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CytRx Reports 2014 First Quarter Financial Results

CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today reported financial results for the 3 months ended March 31, 2014, and also provided an overview of recent accomplishments and upcoming milestones for its clinical development programs.

“In the first quarter of 2014, we continued to successfully execute on our clinical goals with the initiation of our pivotal global Phase 3 trial of aldoxorubicin as a second-line treatment for Soft Tissue Sarcoma (STS),” said Steven A. Kriegsman, CytRx President and CEO. “Also this quarter, we further expanded our albumin-binding anti-cancer drug platform by welcoming Dr. Felix Kratz, inventor of aldoxorubicin, and his scientific team in-house. Their scientific expertise in linker technologies will enable us to generate innovative product candidates that could be added to our future pipeline.”

Mr. Kriegsman added: “We are now looking forward to several key events in the coming weeks, including our first Research and Development Day taking place tomorrow in New York City, and to an upcoming oral presentation at ASCO detailing the results from our global Phase 2b trial of aldoxorubicin in STS. We also expect to report data from the ongoing Phase 2 clinical trial of aldoxorubicin in glioblastoma in the coming year.”

First Quarter 2014 and Recent Highlights

Announced Global Phase 2b Trial of Aldoxorubicin in Soft Tissue Sarcomas was Selected for an Oral Presentation at the 2014 ASCO Annual Meeting. Last week, CytRx announced that its Phase 2b trial comparing first-line treatment with aldoxorubicin, its lead product candidate, versus doxorubicin in patients with advanced soft tissue sarcomas (STS) has been selected for oral presentation at the 2014 American Society for Clinical Oncology (ASCO) Annual Meeting, which is taking place May 30 – June 3 in Chicago. The oral presentation will be given by Sant Chawla, M.D., F.R.A.C.P., Sarcoma Oncology Center on Sunday, June 1, 2014 from 8:24 - 8:36am CDT.

Announced Upcoming Research and Development Day. In April 2014, CytRx announced that it will be hosting its first Research and Development Day on Friday, May 2 from 8:30 - 11:30 am EDT at the Harvard Club in New York City. The event, which will be open to analysts and institutional investors, will include presentations by, and a panel discussion with, key opinion leaders in oncology and sarcoma, including the principal investigator for the Company’s pivotal, global Phase 3 trial of aldoxorubicin in patients with soft tissue sarcoma.

Reported Positive Updated Preclinical Data from a Model of Human Glioblastoma at AACR 2014. At the 2014 American Association for Cancer Research (AACR) Annual Meeting in April, CytRx presented updated preclinical study results which demonstrated that aldoxorubicin significantly increased survival almost 2½ fold compared with doxorubicin treatment in an in vivo xenograft tumor model employing growth of human glioblastoma multiforme (GBM) tumors in mouse brains. Aldoxorubicin, but not doxorubicin, also demonstrated preferential accumulation and prolonged retention in the tumor tissue. These data, combined with aldoxorubicin’s favorable safety profile, support the current evaluation of aldoxorubicin as a treatment for patients with GBM tumors.

Initiated Pivotal Global Phase 3 Clinical Trial of Aldoxorubicin for Second-Line Treatment of Soft Tissue Sarcoma (STS). In March 2014, CytRx announced the initiation of its pivotal global Phase 3 clinical trial to evaluate the efficacy and safety of aldoxorubicin as a second-line treatment for patients with soft tissue sarcoma (STS) under a Special Protocol Assessment with the FDA. This multicenter, randomized, open-label Phase 3 clinical trial is designed to 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. The primary endpoint of the study is progression-free survival (PFS), and secondary endpoints include overall survival, response rates and safety. The Company expects to complete trial enrollment in 2015.

Received Orphan Medicinal Product Designation for Aldoxorubicin in Europe. In March 2014, CytRx announced that aldoxorubicin had received orphan medicinal product designation from the European Commission for the treatment of advanced soft tissue sarcomas.

Established R&D Team with Plans to Open a New Laboratory to Develop Albumin-Binding Anti-Cancer Drug Platform. In March 2014, CytRx announced the appointment of Felix Kratz, Ph.D. as Vice President of Drug Discovery and André Warnecke, Ph.D. as Senior Director of Drug Discovery. Operating from CytRx’s new laboratory, located in Freiburg, Germany, Drs. Kratz and Warnecke and their scientific team have started to conduct discovery and translational research to create drug candidates that utilize novel linker technologies that couple chemotherapeutic agents and proteins either inside the body or externally, and then concentrate drug in tumors. Their work will generate new pipeline product candidates and thereby enable expansion of the Company’s existing patent portfolio, adding to intellectual property that was originally developed by the KTB Tumor Biology Center in Freiburg and licensed exclusively to CytRx.

