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CytRx has exclusive worldwide rights to INNO-206, a proprietary derivative of doxorubicin. The pro-drug INNO-206 is designed to allow controlled release of doxorubicin and to specifically target the delivery of drug to tumors throughout the body, which could prove more effective and less toxic in cancer patients than doxorubicin. INNO-206 has previously demonstrated safety and tolerability, and optimal dosing has been evaluated, in a Phase I clinical trial.
In the animal trial - conducted under the direction of INNO-206 inventor Felix Kratz, Ph.D., Department of Medical Oncology, Clinical Research, at the Tumor Biology Center in Freiburg, Germany - human breast tumor cells were implanted in mice with compromised immune systems to avoid tumor rejection. Seven to eight animals were randomly assigned into each of three experimental groups receiving intravenous injections with either a maximum tolerated dose of INNO-206, a maximum tolerated dose of doxorubicin, or a control solution lacking either compound. At the end of the experiment 43 days after implantation, tumors had increased in volume by an average of approximately 2.7-fold in the control group while tumor growth was marginally inhibited in the doxorubicin group; increasing in volume by approximately 1.9-fold in a result that did not reach statistical significance. By contrast, tumors in the group treated with INNO-206 shrank to approximately one-half their initial volume. The decrease in final tumor volume in INNO-206-treated animals was statistically significant (p<0.05) compared to that of either the control or doxorubicin-treated groups.
"We take pride in identifying and developing drugs that hold the promise of treating debilitating diseases that represent unmet medical needs, as well as have therapeutic and commercial potential in multiple disease indications," said Steven A. Kriegsman, CytRx President and CEO. "INNO-206 is one of several drug candidates in CytRx's asset portfolio that meets these criteria due to its apparent ability to target multiple tumor types, making it potentially efficacious in other cancers."
"We acquired INNO-206 because of our belief that its pro-drug design could improve the efficacy of doxorubicin, a classic chemotherapeutic agent that has proven effective and is commonly used in treating multiple types of cancer," said Joseph Rubinfeld, Ph.D., co-founder of Amgen, a world-renowned expert in cancer drug development and CytRx Chief Scientific Advisor. "If INNO-206 is better than doxorubicin in treating human breast cancer as it demonstrated in this animal breast cancer trial, then we believe that INNO-206 could be a multi-billion dollar drug."
About Breast Cancer
Breast cancer is the most common cancer among women in the U.S., with more than 192,000 new cases of invasive breast cancer expected to be diagnosed this year, according to American Cancer Society estimates. More than 40,000 deaths are expected to be attributed to breast cancer in the U.S. in 2009, making it the second leading cause of cancer death in U.S. women. The chance of a woman having invasive breast cancer some time during her life is about one in eight.
About INNO-206
INNO-206 is a prodrug of the commonly prescribed chemotherapeutic doxorubicin and was designed to reduce adverse events by controlling release and preferentially targeting the tumor. In a Phase 1 study, doses were administered at up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin. The Company is evaluating options for a possible Phase 2 clinical trial.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The CytRx drug development pipeline includes programs in clinical development for cancer indications, including tamibarotene in a registration study for the treatment of acute promyelocytic leukemia (APL). In addition, CytRx is developing two drug candidates based on its industry-leading molecular chaperone technology, which aims to repair or degrade misfolded proteins associated with disease. CytRx also maintains a 45% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ: RXII). For more information on the Company, visit www.cytrx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the timing, outcome or results of any future pre-clinical or clinical testing of INNO-206 as a treatment for breast cancer, the risk that any future human testing of INNO-206 for breast cancer might not produce results similar to those seen in animals, risks related to CytRx's ability to manufacture its drug candidates, including INNO-206, in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's ability to enter into partnerships or other transactions to advance the clinical development of its portfolio of drug candidates, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including any future clinical development of INNO-206, risks related to the future market value of CytRx's investment in RXi and the liquidity of that investment, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE: CytRx Corporation
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