ISBT 2017 – Copenhagen

Banniere horizontale ISBT 2017

We are pleased to invite you to our Symposium at the ISBT 2017 in Copenhagen

Join us Tuesday June 20, 2017 from 12 to 1.30pm, at room C14

Macopharma announce the publication of the first European, Prospective, Non-Interventional Study, of THERAFLEX Methylene Blue Plasma 

Tourcoing – March 29, 2017 — Macopharma today announced the publication of the manuscript related to the European prospective, non-interventional study, of THERAFLEX Methylene Blue Plasma, in Vox Sanguinis (DOI: 10.1111/vox.12510), which was carried out in collaboration with the SynteractHCR international CRO (Contract Research Organization), between May 2013 and April 2015.

The aim of this post-market surveillance study was to collect, during a period of at least one year, all adverse events that might be related to MB-treated plasma transfusions in seven key European hospitals of Belgium, United Kingdom (UK), Spain, and Greece, where MB-treated plasma is in routine use.

In this study, a total of 19,315 transfused units of MB plasma (3,780 transfusions for 3,005 recipients) were monitored. This number may be considered sufficiently robust to determine the safety of MB Plasma solidly. The incidence of serious Adverse Transfusion Reactions (ATRs) was 1 per 19,315 transfused units of MB plasma, which is similar to the incidence for untreated fresh frozen plasma reported by the French National Authority, ANSM. There were no ATRs reported in Greece where 9,241 units of MB plasma were transfused, nor in the UK where 434 units were transfused during the observation period.

“We are very pleased with the outcome of this trial; this prospective study confirms that Methylene Blue Plasma is a very safe product in routine use” Macopharma Medical Director Dr Ignacio Alvarez, said. “We are also very satisfied about the great collaboration we had with SynteractHCR.”

 

About Macopharma

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 leucodepletion 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 90 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 http://blood-safety.macopharma.com/ for more information.

About SynteractHCR

SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. SynteractHCR has conducted Phase I-IV studies on six continents and in more than 50 countries, offering expertise across multiple therapeutic areas and with notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications. With its “Shared Work – Shared Vision” philosophy and ICD+ approach, SynteractHCR provides customized services collaboratively and cost effectively, ensuring on-time delivery of quality data so clients get to decision points faster.

See www.SynteractHCR.com, for more information.

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

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” [1].

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.

About Macopharma

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.

Tourcoing, 20th of November 2015

Following the report of a case of apparent failure of viral inactivation with methylene blue, Macopharma contests the analysis provided in the Transfusion journal and asserts the efficacy of their pathogen inactivation procedure on HIV as long as it is used properly.

As announced today in the « Early View » of the Transfusion journal, an article by Alvarez et al. is published online ahead of print, reporting a case of HIV-1 transmission through plasma treated with methylene blue and visible light in Valencia’s blood centre, in Spain. Macopharma has submitted their answer to this « Case Report » to the Transfusion journal for publication in their next edition. Several points can already be clarified to obviate any misinterpretation of this article.

This case, which dates back to more than 10 years ago and has already been mentioned in a congress poster and a review article, is the only case of HIV transmission reported to date since the development and use of methylene blue inactivation, more than twenty years ago.

Following the report of the case in 2009, a deeper investigation was conducted in close cooperation with Valencia’s blood centre. It was not possible to identify the origin of the fault with certainty, due to the very long time span between the transfusion itself and the detection of transmission, but also because the blood centre was not able to provide the necessary internal traceability elements to either confirm or invalidate the fact that the plasma bag had been properly treated prior to transfusion.

However, the studies allowed us to confirm the following:

Accordingly, it appears that in all likelihood, the transmission of HIV-1 could be linked to wrong manipulation, and not to a failure of the THERAFLEX MB-Plasma system.

Nevertheless, Macopharma has implemented additional safety procedures to fully guarantee the quality of the devices provided to users. Macopharma has also renewed the training of staff from Valencia’s blood centre, who is still using methylene blue inactivation today.

To conclude, since 1992, more than 6.5 million units of plasma treated with methylene blue have been transfused in different clinical settings. Macopharma confirms that the THERAFLEX MB-Plasma system provides the highest guarantees in terms of safety and efficacy. Macopharma’s priority remains to meet at best the expectations of their partners and to work towards the safety of transfused patients, as demonstrated by the vote of confidence granted to the THERAFLEX MB-Plasma procedure by 120 customers in 19 countries.

Tourcoing, le 20 novembre 2015

Suite à l’annonce d’un cas de défaillance apparente de l’inactivation virale au bleu de méthylène, Macopharma conteste l’analyse livrée dans la revue Transfusion et rappelle l’efficacité de son dispositif d’inactivation des pathogènes sur le VIH dès lors qu’il est correctement utilisé.

Un article d’Alvarez et al., annoncé aujourd’hui dans la section « Early View » de la revue Transfusion, et à paraître dans la prochaine édition papier, rapporte un cas de transmission de VIH-1 par du plasma traité au bleu de méthylène et à la lumière visible, au centre de transfusion de Valence en Espagne. Macopharma a soumis au journal Transfusion sa réponse à ce « Case Report », pour publication dans la prochaine édition de la revue. Plusieurs points peuvent d’ores et déjà être précisés pour prévenir toute interprétation erronée de cet article.

