CytRx Corporation Drug Candidate INNO-206 Results in Ovarian Tumor Shrinkage in Animal Trials
“Ovarian cancer ranks ninth in prevalence and fifth in mortality among cancers in American women, making it a major women’s healthcare concern,” said Steven A. Kriegsman, CytRx President and CEO. “Data from this highly promising animal trial showed actual shrinkage of ovarian cancer tumors following treatment with INNO-206 and further add to accumulating evidence that INNO-206 has therapeutic potential in multiple cancer forms.”
CytRx has the exclusive worldwide rights to INNO-206, which holds the potential as an effective treatment in a variety of cancer indications, including sarcomas, breast cancer, pancreatic cancer and non-Hodgkin’s lymphoma. INNO-206 is a pro-drug derivative of doxorubicin, itself an effective and often prescribed chemotherapeutic drug. INNO-206 is designed to reduce adverse events by controlling drug release and to increase efficacy by preferentially targeting tumors throughout the body, allowing accumulation of the toxic drug at the tumor site. In a Phase 1 study, INNO-206 was administered at up to six times the standard dosing of doxorubicin without an increase in observed side effects compared to those historically seen with doxorubicin.
In the animal study, 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, 10 million human A2780 ovarian tumor cells from cell culture were transplanted under the skin in the left flank region of 18 mice with immune systems compromised to allow tumor cell growth. After 10 days, the tumors reached a palpable size and the experimental animals were then randomized into three groups for administration of two cycles of weekly intravenous injections with a previously optimized dose of doxorubicin or CytRx’s INNO-206, or received an intravenous injection lacking either drug to serve as a control. Tumor growth was monitored continuously for 12 days following initiation of treatment.
In the control group, tumors grew rapidly, increasing in average volume by approximately 20-fold. A statistically significant decrease in the rate of tumor growth compared to the control was observed in the doxorubicin treated group, with tumors increasing in volume by only four- to five-fold during treatment. By contrast to the other two groups of animals, the average tumor growth in animals treated with INNO-206 was completely inhibited, and in fact these tumors shrank in volume, resulting in a net two- to three-fold decrease in tumor volume during treatment. The decrease in average tumor volume in animals treated with INNO-206 was statistically significant (p<0.05) compared to the average tumor volume in both the doxorubicin-treated animals and the control.
CytRx’s Chief Scientific Advisor, co-founder of Amgen and noted oncology expert Joseph Rubinfeld, Ph.D., added, “Doxorubicin itself is known to be effective in treating recurrent ovarian cancer in humans so we were not surprised to see its efficacy in this animal model of ovarian cancer. However, the remarkable and statistically significant superiority of INNO-206 compared to this gold standard chemotherapeutic drug in the same experiment increases our confidence that its tumor-targeting mechanism could be key in effectively treating a variety of cancers that respond to drugs like doxorubicin. This has the potential to be of significant value to CytRx stockholders.”
About Ovarian Cancer
According to the American Cancer Society (ACS), ovarian cancer is the ninth most prevalent form of cancer but the fifth most common cause of cancer mortality in women in the U.S. with a 45% five-year survival rate. In 2009, approximately 22,000 new cases and almost 15,000 deaths are expected from ovarian cancer in the U.S. alone. The ACS estimates that one out of 71 women will develop ovarian cancer sometime in their life.
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 - News). 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 ovarian cancer, the risk that any future human testing of INNO-206 for ovarian 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.
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