Marina Biotech, Inc., a RNAi-based drug discovery and development company, have announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for patent application U.S. 12/114,284, covering its proprietary DiLA2 delivery platform. The allowed claims provide patent protection for a broad array of DiLA2 molecules as well as formulations based on these DiLA2 molecules, including liposomes, emulsions and micellar dispersions; and pharmaceutical compositions of DiLA2 molecules with therapeutic nucleic acids, including siRNA, microRNA, meroduplex siRNA (3-stranded siRNA), single-stranded RNA and short-hairpin RNA (shRNA); and finally, methods for treating human disease using the DiLA2 delivery platform.
"Our proprietary DiLA2 delivery technology provides a means for creating an extensive library of delivery formulations that may be tailored for delivery of RNAi-therapeutics to specific tissues," stated J. Michael French, President and CEO at Marina Biotech. "With our newest DiLA2-based formulations, we have recently achieved a 10-fold improvement in activity with an accompanying increase in the therapeutic window. We have applied the technology to the delivery of our proprietary UsiRNA constructs as both single agents and as a combination of two UsiRNAs, as well as the delivery of a microRNA mimetic. We are pleased that the USPTO recognizes the novelty and significance of our DiLA2 delivery platform. This allowance significantly enhances the company's IP position, reinforces Novartis' decision to non-exclusively license the technology and further establishes our competitive advantage with respect to RNAi-based delivery systems."
In summary, the allowed claims protect DiLA2 molecules, DiLA2-based formulations, methods for delivering biological agents (e.g., siRNA) with DiLA2 molecules/formulations and methods for treating human diseases with DiLA2-based formulations.
Thus far, DiLA2-based formulations have demonstrated:
-- Physical and chemical stability for over a year in storage conditions
ranging from -80 degreesC to -40 degreesC while maintaining in vivo
-- Effective delivery of the Company's Unlocked Nucleic Acid (UNA)
modified small interfering RNA (UsiRNA) in cancer models involving
both local (intravesical) and systemic (intravenous) delivery for
bladder and liver cancer, respectively
-- Effective systemic delivery of a microRNA in a subcutaneous tumor
-- Increased efficacy as measured by a reduction in tumor volume in a
bladder cancer model with two unique UsiRNAs combined within a single