Strengthened the Corporate Balance Sheet and Leadership Team. In February 2014, CytRx successfully completed a public offering of common stock securing gross proceeds of approximately $86 million. CytRx intends to use the net proceeds of the offering to fund clinical trials of its drug candidate aldoxorubicin and for general corporate purposes, which may include working capital, capital expenditures, research and development and other commercial expenditures. In January 2014, the Company appointed Shanta Chawla, M.D. as Vice President, Clinical Development. Dr. Chawla brings more than 13 years of clinical research, operations and development experience, with a focus on oncology therapeutics and will support the Company’s ongoing global Phase 3 clinical trial of aldoxorubicin in STS.

Initiated Phase 2 Clinical Trial of Aldoxorubicin as a First-Line Treatment for AIDS-related Kaposi’s Sarcoma. In January 2014, CytRx announced the initiation of a Phase 2 clinical trial to determine the preliminary efficacy and safety of aldoxorubicin for HIV-infected patients with Kaposi’s sarcoma (KS). This open-label study will be conducted at the Louisiana State University Health Sciences Center in New Orleans and is expected to enroll up to 30 patients.

Received Approval from FDA to Extend Aldoxorubicin Dosing Cycles Until Disease Progression in Global Pivotal Phase 3 Clinical Trial for Soft Tissue Sarcomas (STS). In January 2014, the Company announced it had received approval from the U.S. Food and Drug Administration (FDA) to amend the Phase 3 protocol to continue dosing patients with aldoxorubicin until disease progression (defined as an increase in the size of measurable tumors by 20% or the development of a new tumor lesion). This FDA decision, which will be incorporated into the existing special protocol assessment (SPA), reflects a level of comfort with the cardiac safety of aldoxorubicin as demonstrated in previous clinical trials. 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 pivotal Phase 3 clinical trial to be used in support of a potential New Drug Application (NDA) for aldoxorubicin. The Company believes that the additional treatment cycles create the potential for substantially improved Phase 3 efficacy results.

Commenced Dosing in Phase 2 Clinical Trial of Aldoxorubicin in Patients with Unresectable Glioblastoma Multiforme. In January 2014, CytRx announced dosing of the first patient in its Phase 2 clinical trial of aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer. The open-label, multi-center study, which is expected to enroll up to 28 patients, is designed to investigate the preliminary efficacy and safety of aldoxorubicin in subjects with unresectable GBM whose tumors have progressed following prior treatment with surgery, radiation and temozolomide. The primary objective of this trial is to determine PFS and OS, and the principal secondary objective is an evaluation of the safety of aldoxorubicin in the study subjects.

Reported Positive Data from Additional Analyses of Global Phase 2b Clinical Trial of Aldoxorubicin as First-Line Treatment for STS. In January 2014, CytRx reported additional statistical analyses from its multicenter, randomized, open-label global Phase 2b clinical trial. The results demonstrated that aldoxorubicin treated patients experienced a highly statistically significant reduction in risk of disease progression compared to patients treated with doxorubicin alone. Kaplan-Meier analysis of the trial results, which describes the time it takes for tumors to progress in individual patients, also showed significant improvement in subjects treated with aldoxorubicin versus subjects treated with doxorubicin.

Upcoming Milestones
  • Present Phase 2b trial of aldoxorubicin in soft tissue sarcomas in an oral presentation session at the 2014 ASCO Annual Meeting. ASCO’s embargo for this abstract will lift on Wednesday, May 14 at 5pm EDT.
  • Announce preliminary results from the ongoing Phase 2 clinical trial of aldoxorubicin in Glioblastoma Multiforme in the coming year.
  • Initiate a global Phase 2b clinical trial of aldoxorubicin as a second-line treatment for small cell lung cancer (SCLC) in the second half of 2014
  • Announce OS results from the ongoing global Phase 2b clinical trial of aldoxorubicin as a first-line treatment for STS in the second half of 2014
  • Expand the oncology pipeline by combining the Company’s novel linker platform technology with additional chemotherapeutic agents

First Quarter 2014 Financial Results

CytRx reported cash, cash equivalents and short-term investments of $112.6 million as of March 31, 2014.

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