Newsletter January 2017
CEO comments
December has been very busy due to Christmas holidays and because many results had to be brought in from our collaborative partners to start our planning for year 2017. Thanks to Cyxone’s new project manager Leonard Saffer, the process worked very well and we are looking forward to a new, exciting year with Cyxone and T20K.
Some key results in December
We have now confirmed that T20K does not give any toxic effects up to between 100 and 250 mg/kg. This provides an excellent safety margin considering the effective dose level 20 mg/kg in “mouse-MS”.
Together with our partners Cyxone has made a concerted effort to investigate how T20K is taken up by the body. It is important to correlate the dose that gives toxicity with the dose causing the desired pharmacological effects in order to continue studies in man. After thorough discussions, we have initiated a series of studies where we are investigating how different oral formulations can increase the uptake of T20K into the body.
We are very happy to find that T20K seem to be taken up into the CNS, i.e. to treat the disease at the site of action of MS. It is rare to see uptake of new drugs in the CNS. If T20K would be able to reach tissues where the disease is active chances to arrive at a functional MS drug in man will be significantly increased. A very good “Christmas present”.
Through a fruitful cooperation with our partners we have made several important findings with T20K since June 2016
- Established a rational method to synthesize T20K
- Developed a method to analyse T20K
- Developed alternative salts of T20K to optimize drug stabilitet
- Initiated a long-term stability program to demonstrate T20K’s stability upon storage
- Through repeated experiments shown that T20K has the low toxicity we were hoping for at the start of our studies
- Developed sensitive bioanalysis methods for T20K in plasma and in tissue such as brain
- Carried out pharmacokinetic studies where we measured the amount of T20K in plasma and brain after different routes of administration
- Initiated a comparative study with different T20K formulations with objective to increase bioavailability of the drug
- Initiated a study in ”mouse-MS”(EAE-model)
- Identified and contracted many collaboration partners in different countries to perform the various types of studies
- Presented T20K to most of the large pharmaceutical companies as potential acquirer of T20K for MS
By the studies performed during second half of 2016 we have laid the foundation for a rational design of the development program during 2017 aimed to gain approval for studies in man (phase I) in 2018.
Shareholders meeting in Stockholm
It was very stimulating to meet so many shareholders on December 5. I got many good and insightful questions from the shareholders and I am also glad to discuss Cyxone with those who came forward during the breaks.
Warrant,TO1
I will take the opportunity to remind those of you who have the warrant, TO1 that you can exercise your TO1 between January 30 and February 10. This means that for each TO1 you can buy one Cyxone share for 5 SEK. A good deal when the share prize is about 7 SEK per share.
Meetings in January
We will meet our API supplier Bachem, Switzerland on January 12 to discuss refining the manufacturing process of T20K. We will also meet our bioanytical experts from Pharm-analyt from Austria on January 26 to discuss our pharmacokinetics study results.
On January 17 we will meet for a full day with representatives from our collaboration partners including Sourcia from The Netherlands, which will advise and coordinate our preclinical and clinical studies in 2017 and 2018. The meeting goal is to establish a development plan for T20K that will allow clinical phase I studies in 2018.
On January 31 I will present Cyxone and T20K at the ”Aktiespararnas” meeting in Lund. I am looking forward to good discussions on Cyxone and T20K.
Wish you all a great year 2017!
Malmö January 11, 2017
Kjell G Stenberg
CEO