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

Things that passed at Numoda Corporation

Cowen Group 31st Annual Healthcare Conference
March 7-9, 2011, Boston MA

JP Morgan 11th Annual Healthcare Conference
January 10-13, 2011, New York NY

Biotech Showcase 2011
January 10-12, 2011, San Francisco – Union Square

One Med Forum
January 11-13th, 2011, San Francisco

Rodman & Renshaw 12th Annual Healthcare Conference 
September 12-15, 2010, New York NY

Canaccord Adams Global Growth Conference
August 10-13, 2010, Boston, MA

BMO Capital Markets, 10th Annual Focus on Healthcare Conference
August 5, 2010, New York, NY

Numoda Lawsuit

Rules of procedure and complications in lawsuits

Rules of criminal or civil procedure govern the conduct of a lawsuit in the common law adversarial system of dispute resolution. Procedural rules are additionally constrained/informed by separate statutory laws, case law, and constitutional provisions that define the rights of the parties to a lawsuit (see especially due process), though the rules will generally reflect this legal context on their face. The details of procedure differ greatly from jurisdiction to jurisdiction, and often from court to court within the same jurisdiction. The rules are very important for litigants to know, however, because they dictate the timing and progression of the lawsuit—what may be filed and when, to obtain what result. Failure to comply with the procedural rules may result in serious limitations upon the ability to present claims or defenses at any subsequent trial, or even dismissal of the lawsuit.

Though the majority of lawsuits are settled and never reach trial,^[3] they can be very complicated to litigate. This is particularly true in federal systems, where a federal court may be applying state law (e.g., the Eriedoctrine in the United States) or vice versa, or one state applying the law of another, and where it additionally may not be clear which level (or location) of court actually has jurisdiction over the claim or personal jurisdiction over the defendant. For example, about 98 percent of civil cases in the United States federal courts are resolved without a trial. Domestic courts are also often called upon to apply foreign law, or to act upon foreign defendants, over whom they may not, as a practical matter, even have the ability to enforce a judgment if the defendant's assets are outside their reach.

Lawsuits become additionally complicated as more parties become involved (see joinder). Within a "single" lawsuit, there can be any number of claims and defenses (all based on numerous laws) between any number of plaintiffs or defendants, each of whom can bring any number of cross-claims and counterclaims against each other, and even bring additional parties into the suit on either side after it progresses. However, courts typically have some power to sever claims and parties into separate actions if it is more efficient to do so, such as if there is not a sufficient overlap of factual issues between the various associates.

Welcome| Numoda Corporation

Numoda is the pioneer of a new model for supporting life sciences companies as they move from clinical development of innovative treatments to ultimate relationships with marketing partners.

Our model aligns with both sponsor and vendor needs, addressing the broader issues that active and complex clinical trials face, by providing a single integrated location your entire trial.

The Numoda approach – which has been proven across scores of relationships – calls for Numoda to share the risk with promising life sciences companies by assisting in business functions such as budgeting and logistics, and to apply patented information technologies and management expertise to achieve the successful completion of vital clinical trials.

The result is a unique partnership between Numoda’s finance, technology, and trial management specialists and innovative companies that, in the process, become better able to develop life-enhancing and life-saving treatments for the health of consumers of the future

Numoda Corporation: Events

Cowen Group 31st Annual Healthcare Conference
March 7-9, 2011, Boston MA

JP Morgan 11th Annual Healthcare Conference
January 10-13, 2011, New York NY

Biotech Showcase 2011
January 10-12, 2011, San Francisco – Union Square

One Med Forum
January 11-13th, 2011, San Francisco

Rodman & Renshaw 12th Annual Healthcare Conference 
September 12-15, 2010, New York NY

Canaccord Adams Global Growth Conference
August 10-13, 2010, Boston, MA

BMO Capital Markets, 10th Annual Focus on Healthcare Conference
August 5, 2010, New York, NY

Numoda Technologies

Our Point of View

All our work is driven by the knowledge that successful clinical trials are the pathway to consumer use – and ultimate commercial success. To be successful, however, is not easy: Too many good drugs fail to reach people in need simply because of mismanaged clinical trials.

It is surprising — even shocking — that one of the top five reasons that clinical trials fail is the inability to maintain adequate and accurate records. This means that what is essentially sloppy bookkeeping prevents important new treatments from reaching the market — and eventually helping people in need.

Our point of view is clear: We hate to hear of good drugs failing as a result of mismanaged trials. We create new platforms and applications designed for efficient clinical trials because we never want to see promising new treatments fall victim to the avoidable flaws of clinical research.

All our applications development is measured by these bedrock principles. To all our partners we say: Our goals are your goals.

• Transparency
• Speed
• Collaboration
• Efficiency
• Integration
• Commercialization

These principles drive our culture. They pervade all we do, govern our work, and drive our results.

A Green Trial

In addition to its commitment to bring efficiencies and reduced risk to the drug development process, Numoda is also committing to reducing the amount of unnecessary paper utilized by the pharmaceutical industry.
Numoda’s single interface provides the life science industry with a green alternative to traditional paper studies.  By having one centralized location for all trial documents and reports, you can access your trial from any location, without having to print countless spreadsheets, patient diaries, etc.
You will be able to have the security of knowing that all your trial data is all in one place, and the comfort of knowing you benefit the environment. And of course travel, particularly global travel, is greatly reduced thanks to the single interface capabilities.

Numoda

Numoda is the pioneer of a new model for supporting life sciences companies as they move from clinical development of innovative treatments to ultimate relationships with marketing partners.

Our model aligns with both sponsor and vendor needs, addressing the broader issues that active and complex clinical trials face, by providing a single integrated location your entire trial.

The Numoda approach – which has been proven across scores of relationships – calls for Numoda to share the risk with promising life sciences companies by assisting in business functions such as budgeting and logistics, and to apply patented information technologies and management expertise to achieve the successful completion of vital clinical trials.

The result is a unique partnership between Numoda’s finance, technology, and trial management specialists and innovative companies that, in the process, become better able to develop life-enhancing and life-saving treatments for the health of consumers of the future