CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced that an in vivo trial investigating aldoxorubicin, its tumor-targeting conjugate of the widely used chemotherapeutic agent doxorubicin, in combination with unconjugated doxorubicin, demonstrated positive results and provided the basis for the Company’s current evaluation of the combination therapy in cancer patients with advanced solid tumors in a Phase 1b clinical trial.
The trial compared the antitumor efficacy and tolerability of weekly intravenous treatments with saline or doxorubicin compared with three dosing regimens of either aldoxorubicin alone or combination aldoxorubicin and doxorubicin in a xenograft model of human pancreatic cancer. As single agents, doxorubicin and aldoxorubicin were administered at their maximum tolerated doses (MTD), while each agent was given at 50% of their MTD when combined. Doxorubicin alone produced only modest tumor inhibition. Aldoxorubicin alone and each combination therapy arm induced both complete and partial remissions, with antitumor efficacy within all arms essentially identical. Importantly, the trial data showed better tolerability for the combination therapy at these low dose levels compared with single agent aldoxorubicin.
The study, “Evaluation of combination therapy schedules of doxorubicin and an acid-sensitive albumin-binding prodrug of doxorubicin in the MIA PaCa-2 pancreatic xenograft model,” Kratz, F., et al., was published in the peer-reviewed International Journal of Pharmaceutics, 441 (2013) pages 499-506.
“The data from this trial are particularly encouraging as pancreatic cancer typically responds poorly to chemotherapy,” said CytRx Executive Vice President and Chief Medical Officer Daniel Levitt, M.D., Ph.D. “The ability of a combined therapy with aldoxorubicin and doxorubicin to demonstrate efficacy in this cancer at doses that were well-tolerated indicates its potential for the treatment of other chemotherapeutic-resistant tumors such as chondrosarcoma and chordomas. The design and rationale behind this trial produced valuable information and we are currently testing this combination in a phase 1b clinical trial in patients with solid tumors. A study abstract has been submitted for presentation at the American Society for Clinical Oncology (ASCO) meeting later this year.”
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, and has 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. 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 or uncertainties related to the outcome, timing and results of CytRx's clinical trials with aldoxorubicin and tamibarotene, including the planned Phase 3 clinical trial for aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy, the risk that any future human testing of the Company’s drug candidates might not produce results similar to those seen in earlier human or animal testing, uncertainties regarding regulatory approvals for current and future clinical testing, including the planned Phase 3 clinical trial for aldoxorubicin, and the scope of the clinical testing that may eventually be required by regulatory authorities, the significant time and expense that will be incurred in developing any of the potential commercial applications for aldoxorubicin or tamibarotene, 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.