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NeoPharm Announces Additional Clinical Data for IL13-PE38 at European Association of Neuro-Oncology (EANO) Congress Encouraging Preliminary Data From Ongoing Phase I/II Trial Presented On Potential New Treatment for Deadly Brain Cancer

Posted on: 09/09/2002

Press Release Source: NeoPharm, Inc.

NeoPharm Announces Additional Clinical Data for IL13-PE38 at European Association of Neuro-Oncology (EANO) Congress Encouraging Preliminary Data From Ongoing Phase I/II Trial Presented On Potential New Treatment for Deadly Brain Cancer

Monday September 9, 7:00 am ET

LAKE FOREST, Ill., Sept. 9 /PRNewswire-FirstCall/ -- NeoPharm, Inc. (Nasdaq: NEOL - News) today announced additional Phase I/II human clinical data for IL13-PE38, the Company's investigational tumor-targeting agent being developed for the treatment of malignant glioma, a deadly form of brain cancer for which there is currently no known cure. The new findings were presented on September 8th at the Fifth Congress of the European Association of Neuro-Oncology (EANO) held in Florence, Italy (September 7 - 10, ). This premier European medical association hosts an annual peer-reviewed scientific forum for leading researchers in the field of neuro-oncology. The presentation was drawn from experience in 18 patients from one of three ongoing Phase I/II clinical trials NeoPharm is conducting for IL13-PE38.

The preliminary data provided additional evidence of IL13-PE38's cytotoxic (cell killing) effects against malignant glioma tumor cells when infused prior to surgical resection of the tumor. The pre-resection regimen involved convection-enhanced delivery (CED) of IL13-PE38 at various concentrations (0.25, 0.50, 1.0 or 2.0 ug/ml) and appeared to be well tolerated with no reports of dose-limiting toxicity. Although not an efficacy study, prolonged survival has been observed to beyond one year. "These encouraging findings signify the progress we're making to achieve an important company milestone -- to fulfill an unmet global need for a safe and effective cancer treatment for malignant glioma," commented James M. Hussey, NeoPharm's President and Chief Executive Officer. "This exciting progress demonstrates the commitment of NeoPharm and our global collaborators to quickly advance IL13-PE38 into Phase II/III trials. The sooner we can bring IL13-PE38 to market, the sooner we might improve the outlook of people around the world combating this devastating disease."

IL13-PE38 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 has exclusively licensed IL13-PE38 from the National Cancer Institute and the 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)

. Phase I/II Trial Design and Preliminary Conclusions

The Phase I/II scientific findings presented at the EANO Congress involved several research institutions including M.D. Andersen Cancer Center (MDACC), Memorial Sloan Kettering Cancer Center (MSKCC), the University of California San Francisco (UCSF), Yale University, CBER/FDA and NeoPharm, the trial sponsor. This trial was designed to assess the dose escalation, safety, tolerability and effectiveness of IL13-PE38 as a complement to surgical resection treatment of glioblastoma multiforme (GBM) tumors -- the most deadly, invasive and rapidly growing tumor types in malignant glioma.

To date, this trial has enrolled 18 patients and is designed to determine the histologically effective concentration (HEC) of IL13-PE38; important evidence of the drug's ability to destroy malignant tumor cells. Patients undergo an initial tumor biopsy on Day 1, followed by the placement of one intratumoral catheter and continuous convection-enhanced delivery (CED) of IL13-PE38 at a low flow rate over 48 hours on Days 2-4. The tumor is then surgically resected (en bloc, or completely in one piece, if possible) on Day 8. Tumor tissue is evaluated for necrosis (cell death) in relation to catheter placement. At the end of the resection procedure, two or three catheters are placed into the brain adjacent to the tumor resection cavity. Post-resection CED regimen of IL13-PE38 is then administered for 96 hours on Days 10-14 to protect normal brain tissue from tumor recurrence.

Pre-operative CED was well-tolerated. Thus far, IL13-PE38 at concentrations ranging from 0.25 - 2.0 ug/mL appear to be cytotoxic (active) against GBM. Preliminary results of resected tumors in 5 patients demonstrate necrosis (cell death) in an ovoid zone extending 0.3-2.0 cm from the catheter tip. The CED route of administration may optimize delivery of IL13-PE38 for treatment of malignant glioma.

"Our team is encouraged by the evidence we've seen to date for IL13-PE38," commented Michael Prados, MD, Director, Neuro-Oncology Service, Department of Neurosurgical Surgery, University of California San Francisco, who presented the abstract at EANO. "This has strengthened our interest in the compound's ability to induce tumor necrosis at drug concentrations that are well below what is believed to be the maximum tolerated dosage (MTD). These new findings will allow us to move ahead and focus on defining the post-resection regimen for IL13-PE38 and planning subsequent Phase II/III trials."

The Mechanism of IL13-PE38 Compared with Standard Chemotherapy

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 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 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 toxic concentrations to kill tumor cells while minimizing toxic exposure to healthy tissues.

Background Information

Phase I/II IL13-PE38 Clinical Program

IL13-PE38 is currently under investigation in three ongoing Phase I/II clinical trials. The first IL13-PE38 clinical study 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. The first human clinical data on IL13-PE38 from this study was presented last Fall at the Sixth Annual Meeting of the World Federation of Neuro-Oncology/Society for Neuro-Oncology (SNO). These data indicated that IL13-PE38 might have potential as a safe and effective treatment for malignant glioma. Noticeable response to IL13-PE38 was observed in two of six patients in the NABTT study at the initial dose level. One patient, who was treated with IL13-PE38, subsequently underwent surgical removal of the tumor mass. A histopathologic evaluation following surgery found IL13-PE38 effective in destroying approximately 95 percent of the malignant tumor cells. In a second patient, following IL13-PE38 administration, radiographic scans of the brain revealed a significant reduction and disappearance in the size of the tumor, and the patient did not require a scheduled, additional, IL13-PE38 infusion.

The second clinical study includes M.D. Andersen Cancer Center (MDACC), Memorial Sloan Kettering Cancer Center (MSKCC), the University of California San Francisco (UCSF) and Yale University as participating centers, was initially presented at the World Federation of Neuro-Oncology Society/SNO meeting. Additional data was announced in April 2002 at the CNS Section on Tumors Fifth Biennial Satellite Symposium, held in conjunction with the American Association of Neurological Surgeons (AANS) Annual Meeting in Chicago. The most recent findings were presented at the Fifth Congress of the European Association of Neuro-Oncology (EANO) and are discussed in this press release.

In addition, enrollment has begun 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.

For additional details regarding IL13-PE38 trial design, enrollment criteria and participating centers please refer to (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: . For copies of the scientific abstracts mentioned in this press release, contact Larry Kenyon, 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 Companies' drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Companies' 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 Securities and Exchange Commission including their annual reports of 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.

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