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IN THIS ISSUE
BARDA Releases Additional Funds to Support INTERCEPT Red Blood Cell System Development | First Patient Enrolled in INTERCEPT RedeS Clinical Trial to Assess Safety and Efficacy of INTERCEPT Blood System for Red Blood Cells  | Cerus Industry Workshop at SCABB-Ensuring Hospital Readiness to Receive and Transfuse Pathogen Reduced Blood Products  |  Customer Spotlight: Bonfils Blood Center |  Science Section: What We're Reading  |  Calendar of Events
BARDA Releases Additional Funds to Support INTERCEPT Red Blood Cell System Development
Additional options totaling $46.6 million have been exercised under Cerus' contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services. "The allocation of additional options, coupled with recent FDA feedback on the dossier of clinical data required for a possible future red cell PMA submission, confirm our next steps forward for INTERCEPT red blood cells (RBCs) in the U.S.,” said Dr. Richard Benjamin, Cerus’ chief medical officer. “Importantly, funds have now been allocated to support our planned Phase III ReCePI study, which is designed to evaluate the efficacy and safety of INTERCEPT RBCs to treat acute anemia in cardiovascular surgery patients.” In addition to funding the proposed Phase III ReCePI study, the newly exercised options include support for a clinical study in the UK to evaluate the efficacy and safety of INTERCEPT red blood cells in patients undergoing exchange transfusion for sickle cell disease. The total value of the full five-year contract is up to $186 million, subject to funding of additional contract options, and provides non-dilutive funding to support a comprehensive development program for the pathogen reduction of RBC components in the U.S.

Read the Full Press Release Here
First Patient Enrolled in INTERCEPT RedeS Clinical Trial to Assess Safety and Efficacy of INTERCEPT Blood System for Red Blood Cells
The first patient has been enrolled in Puerto Rico for the “INTERCEPT Blood System for Red Blood Cells in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections (RedeS)” clinical trial to assess the safety and efficacy of the INTERCEPT Blood System for Red Blood Cells (RBCs) when compared to conventional RBCs in regions impacted by the Zika virus epidemic. RedeS is a two-stage study being conducted initially in Puerto Rico, a region significantly impacted by the Zika virus epidemic. The objective of the second stage is to provide early access to the INTERCEPT pathogen reduction system for RBCs in regions where a substantial proportion of the population has been infected or is at risk of infection by the Zika virus, and the risk of asymptomatic infection among qualified blood donors is recognized. “RedeS marks the first of three pivotal trials that will support our submission to FDA for US licensure of the INTERCEPT Blood System for red cells,” said Richard Benjamin, Cerus’ chief medical officer. “It will lay the groundwork for our subsequent US Phase III trials designed to demonstrate safety and efficacy of INTERCEPT RBCs in cardiovascular surgery patients (the ReCePI study) and sickle cell patients.”

Read the Full Press Release Here
Cerus Industry Workshop at SCABB Annual Meeting, May 25, 2017-Ensuring Hospital Readiness
In recent years, the US blood transfusion industry has expressed significant concerns regarding bacterial contamination of blood components. There are currently over 20 US blood centers distributing INTERCEPT platelets to hospitals and more than 20 additional blood centers contracted. Hospital readiness to receive transfusion-ready pathogen reduced platelet and plasma components is imperative for a smooth implementation and reliable product availability. This symposium will describe essential considerations needed for hospital readiness related to the onboarding of pathogen reduced blood components. The discussion will include aspects such as Information Systems updates, Blood Bank operations and policy updates, new ISBT and outpatient reimbursement product codes, and a hospital-wide educational in-service program.



Cerus Industry Workshop at SCABB
Customer Spotlight: Bonfils Blood Center
Bonfils Blood Center is located in Denver, Colorado and has been using INTERCEPT Blood System since July 2016. This spotlight was provided by the Bonfils Blood Center Marketing and Communications Department and Client Team.

