CytRx's Aldoxorubicin Clinical Data Presented at Connective Tissue Oncology Society (CTOS) 7th Annual Meeting in Prague, Czech Republic
Favorable Phase 1b/2 clinical trial results in soft tissue sarcoma featured at third preeminent oncology conference
Company is planning to submit a special protocol assessment to the FDA related to its Phase 3 pivotal trial with aldoxorubicin for patients with advanced soft tissue sarcomas
LOS ANGELES--(BUSINESS WIRE)--Nov 15, 2012 - CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced the presentation today of favorable results from a Phase 1b/2 clinical trial with its tumor-targeting doxorubicin conjugate aldoxorubicin (formerly INNO-206) in patients with advanced soft tissue sarcoma at the Connective Tissue Oncology Society (CTOS) 17th Annual Meeting in Prague, Czech Republic. The poster-discussion presentation was delivered by Dr. Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, California.
“We concluded from the trial data that aldoxorubicin is an active drug for the treatment of patients with metastatic soft tissue sarcomas who have progressed on prior chemotherapies, including those previously treated with doxorubicin,” said Dr. Chawla, a world renowned expert in the treatment of soft tissue sarcomas who served as the trial's principal investigator. “Patients treated with aldoxorubicin in this clinical trial were delivered doxorubicin in a cumulative dose of more than 3½ times the peak cumulative dose of standard doxorubicin with no observed cardiac toxicities, even though cardiac safety is considered one of the dose-limiting side effects for standard doxorubicin.”
The Phase 1b/2 trial data 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 soft tissue sarcomas. The data were first announced in early June 2012 at the American Society of Clinical Oncology (ASCO) conference in Chicago and also were presented at the European Society of Medical Oncology (ESMO) 2012 Congress in Vienna, Austria in October 2012.
CytRx President and CEO Steven A. Kriegsman said, “Data from this and other trials strongly indicate that aldoxorubicin warrants further investigation in this indication. We recently held a positive meeting with the U.S. Food and Drug Administration (FDA) to discuss a potential Phase 3 pivotal trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. Last week we announced that we are submitting a special protocol assessment (SPA) with respect to this potential trial.”
By reaching agreement with the FDA on a pivotal trial protocol under an SPA, the FDA agrees that the Phase 3 trial design, statistical analysis and endpoints are acceptable to support regulatory approval, subject to trial results. 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
The Connective Tissue Oncology Society (CTOS) 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, initiated a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors, 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. The Company has held a positive meeting with the FDA to discuss a potential Phase 3 pivotal trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy, and is planning to submit a special protocol assessment related to this trial. 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 CytRx Corporation, 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 relating to the outcome, timing and results of CytRx's clinical trials, the risk that any future human testing of aldoxorubicin might not produce results similar to those seen in past human or animal testing, risks related to CytRx's ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, uncertainties regarding whether CytRx will be permitted to conduct a Phase 3 clinical trial with aldoxorubicin as a treatment for STS, 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, tamibarotene or bafetinib, 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.
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Posted: November 2012