CytRx's Aldoxorubicin (INNO-206) Clinical Data to Be Featured at the ESMO 2012 Congress
Noted sarcoma authority Dr. Sant P. Chawla to present favorable Phase 1b/2 data at prominent international conference
Abstract to be published in ESMO conference supplement to the peer-reviewed journal Annals of Oncology
LOS ANGELES--(BUSINESS WIRE)--Aug 7, 2012 - CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, announced that favorable results from its Phase 1b/2 clinical trial with its tumor-targeting doxorubicin conjugate aldoxorubicin (formerly known as INNO-206) primarily in patients with advanced soft tissue sarcoma will be featured in a poster presentation at the ESMO (European Society of Medical Oncology) 2012 Congress being held September 28 - October 2 in Vienna, Austria.
The abstract “INNO-206 is an active drug for relapsed advanced soft tissue sarcoma” will be presented by the clinical trial's principal investigator and renowned sarcoma expert Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, Calif. The abstract will be published in the ESMO 2012 Congress Abstract Book, which is a supplement to the peer-reviewed ESMO journal Annals of Oncology.
On June 3, 2012, CytRx reported data from the Phase 1b/2 trial showing 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 (76.9%) evaluable patients with relapsed or refractory soft tissue sarcoma. CytRx holds exclusive worldwide rights to aldoxorubicin, as well as to the protein-binding platform technology that serves as the linker with doxorubicin. The Company plans to meet with the FDA in the second half of 2012 to discuss a potential Phase 3 pivotal trial for aldoxorubicin as therapy for patients with soft tissue sarcomas who have relapsed after or were refractory to chemotherapy.
“We are delighted with the opportunity to gain greater visibility for these impressive clinical results with aldoxorubicin from the international oncology community,” said Steven A. Kriegsman, CytRx President and CEO. “The acceptance of this abstract is noteworthy as the ESMO conference serves as a platform for the presentation of the latest oncology research and the Annals of Oncology is known for publishing new oncology findings and for its high scientific quality. We thank Dr. Chawla for his continued support and for taking his valuable time to present the aldoxorubicin data.”
About the European Society for Medical Oncology
The European Society for Medical Oncology (ESMO) is the leading European professional organization committed to advancing the specialty of medical oncology and promoting a multidisciplinary approach to cancer treatment and care. Since its founding in 1975 as a non-profit organization, the ESMO's mission has been to advance cancer care and cure.
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 a Phase 2 trial for patients with advanced pancreatic ductal adenocarcinomas, 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.
Contact: Investor Relations
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Posted: August 2012