New trial drug a 'Trojan Horse' attacking pancreatic cancer

The Phase 2 clinical trial tests the effectiveness and safety of INNO-206 in patients with advanced pancreatic ductual adenocarcinomas (PDA) who have not responded to prior standard treatment. PDA is a malignant tumor arising from the duct cells within a gland in the pancreas, and represents about 80 percent of all pancreatic cancers.

Pancreatic cancer is extremely difficult to treat and the fourth most common cause of cancer-related deaths in the U.S., with more than 43,000 new cases reported in 2010 and 37,000 deaths attributed to this disease each year. Tumors may grow in the pancreas without any early symptoms, which means that the disease is often in an advanced stage when it is diagnosed.

"The drug's effectiveness works like a Trojan Horse because it is prepared in albumin which pancreatic cancer likes to eat, thereby transporting the drug into the cancer cells and destroying them," said Jasgit Sachdev, M.D., of the Virginia G. Piper Cancer Center Clinical Trials.

Preclinical results showing the drug induced complete tumor remissions in the laboratory were presented at the American Association for Cancer Research (AACR) 2012 Annual Meeting.

"We are encouraged by early study results and looking forward to the next step in evaluating the activity and safety of INNO-26 in patients with advanced pancreatic ductual adenocarcinomas," said Dr. Ramesh Ramanathan, Medical Director of Virginia G. Piper Cancer Center Clinical Trials, and Clinical Professor and Deputy Director of the Clinical Translational Research Division at TGen.

Los Angeles-based CytRx holds the worldwide rights to INNO-206, which is a tumor-targeted conjugate of the widely used chemotherapeutic agent doxorubicin. INNO-206 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with pancreatic cancer.

Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare is co-lead site Stand Up to Cancer of the Pancreatic Cancer Dream Team, comprised of scientists working collaboratively to develop new treatments for pancreatic cancer.

TGen Drug Development (TD2), a TGen subsidiary, is managing this Phase 2 clinical trial on behalf of CytRx.

The Phase 2 clinical trial will enroll up to 27 patients at multiple clinical sites in the U.S. The trial patients will be treated with intravenously administered INNO-206 once every three weeks for up to eight cycles. Trial patients will be evaluated for complete and partial tumor responses, side effects and overall survival.

Provided by The Translational Genomics Research Institute