SCOTTSDALE, Ariz. — June 13, 2012 — An investigational drug that acts like a Trojan Horse to deliver cancer killing agents for pancreatic cancer is being studied at the Virginia G. Piper Cancer Center Clinical Trials, a partnership between Scottsdale Healthcare and the Translational Genomics Research Institute (TGen) that treats cancer patients with promising new drugs.
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.
Individuals seeking information about eligibility to participate in clinical trials at the Virginia G. Piper Cancer Center at Scottsdale Healthcare may contact the cancer care coordinator at 480-323-1339; toll free at 1-877-273-3713 or via email at clinicaltrials@shc.org.
About the Virginia G. Piper Cancer Center at Scottsdale Healthcare
The Virginia G. Piper Cancer Center at Scottsdale Healthcare opened in 2001 as the first major cancer center in greater Phoenix, offering comprehensive cancer care and research through Phase I clinical trials, diagnosis, treatment, prevention and support services in collaboration with leading researchers and community oncologists. The Scottsdale Healthcare cancer program holds Accreditation with Commendation from the Commission on Cancer of the American College of Surgeons. Scottsdale Healthcare is the nonprofit parent organization of the Virginia G. Piper Cancer Center at Scottsdale Healthcare, Scottsdale Healthcare Research Institute, Scottsdale Healthcare Osborn Medical Center, Scottsdale Healthcare Shea Medical Center and Scottsdale Healthcare Thompson Peak Hospital. For more information, visit www.shc.org.
Press Contact:
Jamie Houston
Public Relations Coordinator
Virginia G. Piper Cancer Center
480-323-1387
jhouston@shc.org
About TGen
The Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. Research at TGen is focused on helping patients with diseases such as cancer, neurological disorders and diabetes. TGen is on the cutting edge of translational research where investigators are able to unravel the genetic components of common and complex diseases. Working with collaborators in the scientific and medical communities, TGen believes it can make a substantial contribution to the efficiency and effectiveness of the translational process. For more information, visit: www.tgen.org.
Press Contact:
Steve Yozwiak
TGen Senior Science Writer
602-343-8704
syozwiak@tgen.org
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: INNO-206, tamibarotene and bafetinib. With its tumor-targeted doxorubicin conjugate INNO-206, CytRx has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, is completing its ongoing Phase 1b/2 clinical trial primarily in the same indication, and plans to initiate a Phase 2 trial for patients with advanced pancreatic ductual adenocarcinomas in the first half of 2012. CytRx's pipeline also includes tamibarotene, which it is testing in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer, and which is in a clinical trial as a treatment for acute promyelocytic leukemia (APL). The Company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about the Company, visit www.cytrx.com.
About TD2
TGen Drug Development (TD2), a wholly owned subsidiary of the Translational Genomics Research Institute (TGen), is a 501(c) 3 non-profit organization. TD2 provides innovative services for oncology focused biopharmaceutical companies using a dedicated team of professionals with broad experience and understanding in drug development. TD2 is uniquely positioned to support the need for improved and accelerated development of new chemical entities (NCE's) for life-threatening diseases. TD2 uses a unique combination of experience gained through its contract research organization business, and an integrated suite of proprietary and non-proprietary tools, preclinical study execution, regulatory affairs assistance, clinical trial design and management, and drug development experts to successfully move therapeutics towards regulatory approval. TD2 is dedicated to reducing the risks and uncertainty inherent in the drug development process. For more information, visit www.td2.org.