I once read a comment from a Cyxone shareholder that said the less the company communicates, the more we are getting done. With this newsletter, I want to prove that statement accurate!
In recent months, Cyxone has focused on two key activities: the tests necessary to bring T20K for multiple sclerosis to clinical trials during 2018; and the financing of Phase 2B with Rabeximod for rheumatoid arthritis patients.
I would like to take this opportunity to provide a brief overview of Cyxone’s activities and progress.
T20K for multiple sclerosis
As Cyxone set out in its prospectus prior to listing on the Nasdaq/First North in 2016, the company began its work by verifying research results for T20K, with tests conducted during the autumn of 2016 and the first half of 2017. These tests revealed that what researchers in Vienna and Freiburg had found could be reproduced in independent laboratories, which in my experience is fairly unusual. Cyxone also examined T20K’s toxicity and found a wide margin between active doses and toxic doses, sometimes referred to as “therapeutic index”.
Studies conducted in 2017 identified more of T20K’s physical and biological properties. These indicated that the substance has qualities that could make it extremely suitable as a drug. A crucial observation was that T20K is highly effective in inhibiting symptoms in the mouse-MS model, despite being unable to find a free substance in the blood, (pharmacological effects are often determined by how much free substance is present in the blood). This tallies with the observation that T20K continues to have strong inhibition of mouse-MS even if the animals are pre-treated prior to the T20K trial. In tests carried out during 2017, we found that T20K seems to search for and remain in body tissue that regulates inflammation: the spleen and the intestines.
This “natural homing” to immunoregulating organs could enable a specific treatment for MS patients with a potentially low risk of side-effects due to extremely low levels of T20K in the bloodstream. So Cyxone’s vision of an effective treatment for MS with low toxicity has progressed.
Current T20K focus
Even if T20K’s lower levels in the blood and distribution to immunoregulating organs are extremely positive developments, they do mean that the company is required to conduct initial Phase 1 trials of T20K with intravenous injection. For safety reasons, we need to be able to demonstrate a safe level of free T20K in the blood before we continue with the programme of clinical trials. Cyxone’s studies are therefore designed to examine T20K’s effectiveness after intravenous injection, and subsequently to conduct Phase 1. In Phase 1, the company will identify a safe, free blood level of T20K and thereafter switch development work to an oral T20K treatment.
Work to identify the right dose interval is in its closing stages, and studies in two animal types with repeated doses of T20K can begin once this work is complete. Phase 1 studies are planned for completion this year.
Financing of Rabeximod and Phase 2B rheumatoid arthritis studies
In the past four months, I have probably met more investors than I have ever done throughout my career. I have, for example, found time for two trips to the US, and one in Europe in the past month alone. Cyxone is looking for institutional investors willing to stay with the company throughout its development. We have been received very encouragingly, and experienced investors say that they see excellent potential in the company. As and when we achieve our goal for this investment round, we will make this public.
Cyxone and Sourcia have started substantive project planning ahead of Phase 2B trials in patients with rheumatoid arthritis. As previously communicated, the company already has sufficient quantities of certified Rabeximod to be able to quickly start Phase 2B trials.
Pilot study for inflammatory bowel disease (IBD)
As previously announced, a study into a cyclotide in animal models for IBD is underway at the Medical University of Vienna. Results are expected in March this year. Positive results could lead to a broadening of Cyxone’s portfolio under existing patent protection.
Structuring of project work
Work with Cyxone’s projects is rapidly increasing, and as a result, the company is strengthening its co-operation with Sourcia. Cyxone and Sourcia structure their work through clear delineation of responsibilities, as well as establishing clear reporting and decision making that is crucial to meet deadlines and budgets. The list below summarises current working structures.
The Cyxone Board of Directors sets long-term goals, and reviews progress and costs related to them.
The Cyxone/Sourcia Project Group discusses and proposes how studies are to be conducted.
The Steering Committee decides which studies are to be conducted and when.
Project Leaders contact companies in different countries to obtain cost estimates and ensure that studies are conducted on schedule and as planned.
The Scientific Advisory Board provides advice on the scientific background for studies.
Cyxone will present the company at BioStock Live on February 28 in Stockholm. Information about the event and registration form are available on the BioStock website.
We will also be at BioEurope Spring in Amsterdam, March 12-14.
Malmö in February 2018
Kjell G Stenberg