Cereno Scientific receives approval for the start of a Phase II clinical trial in Russia
Cereno Scientific AB announces today, that the authorities in Russia have issued approval regarding the company's application to initiate a Phase II clinical trial with the drug candidate CS1. The company intends to start the study the first half of 2020 with the intention of demonstrating CS1's preventative effect against the formation of blood clots after orthopedic surgery.
– It is with great pleasure that we can now confirm 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 central milestone and the largest event in the company's history, says Cereno Scientific's CEO Sten R. Sörensen.
In May, Cereno Scientific also submitted an application to start the study with CS1 to the authorities in Bulgaria. Cereno Scientific expects approval for the Phase II study by the Bulgarian authorities this fall.
The Phase II study with CS1
The Phase II study will be conducted in collaboration with the clinical research organization OCT Group. In total, approximately 30 clinics in Bulgaria and Russia will participate and include patients undergoing orthopedic surgery where the risk of blood clots increases in connection with surgery.
The aim of the Phase II study is to show that the drug candidate CS1 has a preventive effect against the formation of blood clots after surgery with little or no risk of bleeding compared to already established treatments. Cereno's drug candidate CS1, which is the first of its kind (first-in-class), has the potential to redefine preventive treatment against blood clot formation by enhancing the body's own clot-busting mechanism rather than inhibiting blood’s coagulation ability. Through CS1's mechanism of action, the treatment is expected to lead to effective preventive treatment of blood clots and at the same time reduce the risk of frequent, and sometimes severe bleeding associated with today's so-called "blood thinning" drugs.
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 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 September 26, 2019.