Message from the CEO
The month began with BioEurope in Cologne, where we had meetings with new pharmaceutical companies and companies that can coordinate Cyxone’s regulatory studies (CROs). I met representatives from pharmaceutical companies that are very active in Multiple Sclerosis (MS) and had very good discussions about T20K and Multiple Sclerosis. I also had some very important second round meeting with various CROs that will perform the important preclinical studies in 2017 for Cyxone, these studies will form the basis for Cyxone’s Phase I clinical study. Talks with three different CROs have been ongoing since September and we are now waiting for their concrete activity plans and prices. To optimize the development plan for T20K, discussions with drug developers that have different backgrounds are ongoing and very positive.
The candidate drug manufacturer sent us two different salts of T20K and our formulation experts in Denmark are now investigating their properties. Assay Development and regular analyses of T20K after “stress tests” of the drug candidate are being performed by a company in Lund. I hope that we will soon have data that enables us to choose the salt of T20K that will be included in the final formulation. The Swiss manufacturer will then be able to convert the T20K produced to the correct salt, which will then be used in the studies during 2017.
The experimental phase of the oral toxicity study with T20K has been completed and the report is expected later in December.
As I previously stated, we have spent some time selecting a good laboratory to do the “mouse MS” (EAE) study, to validate the studies performed by the research group in Vienna, Austria. I have rarely seen such a well-designed, consistently implemented and well documented mouse MS study from any other research laboratory than the one made at the Medical University of Vienna. Regardless of this, a new study in a different laboratory needs to be done to confirm the results. Unlike the Toxicity studies for example, (which have not been done before) I do not expect this new study to show any significant information that would require us to change our development plans. The laboratory selected is in Australia and has a lot of experience performing mouse MS studies; they can start the study in January.
Administration of T20K intravenously and abdominal yielded the expected results. The amount of free T20K in plasma following oral administration that showed pharmacological effects on the animals, was too low to be measured with certainty. Our bioanalysis laboratory in Austria are developing the analytical methods for us to be able to also measure low amounts of T20K.
So far, the work on T20K is as expected and we have experienced fewer “surprises” than I usually see in other projects.
I will meet the shareholders at the Aktiespararnas aktieträff at Hotel Anglais in Stockholm on 5 December. I am hoping that there will be many participants and questions to answer.
Stora Aktiedagen on November 28 was well attended and I am pleased with the interest in Cyxone that many demonstrated. Please take a look at the video presentation that can be accessed from our our website.
On December 6 we published an updated website, which we hope will make it easier to find information about the company and its activities. You will shortly be able to request the newsletter from the website to be delivered directly to your email.
New project manager at Cyxone
Last but not least, we welcome Leonard Saffer to Cyxone, he began on 1 December as the project manager for the various activities we have with companies around the world. Leonard is an experienced project manager and will ensure that our partners are working effectively towards our goals. You can read more about Leonard under the heading “About Us” on our website.
As this is the last newsletter for 2016 wishing everyone a Merry Christmas and New Year holidays!
Malmo December 6, 2016
Kjell G Stenberg