CytRx Corp. (CYTR) is a biopharmaceutical research and development company specializing in the optimized delivery of anti-cancer drugs. The CYTR oncology pipeline is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin.
CYTR 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 is preparing for 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. CYTR plans to start a Phase 2 trial in Q4 2013 with aldoxorubicin as a treatment for stage IV brain cancer, also called glioblastoma. A Phase 2 trial in Kaposi’s sarcoma is set to commence in Q4 2013 as well. CYTR is expanding its pipeline of oncology candidates based on a novel linker platform technology that can be utilized with multiple chemotherapeutic agents and could allow for greater concentration of drug at tumor sites.
CYTR also has rights to two additional drug candidates: tamibarotene and bafetinib. The Company 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, and is evaluating further development of tamibarotene.
- FDA granted SPA for Pivotal Phase 3 trial with aldoxorubicin in 2nd-line soft tissue sarcomas
- Aldoxorubicin Phase 2b trial results expected in 4Q 2013
- Aldoxorubicin more than doubled survival in animal models of glioblastoma leading to a Phase 2b trial in Q4 2013
- Statistically significant results in glioblastoma animal models leading to a Phase 2b trial in 2H 2013
- Unique platform technology provides pipeline of additional drug candidates and intellectual property
- Capital to support near and mid-term milestones
- $28 million as of 6/30/13
- No debt
Aldoxorubicin (formerly INNO-206) is a novel conjugate of the commonly prescribed chemotherapeutic agent doxorubicin that binds covalently to albumin, the most abundant protein in blood plasma, and is circulated throughout the body. Aldoxorubicin has been granted orphan drug designation by the Office of Orphan Product Development of the U.S. Food and Drug Administration (FDA) for the treatment of patients with soft tissue sarcomas and pancreatic cancer.
Doxorubicin is a standard chemotherapeutic treatment for a variety of cancers and is used either alone or in combination with other chemotherapy agents. Aldoxorubicin is designed with a linker that releases doxorubicin in the low pH environment of tumors, concentrating the chemotherapeutic agent where it preferentially damages the tumor while minimizing the effect on healthy tissues. This conjugate formulation has the potential to safely deliver greater amounts of doxorubicin directly to the tumor compared with standard doxorubicin treatment, which could lead to improved efficacy. CYTR holds the exclusive worldwide rights to aldoxorubicin.
In a Phase 1 clinical trial, aldoxorubicin was administered in doses at up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin. Animal studies conducted by aldoxorubicin inventor Dr. Felix Kratz, Department of Medical Oncology, Clinical Research, at the Tumor Biology Center in Freiburg, Germany, demonstrated statistically significant results in breast, ovarian, pancreatic and small cell lung cancers. Results of these studies were published in several peer-reviewed journals. Aldoxorubicin has also demonstrated activity in pre-clinical models of glioblastoma and multiple myeloma.
CYTR completed a Phase 1b/2 clinical trial with aldoxorubicin in patients with advanced solid tumors and presented favorable data at the ASCO conference in Chicago, Illinois, in June:
- Clinical benefit (defined as partial response and stable disease of more than four months) with aldoxorubicin at the maximum tolerated dose was shown in 10 of 13 (76.9%) evaluable patients with relapsed or refractory soft tissue sarcoma.
- Best response for the 13 evaluable soft tissue sarcoma trial subjects included the following:
- Five (38.5%) achieved partial response, as defined as tumor shrinkage of more than 30%;
- Seven (53.8%) showed prolonged stable disease (defined as tumor shrinkage <30% from baseline or tumor growth <20% from the nadir);
- Eight (61.5%) had tumor shrinkage; and five of eight patients (62.5%) who demonstrated either partial responses or prolonged stable disease after treatment with aldoxorubicin had been previously treated with doxorubicin and had failed to respond.
- There were no observed cardiac toxicities and no drug-related patient deaths. The most common adverse event, neutropenia, also observed with doxorubicin treatment, resolved prior to the start of the next treatment.
- Median estimated progression-free survival for advanced soft tissue sarcoma patients in the trial was 6.4 months with a range of 1.0 to more than 10.7 months. This compares favorably with the historical median progression-free survival for this patient population of approximately three months.
