by John McCamant, editor The Medical Technology Stock Letter
Coronado (CNDO) recently announced the initiation of TRUST- I, a Phase II trial of TSO (CNDO-201) in patients with Crohn's disease.
TSO, the microscopic eggs of the porcine whipworm, is a novel, orally administered, natural immunomodulator that regulates T-Cells and inflammatory cytokines.
TRUST-I is a randomized, double-blind, placebo-controlled, U.S. multicenter study designed to evaluate the safety and efficacy of TSO.
Approximately 220 patients with Crohn's disease will be enrolled and randomized to receive either 7500 ova or placebo once every 2 weeks, over a period of 12 weeks.
The primary endpoint for the study is induction of response, as measured by the Crohn's Disease Activity Index (CDAI), with induction of remission being the secondary endpoint. The study is expected to be completed in the second half of 2013.
Coronado's development partner for TSO in Crohn's disease, Dr. Falk Pharma GmbH, is also conducting a Phase II double-blind, randomized, placebo-controlled, multi-center study in Europe to evaluate the efficacy and safety of TSO in active Crohn's disease.
Dr. Karin Hehenberger, their Executive Vice President and Chief Medical Officer, is a recognized expert and has spent most of her career in diabetes research.
She is currently leading and coordinating Coronado's research programs for TSO, the company's biologic agent for the treatment of autoimmune diseases, in such therapeutic areas as inflammatory bowel disease, type-1 diabetes, multiple sclerosis, psoriasis and autism.
The timely start of Phase II in Crohn’s disease in the U.S. is a positive for CNDO. We look forward to seeing what we expect to be positive data in the second half of 2013.
The ability of TSO to potentially have efficacy in type-1 diabetes is truly revolutionary as, to date, the medical community has had zero success in preventing type-1 diabetes.
The potential markets that TSO may address are so large, that eventually there is no way CNDO will be able to fully develop TSO by themselves.
Thus, once TSO delivers positive Phase II data, we would expect CNDO to ink multiple partnerships as Phase II data that demonstrates both efficacy and safety, opening up the entire field of autoimmune disease as potential markets for TSO.
Coronado just announced hat it has entered into a $15 million secured loan facility with Hercules Technology Growth Capital. We believe the loan ensures CNDO has enough cash to fund its clinical operations into 2014.
We are buyers of CNDO at current levels as we believe the current valuation will look ridiculous once positive Phase II TSO data is delivered. CNDO is a buy under $8.
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