We have established new partnerships for Unidym. We have decreased Arrowhead’s capital requirements for Unidym by bringing in non-dilutive outside capital into the subsidiary. We have expanded our leadership with key additions to our Board, and we have improved our balance sheet, reduced our costs, and streamlined our operations.
That said, at the end of September, we introduced an aggressive list of goals for the remainder of the calendar year. We knew when we introduced this roadmap that our rapid and diligent action would be critical to meeting our objectives. We had 13 goals to accomplish in only three months. We have accomplished a vast majority of these goals, and I’m proud of their achievements. However, there were two key accomplishments that we have not yet achieved. So I’d like to start with those.
It was our goal to complete enrolling patients in Calando’s Phase 1 clinical trial and to complete its first partnership, and we are still working on these. I actually believe that the circumstances surrounding the need to extend our time horizon on these goals may ultimately be a positive for our mid and long-term value proposition. Allow me to explain.
Calando’s Phase 1 trial has been running for over two years now at two different sites. It is a dose escalation trial whose primary objectives are to determine the safety profile and to assume parameters of Calando’s lead candidate, CALAA-01. As you know, interim data were published at the 2010 ASCO Meeting and in the Scientific Journal of Nature reporting the early safety profile and positive delivery results respectively.We have reached dose levels where we can see targeted RNA and protein [ph] silencing via RNAi, but have still not determined the maximum tolerated dose, or MTD. While we are hoping to complete enrolling patients by the end of 2010, I think the fact that we are still recruiting patients is a positive sign. Our delivery system RONDEL has been very well tolerated, and we are still trying to determine what the MTD is. Read the rest of this transcript for free on seekingalpha.com