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Will Coronado's Data Help Sell Wall Street and Big Pharma?
Earlier this week, Coronado Biosciences, Inc. (NASDAQ: CNDO) announced that Phase 1 TSO Data will be presented as an oral presentation at the 8th International Congress on Autoimmunity to be held May 9-13, 2012 in Granada, Spain. Why should investors care?
If you don't yet know what this biopharmaceutical company is up to and why this is one of the most intriguing biotech plays in healthcare, then chances are you haven't heard about TSO (Trichuris suis ova or CNDO-201). This treatment is made up of microscopic eggs of the porcine whipworm and while you may not yet understand it, there is more and more evidence that this novel, orally administered, natural immunomodulator regulates T-Cells and pro-inflammatory cytokines.
As you will see in my interview with CEO Bobby W. Sandage, Jr., Ph.D., the use of porcine whipworm eggs as a promising therapeutic agent is based on the "hygiene hypothesis" and numerous animal and human studies which presented truly compelling data.
"It’s an intestinal worm," explains Sandage. "It’s an intestinal parasitic worm and the one that we used that was invented at the University of Iowa by these three doctors we call it TSO. It’s short for Trichuris ova and it’s the pig whipworm eggs if you will. TSO, Trichuris was selected by the inventors at the University of Iowa because it had a number of features that were beneficial to human exposure. One, when you take it, it causes the immunological immuno-modulating response that you want but it doesn’t cause any permanent infection and they simply die in a couple of weeks and are eliminated from the body. You have to take it every two weeks to continue to get the effect. It has some other features. It never leaves the GI tract, doesn’t get in the bloodstream. There’s no way to infect another person with it and it turns out the ova or the eggs are very stable and I can put it through what it needs to do to become a pharmaceutical grade dosing unit." The management team and early investors behind Coronado Biosciences chose TSO as the biological agent precisely because it is not a human pathogen, and is spontaneously eliminated from the body just weeks after dosing. What these organisms appears to do while they are in the human body, however, is what is causing the medical community to take a long, hard look at the implications presented by this discovery for many, many autoimmune diseases.
"We have four studies completed," says Sandage."The first one was done in 29 patients with Crohn’s disease where we were able to demonstrate that over 72% of the patients had clinical remission at the end of 24 weeks of treatment and almost 80% had a clinical response. We also have a double-blind, placebo-controlled trial in ulcerative colitis patients in where the placebo rate was about a 17% response whereas the TSO group had a 43% response, more than doubling the response rate in the patients with ulcerative colitis. Then we have an initial trial in multiple sclerosis where the investigator at the University of Wisconsin showed a 70% reduction in what’s known as a gadolinium-enhanced MRI lesion so a surrogate of the disease of the neurons found in multiple sclerosis patients. When he stopped the treatment it went right back up to having diseased neurons.The fourth study is a study we just finished in which it was called a single-dose dose escalation. We went up to very high doses, more eggs, up to 7500 eggs and it was extremely well tolerated with only mild GI side effects being seen in just a few people that were self-limiting and didn’t even require any treatment."
Despite attempting to run and stay higher, the big-board listed stock continues to find it's way back to the $6.50-$7.00 range. As investors have begun to discover the emerging biotech company, new speculators appear captivated by the science and Coronado's story, but it may take the type of data seen in earlier studies to really sell Wall Street into buying and keeping Coronado shares. I would not bet against that scenario or the senior managers, board of directors and the scientific advisory board. The list here reads like an impressive who's who and this is a company built not only for the race, but to get across the finish line.
In addition, Dr. Lindsay A. Rosenwald, M.D.- who among other things, helped shape and sell Cougar Biotech for $1 billion in cash to Johnson&Johnson in record time back in 2009-- is placing a big bet on CNDO; telling me candidly about his hopes for Coronado; one of his "all-time favorites."
The BioMedReports FDA Calendar shows several milestones for the company, including some key data reveals this year. I invite our readers to become familiar with CEO Bobby Sandage and Coronado Biosciences by paying close attention to our exclusive interview. Keep CNDO on your watchlist they could be on to something big with these porcine whipworm eggs. Really.
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