Cereno Scientific is announcing that the authorities in Bulgaria have issued approval of start of Phase II clinical trial
Cereno Scientific AB is announcing, that the authorities in Bulgaria 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 at mid-year 2020 with the intention of demonstrating CS1's preventative effect against the formation of blood clots after orthopedic surgery. The study will be conducted in both Bulgaria and Russia, and the company has previously been granted to start the study in Russia.
– The fact that initiation of our Phase II clinical trial was approved in both Bulgaria and Russia is very positive as an important milestone now has been achieved. We are now working fully on the preparations and look forward to start the study next year, says Cereno Scientific's CEO Sten R. Sörensen.
The Phase II study will examine preventive measures of CS1 on venous thrombosis in patients undergoing orthopedic surgery. The study is a prospective, randomized study and will be conducted at approximately 30 clinics in Bulgaria and Russia. The patient group includes both men and women aged 55-90.
Facts about the Phase II clinical trial with CS1
The primary efficacy variable (endpoint) of the study are fatal and non-fatal thromboembolic events, which includes both symptomatic events as well as asymptomatic deep vein thrombosis detected with a mandatory phlebography at the end of the study. The secondary effect variable is the number of bleeding episodes classified according to severity. Security is evaluated with standardized monitoring procedures. CS1 is given once a day in two different doses over a sex week period: two weeks before surgery and four weeks after surgery and is compared with the standard treatment Enoxaparin once a day in a parallel group design.
This is an English translation of the main press release in Swedish
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 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 November 19, 2019.