Tourcoing — September 9th, 2015 –
Macopharma today announced the finalization of the European prospective non-interventional study for THERAFLEX MB-Plasma that has started in collaboration with an international CRO (contract research organization) SynteractHCR in November 2013, with the first patient enrolment in Spain.
The aim of this post marketing surveillance study was to collect, during a period of at least one year, adverse events related to MB-treated plasma transfusions in seven key European hospitals in Belgium, UK, Spain and Greece where MB-treated plasma is in routine use.
Last patient enrolment was in March 2015.
In this study the outcome of a total of 19,315 transfused units of MB plasma (3,780 transfusions) was observed. This number is considered adequate to determine the safety of MB plasma. 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 happy of the outcome of this study; this observational trial in patients confirms that Methylene Blue plasma is a safe product” Macopharma Clinical Research Manager Dr. Ignacio Alvarez, said. “We are also very satisfied about the great collaboration we had with SynteractHCR.”
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 70 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.
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.