Marina retains Numoda for Phase Ib/IIa trial of lead compound

Marina Biotech (NASDAQ:MRNA) will work with the CRO Numoda Corp for the Phase Ib/IIa trial of its
lead compound, CEQ508, in familial adenomatous polyposis (FAP), CEO J. Michael French said.
The Phase Ib/IIa trial will begin within the next few weeks, French said, noting that enrollment will
begin soon after local approval from the clinical trial site, Massachusetts General Hospital, is attained.
The company will work with Numoda for the 30 patient trial that will assess the knock-down of betacatenin
in the epithelial cells of the small and large intestine—regions where beta-catenin is
known to be dysregulated in FAP. Results from the 28 day study and subsequent dose escalation
portion are expected by 3Q11, with interim results in between, French said.
FAP is predominantly a genetic condition in which individuals develop colon polyps in their teens and
colon cancer by their early 40s, often requiring colon resection, French said. Since FAP is an orphan
disease that afflicts approximately one in 10,000 individuals, Marina will consider filing for orphan drug
status, the CEO said, noting that the timing and strategy on doing so is currently undetermined.
CEQ508, an oral agent, utilizes the TransKingdom RNA interference platform. The agent is comprised
of attenuated bacteria that are engineered to enter into dysplastic tissue and release short-hairpin
RNA, which targets the mRNA of beta-catenin, French explained, adding that he is "confident" in the
safety profile of the agent as there have been no safety concerns seen to date in long-term toxicology