CytRx Drug Candidate INNO-206 Results In Ovarian Tumor Shrinkage In Animal Trials

Main Category: Ovarian Cancer
Also Included In: Cancer / Oncology
Article Date: 29 Jul 2009 - 6:00 PDT


CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, announced that results demonstrating that its cancer drug candidate INNO-206 caused statistically significant tumor shrinkage in an animal model of ovarian cancer have been accepted for publication in the peer-reviewed journal Investigational New Drugs. The manuscript based on this animal trial, "INNO-206, the (6-maleimidocaproyl hydrazone derivative of doxorubicin), shows superior antitumor efficacy compared to doxorubicin in different tumor xenograft models and in an orthotopic pancreas carcinoma model," was made available ahead of journal printing in electronic format in the January 8, 2009 on-line issue of Investigational New Drugs.

"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.

Source
CytRx Corporation

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