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NeoPharm Presents Phase I/II Data for IL13-PE38 at the 7th Annual Society Of Neuro-Oncology (SNO) Annual Meeting


Posted on: 11/26/2002

NeoPharm Presents Phase I/II Data for IL13-PE38 at the 7th Annual Society Of Neuro-Oncology (SNO) Annual Meeting

Additional Preliminary Data Shows Potential as Treatment for Devastating Form Of Brain Cancer

LAKE FOREST, Ill., Nov. 26 /PRNewswire-FirstCall/ -- NeoPharm, Inc. (Nasdaq: NEOL) today announced that additional Phase I/II clinical trial data on IL13-PE38, the Company's novel tumor-targeting agent for malignant glioma, were presented at the Seventh Annual Meeting of the Society for Neuro-Oncology (SNO) in San Diego. This premier laboratory and clinical research society is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education. An abstract of the presentation -- "Phase I/II Study: Intra-Tumoral Infusion of IL13-PE38QQR Cytotoxin for Recurrent Supratentorial Malignant Glioma" -- appeared in the October 2002 issue of Neuro-Oncology (the official journal of the World Federation of Neuro-Oncology/Society for Neuro-Oncology/Japan Society for Neuro-Oncology/European Association for Neuro-Oncology), Volume 4, Issue 4. Information on the SNO meeting also is available at: www.soc-neuro-onc.org .

On Sunday, November 24, 2002, Jon Weingart, MD, Assistant Professor of Neurosurgery and Oncology, Department of Neurosurgery, The Johns Hopkins University Medical Center, presented the experience of 14 patients from one of three ongoing IL13-PE38 Phase I/II clinical trials. This preliminary data built on previous study findings indicating the cytotoxic (cell killing) effects of IL13-PE38 against malignant glioma tumor cells, when infused into the tumor site using convection-enhanced delivery (CED). This particular trial was designed to assess the dose escalation, safety and tolerability of IL13-PE38 in patients with supratentorial malignant glioma tumors. The study findings indicated that IL13-PE38 was well tolerated in this patient population and, although not designed as an efficacy study, evidence of tumor necrosis and prolonged patient survival has been observed.

"Since the first preliminary human clinical data on IL13-PE38 was unveiled last year at the Sixth Annual SNO Meeting, we have continued to move the development program for IL13-PE38 forward as quickly as possible," said James Hussey, President and CEO of NeoPharm, Inc. "Based on the encouraging preliminary results we have seen to date, we are moving forward with the planning of our Phase II/III development program for IL13-PE38 in malignant glioma. In fact, we plan to meet with the FDA in December to discuss the next steps for this promising treatment advance for patients with this devastating disease."

NeoPharm has exclusively licensed IL13-PE38 from the National Cancer Institute (NCI) and the U.S. Food and Drug Administration (FDA), and is developing the agent under a Cooperative Research and Development Agreement (CRADA) with the FDA's Center for Biologics Evaluation and Research (CBER). IL13-PE38 has received orphan drug designation in Europe and in the U.S., and fast track drug development program status from the U.S. Food and Drug Administration. Additionally, NeoPharm has scheduled a meeting with the FDA in December 2002 to determine the requirements to begin IL13-PE38 Phase II/III clinical trials.

Phase I/II Trial Design and Preliminary Conclusions

The clinical study discussed here is being conducted through the NCI Clinical Trial Evaluation Program (CTEP)-funded New Approaches to Brain Tumor Therapy (NABTT) Consortium. Johns Hopkins University Medical Center is the coordinating site for NABTT.

At this year's SNO meeting, Dr. Weingart from Johns Hopkins presented results from the initial 14 patients enrolled in this trial. These patients were all diagnosed with recurrent supratentorial malignant glioma. IL13-PE38 was administered with CED, using positive pressure infusion -- a new approach to administering therapeutic agents within tumors or adjacent to tumor resection sites to optimize drug distribution in the brain. Two infusions were planned eight weeks apart. Patients were dosed with IL13-PE38 via two, intra-tumoral catheters at 200 ul/catheter/hour for 96 hours (total 38.4 ml). The IL13-PE38 concentration was increased in individual cohorts to determine the maximum tolerated dose (MTD). Six patients received IL-13PE38 at 0.125 ug/ml; three patients received the drug at 0.25 ug/ml; three patients were dosed at 0.50 ug/ml; and to date, two patients have been dosed at the 1.00 ug/ml level. Intra-tumoral infusion of the drug appeared to be well tolerated. In addition, although this study was not designed to show efficacy, evidence of tumor necrosis and prolonged patient survival has been observed.

Background Information

Malignant Glioma: The Disease

Malignant glioma, which includes glioblastoma multiforme and anaplastic astrocytoma tumors, is diagnosed in approximately 17,500 people in the U.S. annually and claims approximately the same number of lives each year. Most people with malignant glioma usually live for less than one year after diagnosis, as there are very limited treatment options to prevent rapid recurrence of the cancer once the tumor is surgically removed from the brain.

