NeoPharm and Collaborators Present Preliminary Phase I LE-SN38 And NeoLipid(TM)
Data
Presentations Made at AACR-NCI-EORTC Conference and Chemotherapy Foundation
Symposium
LAKE FOREST, Ill., Nov. 20 /PRNewswire-FirstCall/ -- NeoPharm, Inc. announced
today the first preliminary Phase I clinical trial data for LE-SN38 (Liposomal
SN38), NeoPharm's NeoLipid(TM) formulation of SN38, the active metabolite of the
approved cancer fighting pro-drug known as irinotecan. Preliminary results
indicate that stable disease has been observed in 9 of 27 patients to date
(33%), LE-SN38 appears to be safe and well tolerated at doses up to 20mg/m2 and
dose escalation will continue beyond 20 mg/m2, as planned. Details of the
LE-SN38 findings to date were reported on Wednesday, November 19, 2003, at the
AACR-NCI-EORTC International Conference on Molecular Targets and Cancer
Therapeutics held in Boston, Massachusetts. The poster can be viewed on the
NeoPharm website at http://www.neophrm.com/ .
"We are very pleased with the progress our investigators have made in the
LE-SN38 clinical program," said James Hussey, President and Chief Executive
Officer of NeoPharm. "We are encouraged by the preliminary results indicating
that we have achieved stable disease in some patients without yet reaching our
target dose, while at the same time the side effects appear to be mild and
transient. This ongoing pharmacogenomic study will give us the best chance to
administer the right dose for the right patient, which has been a major
limitation for current topoisomerase inhibitors." AACR-NCI-EORTC International Conference on Molecular Targets and Cancer
Therapeutics A scientific poster presentation entitled, Phase I Study of Liposomal SN- 38
(LE-SN38) in Patients with Advanced Cancer: Pharmacogenomics and
Pharmacokinetics, was made on November 19th at the joint meeting of the American
Association for Cancer Research (AACR), U.S. National Cancer Institute (NCI) and
European Organization for Research and Treatment of Cancer (EORTC) in Boston,
Massachusetts. The poster described preliminary findings from the first human
study of LE-SN38 conducted by collaborators from H. Lee Moffitt Cancer Center
(University of South Florida), Karmanos Cancer Center (Wayne State University),
and Ohio State University. LE-SN38 is a novel liposomal formulation of SN38,
the active but insoluble metabolite of irinotecan (CPT-11), marketed as
Camptosar(TM) (Pfizer). Current dose- limiting toxicities (DLT) observed with
CPT-11 are diarrhea and neutropenia. NeoLipid(TM) technology is designed to
enhance the solubility of SN38 and provide protection from rapid drug
degradation. Pre-clinical data suggest that LE-SN38 may provide an increased
safety profile, broad anti-tumor efficacy and permit dose intensification as
compared to CPT-11, since the usually inefficient and highly variable conversion
of the inactive pro-drug (CPT-11) to active metabolite (SN38) is not necessary.
The primary objectives of the Phase I study are to determine the
pharmacogenomics, pharmacokinetics and safety of LE-SN38 in patients with
advanced local or metastatic solid tumors who have failed conventional therapy. Tumor progressioin is also monitored. Cohorts of patients receive escalating
doses (from 2.5 up to 90 mg/m2 depending on patient tolerability) of intravenous
LE-SN38 infusion over 90 minutes every 21 days until disease progression or
unacceptable toxicity. Presence of a genetic polymorphism in the UGT1A1 gene can
affect SN-38 metabolism, so patients are divided into three dose cohorts
depending on genotype. To date, successful dosing and dose escalation has
occurred, with patient accrual continuing at doses up to 30 mg/m2 and further
dose escalation is planned. "I am encouraged by the fact that neither of the
expected severe toxicities, diarrhea or neutropenia, have been dose-limiting to
date. Thus far, LE-SN38 appears to be safe and well-tolerated. The prospective
genotyping of patients will facilitate the individualization of drug dosing for
further testing," said lead study investigator Mayer Fishman, MD, PhD,
Department of Interdisciplinary Oncology at the H. Lee Moffitt Cancer Center and
Research Institute, University of South Florida. Phase II clinical trial
planning is underway and studies are currently anticipated to start in 2004.
AACR, founded in 1907, is a nonprofit scientific society of more than 20,000
laboratory, translational, and clinical cancer researchers. Its mission is to
prevent and cure cancer through research, education, and communication. This
work is carried out through high-quality scientific programs in all disciplines
in the cancer field. For more information on the meeting please visit:
http://www.aacr.org/ .
Chemotherapy Foundation Symposium XXI Additionally, an abstract entitled, Phase I Trials of Liposome Encapsulated
Mitoxantrone (LEM) and SN-38 (LE-SN38), was given as an oral presentation by
Mayer Fishman, MD, PhD, Department of Interdisciplinary Oncology at the H. Lee
Moffitt Cancer Center and Research Institute, University of South Florida, on
Friday, November 14th, 3:05 pm, Marriott Marquis Hotel, New York City.
In his presentation, Dr. Fishman highlighted NeoPharm's NeoLipid(TM) technology
which combines drugs or biologic compounds with proprietary lipids, such as
cardiolipin, to create stable microscopic membrane-like structures called
liposomes. He discussed several liposomal formulations that are being developed
in an attempt to improve drug solubility, prolong circulation times, increase
tumor vascular trapping and reduce toxicity of potent chemotherapeutic drugs.
Dr. Fishman discussed the evolution and status of LEM and LE-SN38 as examples of
how NeoLipid(TM) technology may enable more comfortable to administer, safer,
and well-tolerated treatment for cancer patients.
The Chemotherapy Foundation Symposium XXI is jointly sponsored by the Page &
William Black Post-Graduate School and the Division of Hematology/Oncology of
the Mount Sinai School of Medicine and The Chemotherapy Foundation. In its
fourth decade, the symposium attracts a worldwide audience of professionals
involved in the management of cancer patients to discuss emerging advances in
the treatment of neoplastic diseases. For additional details please visit:
http://www.mssm.edu.tcf/ .
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: http://www.neophrm.com/ or contact Investor Relations, NeoPharm, 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 status, development or results from any clinical trial involving
LE-SN38, 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, such as LE-SN38, uncertainty regarding the availability of
third party lyophilization capacity, uncertainty regarding the outcome of damage
claims made by or against the Company, including the outcome of the pending
arbitration with Pharmacia, 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, 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 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. DATASOURCE: NeoPharm, Inc.
CONTACT: Larry Kenyon, CFO of NeoPharm, Inc., +1-847-295-8678, or 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.neophrm.com/ http://www.aacr.org/ http://www.mssm.edu.tcf/
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