Cereno Scientifics drug candidate CS1 is an advanced formulation with controlled release of the active substance valproic acid. CS1 is being developed as a thromboprophylactic treatment and works by strengthening and restoring the body's own ability to dissolve blood clots. The mechanism is via the body's own intelligent clot-dissolving system – the fibrinolytic system – to prevent blood clots from forming and blocking the vessels.
CS1 attacks the clot problem in a different way than traditional blood clot treatment which focuses on inhibiting the blood's ability to clot, so-called blood thinning drugs. These have an anti-thrombotic effect but also mean that the patient runs a constant increased risk of bleeding, which patients treated with CS1 are not expected to have. To manage the bleeding risk, today's anti-thrombotic drugs are given a restrictive dosage regimen, which in turn means that in many cases the optimal anti-thrombotic treatment effect is not achieved.
OK to start studying in Russia
Since last year's positive Phase I data, Cereno Scientific has been preparing a Phase II study to document the candidate's thromboprophylactic effect in humans. As BioStock previously reported In late spring, permission was applied for to conduct the planned study in both Russia and Bulgaria. Now, they have received positive news from the Russian authorities.
– We are now pleased to announce that the authorities in Russia have approved the start of our Phase II study in Russia, which we intend to initiate during the first half of 2020. The approval is a key milestone and the single largest event in the company's history, says Cereno Scientific's CEO Sten R. Sörensen.
Phase II study with CS1
The Phase II study will be conducted in collaboration with the clinical research organization OCT Group. The plan is for around 30 clinics in Bulgaria and Russia to participate. The patient sample will consist of patients undergoing orthopedic surgery where the risk of blood clots increases in connection with surgery. This is a common focus group in clinical studies of anti-thrombotic drugs because one can follow the development of thrombosis over a short period in a well-defined group.
The aim of the study is to demonstrate that CS1 has a preventive effect against the formation of blood clots after surgery with little or no risk of bleeding compared to established treatment. Through CS1's mechanism of action, the treatment is expected to provide an effective preventive treatment of blood clots while at the same time entailing a lower risk of the frequent and sometimes serious bleeding associated with today's so-called "blood-thinning" anti-thrombotic drugs.
Next steps
Now that Cereno Scientific has received a positive response from Russia, they are awaiting a response from the Bulgarian authorities, which is expected to come in the autumn. Authority approval in both study countries is of course a prerequisite for being able to keep to the communicated timetable, which is also conditional on the company's partners Galenica succeed in scaling up the production of trial materials. Cereno Scientific has previously signaled that it believes that these conditions will be met and that the study start schedule in the first half of 2020 can be met.
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