The Mechanism of IL13-PE38

Malignant glioma cells, as compared to normal brain cells, express interleukin-13 (IL13) receptors at a high density. IL13 is an immune regulatory cytokine, or protein, secreted by cells. IL13-PE38 (a recombinant protein) is designed to detect and bind to IL13 receptors on the surface of malignant glioma cancer cells. It then selectively delivers a potent bacterial cytotoxic agent called PE38, derived from Pseudomonas bacterium, to destroy tumor cells while sparing healthy surrounding cells. In contrast, conventional, non-specific chemotherapeutic drugs attack abnormal cancer cells by stopping them from dividing and reproducing, but can also damage normal cells because these agents are not selective for just cancer cells and are almost always administered systemically. This means that the systemic medicines are diffused throughout the body rather than being localized to one area, such as a tumor in the brain, and cannot discriminate between cancer and healthy cells. Common chemotherapy side effects occur when bone marrow is damaged and cannot produce enough red blood cells (causing weakness and fatigue), white blood cells (lowering the body's resistance to infections) or platelets (preventing blood from clotting properly, which can lead to excessive bleeding).

IL13-PE38, on the other hand, is being developed as a highly specific tumor-targeting agent. It is administered directly to the tumor through positive-pressure CED, which uses catheters inserted in the brain before and/or following surgical resection (removal) of the tumor. CED is designed to infuse IL13-PE38 directly to the tumor site and adjacent brain tissue to prevent recurrence of tumor cell growth. Investigators have sought to identify the optimum "therapeutic window" to provide patients with the safest, most effective dose levels at sufficient tumor toxic concentrations to kill malignant cells while minimizing toxic exposure to healthy tissues.

A study involving IL13-PE38 was published in the October 2002 issue of Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research ( http://mct.aacrjournals.org ). In a series of laboratory experiments designed to help define the molecular mechanisms for the therapeutic properties of IL13-PE38, the authors identified that human glioma tumor cells that express the IL-13 receptor undergo programmed cell death, or apoptosis, following intratumoral administration of IL13-PE38, leading to regression of established tumors. IL13-PE38 appears to be tumor-selective and induces apoptosis, which persists after the drug is no longer detectable.

Additional Phase I/II IL13-PE38 Clinical Studies

NeoPharm is also currently conducting two other clinical trials for IL13-PE38 in malignant glioma. Additional preliminary clinical data for this study was recently presented at the Fifth Congress of the European Association of Neuro-Oncology (EANO) in Florence, Italy. This study is being conducted at various leading brain cancer research centers including, M.D. Andersen Cancer Center (MDACC), Memorial Sloan Kettering Cancer Center (MSKCC), the University of California San Francisco (UCSF) and Yale University.

Additionally, enrollment is currently underway in the first global Phase I/II clinical trial of IL13-PE38 -- the third NeoPharm sponsored clinical study to date in patients with recurrent or progressive malignant glioma. The trial is being conducted at six participating sites including University Hospital Eppendorf and University Hospital Kiel in Germany, Chaim Sheba Medical Center and Dana Hospital Tel Aviv in Israel, Cleveland Clinic and University of Colorado in the United States. The trial's first cohort of three patients was enrolled in the first month of the study and enrollment is ongoing in the second cohort of patients.

For additional details regarding IL13-PE38 trial design, enrollment criteria and participating centers please refer to www.clinicaltrials.gov (keyword: IL13-PE38QQR).

About NeoPharm

NeoPharm, Inc., based in Lake Forest, IL, is a publicly traded biopharmaceutical company dedicated to the research, discovery 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 and recent news releases can be obtained by visiting NeoPharm's Website at: www.neophrm.com. For copies of scientific abstracts related to IL13-PE38 from recent medical meetings, contact Lauren Greis, NeoPharm, at 847.295.8678.

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. Such statements include, but are not limited to, any statements relating to the Company's drug development program 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 candidates, uncertainty regarding the outcome of damages claims made by or against the Company, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent products coming to market, the uncertainty of patent protection for the Company's intellectual property or trade secrets and other risks detailed from time to time in filings the Company makes with the Securities and Exchange Commission including their annual reports on Form 10-K and their 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.

SOURCE NeoPharm, Inc.

-0- 11/26/2002

/CONTACT: Larry Kenyon, CFO, of NeoPharm, Inc., +1-847-295-8678; Investors, Janet Dally of MontRidge, LLC, +1-203-894-8038; or Media, Kristin Fayer of Outlook Marketing, +1-847-509-3099/

/Web site: http://www.soc-neuro-onc.org

http://mct.aacrjournals.org

http://www.clinicaltrials.gov

http://www.neophrm.com / (NEOL)


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