Updated on 7 February 2013
What were some of the highlights of 2012?
Clinical and preclinical development of intravenous product formulation for a wide range of systemic diseases is one highlight. The company generated positive preclinical results in primate model of type 2 diabetes; commenced phase II trial for type 2 diabetes and its complications; generated positive preclinical results in large animal model of inflammatory arthritis, showing concomitant effects on multiple pathways of joint inflammation; and plans are underway to initiate phase II clinical program in rheumatoid arthritis with additional planned applications including diabetic kidney disease, lung diseases.
Also, we completed enrollment in the phase II trials for non-surgical treatment of degenerative lumbar disc disease and for spinal fusion surgery. Phase II trial in congestive heart failure (CHF), identifying an MPC dose that prevented any hospitalization or death for a mean follow-up period approaching three years, was also completed.
The company also implemented product manufacturing strategy to facilitate scale-up, meet regulatory compliance for phase III and provide commercial supply. It reached an agreement with the US FDA on the manufacturing process to supply MPCs for use in the upcoming phase III trial for congestive heart failure, in phase III trials for other indications, and on the path forward for commercial supply.
What are the plans and strategies for 2013?
This year, we expect commencement of phase III trial for congestive heart failure involving an early interim analysis to evaluate evidence of efficacy; commencement of phase III trial for lumbar spinal fusion and clinical results in phase II trials with early type 2 diabetes and intervertebral disc repair.
Also, phase II trial for acute myocardial infarction and phase III for bone marrow transplant will continue. The company also plans to expand focus on intravenous product franchise with commencement of phase II trials for rheumatoid arthritis, diabetic kidney disease and lung diseases. We will explore additional partnering opportunities and optimal timing for growth.