Cereno Scientific and OCT signs contract for the conduct of a phase II study in patients undergoing knee replacement12 September, 2018
Cereno Scientific and OCT Group LCC (‘’OCT’’) have previously signed a Letter of Intent regarding their collaboration to conduct a phase II study to investigate the antithrombotic effects of Cereno’s candidate drug CS1. The two companies have now reached a definitive agreement and set out the framework for the planned phase II study. Applications to regulatory authorities to conduct the study are expected to be submitted in the fourth quarter of 2018.
“The planned phase II study will be the second clinical study with CS1. The study is based on solid results from preclinical studies and a successful clinical study in humans which demonstrated that CS1 is well tolerated with a positive side effect profile, a good controlled release pharmacokinetic profile and significant lowers PAI-1 levels, where PAI is an important risk factor for thrombosis formation. Together with OCT, we are now working intensively on the preparations for the phase II study,” says Cereno Scientific’s CEO Sten R. Sörensen.
The study will be performed in patients undergoing orthopedic surgery. The risk of blood clots increases during surgery and the aim of the study is to document the effect of the drug candidate CS1, in preventing thrombosis.
OCT will involve regional hubs and key opinion leaders in Russia and Bulgaria to enrol patients into this phase II study. In total, approximately 20 clinics are estimated to be included in the study.
“We are pleased to assist Cereno Scientific in the development of their innovative product. We hope that our collaboration will provide the pharmaceutical market with a valuable drug which improves preventive therapy against thrombosis and improves the quality of life for patients. To achieve this, we are ready to apply our strong expertise and relationships with the leading investigational sites”, says OCT President Dmitry Sharov.
OCT is a full-service clinical Contract Research Organisation (‘’CRO’’) operational in Central and Eastern Europe and the US. In Russia, where their HQ is located, OCT is officially considered the leading CRO based on the number of clinical trials approved. With nine offices in Eastern Europe and the US, OCT provides clinical research services to both Big Pharma and small or mid-sizes biotechnology companies – American, European and Asian.
Since 2005 when OCT was founded, over 260 studies in diverse therapeutic areas and phases have been conducted by various OCT teams for over 100 Sponsors. With over 190 people on staff including local regulatory and logistics specialists, medical writers and biostatisticians, project managers and clinical research assistants, OCT can successfully plan and perform a clinical study from scratch.
For more information, please visit www.oct-clinicaltrials.com
Related press releases:
- Cereno Scientific presents positive results from the first clinical study with CS1
- Cereno Scientific initiates collaboration with CRO partner OCT to conduct a phase II study
About Cereno Scientific AB
Cereno Scientific is developing a 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. The Gothenburg-based company is located in AstraZeneca’s BioVentureHub 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 available publically by the Company’s contact person on September 12th 2018.