FWIW, Cytodyn posted this on social media a little while ago. Does t his mean Amarex is using Leronlimab? Why not mention it by name?
US FDA Grants Fast Track Designation to an Amarex Client Treating mTNBC
Germantown, MD, USA (May 14, 2019) – Amarex Clinical Research, LLC announces that the US FDA has granted Fast Track Designation to a novel monoclonal antibody for use in combination with carboplatin in the treatment of CCR5-positive metastatic triple-negative breast cancer (mTNBC) patients. The FDA granted the designation to the drug sponsor following significant preclinical results demonstrating a greater than 98% reduction in human breast cancer metastasis in preclinical models.
Dr. Kazem Kazempour, President & CEO of Amarex stated that, “We have collaborated with this sponsor on a number of projects for this specific drug over the last few years. We have been pleased to work on this product, now including a Fast Track Designation status.”
The FDA Fast Track Designation (FTD) is an approval process designed to facilitate the development, and expedite the review, of drugs that treat serious conditions and fill a current unmet medical need. The intent of this program is to get important new drugs to the patient earlier. A condition is considered to be serious based on whether the drug will impact factors such as survival, day-to-day functioning, or likelihood that the condition will progress from less severe to more serious if left untreated. Filling an unmet medical need is defined as providing a therapy where none currently exists, or providing a potentially superior therapy than currently available.
About Amarex Clinical Research
Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services. For more information visit www.amarexcro.com.
Contact:
Patrick J. Burke
Business Development
20201 Century Blvd., Fourth Floor
Germantown, MD 20874 USA
+1 301 528 7000
patrickb@amarexcro.com
US FDA Grants Fast Track Designation to an Amarex Client Treating mTNBC
Germantown, MD, USA (May 14, 2019) – Amarex Clinical Research, LLC announces that the US FDA has granted Fast Track Designation to a novel monoclonal antibody for use in combination with carboplatin in the treatment of CCR5-positive metastatic triple-negative breast cancer (mTNBC) patients. The FDA granted the designation to the drug sponsor following significant preclinical results demonstrating a greater than 98% reduction in human breast cancer metastasis in preclinical models.
Dr. Kazem Kazempour, President & CEO of Amarex stated that, “We have collaborated with this sponsor on a number of projects for this specific drug over the last few years. We have been pleased to work on this product, now including a Fast Track Designation status.”
The FDA Fast Track Designation (FTD) is an approval process designed to facilitate the development, and expedite the review, of drugs that treat serious conditions and fill a current unmet medical need. The intent of this program is to get important new drugs to the patient earlier. A condition is considered to be serious based on whether the drug will impact factors such as survival, day-to-day functioning, or likelihood that the condition will progress from less severe to more serious if left untreated. Filling an unmet medical need is defined as providing a therapy where none currently exists, or providing a potentially superior therapy than currently available.
About Amarex Clinical Research
Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services. For more information visit www.amarexcro.com.
Contact:
Patrick J. Burke
Business Development
20201 Century Blvd., Fourth Floor
Germantown, MD 20874 USA
+1 301 528 7000
patrickb@amarexcro.com
