LOS ANGELES--(CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, today announced that favorable results from a Phase 1b/2 clinical trial with aldoxorubicin (formerly INNO-206) in patients with advanced soft tissue sarcoma will be featured in a poster and discussion presentation at the Connective Tissue Oncology Society (CTOS) 17th Annual Meeting on November 15 in Prague, Czech Republic.)--
“We are excited to share the powerful data from our aldoxorubicin clinical trial with experts from the international oncology community at this preeminent sarcoma conference, as well as at the upcoming ESMO 2012 Congress in Vienna, Austria”
The abstract, “Aldoxorubicin (INNO-206) is an active drug for the treatment of relapsed or refractory soft tissue sarcomas,” will be presented by the clinical trial’s principal investigator Dr. Sant Chawla, M.D., F.R.A.C.P. Dr. Chawla, a world renowned expert in the treatment of soft tissue sarcomas, is Director of the Sarcoma Oncology Center in Santa Monica, Calif. The Phase 1b/2 clinical trial results, first announced in early June 2012 at the American Society of Clinical Oncology (ASCO) conference, showed clinical benefit (defined as partial response and stable disease of more than four months following up to eight cycles of treatment) with aldoxorubicin at the maximum tolerated dose in 10 of 13 evaluable patients with advanced, metastatic soft tissue sarcomas who had either not responded or relapsed after receiving one to three prior chemotherapies. Eight of the 13 patients had been treated previously with doxorubicin.
“We are excited to share the powerful data from our aldoxorubicin clinical trial with experts from the international oncology community at this preeminent sarcoma conference, as well as at the upcoming ESMO 2012 Congress in Vienna, Austria,” said Steven A. Kriegsman, CytRx President and CEO. “The results from this clinical trial are impressive, especially given that these patients had failed prior chemotherapy regimens. Further, there were no observed cardiac toxicities with aldoxorubicin in this clinical trial, with cardiac toxicity considered a major dose-limiting factor for standard doxorubicin. Again, we thank Dr. Chawla for his valuable time to present at these international conferences.”
CytRx holds exclusive worldwide rights to the tumor-targeting doxorubicin conjugate aldoxorubicin and to the protein-binding platform technology that serves as the linker with doxorubicin.
About the Connective Tissue Oncology Society (CTOS)
The Connective Tissue Oncology Society was formed in 1995 and incorporated in 1997. CTOS is an international group comprised of physicians and scientists with a primary interest in the tumors of connective tissues. The goal of the society is to advance the care of patients with connective tissue tumors and to increase knowledge of all aspects of the biology of these tumors, including basic and clinical research. More information is available at www.ctos.org.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline includes two programs in clinical development for cancer indications: aldoxorubicin (formerly known as INNO-206) and tamibarotene. With its tumor-targeted doxorubicin conjugate aldoxorubicin, CytRx has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication, recently initiated both a Phase 2 trial for patients with advanced pancreatic ductal adenocarcinomas and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors, and plans to meet with the FDA in the second half of 2012 to discuss a potential Phase 3 pivotal trial as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. Tamibarotene is being tested in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer, and is in a Phase 2 clinical trial as a treatment for acute promyelocytic leukemia (APL). The Company completed its evaluation of a third drug candidate, 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.
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 clinical trials with aldoxorubicin, including the Phase 2b clinical trial for INNO-206 as a treatment for soft tissue sarcomas and the Phase 2 clinical trial in patients with pancreatic cancer, the risk that any future human testing of aldoxorubicin might not produce results similar to those seen in the Company's Phase 1b/2 clinical trial for INNO-206 in patients with advanced solid tumors, uncertainties regarding regulatory approvals for current and future clinical testing, including CytRx's planned Phase 3 clinical trial for aldoxorubicin, and the scope of the clinical testing that may eventually be required by regulatory authorities, the risk that aldoxorubicin 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 aldoxorubicin might cause adverse events not seen to date in CytRx's Phase 1b/2 trial, uncertainties regarding whether aldoxorubicin effectively targets doxorubicin to tumors, the significant time and expense that will be incurred in developing any of the potential commercial applications for aldoxorubicin, including for soft tissue sarcomas, risks related to CytRx's ability to manufacture its drug candidates, including aldoxorubicin, 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 aldoxorubicin, 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.