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Marina Biotech Reports That Licensee ProNAi Therapeutics Initiates 'Brighton' Phase II Trial of PNT2258 in Patients With Richter's Transformation

BOTHELL, WA--(Marketwired - Nov 3, 2015) - Marina Biotech, Inc. (OTCQB: MRNA), a leading nucleic acid-based drug discovery and development company focused on rare diseases, today reported that its licensee, ProNAi Therapeutics, Inc. (NASDAQ: DNAI) has enrolled the first patient into the "Brighton" study, a Phase II clinical trial evaluating PNT2258 in patients with Richter's transformation. The international multi-center trial is expected to enroll approximately 50 patients with this rare form of cancer for which there are currently no approved therapies. PNT2258 is one of two nucleic acid-based therapeutics in clinical development which are formulated with Marina Biotech's proprietary SMARTICLES® delivery technology.

Marina Biotech further announces the issuance of Canada Patent 2,622,584, which covers the company's SMARTICLES delivery technology. The '584 patent broadly covers an amphoteric liposomal composition over a wide range of molar concentrations, with pH sensitivity for appropriate cellular uptake and release. In addition, the composition of NOV340, the clinical SMARTICLES formulation currently licensed to ProNAi Therapeutics, Inc., Mirna Therapeutics, Inc. (NASDAQ: MIRN) and MiNA Therapeutics, Ltd., is specifically covered. The claims cover liposomes for a wide range of possible nucleic acid therapeutics including single- or double-stranded payloads triggering various biological mechanisms of action. Additional claims are directed to pharmaceutical compositions and methods of use for gene silencing and treating disease.

"ProNAi Therapeutics' progress in developing this novel BCL2 DNAi therapeutic continues to be impressive," stated J. Michael French, president and Chief Executive Officer of Marina Biotech. "The ProNAi team has advanced multiple Phase II trials with PNT2258 establishing a comprehensive approach to the development of this therapeutic with the hope of treating numerous rare and underserved oncology indications. We believe SMARTICLES will continue to emerge as the most versatile delivery technology in the nucleic acid therapeutics sector, leading to additional licensing and partnering opportunities throughout the nucleic acid therapeutics sector. We look forward to the continued success of the ProNAi team in advancing PNT2258."

The Brighton Phase II study was designed on the basis of results from a pilot Phase II study of PNT2258, which were reported at the 2014 Annual Meeting of the American Society of Hematology (ASH). The investigators for that study concluded that PNT2258 treatment was well...


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