Cereno Scientific submits application for the start of clinical Phase II study to Bulgarian authorities
Earlier in May 2019, Cereno Scientific announced that the company had submitted an application for a clinical Phase II study with the drug candidate CS1 to the Russian authorities. Today, the company is announcing that an application has also been submitted to the authorities in Bulgaria.
“We have worked hard to be able to complete our applications to both Russia and Bulgaria, the two countries where the study will be performed. Now we look forward to obtaining the approval of said authorities during the fall this year and subsequently to initiate the study, which is expected to take place during the first half of 2020,” says Cereno Scientific’s CEO Sten R. Sörensen.
The completed submission of the application to both Bulgaria and Russia means that the company has been able to achieve this important milestone earlier than in the third quarter of 2019, which was previously communicated.
The study will be conducted in Bulgaria and Russia
The Phase II study will be conducted in collaboration with the clinical research organization OCT Group. The study will be conducted at approximately 30 clinics in Russia and Bulgaria and will be performed on patients undergoing orthopedic surgery where the risk of blood clots increases during surgery.
The aim of the Phase II study is to show the drug candidate CS1’s preventive effect against the formation of blood clots after surgery. The drug candidate has the potential to redefine the preventive treatment against the formation of blood clots by enhancing the body’s own clot-busting system instead of inhibiting the blood’s coagulation ability.
About Cereno Scientific AB
Cereno Scientific is developing novel preventive medicine to treat thrombosis-related disease, based on the body’s own intelligent clot-busting system. Cardiovascular disease is currently the leading cause of death worldwide. Current therapies are connected to an increased risk of bleeding and, as a result, low effectiveness due to lower dosing levels. In turn, this leads to a high risk of new blood clots. Cereno Scientific’s drug candidate, CS1, is expected to provide a possibility for an effective prevention of thrombosis and a lower risk for serious bleeding complications than with current blood thinning therapies. CS1 is an innovative controlled release formulation of a known compound, and as such is expected to have a relatively short development time. In parallel with the development of CS1, Cereno Scientific develops CS014, a preclinical phase compound with promising and innovative characteristics in cardiovascular diseases. The Gothenburg-based company is located in AstraZeneca’s BioVenture Hub and is supported by GU Ventures. Cereno Scientific’s B share has been listed on Spotlight Stock market since June 2016 with the ticker CRNO B, ISIN SE0008241558.
This information is such that Cereno Scientific AB is required to make public in accordance with the EU’s Market Abuse Regulation (MAR). The information was made public by the Company’s contact person above on May 31, 2019.