180 0 Kommentare Cerus Corporation Provides Update on COVID-19 Related Activities - Seite 2

The safety and well-being of our employees and their families during the pandemic is a top priority. We have taken steps to ensure their safety and minimize the risk of community transmission to help reduce the rate of new infections. Headquartered in Concord, California, we are part of current state-wide orders to “shelter-in-place.” Globally, our offices and individual employees are also operating under regional health environments that restrict face-to-face interactions and movement. As a result, most of our employees are working from home to maintain Cerus’ day-to-day operations. However, we continue to work diligently to advance our development portfolio and to expand the label claims and ease of use of the INTERCEPT Blood System.
Our field team is collaborating with our blood center and hospital customers in new ways including the use of enabling technology such as video conferencing for technical support and training. In situations where our field team needs to be on-site, we will take every necessary travel precaution to keep our employees safe while ensuring our customers can continue to manufacture INTERCEPT treated blood components.

Our commitment to our R&D programs and impact to clinical trials and studies:

Pathogen-reduced cryoprecipitate: Pathogen-reduced cryo continues to be one of our highest priority R&D programs given the expected clinical utility and potential benefit to patients. For this FDA Breakthrough Device designated program, we do not anticipate disruptions to our activities surrounding data collection and regulatory submission. We continue to expect to file our PMA supplement in the first half of the year.
U.S. red blood cell (RBC) development program: As a result of COVID-19, many of our participating clinical trial hospital sites have suspended enrollment. In addition, three out of the four blood center partners that produce pathogen-reduced RBCs for these studies have suspended production because of the need to conserve red blood cells to meet hospital demand during the pandemic. While we plan to continue the study enrollment at the sites we can, we will look to reinitiate enrollment at all study sites as quickly as possible. In support of the planned U.S. regulatory filing, we expect to initiate a study in sickle cell chronic exchange transfusion in the U.K., although the timing has been impacted due in part to the COVID-19 pandemic.
European red blood cell regulatory status: The transition of our CE mark submission from a medical device directive (MDD) filing to a medical device regulation (MDR) filing as a result of the change in European regulatory laws is expected in the second quarter of 2020. However, a recent European Commission letter to the European Parliament and European Council has proposed postponing the MDR compliance date by a year to May of 2021, and it is unknown at this time whether the CE mark submission will continue its review under the MDD pathway or transition at some later point to the MDR pathway.
U.S. INTERCEPT plasma with DEHP-free plastic disposable kits: The U.S. regulatory filing for INTERCEPT plasma with alternate plastic kits was submitted to the FDA during the fourth quarter of 2019. We anticipate FDA approval during the second quarter of 2020.
Efficacy of INTERCEPT to pathogen-reduce SARS-CoV-2: To date, there have been no documented cases of COVID-19 as a result of transfusion transmitted infections. However, SARS-CoV-2 has been found in the serum of COVID-19 patients which raises concerns, even though there is no historical evidence of respiratory viruses being associated with transfusion transmitted infectious disease. Building off of our previous studies demonstrating robust inactivation of SARS and MERS in blood components, we are conducting tests to assess the efficacy of INTERCEPT in inactivating SARS-CoV-2. Results of these tests are anticipated in mid-2020.