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IN THIS ISSUE
US BARDA Funding Awarded to Cerus for up to $180 million to Advance its INTERCEPT Red Blood Cell Program INTERCEPT Blood System Kits Donated to HEMORIO for Emergency Preparedness Ahead of the Summer Olympic Games in Rio de Janeiro | The Community Blood Center Introduces First Pathogen Reduced Platelets in Wisconsin | Science Section: What We're Reading | Calendar of Events
US BARDA Funding Awarded to Cerus for up to $180 million to Advance its INTERCEPT Red Blood Cell Program
In June, the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HSS), awarded Cerus a 5-year contract entailing potential funding of up to ~$180M to support the development of the INTERCEPT Red Blood Cell System. Initial funding of ~$30M will include the support of a clinical trial to assess the safety and efficacy of INTERCEPT RBCs in Puerto Rico, a region impacted by the current Zika virus epidemic. There will be an option to extend the contract for up to 5 years with an additional $150M to cover additional clinical studies, manufacturing, and next generation INTERCEPT RBC system development. “This contract offers the potential to fund activities related to anticipated Phase III clinical studies for the INTERCEPT Red Blood Cell System in the United States and the required manufacturing and development activities needed to pursue a potential U.S. commercial launch,” said Dr. Laurence Corash, Cerus’ chief scientific officer.

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Read the HHS press release
INTERCEPT Blood System Kits Donated to HEMORIO for Emergency Preparedness Ahead of the Summer Olympic Games in Rio de Janeiro
Cerus and its distribution partner CEI Group (Brazil) have made a donation of INTERCEPT Blood System pathogen reduction kits for platelets and plasma to HEMORIO, a public hospital responsible for transfusion medicine and hematology care for the state of Rio de Janeiro and part of the State Health Department and coordinator of the State Blood Network. HEMORIO is also the designated emergency preparedness blood center in Rio de Janeiro for the Summer Olympic Games. The donation is aimed at protecting HEMORIO’s platelet and plasma transfusion needs for emergency preparedness during the Olympic Games.

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The Community Blood Center Introduces First Pathogen Reduced Platelets in Wisconsin
The Community Blood Center announced the shipment of Wisconsin’s first Pathogen Reduced Platelets to hospital patients. The adoption of pathogen reduction reduces the risk of transfusion-transmitted infections (TTI) by inactivating a broad range of pathogens. Pathogen reduced platelets offers the potential to avoid bacterial testing, per the recent FDA Draft Guidance.1 This may help enable hospitals to avoid complex secondary testing and associated costs.

“The Community Blood Center has served North and Eastern Wisconsin communities for 61 years,” stated Vice President and Chief Operating Officer Matt McCarter. “We have maintained an excellent record of achieving our mission to ensure a safe, reliable blood supply to local hospitals and patients. Offering Pathogen Reduced Platelets is a major milestone of our ongoing focus on innovation that supports patient well-being.”


1. FDA Draft Guidance, March 2016: “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion.”

Read the press release
Science Section: What We’re Reading

Probable transfusion-transmitted Zika virus in Brazil
Barjas-Castro, et al, Transfusion, 2016 Jul;56(7):1684-8. doi: 10.1111/trf.13681. Epub 2016 Jun 21.
Read the abstract
 
Zika Virus, the new kid on the block
Zambon N et al, Eurosurveillance, 2016;21(23):pii=30255.
Read the abstract
 
Transfusion-transmitted malaria not preventable by current blood donor screening guidelines: a case report,
Holtzclaw A, et al. Transfusion, 2016 doi: 10.1111/trf.13680.
Read the abstract
Calendar of Events

ABC Summer Meeting
August 2-4, 2016 | Honolulu, HI
Additional Information

 
SABM Annual Meeting (Society for the Advancement of Blood Management)
September 29 - October 1, 2016 | Grand Rapids, Michigan
Additional Information


AABB (American Association of Blood Banks) Annual Meeting
October 22-25, 2016 | Orlando, FL
Additional Information


ASA Annual Meeting (American Society of Anesthesiologists)
October 22-25, 2016 | Chicago, IL

Additional Information
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.

Rx only. For full prescribing information, please see package insert.
MKT-EN 00165-13
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Cerus, INTERCEPT Blood System and INTERCEPT are registered trademarks of Cerus Corporation.

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