LErafAON-ETU : a Liposome Entrapped c-raf Antisense Oligonucleotide for Advanced Cancer
May 21, 2005 - 10:42:00 AM
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"The emerging technology of the liposome formulation used for LErafAON-ETU in this study represents an opportunity for potentially improving the delivery of novel cancer therapies."
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By NeoPharm, Inc.,
[RxPG] NeoPharm (Nasdaq:NEOL) announced that preliminary Phase I clinical trial data for the Company's NeoLipid(TM) compound LErafAON-ETU was published in the American Society for Clinical Oncology (ASCO) Annual Meeting Proceedings. ASCO was held May 13-17, 2005 in Orlando, Florida.
LErafAON-ETU - ASCO Meeting Proceedings - Abstract #3214
LErafAON-ETU is NeoPharm's easy-to-use liposomal formulation of an antisense oligonucleotide (AON) complementary to the c-raf mRNA sequence, which mediates tumor cell growth.
This drug formulation utilizes the Company's NeoPhectin(TM) transfection reagent which consists of a novel, positively charged, synthetic cardiolipin (PCL-2) and appears to eliminate the need for extensive phosphorothioate modification of the AON which can be associated with toxicity.
This reagent also has potential use in the delivery of nucleic acids and siRNA molecules.
"The emerging technology of the liposome formulation used for LErafAON-ETU in this study represents an opportunity for potentially improving the delivery of novel cancer therapies," stated Michael Gordon, MD, Associate Professor of Medicine - University of Arizona College of Medicine, Associate Director-Arizona Cancer Center-Greater Phoenix Area and the Investigator on the NeoPharm Phase I LErafAON-ETU Clinical Study.
The published abstract entitled, "Phase I Study of LErafAON-ETU, an Easy-To-Use Formulation of Liposome Entrapped c-raf Antisense Oligonucleotide, in Advanced Cancer Patients," highlights the successful initial clinical dosing of this novel drug formulation.
This Phase I dose-escalation study is designed to determine the dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of LErafAON-ETU in patients with advanced cancer. LErafAON-ETU is planned to be administered as an intravenous infusion once weekly for 3 consecutive weeks (a treatment cycle).
Patients are eligible to receive repeated treatment cycles until disease progression or unacceptable toxicity occurs. Dose levels of 7.5, 15, 30, 60, 120, 240, and 480 mg/m2 are planned, depending on the tolerability of LErafAON-ETU. Dose escalation is ongoing in this study.
Publication:
The Study was published in the American Society for Clinical Oncology (ASCO) Annual Meeting Proceedings. ASCO was held May 13-17, 2005 in Orlando, Florida.
On the web:
www.neophrm.com 
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Additional information about the news article
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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, LErafAON-ETU, progress and outcomes of clinical trials of the Company's drug product candidates, including LErafAON-ETU, 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 LErafAON-ETU, 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, LErafAON-ETU, uncertainty regarding the Company's ability to market its drug and non-drug products directly or through independent distributors, including, but not limited to LErafAON-ETU, the uncertainty of patent protection for the Company's intellectual property or trade secrets, including, but not limited to LErafAON-ETU, 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.
Contact NeoPharm Paul Arndt, 847-295-8678 Ext. 215 [email protected]
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