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FOR IMMEDIATE RELEASE
SAN DIEGO (September 10, 2007) –CytRx Corporation's (NASDAQ:CYTR) majority-owned subsidiary RXi Pharmaceuticals Corporation (RXi) today announced that it has entered into an agreement with privately-held TriLink Biotechnologies, Inc. to exclusively license three RNA interference (RNAi) chemistry technologies for all therapeutic RNAi applications. The agreement includes rights to sublicense a patented RNA linker technology, a patent application on novel RNAi compositions and a novel, undisclosed chemistry approach that has potential applications in improving existing RNAi compounds.
Terms of the license agreement include upfront and yearly minimum licensing payments, royalties of 1% or less from RXi to TriLink on sales of therapeutic products developed from technologies included in the license agreement, and payments based on the achievement of certain clinical milestones. Additional terms of the agreement were not disclosed.
RNAi has been shown to effectively interfere with the expression of targeted disease-associated genes and was co-discovered by 2006 Nobel Laureate Dr. Craig C. Mello, who is a co-founder and Scientific Advisory Board Chairman of RXi.
Tod Woolf, Ph.D., CEO of RXi, stated, "This chemistry technology adds components to our expanding RNAi toolbox and can be integrated with our existing technology portfolio to create advanced proprietary RNAi compounds that we call rxRNA(TM). rxRNA(TM)is patently distinct from first generation siRNA and has shown certain potential advantages in terms of potency and other pharmacological properties. The licensed technology was created by the TriLink chemists, who have been recognized leaders over the past decade in the design and manufacture of advanced RNA compounds."
TriLink President and CEO Richard Hogrefe said, "We are delighted to license these technologies for RNA therapeutic applications to RXi. We believe RXi is well positioned to make an immediate impact in advancing RNAi-based therapeutics and the addition of our chemistry technologies will further facilitate this important work."
Licensed RNA Chemistry
The license agreement includes rights to the following technologies:
-- Pre-Activated Carbonyl Linker for the modification of oligonucleotides (U.S. Patent No. 6,320,041): This compound allows for modification of RNA, such as coupling carrier molecules for targeted delivery, in a convenient and inexpensive manner during solid phase synthesis. The compound allows rapid screening of a wide variety of compounds without the need to create expensive activated reagents for each conjugation. Following target conjugate identification, the reagent allows for direct scale-up to the amount of material required for clinical study.
-- Chimeric RNA-DNA duplexes (Patent Pending): These novel RNAi-like compounds, comprised of a RNA antisense strand and a modified DNA sense strand, were designed to provide potential specificity advantages compared with first generation siRNA. These compounds were reportedly effective in a collaborative HER-2 breast cancer model studied by Prof. Esther Chang of Georgetown University and TriLink.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The Company owns three clinical-stage compounds based on its small molecule "molecular chaperone" co-induction technology. In September 2006, CytRx announced that arimoclomol was shown to be safe and well tolerated at all three doses tested in its Phase IIa clinical trial in patients with ALS. The Company plans to enter a Phase IIb clinical trial with arimoclomol in ALS in 2007, subject to FDA clearance. The FDA has granted Fast Track designation and Orphan Drug status to arimoclomol for the treatment of ALS, which has also been granted orphan medicinal product status for the treatment of ALS by the European Commission. The Company has announced plans to commence a Phase II clinical trial for arimoclomol in stroke recovery in the first half of 2008, subject to FDA clearance. The Company has also announced plans to commence a Phase II clinical trial with its next drug candidate, iroxanadine, for diabetic foot ulcers in the first half of 2008, subject to FDA clearance. CytRx has recently opened a research and development facility in San Diego. For more information on the Company, visit www.cytrx.com.
About RXi Pharmaceuticals Corporation
Worcester, Massachusetts-based RXi Pharmaceuticals Corporation, a majority-owned subsidiary of CytRx, is a biopharmaceutical research and development company that focuses on developing RNAi-based therapeutics for the treatment of human disease. RXi's initial focus is on neurodegenerative diseases, oncology, type 2 diabetes and obesity. RXi has licenses to a diverse series of early patents and patent applications that were filed from 1998 to 2006 in the areas of RNAi target sequences, RNAi chemistry and RNAi delivery. The Company was founded by CytRx and RNAi pioneers Craig Mello, Ph.D., 2006 Nobel Laureate for discovering RNAi and inventing RNAi therapeutics; Tariq M. Rana, Ph.D., inventor of fundamental technology for stabilizing RNAi and of RNAi nanotransporters; Greg Hannon, Ph.D., discoverer of RNAi mechanism (RISC) and short hairpin RNAi (shRNAi); and Michael Czech, Ph.D., a leader in the application of RNAi to diabetes and obesity. RXi's CEO, Tod Woolf, Ph.D., previously co-invented and commercialized STEALTH(TM) RNAi, one of the most widely used second-generation RNAi research products. For more information on RXi, please visit www.rxipharmaceuticals.com.
About TriLink
TriLink BioTechnologies, Inc. manufactures custom oligonucleotides, nucleoside triphosphates, and synthesis reagents for research and diagnostic laboratories. In addition, it offers radiolabeling services, custom chemistry, contract research services and GMP production facilities for oligos and small molecules. TriLink employs leaders in the field of RNA chemistry and had been awarded several research grants from the National Institutes of Health (NIK). TriLink's solutions help advance drug discovery and biomedical research. For more information visit www.trilinkbiotech.com.
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. 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 RXi's need to raise future capital to fund operations and development of its potential products, intense competition with other companies focused on RNAi and other larger companies with RNAi programs and with other existing or new therapeutic modalities, the early stage of development of RXi's technology, and the scope, timing and outcome of pre-clinical and clinical testing and regulatory review of RXi's potential products. Additional risks or uncertainties are described in CytRx's most recently filed SEC documents, such as its most recent annual report on Form 10-K 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.
TriLink BioTechnologies
Lisa Olivier, 858-546-0004