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BARDA Exercises Additional Contract Options Totaling 10M for Activities Related to its Planned Phase III Trial of the INTERCEPT Red Blood Cell System
Cerus recently announced that additional options totaling $10,825,555 have been exercised under its contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS). The newly exercised options include funding for in vitro pathogen inactivation and red blood cell (RBC) function studies to support FDA licensure, as well as the manufacturing of clinical trial materials needed for a Phase III trial in the continental United States.
“The exercise of these additional options reflects the substantial progress our team has made in just a few short months since initiating activities related to this important contract with BARDA,” said Dr. Laurence Corash, Cerus’ chief scientific officer. “We are working closely with the FDA to reach an agreement on the protocol design for our Phase III trial, and this additional funding ensures that we can begin preparing the necessary clinical trials materials to move forward quickly upon such agreement.”
In June 2016, BARDA granted Cerus a five-year contract, the value of which has since increased to be worth up to $185 million in non-dilutive funding to support the development program for pathogen reduction of RBC components in the U.S. This includes the potential to fund activities related to anticipated Phase III clinical studies and the required manufacturing and development activities needed to pursue a potential U.S. commercial launch.
Read the Full Press Release Here
Read the Full June 2016 Press Release Here
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RAND Report - Toward a Sustainable Blood Supply in the United States
The U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary of Health (OASH), sponsored a study conducted by the RAND Corporation to evaluate the current sustainability of the US blood supply system. The objectives of the study were to evaluate the status quo of the current US blood system, to identify inefficiencies and outline opportunities to improve the issues. The study was conducted by analyzing available data and via interviews of individuals from blood centers, hospitals, government agencies, and suppliers. Overall, RAND concluded that the current US blood system is sustainable and operates effectively and mostly efficiently and there are unlikely but possible scenarios in which the supply of blood could be disrupted. The recommendations outlined in the report include the comprehensive collection of blood usage data, defining and subsidizing surge capacities, contingency planning for key supplies and encouraging new technology adoption where a public health benefit exists.1
Industry feedback to the report, including responses from AABB2 and ABC3 has been critical as the report fails to accurately reflect the level of urgency in US blood sustainability beyond immediate capacity status and needs. The Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA), an HHS subcommittee, presented its response to the RAND recommendations to address report limitations and concerns.3
1Read the Rand Report Here
2Read the AABB Public Comment [Subscription Required for Full Access]
3Read the ABC Newsletter #42 [Subscription Required for Full Access]
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AABB US Hemovigilance Symposium, February 13-14, 2017
Cerus is pleased to announce the AABB Hemovigilance Symposium in Atlanta, Georgia on February 13-14, 2017. The AABB US Hemovigilance Symposium is the first of what is intended to become an annual event to bring experts from around the United States and around the world to discuss US hemovigilance. Experts will address the state of US hemovigilance, recognizing the successes of the past 10 years, identify the challenges such as perceived barriers to participation and share recommendations for future improvement and harmonization. Click here to register and to see more information about keynote speakers.
Register Here
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Science Section: What We’re Reading
Texas Reports First Case of Zika Spread by Local Mosquitos
J. Steenhuysen. Reuters. 2016 Nov 29. "Texas reports first case of Zika spread by local mosquitos".
Read the Article Here
Screening for Babesia microti in the U.S. Blood Supply
Moritz E. et al. N Engl J Med. 2016 Dec 8. DOI: 10.1056/NEJMoa1600897
Read the Article Here (subcription required for full access)
Pediatric Blood Transfusion practices as a regional referral hospital in Kenya
Nabwera H. et al. Transfusion. 2016 Sept 2016. DOI. 10.1111/trf.13774
Read the Article (subsription required for full access)
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Calendar of Events
SCCM (Society of Critical Care Medicine)
January 21-25, 2017 | Honolulu, HI
Additional Information
AABB US Hemovigilance Symposium
February 13-14, 2017 | Atlanta, GA
Additional Information
BMT Tandem Meetings (Center for International Blood & Marrow Transplant Research & American Society for Blood and Marrow Transplantation)
February 22-27, 2017 | Orlando, FL
Additional Information
ABC (America's Blood Centers) Spring Meeting
March 24-29, 2017 | Washington DC
Additional Information
CSTM (Canadian Society for Transfusion Medicine)
April 20-23, 2017 | Ottowa, Canada
Additional Information
SCA (Society of Cardiovascular Anesthesiologists)
April 22-26, 2017 | Orlando, FL
Additional Information
ASPHO (The American Society of Pediatric Hematology/Oncology)
April 26-29, 2017 | Montreal, Canada
Additional Information
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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 00165-18
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