15.11.2005 17:30:00
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NeoPharm Investigators Present Preliminary LErafAON-ETU Phase I Data at AACR-NCI-EORTC International Conference
NeoPharm, Inc. (Nasdaq:NEOL) today announced the presentation ofpreliminary Phase I results of the Company's NeoLipid(R) formulationof c-raf Antisense Oligonucleotide at the American Association ofCancer Research (AACR) - National Cancer Institute (NCI) - EuropeanOrganization for Research and Treatment of Cancer (EORTC)International Conference on Molecular Targets and Cancer Therapeutics.The conference, the premier international meeting featuring novelcancer therapeutics, is being held at the Pennsylvania ConventionCenter in Philadelphia, Pennsylvania from November 14-18, 2005.
"We are pleased with the preliminary Phase I results of ourLErafAON-ETU study," said Guillermo A. Herrera, NeoPharm's Presidentand Chief Executive Officer. "These preliminary results provideinitial clinical proof-of-concept of our proprietary NeoPhectin(TM)cationic cardiolipin technology in the treatment of cancer. Wecontinue to identify further expansion opportunities of ourNeoLipid(R) platform in the treatment of cancer."
Poster Presentation - Abstract #A38
LErafAON-ETU has evidenced an ability to inhibit tumor growth inmouse models of human breast, ovarian, and prostate cancer.LErafAON-ETU also appears to enhance the tumor treatment effect ofradiation therapy and chemotherapeutic drugs such as Taxol(R) andTaxotere(R) as well as other cytoxic tumor agents. Liposomalformulation is intended to eliminate the need for extensivephosphorothioate modification of the antisense oligonucleotide,removing a potential source of toxicity.
This Phase I dose-escalation study is designed to determine thedose-limiting toxicity and maximum-tolerated dose of LErafAON-ETU inpatients with advanced cancer. LErafAON-ETU is administered as a60-to-180-minute infusion once weekly for 3 consecutive weeks (atreatment cycle) until disease progression or unacceptable toxicityoccurs.
"LErafAON-ETU may potentially have broad clinical applicability inenhancing the therapeutic effects of radiation therapy andchemotherapy in the treatment of cancer. Dose escalation continues inthe Phase I study of this novel agent," said Michael S. Gordon, MD,Associate Professor of Medicine at the University of Arizona Collegeof Medicine and Associate Director of the Arizona Cancer Center,Greater Phoenix Area.
Preliminary study results indicate that administration ofLErafAON-ETU was generally well tolerated. A variable rate infusionregimen was developed to address mild-to-moderate infusion relatedreactions (IRRs) in patients. Subsequently, these patients completedat least one infusion at the same dose without IRRs using thisregimen. Measurable blood levels of drug which increase with doseescalation have been observed in patients administered LErafAON-ETU.Seven patients have been treated with LErafAON-ETU for a median of 4cycles (12 weekly infusions). No dose limiting side effects have beenobserved.
About LErafAON-ETU
LErafAON-ETU is NeoPharm's easy-to-use liposomal formulation of anantisense oligonucleotide (AON) complementary to the c-raf mRNAsequence, which mediates tumor cell growth. This drug formulationutilizes the Company's NeoPhectin(TM) transfection reagent whichconsists of a novel, positively charged, synthetic cardiolipin (PCL-2)and appears to eliminate the need for extensive phosphorothioatemodification of the AON which can be associated with toxicity. Thisreagent also has potential use in the delivery of nucleic acids andsiRNA molecules.
About NeoPharm, Inc.
NeoPharm, Inc., based in Waukegan, Illinois, is a publicly tradedbiopharmaceutical company dedicated to the research, development andcommercialization of new and innovative cancer drugs for therapeuticapplications. The Company has a portfolio of cancer compounds invarious stages of development. Additional information can be obtainedby 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 theSecurities Act of 1933 and Section 21E of the Securities Exchange Actof 1934. The Company has tried to identify such forward-lookingstatements by use of such words as "expects," "intends," "hopes,""anticipates," "believes," "could," "may," "appears," "evidences" and"estimates," and other similar expressions, but these words are notthe exclusive means of identifying such statements. Such statementsinclude, but are not limited to, any statements relating to theCompany's drug development program, including, but not limited toclinical studies involving LErafAON-ETU, and any other statements thatare not historical facts. Such statements involve risks anduncertainties, including, but not limited to, those risks anduncertainties relating to difficulties or delays in financing,development, testing, obtaining regulatory approval, production andmarketing of the Company's drug and non-drug compounds, including, butnot limited to, LErafAON-ETU, uncertainty regarding the availabilityof third party production capacity, unexpected adverse side effects orinadequate therapeutic efficacy of the Company's drug and non-drugcompounds, including, but not limited to, LErafAON-ETU, that couldslow or prevent products coming to market, uncertainty regarding theCompany's ability to market its drug and non-drug products, including,but not limited to, LErafAON-ETU, the uncertainty of patent protectionfor the Company's intellectual property or trade secrets, including,but not limited to, LErafAON-ETU, and other risks detailed from timeto time in filings the Company makes with the Securities and ExchangeCommission including its annual reports on Form 10-K and quarterlyreports on Forms 10-Q. Such statements are based on management'scurrent expectations, but actual results may differ materially due tovarious factors, including those risks and uncertainties mentioned orreferred to in this press release. Accordingly, you should not rely onthese forward-looking statements as a prediction of actual futureresults.
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