CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today 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. Drs. Kratz and Warnecke and their scientific team will expand the Corporation’s novel albumin-binding anti-cancer drug pipeline. Dr. Kratz, one of the most highly regarded conjugation chemists in oncology, joins CytRx with 25 years of experience in drug discovery and research. Dr. Kratz’s research includes the development of novel, targeted molecules for cancer therapies, with a special emphasis on the use of albumin as a targeting agent. His research in preclinical and early clinical development of these therapies has led to the creation of a number of new cancer-fighting agents that use albumin to concentrate chemotherapeutics inside cancers, including the invention of CytRx’s lead compound, aldoxorubicin. Dr. Kratz has been at the forefront of designing novel agents, using various linker chemistries to create a variety of protein-drug conjugates. Dr. Warnecke comes to CytRx with 16 years of experience in chemistry research, including the development of chemical architectures for innovative drug release mechanisms and albumin conjugates of anti-cancer agents. The new laboratory, located in Freiburg, Germany, will 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. The work done at the laboratory 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. “Dr. Kratz is one of the most widely published researchers on the use of albumin as a targeting agent for cancer therapies and he brings a tremendous wealth of experience and insight to the development programs at CytRx,” said Steven A. Kriegsman, CytRx President and CEO. “Felix and André have worked side by side for many years and we are quite fortunate to have the opportunity to bring their drug discovery potential in-house.”
Mr. Kriegsman added: “With human clinical results successfully established with aldoxorubicin, our conjugates and albumin-binding approach has been shown to be a viable treatment pathway and one that has the potential to be used with multiple therapeutic agents. We believe that Dr. Kratz’s and Dr. Wernecke’s leading-edge scientific contributions on linker technologies will provide a platform for the generation of innovative product candidates that could be added to our future pipeline.”Prior to joining CytRx, Dr. Kratz was the Head of the Division Macromolecular Prodrugs, which he founded in 1994, in the Clinical Research Department at the Tumor Biology Center (KTB TumorforschungsGmbH) in Freiburg, Germany. The Tumor Biology Center is a private cancer clinic and research institution within the University of Freiburg which focuses on the development of novel drugs and drug delivery concepts for improving the efficacy and toxicity of anticancer agents. Dr. Kratz was in charge of preclinical drug development and organizing and managing translational research from the laboratory to the clinic. His research areas are drug targeting, drug delivery systems in oncology, prodrugs, receptor and antigen targeting, bioconjugate chemistry, polymer therapeutics and nanocarriers. Dr. Kratz graduated in Chemistry from the University of Heidelberg in 1991. He carried out postdoctoral research at the University of Florence in the Bioinorganic Institute of Professor Ivano Bertini and developed transferrin-based tumor-specific carrier systems with ruthenium(III) complexes. He serves on the Editorial Board for Bioconjugate Chemistry, Current Medicinal Chemistry, Current Bioactive Compounds, and Pharmacology & Pharmacy. He has authored approximately 260 scientific publications and proceedings and is the inventor of 23 patents and patent applications. Dr. Warnecke previously served on Dr. Kratz’s research team as Head of Chemistry, Division Macromolecular Prodrugs in the Clinical Research Department at the Tumor Biology Center in Freiburg, Germany. Dr. Warnecke studied chemistry at the universities of Clausthal and Freiburg (Germany) and received his diploma in the field of metallocene chemistry in 1997. He then conducted his Ph.D. thesis research on albumin-binding prodrugs of anticancer agents. Dr. Warnecke has authored or co-authored 23 scientific publications.
CytRx is currently conducting a Phase 2 clinical trial evaluating aldoxorubicin in patients with late-stage glioblastoma (brain cancer). In late 2013, the Company reported highly statistically significant results from its global Phase 2b clinical trial evaluating aldoxorubicin as a first-line therapy in patients with soft tissue sarcomas. In this trial, aldoxorubicin demonstrated 80-100% superiority over doxorubicin in progression-free survival (PFS). Median PFS, 6-month PFS and overall response rates all significantly favored aldoxorubicin treatment over doxorubicin. Aldoxorubicin is also being studied in a Phase 2 clinical trial in HIV-related Kaposi’s sarcoma. CytRx plans to initiate, under a special protocol assessment, a pivotal Phase 3 global clinical trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas in the first quarter of 2014.About Aldoxorubicin The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2 g/m2. About CytRx Corporation CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx has completed a global Phase 2b clinical trial with aldoxorubicin as a first-line therapy for soft tissue sarcomas, a Phase 1b/2 clinical trial primarily in the same indication, a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. This month, CytRx plans to initiate under a special protocol assessment a pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy, and recently announced that it has received approval from the FDA to continue dosing patients with aldoxorubicin until disease progression in that clinical trial. CytRx has initiated a Phase 2 clinical trial with aldoxorubicin in patients with late-stage glioblastoma (brain cancer), and a Phase 2 clinical trial in HIV-related Kaposi’s sarcoma. CytRx will be opening a drug discovery laboratory to expand its pipeline of albumin-binding anti-cancer drug candidates based on a linker platform technology that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib. CytRx completed its evaluation of 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 the Company’s drug discovery operations will not identify any drug candidates suitable for further development, or that any future preclinical or clinical testing of any new drug candidates based on the Company’s albumin-binding linker technology platform might not produce positive results, 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.