional human brain tissue. Functional human brain tissue often has to be targeted for treatment with CED as malignant gliomas infiltrate normal brain tissue.

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Dr. Kunwar and colleagues retrospectively reviewed all patients treated using two clinical Phase I/II protocols at their institution in which CED of tumor-selective recombinant cytotoxins for recurrent malignant gliomas were used. Patients had two to three catheters inserted into brain tissue at risk for tumor spread after resection of gross tumor. The relationship between catheter location, anatomical structures, and clinical examinations of patients pre- and post-infusion and at follow-up were assessed.

Most notably, Dr. Kunwar highlighted the importance of catheter placement on improving patient survival. The data further supported the findings that had previously been presented at the Society of Neuro-Oncology (SNO) meeting in November.

Dr. Kunwar and colleagues concluded that CED of macromolecules into functional brain is safe but can cause mild transient neurological deficits to develop which resolve after completion of treatment. Findings of radiographic changes and absence of tumor recurrence suggests adequate drug distribution into the adjacent brain. Greater experience with intracerebral CED will expand its use for brainstem delivery and the treatment of other CNS disorders.

Poster Presentation – Abstract #1381

On Wednesday, May 5, 2004, Dr. Sampson of Duke University and co-Principal Investigator in a planned Phase I study with IL13-PE38QQR in newly diagnosed patients with malignant glioma, presented a poster entitled “Convection Enhanced Delivery of IL13-PE38QQR in Malignant Glioma: Effect of Catheter Placement on Drug Distribution.” Dr. Sampson’s presentation focused on the distribution of IL13-PE38QQR using a radiolabeled surrogate tracer when administered by CED into the main tumor mass, tissue surrounding the main tumor mass or adjacent to the cavity left after tumor resection. Little is known about the drug distribution achieved within brain tissue, or how parameters such as catheter positioning affect distribution. Previous studies suggest that optimum drug delivery may occur in as few as 20% of patients. With a goal towards optimizing IL13-PE38QQR delivery, this pilot study assessed drug distribution by serial SPECT imaging and 123I-human serum albumin (123I-HSA) as surrogate imaging tracer co-infused with IL13-PE38QQR. The study involved infusions before and/or after tumor resection.

The most significant findings in the study were that infusion in tissue surrounding the main tumor mass or adjacent to the cavity left after tumor resection more consistently led to a clinically significant volume of distribution than infusion into the main tumor mass. Catheter positioning also appears to be important for optimal drug distribution. In addition, when administered at a concentration of 0.5µg/mL, IL13-PE38QQR appears to be well tolerated and has a favorable safety profile. Parameters that impact drug distribution by CED, such as catheter positioning and the physiologic and anatomic properties of the target tissue, can be assessed by MRI in a patient-specific manner. Establishing methodologies to consistently achieve optimal drug delivery (e.g., guidelines for catheter trajectory and target tissue selection) will be critical for efficacy assessment of CED of therapeutic agents for malignant glioma. The study design and catheter positioning guidelines being used in the ongoing IL13-PE38QQR Phase III PRECISE Trial are supported by the findings in this study.

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About IL13-PE38QQR

The Company’s tumor-targeting technology has been developed to deliver a highly specific agent designed to destroy specific tumor cells. The Company uses a recombinant protein consisting of a single molecule composed of two parts: a tumor-targeting molecule and a bacterial cytotoxin. The targeting component consists of interleukin 13 (IL13) an immune regulatory cytokine (normally made by cells of the immune system). The cytotoxin is a potent bacterially derived Pseudomonas Exotoxin (PE) toxic to human cells. The original cytotoxin was modified so it cannot enter the cells without IL13 attached to it.

IL13 receptors are found on malignant glioma cells. The IL13 portion is designed to bind to receptors on the tumor like a key fits in a lock. The cancer cell latches onto and absorbs the IL13 and the attached PE. As a result, the cancer cell dies. Normal brain tissue cells are expected to be unharmed because they do not appear to have the IL13 receptors, and thus do not ingest the PE. The Company has engineered IL13-PE38QQR to directly target and destroy tumors while sparing normal brain tissue.

About Convection Enhanced Delivery

IL13-PE38QQR is administered by a technique known as convection-enhanced delivery, in which the drug is delivered through small tubes, or catheters, directly to the tissue surrounding the tumor after the tumor has been surgically removed. A pump is used to slowly push the drug through these catheters. This technique allows relatively large volumes of brain tissue to be treated.

About the PRECISE Trial

PRECISE, which stands 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 IL13-PE38QQR with patients receiving GLIADEL® Wafer (Guilford Pharmaceuticals) in the treatment of glioblastoma multiforme at first recurrence. As one of the largest international Phase III trials of its kind, PRECISE will seek to enroll 300 patients in multiple centers across North America, Europe and Israel. Patients will be randomized so that 200 patients receive IL13-PE38QQR via Convection Enhanced Delivery using catheters placed following the tumor resection, and 100 patients receive GLIADEL® Wafer placed at the time of resection completion. Enrollment in PRECISE is expected to be completed in 2005.

About NeoPharm

NeoPharm, Inc., based in Lake Forest, IL, 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 broad portfolio of compounds in various stages of development. Additional information about NeoPharm, recent news releases, and scientific abstracts related to IL13-PE38QQR can be obtained by visiting NeoPharm's Website at: www.neophrm.com , or calling Paul Arndt at 847-295-8678.

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 involving IL13-PE38QQR, including 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 development, testing, regulatory approval, production and marketing of the Company's drug and non-drug compounds, including, but not limited to IL13-PE38QQR, uncertainty regarding the availability of third party lyophilization capacity, 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, including, but not limited to, IL13-PE38QQR, or trade secrets and other risks detailed from time to time in filings the Company makes with the Securities and Exchange Commission including our annual reports on Form 10-K and our 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

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This transmission contains confidential information protected by law. The information is intended only for the use of the individual or individuals named above. If you are not the intended recipient, you are notified that any disclosure, copying, distribution or taking of action in reliance on the contents of this information is not permissible and may be against the law. If you have received this transmission in error, please delete this message immediately and notify the sender by reply email. Thank you. NeoPharm, Inc. *************************************************************************************************************************


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