CytRx commences INNO-206 Phase 2 clinical trial for pancreatic cancer

CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, today announced the initiation of a Phase 2 clinical trial evaluating the preliminary efficacy and safety of INNO-206 in patients with advanced pancreatic ductual adenocarcinomas (PDA) who have progressed after receiving two prior therapies. PDA is a malignant tumor arising from the duct cells within a gland in the pancreas, and represents about 80% of all pancreatic cancers.

“We are very excited to evaluate the activity and safety of INNO-206 in patients with advanced PDA whose disease has progressed following treatment with both gemcitabine and 5-fluorouracil-containing chemotherapy regimens, which are currently the recognized standard treatments for this cancer”

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.

Daniel Von Hoff, M.D., Physician-in-Chief and Distinguished Professor at the Translational Genomics Research Institute (TGEN) in Phoenix will serve as the clinical trial's principal investigator while TGen's subsidiary, TGen Drug Development, manages this Phase 2 clinical trial on behalf of CytRx. Dr. Von Hoff was a former member of the National Cancer Advisory Board and the FDA's Oncology Drug Advisory Committee, and former President of the American Association for Cancer Research. He currently co-directs the Pancreatic Cancer Dream Team, one of five Stand Up 2 Cancer teams comprised of renowned scientists working collaboratively on innovation, acceleration, targeted therapy and translational research in several major cancers.

"We are very excited to evaluate the activity and safety of INNO-206 in patients with advanced PDA whose disease has progressed following treatment with both gemcitabine and 5-fluorouracil-containing chemotherapy regimens, which are currently the recognized standard treatments for this cancer," said Dr. Von Hoff. "INNO-206 binds rapidly and virtually completely to albumin, the most abundant protein in blood. We know that PDAs are albumin starved and appear to preferentially collect and transport this protein. It is our hope that INNO-206 will use the albumin transport mechanism to collect drug at the tumor site, release cytotoxic doxorubicin and destroy the cancer cells, while being less harmful to normal tissues than free doxorubicin."

The open-label Phase 2 clinical trial will enroll up to 27 patients at multiple clinical sites in the U.S. Trial patients will be treated with intravenously administered INNO-206 once every three weeks for up to eight cycles at a dose of 350 mg/m² (the maximum tolerated dose established in two Phase 1b clinical trials, including the Phase 1b/2 trial currently being completed at the Sarcoma Oncology Center in Santa Monica, California). Trial patients will be evaluated for objective tumor response (measured by Response Evaluation Criteria in Solid Tumors or RECIST 1.1 criteria), with secondary endpoints including disease control (complete and partial responses, and stable disease at four months), as well as progression-free and overall survival.

In a preclinical trial conducted by INNO-206 inventor Felix Kratz, Ph.D., Department of Medical Oncology, Clinical Research, at the Tumor Biology Center, INNO-206 in combination with either doxorubicin or a novel albumin-binding methotrexate drug induced complete tumor remissions in animal models of human pancreatic cancer. The results were presented at the American Association for Cancer Research (AACR) 2012 Annual Meeting this month.

"We are delighted to initiate a Phase 2 trial with INNO-206 in this solid tumor indication and are highly encouraged by prior animal trial results in pancreatic cancer models, which are extremely difficult to treat. Tumors may grow in the pancreas without any symptoms at first, which means that the disease is often in an advanced stage when it is diagnosed," said CytRx President and CEO Steven A. Kriegsman. "Pancreatic cancer is 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."

CytRx also is evaluating INNO-206 in other cancer indications. The Company has completed enrollment and treatment in a Phase 1b/2 clinical trial with INNO-206 in patients with advanced solid tumors (primarily soft tissue sarcomas), and has initiated an international Phase 2b clinical trial in patients with soft tissue sarcomas, comparing the efficacy and safety of INNO-206 to doxorubicin, a standard treatment for soft tissue sarcomas. The Phase 1b/2 clinical trial results will be presented by Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, California, at the American Society of Clinical Oncology (ASCO) meeting in early June 2012. Earlier this month, CytRx announced the issuance of a key patent by the U.S. Patent and Trademark Office covering INNO-206's linker platform technology and INNO-206 pharmaceutical compositions.