CytRx's INNO-206 Significantly Inhibits Pancreatic Cancer Growth In Animal Trials

Main Category: Pancreatic Cancer
Also Included In: Cancer / Oncology
Article Date: 22 Jul 2009 - 2:00 PDT

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CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, announced that treatment with its cancer drug candidate INNO-206 resulted in a statistically significant reduction in the average primary tumor size in an animal model of pancreatic cancer, outperforming the broadly used chemotherapeutic drug doxorubicin, as well as the current standard of care in pancreatic cancer treatment, gemcitabine.

Results from the trial, which was 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, were presented in a poster, "INNO-206 Shows Superior Efficacy Compared to Doxorubicin in an Orthotopic Pancreas Carcinoma Model," at the Annual Meeting of the American Association for Cancer Research on April 21, 2009.

"Few drugs show any benefit for patients suffering from this rapidly progressing and deadliest of cancers, and I am personally delighted that INNO-206 effectively treated tumors in these experimental animals," said Steven A. Kriegsman, CytRx President and CEO. "We now have further evidence that the putative targeting mechanism of INNO-206 could have significant therapeutic benefit in multiple types of cancer."

CytRx has exclusive worldwide rights to INNO-206, which is a proprietary derivative of doxorubicin. CytRx believes that INNO-206, which is a so-called pro-drug designed to control the release of doxorubicin and to target it specifically to tumors throughout the body, may prove to be more effective and less toxic in cancer patients than doxorubicin. Earlier this month, CytRx announced that INNO-206 caused a dramatic destruction of implanted tumors in an experimental animal model of breast cancer, performing considerably better than doxorubicin.

In the animal trial, human AsPC1 pancreatic cancer cells were implanted directly into the pancreas (orthotopic implantation) of 30 experimental mice that lacked a normal immune system that would otherwise reject these cells. This model accurately reflected the hallmarks of the human disease, such as early cancer cell invasion of the surrounding pancreatic tissue and tumor spread to the spleen, liver and peritoneum that surrounds the internal organs. Eighteen days after implantation, the experimental animals were randomized into three treatment groups. Each group received two cycles of weekly intravenous injections with the previously optimized dose of either doxorubicin or INNO-206, or a solution lacking either drug to serve as a control. Tumor growth was monitored continuously. Two weeks after therapy initiation, measurements were taken of the primary tumor volume and the spread of the tumor to the liver, spleen, stomach and peritoneum.

Treatment with CytRx's INNO-206 resulted in a statistically significant (p<0.005) three-fold reduction in the average primary tumor size, compared to the control. Treatment with doxorubicin showed only a 30% primary tumor reduction, which was not statistically significant - a response that was not surprising as pancreatic tumors are typically unresponsive to doxorubicin. In a parallel experiment, treatment with gemcitabine, the approved and most commonly prescribed drug for pancreatic cancer, resulted in activity comparable to doxorubicin, with an approximate 30% primary tumor volume reduction.

Although no statistically significant inhibition of tumor spread was demonstrated by either INNO-206 or gemcitabine, due to large variability between individual animals in the control, a substantial trend was observed in the INNO-206 group with an approximate 10-fold decrease in tumor spread to the liver and stomach. The toxicity associated with drug treatment was comparable among the treated groups, resulting in an average weight loss over the two treatment cycles of about 10% compared to the control group.

"It is truly exciting that in this animal trial our doxorubicin-derivative INNO-206, possibly due to its known tumor-targeting capabilities, inhibited growth in tumors that were not affected by doxorubicin itself," said CytRx's Chief Scientific Advisor Joseph Rubinfeld, Ph.D., co-founder of Amgen and a world-renowned expert in cancer drug development. "This raises the possibility that INNO-206 could have even broader applicability as a cancer treatment than highly prescribed doxorubicin. INNO-206 also demonstrated significantly better tumor reduction capabilities in this model than gemcitabine, the current clinical standard of pharmaceutical care in this cancer."

About Pancreatic Cancer

Pancreatic cancer, although a relatively rare form of cancer, is the fourth leading cause of cancer mortality in the U.S. with only a 20% one-year survival rate, according to the American Cancer Society. This year in the U.S., the American Cancer Society estimates approximately 42,000 new pancreatic cancer cases and more than 35,000 deaths due to this disease. One in 76 people is expected to develop pancreatic 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