First patient enrolled in Phase III CAPTURE* trial for THERAFLEX UV-Platelets initiated and performed under the leadership of the German Red Cross Blood Service

12/12/2016

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.

-Statement sponsor:

“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.”

-Statement Macopharma:

“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.

ABOUT Macopharma

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

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