LOS ANGELES--(BUSINESS WIRE)--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.
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.
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.
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.
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. TGen is affiliated with the Van Andel Research Institute in Grand Rapids, Michigan. For more information, visit: www.tgen.org.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks or uncertainties related to the outcome, timing and results of CytRx's Phase 2 clinical trial for INNO-206 in patients with advanced pancreatic ductual adenocarcinomas, uncertainties regarding whether INNO-206 effectively targets doxorubicin to tumors, uncertainties regarding regulatory approvals for current and future clinical testing of INNO-206 and the scope of the clinical testing that may eventually be required by regulatory authorities for INNO-206, the significant time and expense that will be incurred in developing any of the potential commercial applications for INNO-206, including for advanced pancreatic ductual adenocarcinomas, risks related to CytRx's ability to manufacture its drug candidates, including INNO-206, in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including any future clinical development of INNO-206, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.