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NEOPHARM INITIATES PHASE I STUDY OF IL13-PE38QQR IN PATIENTS AT INITIAL DIAGNOSIS OF MALIGNANT GLIOMA


Posted on: 08/05/2004

NEOPHARM INITIATES PHASE I STUDY OF IL13-PE38QQR IN PATIENTS AT INITIAL DIAGNOSIS OF MALIGNANT GLIOMA

***FOR IMMEDIATE RELEASE***
CONTACT:
Larry Kenyon, Chief Financial Officer , lkenyon@neophrm.com , 847-295-8678 x 210
Paul Arndt, Corporate Communications Manager , parndt@neophrm.com , 847-295-8678 x 215

LAKE FOREST, Illinois – August 4, 2004 – NeoPharm, Inc. (Nasdaq: NEOL) announced today that the first patient in a new Phase I Clinical Trial of its tumor-targeting compound, IL13-PE38QQR, for the treatment of malignant glioma at initial diagnosis, has been treated at the Cleveland Clinic. IL13-PE38QQR is being administered via convection-enhanced delivery (CED) following tumor resection after initial diagnosis, using catheters placed directly in the brain near the tumor resection site.

“We are pleased that enrollment has begun in this Phase I trial of IL13-PE38QQR for the treatment of malignant glioma at initial diagnosis,” said Greg Young, NeoPharm’s President and Chief Executive Officer. “This study was reviewed with FDA as part of the overall IL13-PE38QQR clinical development program. We plan on enrolling up to 24 patients, with the primary endpoint being initial determinations regarding safety and tolerability of IL13-PE38QQR plus radiotherapy with or without temozolomide. We currently expect the enrollment period of the trial to last approximately 12 months.”

IL13-PE38QQR is being studied in patients with malignant glioma at initial diagnosis, which include, but are not limited to:

  • Glioblastoma Multiforme (GBM);
  • Anaplastic astrocytoma; and
  • Malignant mixed oligoastrocytoma.


This clinical trial is being conducted in collaboration with the American College of Surgery Oncology Group (ACOSOG) at 6 centers:

  • Carolina Neurosurgery and Spine Associates,
  • Cleveland Clinic,
  • Duke University,
  • M.D. Anderson Cancer Center,
  • University of California–San Francisco, and
  • University of Virginia.

“This Phase I study in newly diagnosed patients complements the ongoing Phase III PRECISE clinical trial and is intended to determine whether it may be possible to broaden the utility of IL13-PE38QQR for the treatment of GBM at initial diagnosis,” commented Michael Vogelbaum, M.D., Ph.D., Director, Center for Translational Therapeutics, Associate Director of Neurosurgical Oncology, Brain Tumor Institute, Departments of Neurosurgery and Cancer Biology, Cleveland Clinic Foundation. Dr. Vogelbaum is co-Principal Investigator for the Phase I study along with John Sampson, M.D., Ph.D., Duke University.

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 an ongoing Phase III “PRECISE” clinical trial (www.precisetrial.com) in patients with recurrent GBM.

About Malignant Glioma

Malignant gliomas, which includes glioblastoma multiforme (GBM), anaplastic astrocytoma and malignant mixed oligoastrocytoma tumors, are the most common and aggressive form of primary brain tumors. GBM is a highly malignant, rapidly infiltrating, primary brain tumor that penetrates surrounding brain tissue and is the most common and aggressive form of malignant glioma. GBM, like most malignant gliomas, is known to recur in a location close to the resection cavity left by the removal of the tumor. As there are currently limited treatment options to prevent rapid recurrence of the tumor once the tumor is surgically resected, most people usually survive for less than one year after initial diagnosis.

About IL13-PE38QQR

The key to making a useful tumor-targeting drug is the use of a targeting mechanism that is able to select and destroy tumor cells while bypassing healthy normal cells. IL13-PE38QQR is a recombinant protein consisting of a single molecule composed of two parts: a tumor-targeting molecule (IL13) and a cytotoxic agent (Pseudomonas exotoxin, or PE). IL13 receptors are found on malignant glioma cells, but not to an appreciable extent if at all on healthy brain 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 and is destroyed. As a result, the cancer cell dies. Healthy brain cells are expected to be unharmed because they do not have the IL13 receptors, and thus do not ingest the PE.

About Convection-Enhanced Delivery

To overcome the blood-brain barrier (the barrier between the blood and tissues of the brain that prevents the entry of many drugs), IL13-PE38QQR is administered directly in the brain near the tumor resection site through 2-4 small tubes, or catheters, placed by a neurosurgeon. IL13-PE38QQR is then delivered continuously by low flow rate positive pressure infusion through the catheters for a specified period of time. This method of drug delivery is referred to as convection-enhanced delivery (CED).

About NeoPharm

NeoPharm is a publicly traded biopharmaceutical company dedicated to the research, discovery, and commercialization of new and innovative cancer drugs for therapeutic applications. NeoPharm has built its drug portfolio based on its two novel proprietary technology platforms: a tumor-targeting platform and the NeoLipid™ drug delivery system. The Company has a portfolio of anticancer compounds in various stages of development. Additional information about NeoPharm, recent news releases, and scientific abstracts related to the Company’s drug compounds can be obtained by visiting NeoPharm's Website at: www.neophrm.com, or calling Paul Arndt at 847-295-8678x215.

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, 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 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 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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