NEW Treatments for Crohn's, MS, Autoimmune Diseases - Good Read!

Good reading about 2 treatments in the making to treat diseases 

such as MS, IBD & Type 1 diabetes.  This is the 1st I've read about 

this treatment. They discuss a lot of financial aspects in this article, but 

also explain how these treatments work to halt abnormal immune function .  

Intrepid Investors Eye Use Of Pig Whipworm Eggs To Quell Crohn's Disease and MS

Dr. Lindsay Rosenwald is a familiar name on Wall Street, a long-time investor with 23 years of experience as a biotechnology entrepreneur, instrumental in founding and recapitalizing a large number of public and private life sciences companies, including Cougar Biotechnology which was acquired by Johnson & Johnson for $1 billion in 2009.

The latest company he has formed is again catching the eye of biotech investors: Coronado Biosciences (CNDO), which is developing two therapies that alter the activity of the immune system. Its probiotic treatment consists of “Trichuris suis ova (TSO),” or non-infectious porcine whipworm eggs, to quell inflammation and abnormal immune function that causes such autoimmune diseases as multiple sclerosis (MS), inflammatory bowel disease, and type 1 diabetes.

“The lead indication is Crohn’s Disease, though MS is not far behind,” says Dr. Keith A. Markey, life sciences analyst at investment firm Griffin Securities. Its second program, he notes, relies on a proprietary method to activate natural killer cells of the innate immune system to combat cancer. Those killer cells, which have shown promise against solid and hematological malignancies, are being developed to treat acute myeloid leukemia, says the analyst.

“Coronado has a proprietary method of activating the killer cells ‘ex vivo’ to create a personalized medicine for a variety of malignancies, says Dr. Markey. Coronado is collaborating with European companies on the probiotic project and will likely seek other foreign companies to market its natural killer-cells therapy, he adds.

Joseph Pantginis, biotech analyst at Roth Capital Partners, is also high on Coronado’s two therapies. “We see significant potential with Coronado’s two clinical programs, based on encouraging preliminary signs of efficacy and favorable safety,” he says. The analyst expects the launch of a Phase 2 study of TSO in patients with Crohn’s disease in the second quarter of this year, while interim data from a randomized Phase 2 study conducted by Coronado’s partner, Dr. Falk Pharma, is also expected to be announced sometime within that period.

Pantginis rates Coronado’s stock, currently trading on the NASDAQ at $7.44 a share, as a buy with a price target of $24, based in part on his belief that Coronado represents a significant value on TSO’s potential to address large market, if not blockbuster, opportunites.

Dr. Bobby W. Sandage Jr., president and CEO of Coronado, says that results from a series of proof-of-principle clinical studies have demonstrated that TSO is “safe and well tolerated with no side effects or complications.” He says the use of pig whipworm eggs represents a novel approach to treating autoimmune diseases. Sandage says the company has licensed numerous patents in the field to gain exclusive rights to commercialize the technology in North America, South America and Japan.

Griffin’s analyst Dr. Markey says epidemiological data suggest that parasitic worms have played an important yet unappreciated role in helping to hold the human immune system in check. As living standards have improved over the past 100 years and medicines developed to treat helminth infections, autoimmune diseases have become more common.

Preclinical studies have shown, says Dr. Markey, that helminths (parasitic worms) use various mechanisms to protect themselves from detection and attack by the human immune system. Coronado’s therapy, Dr. Market notes, which consists of eggs of the pig whipworm TSO, takes advantage of the natural protective mechanisms of helminths, which have evolved over eons, to treat intractable diseases. Just as important, he adds, the ova or eggs pose no threat to humans as they are not infectious and cannot be spread from one person to another.

These huge, under-served markets offer large potential returns on Coronado’s R&D investments. Dr. Markey says Coronado is “developing its helminth therapy to treat autoimmune diseases that have failed to respond well to medicines thus far.” Yet they affect the daily lives of an estimated 10% of the world’s population, he says.

The difference between Coronado’s approach and traditional therapy is that the new treatment is able to “respond in a multi-faceted manner and perhaps dynamically to an aberrant immune system.” Given the “limited success of today’s drugs, the size of the patient populations, and the unique traits of helminths, it seems likely that Coronado’s R&D investments will yield above-average returns,” says Dr. Markey. Coronado’s CNDO-201 treatment is being developed as a first-line therapy for Crohn’s Disease and Multiple Sclerosis, notes the analyst.

Coronado’s other product, CNDO-109, involving the natural killer cells, is another logical choice for combating cancer, he says. It stems from early work conducted at the National Cancer Institute, based on a proprietary method of activating key cells of the innate immune system. Natural killer cells normally play an important role in inducing apoptosis of cancerous cells and others that have been infected with viruses.

Coronado’s therapy activates the cells ex vivo and then administers those cells to the patient. Results of a Phase 1 study, rcently presented at the 2011 Annual Meeting of the American Society of Hematology, showed three of five patients in their second or third remissions had longer complete responses with CNDO-109 than with other therapies, says Dr. Markey. This is an unusual activty as acute myeloid leukemia is characterized by progressively shorter remission periods regardless of the drug regimen, says the analyst.

“We believe Coronado Bioscience stock is an attractive long-term holding,” says Dr. Markey. Its two development programs, he says, take advantage of the natural characteristics of TSO and the natural killer cells to address serious medical conditions, and as such “we believe they carry less risk than that of traditional drug development projects.”