In December 2011, CYTR initiated its international Phase 2b clinical trial to evaluate the preliminary efficacy and safety of aldoxorubicin as a first-line treatment in patients with soft tissue sarcoma who are ineligible for surgery. The Phase 2b clinical trial will provide the first direct clinical trial comparison of aldoxorubicin with native doxorubicin, which is dose-limited due to toxicity, as a first-line therapy. The top-line results are expected in Q4 2013.
Soft Tissue Sarcomas
Soft Tissue Sarcoma is a very rare form of cancer. The term sarcoma comes from a Greek word meaning fleshy growth. Soft tissue sarcoma can occur in the muscles, fat, blood vessels, tendons, fibrous tissues and synovial tissues (tissues around joints). There are more than 50 subtypes of soft tissue sarcoma.
The National Cancer Institute estimates that in 2011 more than 11,000 new cases of soft tissue sarcomas were diagnosed in the United States and approximately 3,900 deaths were caused by these cancers.
Doxorubicin-based therapy is the standard of care for advanced, metastatic disease. Despite advances in research, all patients will progress on existing treatments. There is a tremendous need for better treatment options.
Chemotherapy is the backbone of cancer treatment and will remain even with newer targeted therapies.
- Limitations of chemotherapy:
- Toxicity: normal organs affected
- Poor efficacy: can’t get high drug concentrations to the tumor
- CYTR’s Tumor Concentrating Technology:
- Harnesses body’s own albumin as a means to concentrate drug in the tumor
- Allows greater amounts of drug to be given at each cycle and for additional cycles than the standard drug
- Reduces adverse events
- Ability to concentrate drug at specific sites
- Large array of chemotherapy agents can be used
CYTR has an exclusive worldwide license from KTB Tumor Biology Institute in Freiburg, Germany. Linker molecules have the potential to treat the majority of solid tumors and blood cancers and have a broad utility: many chemotherapy drugs have been attached to the linker: doxorubicin, paclitaxel, docetaxel, cisplatin, irinotecan, methotrexate.
Linker Is Multi-Functional
- Keeps drug inactive until released and has fewer side effects
- Once infused, linker binds to albumin which takes it to the tumor
- Linker breaks apart due to low pH in the tumor, releases drug
CYTR is backed by a strong management team of highly experienced business leaders, scientists and other professionals. This leadership team has decades of involvement in the biopharmaceutical, drug development, legal, finance and business operations, creating a solid backbone to support the company's growth strategy and product development.
Steven A. Kriegsman - President and Chief Executive Officer
Steven Kriegsman has been CYTR's President and CEO and a director since July 2002. He also serves as a director of Galena Biopharma, Inc. and Chairman of Galena's Compensation and Transaction Committees. He previously served as Director and Chairman of Global Genomics from June 2000. Kriegsman is an inactive Chairman and Founder of Kriegsman Capital Group LLC, a financial advisory firm specializing in the development of alternative sources of equity capital for emerging growth companies in the healthcare industry. He has advised such companies as SuperGen Inc., Closure Medical Corporation, Novoste Corporation, Advanced Tissue Sciences, and Maxim Pharmaceuticals. Kriegsman has a B.S. degree with honors from New York University in Accounting and completed the Executive Program in Mergers and Acquisitions at New York University, The Management Institute.
Kriegsman is a graduate of the Stanford Law School Directors' College. Kriegsman was formerly a Certified Public Accountant with KPMG in New York City. He served as a Director and is the former Chairman of the Audit Committee of Bradley Pharmaceuticals, Inc. (NYSE, the company has since been sold).
Daniel Levitt, M.D., Ph.D. - Executive Vice President and Chief Medical Officer
Dr. Daniel Levitt brings more than 24 years of senior management experience, spearheading numerous drug development programs to commercialization at leading biotechnology and pharmaceutical companies. Prior to joining CYTR, Dr. Levitt served as Executive Vice President, Research and Development at Cerimon Pharmaceuticals, Inc., where he implemented three Phase 3 pivotal trials. Prior to that, he was Chief Medical Officer and Head of Clinical and Regulatory Affairs at Dynavax Technologies Corp., managing clinical trials for four programs and overseeing multi-country regulatory strategies. Dr. Levitt was also Chief Operating Officer and Head of Research and Development at Affymax, Inc., where he spearheaded all aspects of that company’s research, development, and commercialization operations, and he spent six years at Protein Design Labs, Inc., completing his tenure as that firm’s President and Head of Research and Development.
