In Vitro and In Vivo Data Show Alfacell's Onocanse is Active Against Naive and Chemoresistant Neuroblastoma CellsPre-Clinical Results Demonstrate Potential of ONCONASE for Treatment of Neuroblastoma
BLOOMFIELD, N.J., June 27, 2007 /PRNewswire-FirstCall/ -- Alfacell Corporation today announced that new data show ONCONASE, the company's lead drug candidate, is active against naive and chemoresistant neuroblastoma cells.
The pre-clinical in vitro and in vivo data published in Cancer Letters (2007; Vol. 250, Issue 1: 107-116) through a collaboration between Alfacell and Martin Michaelis, M.D., Ph.D., at the Institute of Medicinal Virology at Johann Wolfgang University of Frankfurt, were also recently presented in Germany.
Conclusions from the studies presented indicate that ONCONASE inhibits neuroblastoma cell growth and induces caspase-independent cell death in neuroblastoma cells independently of P-gp expression or p53 status, which has been shown to contribute to multi-drug resistance in neuroblastoma as well as most other human cancers. Transmission electronic microscope investigations suggest that ONCONASE induces a process in neuroblastoma cells called autophagy (the digestion of cellular constituents by enzymes of the same cell), which leads to apoptosis (programmed cell death). Anti-tumor activity of ONCONASE against drug-sensitive and chemoresistant neuroblastoma xenografts was confirmed in animals.
"The data speak to the broad potential application for ONCONASE in various types of cancer other than the gateway indication for mesothelioma," said Kuslima Shogen, Alfacell's chairman and chief executive officer. "We now have an even better understanding of the mechanism of action that ONCONASE utilizes in overcoming multiple drug resistance in various tumor types."
Neuroblastoma is a cancer that forms in the nerve tissue. It is the most common cancer in infants, and the fourth most common type of cancer in children. Neurons (nerve cells) are the main components of the brain and spinal cord and of the nerves that connect them to the rest of the body. Approximately one in 100,000 children develops neuroblastoma in the United States.
ONCONASE is a first-in-class therapeutic product candidate based on Alfacell's proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE has been shown in the laboratory and clinic to target cancer cells while sparing normal cells. ONCONASE triggers apoptosis, the natural death of cells, via multiple molecular mechanisms of action.
About Alfacell Corporation
Alfacell Corporation is the first company to advance a biopharmaceutical product candidate that works in a manner similar to RNA interference (RNAi) through late-stage clinical trials. The product candidate, ONCONASE, is an RNase that overcomes the challenges of targeting RNA for therapeutic purposes while enabling the development of a new class of targeted therapies for cancer and other life-threatening diseases. In addition to an ongoing Phase IIIb study in malignant mesothelioma, Alfacell is conducting a Phase I/II trial of ONCONASE in non-small cell lung cancer (NSCLC) and other solid tumors. For more information, visit www.alfacell.com.
This press release includes statements that may constitute "forward- looking" statements, usually containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, uncertainties involved in transitioning from concept to product, uncertainties involving the ability of the company to finance research and development activities, potential challenges to or violations of patents, uncertainties regarding the outcome of clinical trials, the company's ability to secure necessary approvals from regulatory agencies, dependence upon third-party vendors, and other risks discussed in the company's periodic filings with the Securities and Exchange Commission. By making these forward-looking statements, the company undertakes no obligation to update these statements for revisions or changes after the date of this release.
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Posted: June 2007