This issue of the newsletter is a little later than planned due to two international events, Swiss Nordic Bio and Sachs Forum, which were held in the past two months. Because I presented Cyxone and how T20K can combat MS in presentations at both events, a certain degree of preparation was necessary to deliver as positive and up-to-date information as possible. And once you return home after such meetings, it’s just as important to follow-up with those who have shown interest in T20K.
T20K’s continued development
The knowledge that we have gained since May 2016 clearly suggests that researchers in Vienna and Freiburg were right about T20K being effective against MS in mice and having low toxicity. Even allowing for natural variations between different laboratories in terms of the mouse models of MS, I am extremely pleased that it has been possible to prevent mouse MS with 5 or 10mg single doses, and by giving T20K orally when mouse MS is induced. That T20K seems to be as effective against mouse MS as the leading MS product Gilenya is something that we take with us for clinical evaluations of T20K – and we know that Gilenya can cause significant side effects.
Development programme structure
The structure of T20K’s continued development programme has been the subject of lively debate between Cyxone, researchers in the field, Sourcia and experienced and knowledgeable experts in the companies that conduct preparations, stability studies, toxicity studies and kinetic studies of new drugs.
As I mentioned in the February newsletter, it appears that the toxicity we see is likely due to the free amount of T20K in plasma when administered intravenously, while the effect on MS appears to depend on the total amount of T20K given to animals, regardless of how it is administered. This is particularly evident when T20K’s preventative effect on mouse MS is observed up to seven days after treatment.
Planning prior to clinical studies
To continue to build on these observations, we plan to administer T20K via infusion in upcoming Phase I clinical trials. With an infusion, T20K is slowly introduced to the body’s circulation which creates a low free amount of the substance in plasma, while sufficient amounts of the inhibitor are introduced to the body to have a measurable impact on MS. With greater understanding of how T20K is taken up and distributed in animals and humans, we plan to develop an oral formulation ahead of Phase II clinical trials that supplies the levels of T20K in humans that do not cause side effects, but that do inhibit or even entirely prevent the development of MS. The new MS product that will be marketed after a successful development programme will be in capsule form, tablet or other type of oral preparation.
With this strategy in place, we want to maximise the use of T20K’s excellent anti-inflammatory properties, while at the same time reduce the risk of side effects in MS patients.
Cyxone and our experts are now converting this strategy into concrete animal and human studies together with our co-operation partners around the world.
One effect of this strategy is that if T20K is shown to be very safe, giving it to humans this year – earlier than previously indicated – remains a possibility.
Interest in Cyxone and T20K
During the two recent international meetings at which I met new companies and companies that I have met previously, I had the impression that Cyxone and our new concept for treating MS has made an impression on pharmaceutical company representatives. There are companies that prefer substances in Phase II, but even some of these companies seem interested in establishing a relationship at an earlier stage. I have on-going dialogues with several companies, and we will continue to these discussions until we have found the right partner for T20K.
Our next opportunity for discussions with pharmaceutical companies and with companies that have the necessary expertise to participate in the development of T20K will be during Bio Spring 2017 in Spain, which runs from March 20 to March 22.
TO1 to shares
I hope that everyone who chose to use their stock options have now received their shares. I am delighted that as many as 96 per cent of TO1 shareholders opted to subscribe for shares. We will reciprocate your trust as best we can, and hope that Cyxone’s development will make this investment an excellent deal for all.
I am often asked about progress regarding Cyxone’s patents. As previously communicated, we will obtain all patents from the Medical University in Vienna according to the terms and conditions on which we agreed. The university and Cyxone are now planning the patent transfer that involves a large number of documents and formal processes for implementation. I will report back with an update when there is more information on this process.
Malmö, March 14 2017
Kjell G Stenberg