TBI Trials Update
You may have seen the news: On Friday, Dec.4, we reported the dosing of the first patient in our Phase II-b TBI trial in Switzerland. Frankly, it took a lot longer to get that first patient into the trial than I expected. So I want to use this Blog entry to help you understand why.
Switzerland’s government system played a role in that every Canton (State) has its own set of laws and structures. Two sites are now up and running: Berne and Zurich. In Geneva and St. Gallen the use of Licox probes (devices that are put on the skull with a probe placed into the brain) had to be introduced. Everyone understands that we want to be sure that drilling a hole in a head is done right. So, as you can imagine, that required specific additional logistics and training. In Aarau, our principal investigator was on an extensive sick leave. Lausanne withdrew because of resource reasons, but we are in the process of adding Lugano as a site. Basle and Geneva again had lengthy and complex contract processes, but these are now resolved and they should be up and running shortly.
In Israel three of four sites have final approval from all concerned. We had two main issues to overcome there. The first, extensive contract negotiations to allow for the ever-declining dollar exchange rate, just crawled until an agreement was reached. These contracts have now been executed. Also, three of four sites there did not have Licox probes and we had to purchase them for the sites. Again, training and logistics were the same as in Switzerland. We’re now at a point where Israel should be ready for enrollment within the next week or two. At the fourth site, there are still logistical issues and the contract is still in review by the hospital’s counsel.
In this trial, we’re dealing with peoples’ lives. Our main criterion in the trial is safety. We therefore intentionally did not rush enrollment in the early stage. We believe this caution is prudent. If you look at the history of our failed competitors, they showed us how dangerous it is to rush a trial. We will not do that.
In a related matter, we’ve been asked whatever happened to the application the company submitted for Orphan Drug designation for Oxycyte for the treatment of patients with severe, closed-head TBI. The answer is that there were too many incidences of this kind of TBI in our country to meet the Orphan Drug designation criteria of fewer than 200,000 cases. That is actually a nice official proof of market size. So rather than try to push that further, we kept the issue pending. We felt we have more important things to do right now, and that developing our pipeline is more important than following on a designation that has literally no commercial value.
As for the stock listing change, we have applied to both the NYSE AMEX and NASDAQ. Each has pros and cons. We are diligently working with both exchanges and believe we would fit either one. We hope to make an announcement very soon.
The holidays are approaching fast and we thank you for your loyal support. We extend the greetings of the season and wish you a happy, healthy, and successful new year.