NeoPharm Investigators Present Final Phase I Clinical Trial Data for L

NeoPharm Investigators Present Final Phase I Clinical Trial Data for LE-SN38 at the American Society for Clinical Oncology; Results Provide Evidence of Improved Patient Safety & Tolerability

    Business Editors/Health/Medical Writers
    BIOWIRE2K

    LAKE FOREST, Ill.--(BUSINESS WIRE)--May 16, 2005--NeoPharm (Nasdaq:NEOL) today announced that final Phase I clinical trial data for LE-SN38 was published and presented in poster and poster discussion sessions at the American Society of Clinical Oncology (ASCO) 41st Annual Meeting. ASCO is being held May 13-17, 2005 in Orlando, Florida. LE-SN38 is NeoPharm's NeoLipid(TM) liposomal formulation of SN-38, the active metabolite of irinotecan (Camptosar(R)), a chemotherapeutic pro-drug approved for the treatment of advanced colorectal cancer.

    LE-SN38 - Poster and Poster Discussion - Abstract #2017

    On Saturday, May 14, 2005, in a poster discussion session on Developmental Therapeutics: Cytotoxic Chemotherapy, Eric Kraut, MD, Professor of Medicine, Director, Benign Hematology, Division of Hematology-Oncology, Department of Internal Medicine, The Ohio State University, presented a poster entitled "Final Results of a Phase I Study of Liposome Encapsulated SN-38 (LE-SN38): Safety, Pharmacogenomics, Pharmacokinetics, and Tumor Response." This LE-SN38 clinical trial builds upon results from published studies showing that an enzyme made in the liver, UGT1A1, plays a major role in breaking down, or metabolizing, SN-38. It has also been shown that the rate of metabolism of SN-38 is affected by the presence or absence of variants of the gene encoding this enzyme. The objective of the study was to establish the maximum tolerated dose (MTD) of LE-SN38 for patients with normal, intermediate, and low rates of SN-38 metabolism, based upon UGT1A1 gene expression. In his presentation, Dr. Kraut showed that 87% of the patients tested or screened for participation in the study belonged to either the normal (WT/WT, 42%) or intermediate (WT/*28, 45%) groups for SN-38 metabolism.
    "Genotyping of patients may provide useful information to guide the dose selection of LE-SN38 for future clinical studies," stated Dr. Kraut. "In addition, the observed absence of dose-limiting diarrhea in this Phase I study may also be a potential advance for patients and will be further assessed in Phase II studies."
    The presentation confirmed previously reported preliminary results of the Phase I study. Although the related drug irinotecan can cause severe diarrhea, there have been no reports of this type of dose-limiting diarrhea in the LE-SN38 study. While 35% of patients reported self-limiting mild diarrhea, 38% of patients reported constipation. The dose-limiting toxicity (DLT) of LE-SN38 is neutropenia, which is seen with irinotecan.

    Final LE-SN38 results include:

--	Diarrhea was not dose-limiting and was mild, if present, and self-limiting. Constipation was also reported with a similar incidence to diarrhea.
--	A Maximum Tolerated Dose (MTD) of 35 mg/m2 was established for WT/WT patients due to a Dose Limiting Toxicity (DLT) of neutropenia at the 40 mg/m2 dose. Based upon similarities between the PK profiles of WT/WT and WT/*28 patients, a recommended dose of 35mg/m2 was selected for WT/*28 patients.
--	The low frequency of the *28/*28 (11%) genotype in the general population resulted in a significant lag in enrollment of these patients, such that an MTD could not be reached. Based upon pharmacokinetic extrapolation, it is anticipated that the MTD for *28/*28 patients will be 25-30 mg/m2. It is planned that the MTD for these patients will be addressed in conjunction with future studies.
--	Compared to WT/WT patients, drug exposure in *28/*28 patients was approximately 3-fold higher at the 10 mg/m2 dose level and 2-fold higher at the 20 mg/m2 dose level. Pharmacokinetic differences between WT/WT and WT/*28 patients were less apparent.
--	Stable disease (receiving greater than or equal to 4 cycles of LE-SN38) has been observed in approximately 36% of patients.

    A Phase II study in colorectal cancer is being planned with the Cancer and Leukemia Group B (CALGB), expected to begin in the second half of 2005.

    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 www.neophrm.com.

    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, LE-SN38, progress and outcomes of clinical trials of the Company's drug product candidates, including the LE-SN38, financial projections, 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 LE-SN38, uncertainty regarding the ability of licensees of our drugs, to obtain necessary foreign drug approvals or to adequately develop foreign markets, uncertainty regarding the availability of third party production capacity, 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 that could slow or prevent products coming to market, including, but not limited to, LE-SN38, uncertainty regarding the Company's ability to market its drug and non-drug products directly or through independent distributors, including, but not limited to, LE-SN38, the uncertainty of patent protection for the Company's intellectual property or trade secrets, including, but not limited to LE-SN38, 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.

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CONTACT: NeoPharm, Inc. Paul Arndt, 847-295-8678 ext. 215 parndt@neophrm.com

KEYWORD: ILLINOIS FLORIDA INDUSTRY KEYWORD: BANKING PHARMACEUTICAL MEDICAL BIOTECHNOLOGY PRODUCT SOURCE: NeoPharm, Inc.

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