World Thrombosis Day
On October 13th, the extensive issue that is thrombosis was highlighted under the banner of World Thrombosis Day (WTD).
WTD was founded in 2014 by the International Society on Thrombosis and Haemostasis (ISTH) as a response to members’ calls for a day focused on placing the global spotlight on the great suffering caused by thrombosis as well as the fact that there still is a lot left to do when it comes to improving prevention and treatment of thrombosis. Lead by a global scientific steering committee more than 175 organisations across the world participate in the first edition of WTD.
ISTH is an international organisation consisting of almost 5000 clinics, researchers and opinion leaders from almost 100 countries. The aim of the organisation is to promote understanding, prevention, diagnosis and treatment of thrombosis and risk of bleeding.
Risk of bleeding in thrombosis-preventative treatment is an unsolved problem
Patients who are at risk for blood clots are treated with blood thinners. The down side to such medication is that these can lead to uncontrolled bleeding, as they are designed to inhibit platelet adhesion or the blood’s ability to coagulate. Due to such risk, blood thinners are likely often given in doses that are too low to be effective, or perhaps not given at all. Therefore, the blood thinner approach could mean an ineffective anti-thrombotic treatment for patients.
Despite the attempts to control the risk of bleeding with blood thinners, 1 out of treated patients experience some form of bleeding, leaving a medical vacuum to be filled for a drug that provides a satisfactory anti-thrombotic effect without an increased risk of bleeding.
Cereno Scientific offers a new approach
Cereno Scientific’s candidate CS1 strengthens and restores the body’s own ability to dissolve blood clots – fibrinolysis. Thus, instead of weakening the coagulation mechanism, CS1 restores fibrinolysis through increasing the level of t-PA (a protein that helps dissolve blood clots) and reducing the level of PA1-1 (a protein that inhibits the effect of t-PA). This is a brand-new concept within oral blood clot prevention and, so far, Cereno Scientific appears to be the only company working with this concept.
Nearing studies in humans
Cereno Scientific already has data from a clinical phase I study with CS1 showing good safety, the desired pharmacokinetics as well as the absence of serious side-effects. The data also showed that CS1 significantly reduces PA1-1 levels when they are at their highest in the body.
Backed by strengthened finances after this summer’s oversubscribed rights issues, through which the company raised 60,6 MSEK prior to costs, the company is now planning a phase II study with CS1 together with the CRO OCT Group. The study will be carried out in circa 30 clinics in Russia and Bulgaria and the targeted group will be individuals undergoing orthopaedic surgery. The aim is to investigate CS1’s thrombosis-preventative effect and the plan is to commence the study during the first half of 2020.
If the studies can determine that CS1 has a preventative effect against the development of blood clots following surgery with low or no risk of bleeding compared to the established treatments, this will indicate that the treatment is appropriate for prevention of blood clot in connection with long-term treatment. This would support the development of CS1 as a preventative treatment for large indications within the thrombosis field, indications with a large market potential.
Phase II study approved in Russia
In late September, Cereno Scientific were granted regulatory approval by Russian authorities allowing them to initiate the clinical phase II study. What now remains is to get approval for the study in Bulgaria and to finish upscaling production of the clinical test material before the study can start. This is expected to happen by the end of the first half of 2020.
If the phase II study yields positive results, the plan is to out license CS1 to a larger pharmaceutical company for pivotal studies and final market launch. The market for thrombosis prevention is valued at 10 billion USD in the USA alone and according to a recent report, the global market is expected to grow to 47 billion USD by the year 2026.
Cereno Scientific – increasing international activity and exposure
For Cereno Scientific World Thrombosis Day offers one of several opportunities during the year to raise awareness and debate surrounding this global health challenge. In the end of September, Cereno Scientific also drew attention to World Heart Day.
From a business and partnering perspective there are even more opportunities for Cereno Scientific to draw the market’s and key players’ attention to the company’s research and development of CS1. The company recently participated at the LSX Nordic Congress where BioStock took the opportunity to talk with CEO Sten R. Sörensen. That interview can be viewed below. Sörensen also participated in BioPharm America in Boston 9 – 12 September and LSX World Congress USA in Boston 7 -8 October. Cereno were also present at Nordic Life Science Days (NLSDs) in Malmö in October where CMO Björn Dahlöf represented the company.
CEO Sörensen also partook in the American Congress of Cardiology (ACC) in New Orleans in March as well as Heart Failure Congress in Athens in April. Sörensen and Dahlöf also participated in the European Society of Cardiology (ESC) Congress in Paris in August.
In July, the positive results from the phase I study with CS1 were presented at the International Society of Thrombosis and Haemostasis (ISTH) in Melbourne, Australia, where the company won the Top Poster Award.
The company’s R&D and growing international exposure is probably the reason for Cereno being invited to two important meetings later this year: 3rd Anti-Fibrotic Drug Development (AFDD) in Boston 18-20 November and 16th Global Cardio Vascular Clinical Trialis Forum (CVCT) in Washington DC 5-7 December.
During these two events Cereno Scientific will present the potentially broadened treatment possibilities related to fibrosis that have been identified together with the company’s scientific advisory board. These treatment opportunities might relate to rare diseases as well as major cardiovascular indications. Read more.
A year of abundant international activities will be crowned with CEO Sörensen’s participation and company presentation at the Nordic American Life Science Conference 4 -5 December in New York, an event organised by Business Sweden, DNB and Nasdaq.
Cereno is now driving its concept and development on an international scale with a scientific advisory board. The upcoming phase II study with CS1 in Russia and Bulgaria is also expected to yield increasing attention in the USA, Europe and Asia/China.
Upscaling their network and displaying the company at a number of global conferences gives Cereno increased international exposure both scientifically and in terms of business with a broader target towards investors and potential global or regional pharma partners.
See CEO Sten R. Sörensen being interviewed by BioStock at LSX Nordic 2019 below
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.