LOS ANGELES--(BUSINESS WIRE)--CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, today announced the upcoming presentation of research demonstrating that 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 will be presented at the American Association for Cancer Research (AACR) 2012 Annual Meeting on Monday, April 2, 2012 in Chicago, Illinois. CytRx holds the worldwide rights to INNO-206, which is a tumor-targeted albumin-binding drug incorporating the widely used chemotherapeutic agent doxorubicin.
The posters will be presented by INNO-206 inventor Felix Kratz, Ph.D., Head of the Division of Macromolecular Prodrugs at the Tumor Biology Center, Freiburg. “These studies show that INNO-206 administered in combination with other chemotherapies has significant potential to more effectively treat pancreatic cancer. The combination of half maximum tolerated doses of INNO-206 and doxorubicin was much better tolerated than full doses of either INNO-206 or doxorubicin and was able to induce primarily complete and partial responses in the pancreatic tumor model,” Dr. Kratz said.
The two poster presentations are as follows:
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“Combination therapy of doxorubicin and the acid-sensitive
albumin-binding prodrug of doxorubicin INNO-206 induces complete
regressions in a xenograft pancreatic carcinoma model demonstrating
excellent tolerability,” Kratz, et.al. This research evaluated the
combination of doxorubicin and INNO-206 against each drug alone in
varying dose levels and administered at different time intervals in a
mouse model of human pancreatic cancer. Therapy with doxorubicin alone
produced only moderate tumor inhibition, while the combination
therapeutic arms as well as INNO-206 induced almost all complete and
partial remissions, and the combination schedules were substantially
less toxic.
“The surprising result from this study is that the combination of doxorubicin and INNO-206 has potent antitumor efficacy and is as active as INNO-206 alone, but systemic tolerability is distinctly superior without causing any body weight loss. This synergistic effect may be due to a combination of factors that result in a more homogenous distribution of the drugs within the tumor and tumor cells,” explained Dr. Kratz.
- “Combination therapy of an acid-sensitive albumin-binding prodrug of doxorubicin (INNO-206) and an albumin-binding prodrug of methotrexate (AW054) that is cleaved by cathepsin B and plasmin induces complete remissions against pancreatic cancer in vivo,” Kratz, et. al. This research showed that a combination of two albumin-binding drugs, INNO-206 and AW054, a derivative of methotrexate, administered at half their respective maximum tolerated dose levels in an animal model of pancreatic cancer produced complete remissions with acceptable body weight loss. By contrast, doxorubicin and methotrexate both administered at their maximum tolerated dose levels, or in combination showed only moderate antitumor effects when compared with control animals treated with saline.
“The encouraging result from this in vivo investigation is that all animals responded with a complete response in an essentially chemoresistant tumor indication when treated with two albumin-binding drugs,” Dr. Kratz summarized.
CytRx President and CEO Steven A. Kriegsman said, “These results could signal an important step forward in the treatment of patients with advanced pancreatic cancer, and they open exciting opportunities for CytRx to evaluate INNO-206 alone and in combination with other drugs, including doxorubicin. As the fourth most common cause of cancer death in the U.S. with only a 20% one-year survival rate, advanced pancreatic cancer represents a significant unmet medical need and patients would greatly benefit from a therapy that treats this tumor indication more effectively. CytRx intends to pursue Dr. Kratz’s exciting findings in human clinical trials.”
In a previously conducted preclinical animal study, Dr. Kratz showed that treatment with INNO-206 in an orthotopic human pancreatic cancer model resulted in a statistically significant three-fold reduction in the average primary tumor size, significantly 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 AACR Annual Meeting in April 2009.
CytRx has completed enrollment of 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. The Phase 1b/2 clinical trial results will be presented by a premier soft tissue sarcoma expert at the American Society of Clinical Oncology (ASCO) meeting in early June. The Company also has announced plans in the second quarter of 2012 to begin a Phase 2 trial with INNO-206 in an undisclosed solid tumor indication.
Abstracts for the poster presentations are available at http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=43002f9a-df27-4e50-967a-7a0d201aa85e&cKey=8273344d-808e-4488-9e3f-aba9175f20c0&mKey={2D8C569E-B72C-4E7D-AB3B-070BEC7EB280} and http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=43002f9a-df27-4e50-967a-7a0d201aa85e&cKey=a6c8310c-641e-4997-9fd4-15dddae56489&mKey={2D8C569E-B72C-4E7D-AB3B-070BEC7EB280}.
About the AACR
Founded in 1907, the American Association for Cancer Research (AACR) is the world’s first and largest professional organization dedicated to advancing cancer research and its mission to prevent and cure cancer. The AACR marshals the full spectrum of expertise of the cancer community to accelerate progress in the prevention, biology, diagnosis and treatment of cancer by annually convening more than 20 conferences and educational workshops, the largest of which is the AACR Annual Meeting with more than 18,000 attendees. For more information about the AACR, visit www.AACR.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 metastatic or unresectable soft tissue sarcomas, is completing its ongoing Phase 1b/2 clinical trial in patients whose tumors progressed on chemotherapy, primarily with soft tissue sarcomas, and plans to initiate a Phase 2 trial for an undisclosed solid tumor indication 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 evaluated 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.
Forward-Looking Statements
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 the risk that any future human testing of INNO-206 in combination with doxorubicin or methotrexate as a therapy for cancer, including pancreatic cancer, might not produce results similar to those seen in preclinical studies, risks and uncertainties related to the outcome, timing and results of CytRx's clinical trials for INNO-206 in patients with advanced solid tumors and soft tissue sarcomas, the risk that INNO-206 might not show greater efficacy than doxorubicin notwithstanding the administration of higher doses than the standard of care, the risk that additional longer-term dosing of INNO-206 might cause adverse events not seen to date in CytRx's preclinical or clinical testing, 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 soft tissue sarcomas, the risk that any future human testing of INNO-206, including for pancreatic cancer or for soft tissue sarcomas, might not produce results similar to those seen in animals, 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.