LErafAON-ETU : a Liposome Entrapped c-raf Antisense Oligonucleotide for Advanced Cancer
May 21, 2005 - 10:41:38 AM

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.

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