CytRx is working with the FDA to develop a Phase 3 clinical trial protocol with the doxorubicin tumor-targeting conjugate aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx expects to request the FDA’s agreement to conduct this trial under a special protocol assessment (SPA). If granted, the SPA would indicate the Agency’s agreement that the Phase 3 trial design, statistical analysis and endpoints are acceptable to support regulatory approval, subject to trial results.In the second half of 2013, CytRx expects to announce clinical data from an international Phase 2b clinical trial with aldoxorubicin as a first-line therapy in patients with advanced soft tissue sarcoma who are ineligible for surgery. The data from this trial will provide the first direct clinical trial comparison of aldoxorubicin with native doxorubicin, which is dose-limited due to toxicity. The trial is being conducted under the direction of world-renowned expert in soft tissue sarcoma treatment Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, California, and involves over 30 oncology centers throughout the world. In the second half of 2013, CytRx also expects to report the results of a Phase 2b clinical trial in patients with advanced non-small-cell lung cancer (NSCLC) with its orally available, rationally designed, synthetic retinoid compound tamibarotene. In this randomized clinical trial, patients with advanced NSCLC are treated with paclitaxel plus carboplatin and either tamibarotene or placebo. The trial’s objective is to compare the objective response rates (complete and partial responses) and progression-free survival, as well as evaluate overall survival and quality-of-life between the two treatment regimens, among other measures. 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, 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. 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 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.
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, has named Daniel Levitt, M.D., Ph.D., to the newly created position of Executive Vice President. Dr. Levitt will continue to serve as Chief Medical Officer. “I am delighted to announce Dan’s well-deserved promotion and to express our full confidence in his leadership of our clinical programs, including preclinical research and manufacturing,” said CytRx President and CEO Steven A. Kriegsman. “Since joining CytRx just over three years ago, Dan has successfully implemented a strategy that has allowed us to rapidly evaluate our drug candidates in various cancers, providing us with a cost-effective pathway for entering into late-stage clinical development. He has also enabled CytRx to standardize our manufacturing processes, allowing us to rapidly advance our clinical trials. There is no doubt that we are benefiting from his extensive senior management experience, his prior success in piloting drug programs through the clinical and regulatory processes, seven of which have received marketing approval, and his credibility within the scientific community. “We are currently making progress toward initiating our first Phase 3 pivotal clinical trial with aldoxorubicin. We also expect to report clinical results from additional trials with aldoxorubicin and tamibarotene this year. These are indeed major milestones in our quest to bring new therapies to patients with cancer and enhance shareholder value,” added Mr. Kriegsman. “Dan’s promotion to this senior executive position reflects this significant progress in our clinical programs that moves us closer to our ultimate goal of becoming a leading oncology company.” Dr. Levitt said, “I’m pleased to be appointed Executive Vice President at this key juncture in the development of aldoxorubicin and tamibarotene, both of which could have application in multiple cancers and offer potential advantages over currently marketed oncology therapies. I’m excited to be working with the CytRx team in what promises to be an eventful future.”