ABBOTT PARK, Ill., Abbott (NYSE: ABT) announced today that it has signed an agreement to collaborate with Astellas Pharma Global Development in a Phase 3 clinical trial for ASP0113 (TransVax), an investigational vaccine licensed from Vical Incorporated for preventing cytomegalovirus (CMV) reactivation in transplant patients.
Under the agreement, Abbott's RealTime CMV assay, which is performed on the Abbott m2000 System and intended for investigational use only, will be used to monitor patients for CMV viral load in order to assess the vaccine's efficacy. Viral load is a measure of the severity of a viral infection or the amount of active virus in the blood.
A herpes virus, CMV infects half of all adults by age 40 and is the most common viral infection in transplant recipients. After primary infection, CMV establishes lifelong latency without causing symptoms. The virus is often dormant in those who are healthy but can cause illness in immunocompromised people, such as those undergoing stem cell or organ transplants. Hematopoietic cell transplant patients and other individuals with depressed immune systems are vulnerable to severe complications from CMV infection, including CMV disease and death.
"Our agreement with Astellas gives us an opportunity to collaborate with another leader in the health care industry to better monitor patients to ensure proper treatment," said John Coulter, head of Abbott's molecular diagnostics business. "Abbott's investigational CMV test will be used as an important aid in assessing the efficacy of this promising vaccine which could significantly improve the overall outcome of transplant procedures."
This agreement represents the fourth partnership that Abbott has announced in the last 12 months with a leading pharmaceutical company. Recent collaborations with Pfizer, GlaxoSmithKline and Merck focus on the development of companion diagnostic tests for use in selecting patients for novel oncology therapeutics.
PR Newswire