Ce cas, remontant à plus de dix ans et ayant déjà été cité dans deux publications, constitue le seul et unique cas signalé à ce jour, depuis le développement et l’utilisation de l’inactivation au bleu de méthylène il y a plus de vingt ans.

Une enquête approfondie a été menée suite au signalement du cas en 2009, en coopération étroite avec le centre de transfusion de Valence. L’origine de la défaillance n’a pas pu être identifiée avec certitude, en raison du délai très long entre la transfusion et l’identification de la contamination, mais aussi car le centre n’a pas été en mesure de fournir les éléments de traçabilité internes qui permettent de confirmer ou pas que la poche de plasma a été correctement traitée avant la transfusion.

Les différentes études ont toutefois permis de confirmer que :

En conséquence, il apparaît que selon toute probabilité, la transmission du VIH-1 serait ici liée à une erreur de manipulation, et non à une défaillance du THERAFLEX MB-Plasma.

Macopharma a néanmoins mis en place des procédures de sécurité supplémentaires pour garantir à 100% la qualité des dispositifs livrés aux utilisateurs. Macopharma a par ailleurs formé une nouvelle fois les personnels du centre de Valence, qui continue à utiliser aujourd’hui l’inactivation au bleu de méthylène.

En conclusion, depuis 1992, plus de 6.5 millions d’unités de plasma traité au bleu de méthylène ont été transfusées dans des milieux cliniques divers. Macopharma confirme que le THERAFLEX MB-Plasma présente les garanties les plus fortes en termes de sécurité et d’efficacité. Sa priorité reste de satisfaire au mieux les attentes de ses partenaires et à agir pour la sécurité des patients transfusés. La confiance de ses 120 clients dans 19 pays en témoigne.

On 29th June 2015, a Macopharma lunch symposium took place during the ISBT congress in London, dealing with blood safety and especially with the THERAFLEX MB-Plasma technology, a photodynamic procedure using Methylene Blue and visible light for the inactivation of pathogens in plasma.

About 150 people attended the symposium. During this session, Macopharma shared two major topics with the scientific community: an international prospective clinical study on MB-treated Plasma and the safety profile of THERAFLEX MB-Plasma.

Dr. Hafiz Qureshi from the University Hospitals of Leicester presented the results of a prospective non-interventional study to evaluate the safety of Methylene Blue Plasma. This was an open label, multi-centre, non-controlled, non-randomized, non-interventional study, in 7 hospitals from 4 countries: Belgium, Greece, Spain and the United Kingdom. The aim of this investigation was:

Prof. Axel Seltsam from the German Red Cross blood center NSTOB elaborated on the safety profile of THERAFLEX MB-Plasma. He showed that the THERAFLEX MB-Plasma procedure also reduces bacteria including bacterial spores. Moreover, the inactivation capacity of the procedure on viruses can compensate for reduced transparency of the plasma due to lipaemia.

Dr. Denese Marks from the Australian Red Cross Blood Service added information about the inactivation capacity on Dengue viruses. Inactivation of all four DENV types reached the detection limit of the assay already at half the standard illumination dose.

Moderators, namely Prof. Jean-Pierre Allain (Emeritus Professor of Transfusion Medicine at the Department of Hematology at the University of Cambridge in the United Kingdom) and Prof. Olivier Garraud (Senior Consultant, International Affairs, the Institut National de la Transfusion Sanguine (INTS), France) also contributed to the success of the symposium due to high quality questions,various exchanges and experience feedback.

Many thanks to the presenters, moderators and participants of our symposium on blood safety!

Click here to get access to the abstract book

 

Tourcoing — April 22, 2015 - Macopharma is pleased to inform you that a current article, entitled “Challenge study of the pathogen reduction capacity of the THERAFLEX MB-Plasma technology” has been recently published in the journal “Vox Sanguinis” 1.

Aim of the study was to investigate the bacterial reduction capacity of the THERAFLEX MB-Plasma treatment process. Moreover, the virus inactivation capacity in lipaemic plasma was explored.

The filtration steps of the procedure resulted in efficient bacteria reduction of transfusion-relevant strains like Staphylococcus epidermidis, Staphylococcus aureus, Escherichia coli, Bacillus cereus and Klebsiella pneumoniae ≥ 4.8 logs i.e. to the limit of detection (LOD). In addition, bacterial spores of Bacillus subtilis were eliminated. The overall reduction capacity of the THERAFLEX MB-Plasma technology is expected to be sufficient to prevent transfusion-transmitted bacterial infections, taking into account the concentration of bacteria normally present in contaminated therapeutic plasma.

HIV-1 and model viruses for HBV and HCV were efficiently inactivated by the MB/ light procedure independent of the degree of lipaemia. Its virus inactivation capacity is sufficient to compensate for reduced light transparency caused by intense lipaemia. This underlines the robustness of the system for natural plasma variation.

About Macopharma

Macopharma SA (“Macopharma”) (www.macopharma.com) is an innovator in global healthcare with expertise in the fields of transfusion, infusion and biotherapy. The company has become the largest supplier of in-line leucodepletion 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 100 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, efficiency, 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.

1Reichenberg S, Gravemann U, Sumian C, Seltsam A. Challenge study of the pathogen reduction capacity of the THERAFLEX MB-Plasma technology. Vox Sanguinis 2015: DOI: 10.1111/vox.12257