Dr. Levitt’s past experience includes a position as Head of Drug Development at Geron Corp., and Head of the Cytokine Development Unit and Global Clinical Oncology at Sandoz Pharmaceuticals Ltd., and as Director, Clinical Oncology and Immunology at Hoffmann-LaRoche, Inc. Dr. Levitt graduated Magna Cum Laude and Phi Beta Kappa with a Bachelor of Arts degree from Brandeis University. He earned both his M.D. and his Ph.D. in Biology from the University of Chicago Pritzker School of Medicine. Dr. Levitt has received 10 major research awards and authored or co-authored nearly 200 papers and abstracts.
John Y. Caloz - Chief Financial Officer
John Caloz has an accomplished history of providing senior financial leadership in the life sciences sector, including as CFO of Occulogix, Inc, a NASDAQ listed, medical therapy company. Prior to that, Caloz served as CFO of IRIS International Inc., a Chatsworth, California-based medical device manufacturer. He served as CFO of San Francisco-based Synarc, Inc., a medical imaging company, and from 1993 to 1999 he was Senior Vice President, Finance and CFO of Phoenix International Life Sciences Inc. of Montreal, Canada, which was acquired by MDS Inc. in 1999. Caloz was a partner at Rooney, Greig, Whitrod, Filion & Associates of Saint Laurent, Quebec, Canada, a firm of Chartered Accountants specializing in research and development and high tech companies, from 1983 to 1993. Caloz, a Chartered Accountant, holds a degree in Accounting from York University, Toronto, Canada.
Benjamin S. Levin - General Counsel, Vice President of Legal Affairs and Corporate Secretary
Until 2004, Benjamin Levin practiced at O'Melveny & Myers LLP in Los Angeles as a transactional attorney. He worked in a wide variety of disciplines including mergers and acquisitions, public and private securities offerings, corporate governance and SEC reporting and disclosure. Levin graduated from Stanford Law School with distinction, and graduated Phi Beta Kappa from the Massachusetts Institute of Technology with a B.S. in Economics.
Scott Wieland, Ph.D. - Senior Vice President of Drug Development
Prior to joining CYTR, Dr. Scott Wieland was Vice President of Drug Development and Regulatory Affairs, with clinical and regulatory oversight of an Alzheimer's disease development program. His 23 years of experience in the biopharmaceutical industry has provided Wieland a balanced approached to developing products for the market place. His experience ranges across all aspects of drug development with a focus on neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, and stroke. Wieland received a M.A. and Ph.D. in Biopsychology from the University of Arizona, a M.B.A. from Webster University, and a B.S. in Physiological Psychology from the University of California, Santa Barbara.
David J. Haen - Vice President, Business Development
David Haen is responsible for licensing, mergers and acquisitions, and strategic alliances as well as investor relations. He worked on the acquisition of Innovive Pharmaceuticals which brought with it CYTR’s current oncology delivery platform and aldoxorubicin. He was responsible for the sale of CYTR’s chaperone technologies to Orphazyme. Prior to joining CytRx, he worked at a boutique strategic advisory firm focused primarily in healthcare. Haen graduated Cum Laude with a B.A. from Loyola Marymount University in Business and Communications.
Carrie Nodgaard, MBA, PMP - Director, Project Management
Carrie Nodgaard manages CYTR's drug development programs. Prior to joining CYTR, Nodgaard was with Amgen Inc., where she was a member of the commercial development team for Prolia™/ XGEVA™ (denosumab). While at Amgen, Nodgaard also managed global manufacturing initiatives supporting late-stage clinical and commercial products. Following Amgen, Nodgaard served as the Senior Program Manager at IRIS International Inc., where she managed new product development including NADiA® ProsVue™ and was involved with mergers and acquisitions. Nodgaard holds an MBA from Pepperdine University and a B.A. in Chemistry and Biochemistry from the University of Kansas.