LOS ANGELES, Jan. 30 /PRNewswire-FirstCall/ -- CytRx Corporation , a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced its intention to transfer all of its ribonucleic acid interference (RNAi) therapeutics assets into a newly-formed subsidiary to accelerate the development and commercialization of drugs based on RNAi technology.
CytRx expects to retain significant ownership in the new company. Formation is expected to be completed in the coming months, subject to obtaining financing for the subsidiary to fund this separate and distinct RNAi business.
“A thorough analysis of our corporate structure and current valuation led us to conclude that repositioning our RNAi technology could substantially accelerate the movement of promising, high-value RNAi drug candidates into the clinic, thereby increasing the value of this technology for our shareholders,” said Steven A. Kriegsman, CytRx’s President and CEO. “We believe that this structure will enable us to capitalize on recent progress in the field of RNAi by promoting research collaborations, other strategic alliances, and direct financing opportunities. Most significantly, this subsidiary will be a “pure play” RNAi company and can now more easily be compared with other RNAi companies, which could materially increase CytRx’s overall valuation.
“The proprietary RNAi technology we have exclusively licensed could have profound implications in the development of therapeutics and drug lead generation for many inherited genetic disorders, such as type 2 diabetes, obesity and amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), in addition to other diseases, such as human cytomegalovirus (CMV),” he added. “We have extensive licensing agreements and sponsored research programs with the University of Massachusetts Medical School (UMMS), a pioneer in RNAi technology, Massachusetts General Hospital (MGH), the teaching hospital of Harvard Medical School and Imperial College London, one of the most important research centers in all of Europe. We are enthusiastic about prospects for several drug candidates currently under development.”
Earlier this month, CytRx announced plans to move at least one RNAi-based drug through preclinical development this year and toward the filing of an investigational new drug (IND) application to begin human clinical testing.
Background on CytRx’s Sponsored RNAi Programs * In April 2003, CytRx established an exclusive license agreement with UMMS to use RNAi technology for the development of novel products for the prevention, treatment and cure of obesity and type 2 diabetes. * In April 2003, CytRx signed an exclusive, worldwide license agreement with UMMS to use RNAi gene silencing technology in the development of a treatment for ALS. * In October 2003, CytRx agreed to fund a sponsored research program at UMMS for the use of RNAi gene silencing technology in the development of ALS. In addition, CytRx and MGH jointly initiated a broad-based research program for the use of RNAi technology in the development of a drug for the prevention, treatment or cure for ALS. * In January 2004, CytRx signed a new agreement with UMMS to fund research for the further development of proprietary gene silencing technology for use in the treatment of diseases caused by cytomegalovirus (CMV), with an initial focus on CMV retinitis. * In May 2004, CytRx entered into a license agreement with Imperial College Innovations Limited for exclusive rights to Imperial’s intellectual property covering a drug screening method using RIP140, a nuclear hormone co-repressor which regulates fat accumulation. * In July 2004, CytRx and UMMS significantly broadened their existing strategic alliance with a new collaboration and invention disclosure agreement giving CytRx option rights to license new technologies developed at UMMS over a three-year period in the fields of RNAi, type 1 and type 2 diabetes, obesity, neurodegenerative diseases (including ALS) and CMV. * In December 2005, CytRx further expanded its licensing relationship with UMMS to cover several newly discovered novel drug targets that have demonstrated the ability to regulate insulin activity in fat cells. Decreased insulin activity is known to contribute to type 2 diabetes and other complications such as obesity. Milestones reached in the RNAi programs CytRx sponsors include: * RIP140: In August 2005, CytRx announced that UMMS researchers had developed siRNA inhibitors that target RIP140, a nuclear hormone co-repressor believed to regulate fat accumulation with the goal of regulating insulin signaling and other metabolic pathways. Early investigations in mouse models had shown that suppression of RIP140 resulted in the absence of fat accumulation even when mice were fed a high fat diet. Intellectual property covering a drug screening method using RIP140 was licensed from Imperial Innovations Ltd., the technology transfer company of Imperial College London, in June 2004. * SOD1: In July 2004, UMMS researchers reported they had silenced the mutant SOD1 gene that has been shown to cause familial ALS in a mouse model. This was the first instance known by CytRx of successfully attacking the cause and arresting the development of ALS instead of treating the symptoms.
