CytRx Announces Agreement with FDA on Special Protocol Assessment for Global Pivotal Phase 3 Clinical Trial with Aldoxorubicin for Soft Tissue Sarcoma SPA provides clear pathway through the regulatory process Preparations underway to commence enrollment Business Wire LOS ANGELES -- April 23, 2013 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under a special protocol assessment (SPA) for a global pivotal Phase 3 trial with aldoxorubicin as a treatment for patients with soft tissue sarcomas who have relapsed or were refractory following prior treatment with chemotherapy. The SPA is a written agreement between the Company, as the trial’s sponsor, and the FDA regarding the design, endpoints and planned statistical analysis approach of the Phase 3 clinical trial to be used in support of a potential New Drug Application (NDA) for aldoxorubicin. The Company is actively making preparations for the pivotal Phase 3 trial. “By reaching an agreement on an SPA, the FDA deems that results from this single Phase 3 clinical trial will be acceptable to support the regulatory approval of aldoxorubicin as a second-line treatment for patients with soft tissue sarcoma, with final marketing approval dependent on the results of the trial and other accomplishments,” said Steven A. Kriegsman, CytRx President and CEO. “The ability to conduct the clinical trial under an SPA could save significant time compared with a standard regulatory pathway. Our optimism about aldoxorubicin’s prospects in this difficult-to-treat indication is predicated on positive results from a Phase 1b/2 trial in which this novel agent was associated with objective responses and prolonged progression-free survival in several patients with advanced soft tissue sarcoma who had relapsed or not responded to prior treatments, as well as on additional clinical and preclinical data.” The international, open-label pivotal Phase 3 clinical trial will enroll approximately 400 patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have either not responded to or have progressed following treatment with one or more systemic regimens of non-adjuvant chemotherapies. Trial patients will be randomized 1:1 to be treated with aldoxorubicin or the investigator’s choice of an approved chemotherapeutic regimen to include dacarbazine, pazopanib (Votrient®), gemcitabine plus docetaxel, doxorubicin or ifosfamide, with up to three comparator regimens to be selected by the investigator at each clinical site. The clinical trial will be conducted at approximately 80 clinical sites in the U.S., Europe, China, Canada, Latin America and Australia. The primary endpoint of the study is progression-free survival, and secondary endpoints include overall survival and safety. “There is a critical need for a second-line treatment for patients with soft tissue sarcomas that improves clinical benefit with fewer side effects,” said Daniel Levitt, M.D., Ph.D., CytRx Executive Vice President and Chief Medical Officer. “Multiple chemotherapy regimens have been explored as palliative therapy for these patients with several failures in Phase 3 trials. Additionally, currently approved chemotherapeutic regimens are frequently quite toxic with no significant impact on either progression-free survival or overall survival.” In the Phase 1b/2 clinical trial in patients with advanced soft tissue sarcoma treated with aldoxorubicin in up to eight cycles at the maximum tolerated dose, 77% (10 of 13) of the evaluable patients showed clinical benefit, defined as partial response with tumor shrinkage in excess of 30% or stable disease at four months following treatment. None of the patients in the Phase 1b/2 trial showed cardiotoxicity and there were no drug-related patient deaths. Patients in this trial showed progression-free survival of approximately 6.4 months, with a range of 1.0 months to more than 10.7 months. This compares favorably with the median estimated progression-free survival for advanced soft tissue sarcoma patients of approximately 3 months. About Aldoxorubicin Aldoxorubicin is an albumin-binding conjugate of the chemotherapeutic agent doxorubicin, which is the current standard of care for advanced, metastatic soft tissue sarcoma. It appears to accumulate in higher concentrations in tumors than in normal tissues in the body. Doxorubicin has significant side effects, including chronic cardiotoxicity, which limits the dosage to a level below its maximum anti-tumor capabilities. Aldoxorubicin employs a unique, proprietary linker that binds to albumin in the blood and allows doxorubicin to accumulate preferentially at the tumor site, thereby reducing the toxic side effects associated with systemic delivery of the unconjugated drug. Multiple animal trials have demonstrated that aldoxorubicin may improve upon the activity of doxorubicin without an increase in toxicity. Clinical trials indicate that aldoxorubicin can deliver doxorubicin at 3.5 to 4 times the standard dose of doxorubicin with higher levels of drug concentrating at the tumor site. CytRx holds exclusive worldwide rights to aldoxorubicin, as well as to the protein-binding platform technology that serves as the linker with doxorubicin. About Soft Tissue Sarcoma Sarcoma is an umbrella term for more than 50 subtypes of cancer that occur in the muscles, fat, blood vessels, tendons and other connective tissues in the body. Last year an estimated 38,000 new cases of soft tissue sarcoma were reported and more than 13,000 deaths were attributed to this cancer in the U.S. and Europe. Patients with metastatic, locally advanced or unresectable soft tissue sarcomas have a poor prognosis with progression-free survival of around 2 months to 4.6 months and median overall survival of approximately 9 months to 12 months. CytRx has been granted orphan drug designation by the FDA for the treatment of patients with soft tissue sarcomas. AboutCytRx 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 and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors. The Company plans to initiate a Phase 3 pivotal trial under a special protocol assessment (SPA) with aldoxorubicin 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. The Company reached its enrollment target for that trial in February 2013. 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 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, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 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 Legend Securities, Inc. Thomas Wagner 800-385-5790 x152 718-233-2600 x152 firstname.lastname@example.org or CytRx Corporation David Haen Vice President, Business Development (310) 826-5648 x304 email@example.com
CytRx Announces Agreement with FDA on Special Protocol Assessment for Global Pivotal Phase 3 Clinical Trial with Aldoxorubicin
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