Stephen Huhn, M.D., FACS, FAAPThis morning we have about 20 or 21 Slides to go through and as Martin said I’ll have some brief remarks in the first few slides and then I’m going to have Dr. Curt go through the interim data in more detail and then we’ll finish up with a Q&A at the end. The Phase I/II study design, just to remind everyone is an open label clinical investigation dealing with a single dose and a fixed dose of the human central nervous system stem cell which is delivered directly into the spinal cord at a dose of 20 million cells. Patients are immuno suppressed because this is an alginate transplant for a period of nine months post operatively. The trial is designed to enroll 12 subjects who have a thoracic level injury from the second thoracic segment down to the 11 th segment. Patients are eligible to enroll in this trial who are between three and 12 months after injury and this corresponds to what we believe is generally considered the sub acute or late sub acute to early chronic phase of spinal cord injury. In addition to the timeframe after injury patients who both have a complete and incomplete type of injury are eligible for the trial and will be enrolled in a sequential fashion. The first cohort of the trial, the subject of our discussion today, are those patients who have complete injury and by that I mean patients who have lost sensory function and motor function below the level of spinal cord trauma. This of course corresponds with what we call the AIS cohort A. The trial will then continue after we dose this first cohort into patients with incomplete injury AISA B and ASIA C patients. With each cohort we have a data monitoring committee that will review the status of not only the recent safety data but the equivalent safety data from the prior dosed patients as we continue in the trial. The trial is first and foremost designed to examine safety, tolerability, and feasibility of our interventions but we’re also obviously expanding a lot of effort to determine whether we have any signals of an effectiveness.
In that regard we examine the patients clinically for a number of sensory modalities in the thoracic area which include light touch, pinprick pain, and temperature sensation. We’re also doing tests to examine electrical impulse transmission in the spinal cord across the level of injury and this refers to what is known as somatosensory evoked potentials or SSEPs as well as electrical heat potentials, different sensory stimuli if you will that are then recorded to determine whether any electrical current across the level of injury. And then of course, MRI imaging as well.The summary today that we’ll be providing you with in more detail that Dr. Curt will go through has given us so far a very favorable safety profile. At this point with the six month interim data we have no adverse events that are related to the cells and there’s no evidence of any change in the pain threshold or sensation for the patients in terms of adverse concerns. Also, the surgery immunosuppression have been well tolerated in all three patients. As we have examined these patients over time at both the three and six month intervals, Dr. Curt and his team have observed considerable gains in sensory function in two of the three subjects. The third subject remains stable. What we have seen is changes in sensory modalities over more than one time of sensation and we see these in multiple segments below the level of injury. We’ve also been able to look at these sensory changes in a quantitative way as well as looking at electrophysiology and this is again, details that Dr. Curt will go into. But both the quantitative and electrophysiology are helping confirm the clinical examination changes that we are seeing for sensations in these two patients. So in general what we have seen no win this interim analysis is progressive and consistent changes in sensory function over more than one level in both of these patients and give what we understand to be the history of spinal cord injury recovery we think that these changes are unanticipated and we’ll show you some data from the European network that speaks to this in detail. Read the rest of this transcript for free on seekingalpha.com