Tumor Biology Center to initiate Phase 2 clinical trial with CytRx’s INNO-206

CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company, today announced that the Tumor Biology Center, Freiburg, Germany, plans to initiate a Phase 2 clinical trial with CytRx’s doxorubicin prodrug INNO-206 as a treatment for patients with advanced pancreatic cancer. CytRx, which holds the exclusive worldwide rights to INNO-206, will supply INNO-206 for the clinical trial. CytRx previously announced plans to initiate Phase 2 clinical trials with INNO-206 in patients with advanced soft tissue sarcomas and advanced gastric cancer.

“We are excited about INNO-206 for advanced pancreatic cancer and believe it could become a breakthrough drug not only for the treatment of advanced pancreatic cancer, but also for other solid tumors.”

Prof. Dr. Clemens Unger, Medical Director, Clinic for Medical Oncology at the Tumor Biology Center, said, “We are excited about INNO-206 for advanced pancreatic cancer and believe it could become a breakthrough drug not only for the treatment of advanced pancreatic cancer, but also for other solid tumors.”

The open-label, prospective, multicenter, single-arm Phase 2 clinical trial will enroll up to 15 adult patients with metastatic or inoperative (unresectable ductal) pancreatic cancer who have not been previously treated or have failed gemcitabine therapy, the current chemotherapy standard of care for this cancer. Trial patients will be treated with intravenously administered INNO-206 once every three weeks for up to six cycles. Trial patients will be evaluated for overall survival, cancer progression-free survival and objective overall response rates using the Response Evaluation Criteria in Solid Tumors (RECIST) international standard.

Worldwide, pancreatic cancer is the eighth leading cause of cancer death, and it ranks thirteenth in cancer incidence. In the U.S., pancreatic cancer is the fourth leading cause of cancer mortality. The National Cancer Institute estimates that in 2009 more than 42,000 new cases of pancreatic cancer were reported with deaths due to this cancer exceeding 35,000. The median survival for patients with pancreatic cancer is typically four to six months, with a one-year survival rate of 24% and five-year survival rate of approximately 5%.

In a previously conducted preclinical study, INNO-206 inventor Felix Kratz, Ph.D., Department of Medical Oncology, Clinical Research, at the Tumor Biology Center, showed that INNO-206 treatment of mice grafted with a human pancreatic cancer tumor resulted in a statistically significant three-fold reduction in the average primary tumor size, outperforming gemcitabine and doxorubicin itself. Results from the trial were published in the peer-reviewed journal Investigational New Drugs and presented in a poster at the Annual Meeting of the American Association for Cancer Research in April 2009. In a Phase 1 clinical trial, INNO-206 was administered in doses up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin.

CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D., stated, “Pancreatic cancer typically spreads rapidly, is seldom detected in its early stages and is notoriously difficult to treat. The inability to effectively treat pancreatic cancer represents a failure of modern day cancer therapies with few drugs providing benefit for advanced pancreatic cancer patients. Gemcitabine and doxorubicin often cause significant side effects, such as nausea and fatigue. Based on its prodrug formulation that targets the release of doxorubicin at tumors sites throughout the body, INNO-206 could present a more effective, less toxic treatment option.”

“INNO-206’s demonstrated ability to target tumors could extend its applicability as a cancer treatment beyond that of highly prescribed doxorubicin,” said CytRx President and CEO Steven A. Kriegsman. “We are delighted that the well-respected Tumor Biology Center will be conducting clinical testing in patients with advanced pancreatic cancer, which is in addition to our planned Phase 2 clinical trials with INNO-206 as a treatment for advanced gastric cancer and advanced soft tissue sarcomas.”

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