Tourcoing, France —- Macopharma is proud to announce that the University Hospital at Goethe University Frankfurt, Germany, has enrolled the first patient in the Phase III THERAFLEX UV-Platelets study “Clinical Assessment of Platelets Treated with UVC in Relation to Established Preparations” (CAPTURE) in October 17, 2016. CAPTURE is a randomized, double-blind, multicentre clinical trial evaluating the clinical efficacy and safety of platelet concentrates treated with the THERAFLEX UV-Platelets procedure in comparison to conventional platelet components. The CAPTURE study is expected to include up to 166 patients.
“The CAPTURE trial is the first patient study initiated in Germany on a new platelet product under full Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) requirements”, said Prof. Axel Seltsam, MD, from the German Red Cross Blood Service NSTOB, who is the medical manager of the trial. “We believe that the new pathogen inactivation technology will significantly improve the safety of platelet transfusions.”
“This is an important milestone in the development of THERAFLEX UV-Platelets,” said Ronald De Lagrange-Chancel, CEO of Macopharma. “Macopharma’s mission is strongly dedicated to blood safety and best possible care of patients requiring transfusions. We appreciate German Red Cross Blood Services being our research partner and the sponsor in this study, substantially contributing to achieve our objectives.”
ABOUT THE CAPTURE TRIAL
CAPTURE is a randomized, double-blind, multicentre clinical trial on clinical efficacy and safety of platelet concentrates treated with the THERAFLEX UV-Platelets procedure in comparison to conventional platelet components.
CAPTURE will compare the efficacy and safety of UVC-treated plasma-reduced whole blood or apheresis derived platelets (Test) prepared in SSP+ (Additive Solution for Platelets, Macopharma) with untreated plasma-reduced whole blood or apheresis derived platelets (Control) in haemato-oncological patients with thrombocytopenia or expected to become thrombocytopenic. The primary objective of the trial is to demonstrate the non-inferiority of UVC-treated in comparison to untreated plasma reduced platelet concentrates stored for up to 5 days in adult patients with hematologic or oncologic diseases and thrombocytopenia based on the 1 hour corrected count increment (CCI, 1 hour).
The CAPTURE Phase III trial is currently open and recruiting patients. For more information, please visit https://www.clinicaltrialsregister.eu.
ABOUT THE THERAFLEX UV-Platelets Technology
The THERAFLEX UV-Platelets system is the latest generation of pathogen inactivation technologies for platelet concentrates. It is designed for treatment and storage of whole blood-derived and apheresis platelets. The THERAFLEX UV-Platelets system is a method for pathogen inactivation of labile blood products which is solely based on the treatment with UVC light, without the use of any photoactive substance. UVC treatment mainly affects the nucleic acids of pathogens and leukocytes while leaving proteins largely preserved. This technology was developed by the research foundation of the German Red Cross Blood Services in cooperation with Macopharma to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood.
Preclinical performance and safety of THERAFLEX UV-Platelets has been evaluated. UVC-treated platelets meet the in vitro quality requirements for platelet concentrates, and in vitro quality data is comparable with published data from other pathogen reduced platelet products. In addition, studies in large animals and healthy human volunteers showed adequate recovery and survival as well as a good tolerability of UVC-treated platelets. In the CAPTURE trial, the clinical efficacy and safety of UVC-treated platelets suspended in the additive solution SSP+ (Test) compared to untreated plasma-reduced platelet concentrates (Control) is investigated in thrombocytopenic patients.
Macopharma SA (“Macopharma”) is an innovator in global healthcare with expertise in the fields of transfusion and infusion. The company has become the largest supplier of in-line leucoreduction filtration sets in Europe. It is expanding its efforts in the fields of respiratory masks and cellular therapy by developing products for cell expansion, in addition to cell/organ processing and freezing. Headquartered in the Lille metropolitan area (France), Macopharma has four manufacturing facilities in Europe and its products are sold into more than 80 countries worldwide. One of Macopharma’s aims is to provide a comprehensive product range for the pathogen inactivation of infectious agents in plasma, platelets and red cells. This is aligned with Macopharma’s product development strategy of the continuous quest, through partnerships, for improved safety, efficacy, and quality of transfusion, infusion, masks and cellular therapy.