Q: What motivated your blood center to implement INTERCEPT?
A: At Bonfils Blood Center, we pride ourselves on remaining abreast of emerging and cutting-edge technologies, systems and best practices. When we learned about INTERCEPT, we recognized right away that a number of our health care partners might be interested in the product and we made implementing INTERCEPT a priority.
Q: How have you communicated the implementation of INTERCEPT with the hospitals you serve, and what has been the feedback?
A: We host Technical Advisory Council (TAC) meetings twice per year to discuss relevant topics in the transfusion medicine industry and keep partners in the loop on various initiatives and projects underway at Bonfils. Additionally, account representative site visits and surveys are a regular component of our relationship management strategy so we were able to gauge the interest of partners in INTERCEPT through those channels before officially launching the product. Bonfils also provided educational materials (launch packages) to foster a smooth adoption of this new product. We then reinforced collaboration by employing weekly huddle calls between Bonfils and healthcare partners relating to service in general but ensuring INTERCEPT was a discussion point.




(L-R) Crystal Stanley, Barbie Metzger, Jennifer Applehans, Whitney Vaughn, and Haley Johnson

See the Complete Bonfils Blood Center Spotlight Here
Bonfils Blood Center-Learn More
Science Section: What We’re Reading

Clostridium perfrignens Sepsis Masquerading as a Hemolytic Transfusion Reaction
A L Greninger et al. Transfusion. 20 APR 2017. DOI: 10.1111/trf.13863
Read the Article Here [Subscription Required] 

Dengue Fever: Peru Reports 6000 Cases
R. Herriman. Outbreak News Today. 5 May 2017. www.outbreaknewstoday.com
Read the Article Here

 
Calendar of Events

SCABB (South Central Association of Blood Banks)
May 25-28, 2017 | Orlando, FL
Additional Information


BBANYS (Blood Bank Association of New York State)
June 15-16, 2017 | Syracuse, NY
Visit bbanys.org

KABB (Kentucky Association of Blood Banks)
August 18, 2017 | Frankfurt, KY
Additional Information

SABM (Society for the Advancement of Blood Management)
September 6-10, 2017 | Portland, OR
Additional Information

WABB (Wisconsin Association of Blood Banks)
September 12-13, 2017 | Appleton, WI
Additional Information
Data for pathogen reduction of the ZIKA virus by the INTERCEPT Blood System, pathogen reduction system, have not been submitted for FDA review.

There is no pathogen inactivation process that has been shown to eliminate all pathogens. Certain non-enveloped viruses (e.g., HAV, HEV, B19 and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process.

CONTRAINDICATIONS: Contraindicated for preparation of plasma and platelet components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of platelet and plasma components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.

WARNINGS and PRECAUTIONS: Only INTERCEPT Processing Sets for platelets and plasma are approved for use with the INTERCEPT Blood System. Use only the INTERCEPT INT100 Illuminator for UVA illumination of amotosalen-treated platelet and plasma components. No other source of UVA light may be used. Please refer to the Operator's Manual for the INT100 Illuminator. Discard any platelet or plasma components not exposed to the complete INT100 illumination process. Tubing components and container ports of the INTERCEPT Blood System contain polyvinyl chloride (PVC). Di(2-ethylhexyl) phthalate (DEHP) is known to be released from PVC medical devices, and increased leaching can occur with extended storage or increased surface area contact. Blood components will be in contact with PVC for a brief period of time (approx. 15 minutes) during processing. The risks associated with DEHP released into the blood components must be weighed against the benefits of therapeutic transfusion.

PLATELETS: INTERCEPT processed platelets may cause the following adverse reaction: Acute Respiratory Distress Syndrome (ARDS). An increased incidence of ARDS was reported in a randomized trial for recipients of INTERCEPT processed platelets, 5/318 (1.6%), compared to recipients of conventional platelet components (0/327). Monitor patients for signs and symptoms of ARDS.


PLASMA: Amotosalen-treated plasma may cause the following adverse reaction: Cardiac Events. In a randomized controlled trial of therapeutic plasma exchange (TPE) for TTP, five patients treated with INTERCEPT Blood System processed plasma and none with conventional plasma had adverse events in the cardiac system organ class (SOC) reported. These events included angina pectoris (n=3), cardiac arrest (n=1), bradycardia (n=1), tachycardia (n=1) and sinus arrhythmia (n=1). None of these events resulted in documented myocardial infarction or death. Monitor patients for signs and symptoms of cardiac events during TPE for TTP.

INTERCEPT Blood System for Red Blood Cells is in development and not available for sale.


Rx only. For full prescribing information, please see package insert.
MKT-EN 00165-23
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Cerus, INTERCEPT Blood System and INTERCEPT are registered trademarks of Cerus Corporation.

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