CCST has been a hive of activity this week with the MANE study getting underway. CCST in undertaking this study for the well known international pharmaceutical company Merck.
Why is this study being done?
A side effect of many cancer-fighting treatments is that the body’s bone marrow stops producing white blood cells called neutrophils, which are very important in fighting infection. This is called ‘neutropenia’, and can cause serious infections in patients. Neulasta® increases the production of white blood cells in the bone marrow, and is used in many countries to prevent or neutropenia caused by cancer treatment.
Some people who receive Neulasta® develop antibodies against the drug. Antibodies are special proteins made by the body. Antibodies recognise foreign substances so that the immune system can fight them off. If a person develops antibodies against a drug (called ‘anti-drug antibodies’ or ‘ADAs’), the ADAs can stop the drug from working or cause reactions if the drug is given again.
Merck has developed a drug similar to Neulasta®, called MSB11455. This study aims to show that MSB11455 is very similar to Neulasta®, in terms of the ADAs that develop after dosing. The study will also compare safety and side effects, and levels of drug in the blood over time