THERAFLEX and THERAFLEX UV-Platelets are trademarks of Macopharma.
ABOUT German Red Cross Blood Services
The six regional German Red Cross Blood Services play a critical role in the country’s national health care system. They jointly collect and process approximately 70% of the blood supply in Germany and distribute it to thousands of hospitals and transfusion centers nationwide. Furthermore, they play a leading role in increasing the availability of blood and in protecting the safety of donors and patients. In addition to being the largest suppliers of blood in Germany, the German Red Cross Blood Services are research leaders in the field of transfusion medicine and cell therapy, commissioning and conducting research and development to improve outcomes for patients. Red Cross experts play an important role in setting policies and standards for the industry. By serving on key committees of blood-related organizations and working closely with the regional and national authorities, the Red Cross Blood Services provide valuable data and expertise that influence the direction of the blood banking community.
*CAPTURE : Clinical Assessment of Platelets Treated with UVC in Relation to Established Preparations
Tourcoing — 30 November 2016 – Macopharma is pleased to inform you that a current article, entitled “Cost-utility and budget impact of methylene blue-treated plasma compared to quarantine.” has been recently published in the journal “Blood Transfusion” .
The aim of the study was to estimate the budget impact and cost-utility (sometimes known as cost-effectiveness), from a payer perspective, of using THERAFLEX MB-Plasma compared to quarantine plasma (QP) for pathogen and adverse events reduction of transfused plasma in Spain. Different approaches to plasma collection and the costs of both plasma types were considered.
A model simulating the risks of HBV, HCV, HIV, CMV, a WNV-like infection, allergic reactions and FNHTRs achieved was developed. If QP relies on plasma from whole blood collection and passive quarantine, it is less costly than THERAFLEX MB-Plasma. However, if active donor recall is taken into account, THERAFLEX MB-Plasma reduced cost by 50.46 € per patient and was more effective and led to a net savings.
When previously unaccounted for costs are included, THERAFLEX MB-Plasma approaches cost neutrality for whole blood-derived plasma and is cost savings and more cost-effective under any active QP and/or apheresis approach.
Finally, the analysis of THERAFLEX MB-Plasma shows this technology to be more effective in terms of generating additional health benefit for the plasma-transfused patient population than QP regardless of the quarantine system in place.
Macopharma SA (“Macopharma”) (www.macopharma.com) is an innovator in global healthcare with expertise in the fields of transfusion and infusion. The company has become the largest supplier of in-line leucodereduction filtration sets in Europe, It is expanding its efforts in the fields of respiratory masks and cellular therapy by developing products for cell expansion, in addition to cell/organ processing and freezing. Headquartered in the Lille metropolitan area (France), Macopharma has four manufacturing facilities in Europe and their products are sold into more than 80 countries worldwide. One of Macopharma’s aims is to provide a comprehensive range for the pathogen reduction of infectious agents in plasma, platelets and red cells. This is aligned with Macopharma’s product development strategy of the continuous quest, through partnerships, for improved safety, efficacy, and quality of transfusion, infusion, masks and cellular therapy.
About THERAFLEX MB-Plasma
The THERAFLEX MB-Plasma System has a Class III CE Mark (available for sale in countries where the CE mark is accepted) and is not currently available for sale in the United States. It is a user-friendly in-house treatment for single units of plasma. The GMP-conforming procedure is adapted for the inactivation of FFP from aphaeresis or whole blood plasma. The MB plasma system uses a combination of a membrane filter Plasmaflex PLAS4, (which removes residual leucocytes, red cells, platelets and aggregates, intra-cellular viruses and minimises the amount of microvesicles and microparticles), a dry Methylene Blue pill, visible light and a Blueflex Methylene Blue removal filter.
See www.bloodsafety.macopharma.com, for more information.
1. Babigumira JB, Lubinga SJ, Castro E, Custer B. Cost-utility and budget impact of methylene blue-treated plasma compared to quarantine plasma. Blood Transfus 2016.