CytRx’s principal team of scientific advisors and sponsored researchers includes world leaders in the field of RNAi technology, including:
* Craig Mello, Ph.D. -- Co-discoverer of RNAi, Blais University Chair and Distinguished Professor of Molecular Medicine and a Howard Hughes Medical Institute Investigator at UMMS. * Michael P. Czech, Ph.D. -- Professor and Chair, Program in Molecular Medicine, UMMS -- a recognized leader in the field of insulin action and signal transduction in diabetes and obesity, who recently developed methods for RNAi-mediated gene silencing in cultured adipocytes. * Tariq Rana, Ph.D. -- The founding Director of the Program in Chemical Biology and Professor of Biochemistry & Molecular Pharmacology at the UMMS. * Malcolm Parker, FMedSci -- Professor, Head of the Obstetrics and Gynaecology Department and Director of Research of the Institute of Reproduction and Developmental Biology at Imperial College London. * Robert H. Brown, Jr., M.D. -- Professor of Neurology at Harvard Medical School, Founder of Massachusetts General Hospital Cecil B. Day Laboratory for Neuromuscular Research. * Zuoshang Xu, M.D., Ph.D. -- Associate Professor of Biochemistry & Molecular Pharmacology, University of Massachusetts Medical School. * Timothy Kowalik, Ph.D. -- Associate Professor in the Department of Molecular Genetics & Microbiology at UMMS. Background on RNAi
RNAi is a naturally occurring mechanism within cells for selectively silencing and regulating specific genes. RNAi can shut down disease-causing genes or direct researchers to pathways for effective drug development. Since many diseases are caused by the inappropriate activity of specific genes, the ability to silence genes selectively through RNAi could provide new ways to treat a wide range of human diseases.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company engaged in the development of products. The Company owns three clinical-stage compounds based on its small molecule “molecular chaperone” co-induction technology, as well as a targeted library of 500 small molecule drug candidates that may be used to screen for new drug candidates. CytRx has initiated a Phase II clinical trial with its lead small molecule product candidate arimoclomol for the treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). Arimoclomol has received Orphan Drug and Fast Track designation from the U.S. Food and Drug Administration. CytRx has previously announced that a novel HIV DNA + protein vaccine exclusively licensed to CytRx and developed by researchers at UMMS and Advanced BioScience Laboratories, and funded by the National Institutes of Health, demonstrated very promising interim Phase I clinical trial results that indicate its ability to produce potent antibody responses with neutralizing activity against multiple HIV viral strains. For more information, visit CytRx’s Web site at www.cytrx.com.
About the University of Massachusetts Medical School
The University of Massachusetts Medical School, one of the fastest growing academic health centers in the country, has built a reputation as a world-class research institution, consistently producing noteworthy advances in clinical and basic research. The Medical School attracts more than $174 million in research funding annually, 80% of which comes from federal funding sources. Research funding enables UMMS scientists to explore human disease from the molecular level to large-scale clinical trials. Basic and clinical research leads to new approaches for diagnosis, treatment and prevention of disease. Visit www.umassmed.edu for additional information.
About Massachusetts General Hospital
Massachusetts General Hospital (MGH), established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $450 million and major research centers in AIDS, cardiovascular research, cancer, cutaneous biology, medical imaging, neurodegenerative disorders, transplantation biology and photomedicine. In 1994, the MGH joined with Brigham and Women’s Hospital to form Partners HealthCare System, an integrated health care delivery system comprising the two academic medical centers, specialty and community hospitals, a network of physician groups and nonacute and home health services.
About Imperial Innovations Ltd.
Imperial Innovations is one of the United Kingdom’s leading technology commercialization companies, having created over 54 spin-out companies and concluded 100 licence agreements. Imperial Innovations is committed to the creating of wealth for its shareholders, and the company’s mission to match the outstanding quality of research at Imperial College London with excellence in technology transfer.
About Imperial College London
Consistently rated in the top three UK university institutions, Imperial College London is a world leading science-based university whose reputation for excellence in teaching and research attracts students (10,000) and staff (5,000) of the highest international quality. Innovative research at the College explores the interface between science, medicine, engineering and management and delivers practical solutions that enhance the quality of life and the environment -- underpinned by a dynamic enterprise culture. Website: www.imperial.ac.uk
Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Examples of such statements include, but are not limited to, statements relating to the expected timing, scope and results of our clinical development and research programs, including the initiation of clinical trials, and statements regarding the potential benefits of our drug candidates and potential drug candidates. 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 CytRx’s ability to obtain capital to fund its working capital needs for the RNAi development activities planned to be conducted by the new subsidiary, uncertainties related to the early stage of CytRx’s RNAi, diabetes, obesity, cytomegalovirus and ALS research, the need for future clinical testing of any RNAi-based product candidates and small molecules that may be developed by CytRx, the significant time and expense that will be incurred in developing any of the potential commercial applications for CytRx’s RNAi technology or small molecules, uncertainties related to regulatory approvals for clinical testing and the scope of the clinical testing that may be required by regulatory authorities for its molecular chaperone co-induction drug candidates, including arimoclomol, and other products, and the timing and outcomes of those tests, risks relating to the enforceability of any patents covering CytRx’s products and to the possible infringement of third party patents by those products, and the impact of third party reimbursement policies on the use of and pricing for CytRx’s products. Additional uncertainties and risks are described in CytRx’s most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 8-K filed since the date of the last Form 10-K. 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.
For Additional Information: CytRx Corporation: CEOcast, Inc. Ed Umali (eumali@cytrx.com) Investor Contacts: Director of Corporate Communications Kevin Theiss (ktheiss@ceocast.com) (310) 826-5648, ext. 309 Cormac Glynn (cglynn@ceocast.com) (212) 732-4300
CytRx Corporation
CONTACT: Ed Umali, Director of Corporate Communications of CytRxCorporation, +1-310-826-5648, ext. 309; or Investors, Kevin Theiss,ktheiss@ceocast.com, or Cormac Glynn, cglynn@ceocast.com, both of CEOcast,Inc., +1-212-732-4300, for CytRx Corporation
