RNAI Sirna Therapeutics

Companies Initiate RNAi-based Therapeutic Effort Against Asthma and RSV SAN FRANCISCO, May 4 /PRNewswire-FirstCall/ -- Sirna Therapeutics, Inc. (NASDAQ:RNAI), a leading RNAi therapeutics company, today announced that as part of its exclusive, multi-year collaboration with GlaxoSmithKline (GSK) in respiratory diseases, the companies have initiated programs in asthma and respiratory syncytial virus (RSV). As part of the respiratory collaboration, the companies also plan to pursue RNAi-based therapeutics against chronic obstructive pulmonary disease (COPD) and allergic rhinitis. Sirna will provide GSK with optimized and formulated siRNAs against targets for these diseases and GSK will assume all responsibility for the further preclinical and clinical development of compounds that emerge from these programs. RNA interference (RNAi) is a natural, selective process for turning off genes. Sirna designs and develops short interfering RNA (siRNA) compounds which down regulate the expression of critical proteins responsible for viral replication and pathogenesis. GSK is a world leader in the discovery and development of treatments for respiratory diseases and has a wealth of expertise in inhaled and intranasal drug delivery technologies. Local delivery of siRNA to the respiratory tract will substantially enhance the feasibility of developing successful treatments with this exciting new platform technology. "Sirna has demonstrated the ability to develop chemically modified and optimized siRNA compounds and then deliver those compounds effectively into the lung with our nanoparticle formulations," stated Barry Polisky, PhD, Chief Scientific Officer at Sirna. "Further, we have demonstrated that our proprietary approach to targeting the conserved region of a viral genome has resulted in significant viral knockdown in a non-human primate model. With these encouraging results and together with the combined efforts of Sirna and GSK scientific teams, we expect to expedite the development of novel RNAi-based therapies -- those efforts initially focused on asthma and RSV." Sirna is the first company to file enabling patents for over 250 important mammalian disease targets including respiratory targets such as MMP-13, IL-4, IL-13, VCAM, and ICAM as well as antiviral targets such as RSV. In addition, Sirna has been granted patent claims in the U.K. and has pending claims in the U.S. that broadly cover any siRNA molecule that targets conserved sequences within a virus or a gene. COPD is a disorder characterized by shortness of breath, chronic cough and sputum production. Cigarette smoking is the predominant etiologic factor in the development of COPD, and The World Health Organization (WHO) estimates the prevalence of COPD to be 600 million worldwide. By the year 2020, COPD is expected to be the third leading cause of death and the fifth leading cause of disability. Asthma is a chronic respiratory disease that currently affects 15 million people in the U.S., causes approximately 5,000 deaths per year and accounts for an estimated $13 billion in annual healthcare costs. Allergic rhinitis (AR) results from a local defense mechanism in the nasal airways that attempts to prevent irritants and allergens from entering the lungs. AR affects approximately 20% of the U.S. population. Over-the-counter treatments are estimated to be approximately $55 billion dollars per year and prescription medications exceed $6 billion per year worldwide. The financial impact of lost productivity is estimated to be $1.5 billion dollars per year. Respiratory syncytial virus is a highly infectious agent affecting children under the age of two. RSV can lead to serious lower respiratory infections such as pneumonia and can be fatal to infants born with lung or heart problems. About Sirna Therapeutics Sirna Therapeutics is a clinical-stage biotechnology company developing RNAi-based therapies for serious diseases and conditions, including age-related macular degeneration (AMD), hepatitis B and C, dermatology, asthma, RSV, Huntington's disease, diabetes and oncology. Sirna Therapeutics completed its Phase 1 clinical trial for Sirna-027 in AMD in 2005 and with its strategic partner, Allergan, Inc., will move Sirna-027 into Phase 2 clinical trials in 2006. Sirna has selected a clinical compound for hepatitis C virus, Sirna-034, which the Company plans to bring into Phase 1 clinical trials by the end of 2006. Sirna has established an exclusive multi-year strategic alliance with GlaxoSmithKline for the development of siRNA compounds for the treatment of respiratory diseases. Sirna has a leading intellectual property portfolio in RNAi covering over 250 mammalian gene and viral targets and over 175 issued or pending patents covering other major aspects of RNAi technology. More information on Sirna Therapeutics is available on the Company's web site at http://www.sirna.com/. About RNA interference RNA interference (RNAi) is a natural, selective process for turning off genes. RNAi is triggered by short interfering RNA (siRNA) molecules that engage a group of cellular proteins, known as RISC (RNA induced silencing complex). The RISC guides the siRNA to its target messenger RNA (mRNA, the messenger between DNA and proteins) by complementary base pairing for the targeted break-up of the mRNA thus halting protein expression or viral replication. The RISC-siRNA-complex binds and cleaves multiple mRNA molecules in a catalytic fashion. Safe Harbor Statement Statements in this press release which are not strictly historical are "forward-looking" statements which should be considered as subject to many risks and uncertainties. For example, most drug candidates do not become approved drugs. Sirna currently does not have any clinical drug candidates for the treatment of respiratory diseases, and the development of Sirna-027 and Sirna-034 as well as Sirna's other programs are still at a relatively early stage. All of these programs, and Sirna's ability to obtain milestone and royalty payments for them, are subject to significant risks and unknowns, are highly contingent upon future successes, and require significant funding. In addition, patent applications may not result in issued patents, and issued patents may not be enforceable or could be invalidated. Other risks and uncertainties include, among others, Sirna's early stage of development and short operating history, Sirna's history and expectation of losses and need to raise capital, Sirna's need to obtain clinical validation and regulatory approval for Sirna-027, Sirna-034 and Sirna's other product candidates, any of which could have negative results, Sirna's need to engage collaborators, Sirna's need to obtain and protect intellectual property, and the risk of third-party patent infringement claims. These and additional risk factors are identified in Sirna's Securities and Exchange Commission filings, including the Forms 10-K and 10-Q and in other SEC filings. Sirna undertakes no obligation to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this release. Contacts: Rebecca Galler Robison, Senior Director, Corporate Strategy, Sirna Therapeutics, Inc., 303-449-6500 Alan Zachary, Director of Public Relations, McKinney|Chicago, 312-944-6784 x. 316 DATASOURCE: Sirna Therapeutics, Inc. CONTACT: Rebecca Galler Robison, Senior Director, Corporate Strategy of Sirna Therapeutics, Inc., +1-303-449-6500; or Alan Zachary, Director of Public Relations of McKinney|Chicago, +1-312-944-6784, ext. 316, for Sirna Therapeutics, Inc. Web site: http://www.sirna.com/

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