segunda-feira, dezembro 18, 2006
"Em Portugal participamos num Ensaio com dois centros, mas nenhum dos centros tem pessoas a fazer Brecanavir."
STATEMENT TO HIV PATIENT COMMUNITY
December 18, 2006
GSK Discontinues Clinical Development of Investigational Protease Inhibitor Brecanavir (640385)
GlaxoSmithKline plc (GSK) today confirms that, due to insurmountable issues regarding formulation, the clinical development program for the investigational HIV protease inhibitor brecanavir has been discontinued. Brecanavir had reached Phase II development. This decision has been taken as we have been unable to develop a viable oral dosage formulation capable of delivering the desired drug levels in patients with multi-drug resistant HIV.
As in all of our drug development programs, GSK investigated several formulations of brecanavir. We conducted extensive studies in an effort to identify a formulation that would maximize therapeutic benefit for people living with HIV, especially those who are heavily treatment-experienced. Ultimately, our formulation work could not overcome the limitations of the brecanavir molecule which make consistent delivery of target drug levels unachievable.
Clinical trial investigators and their Institutional Review Boards (IRBs) are being notified of the situation and directed to transition their patients to marketed antiretrovirals or appropriate treatments available through expanded access programs. GSK will work with our clinical trial investigators to identify and implement alternative treatment arrangements for individual trial patients.
“GSK is dedicated to excellence in the care of individuals with HIV infection, and we will continue our efforts to find effective treatments with improved resistance profiles for these patients,” said Lynn Marks, MD, Senior Vice President, GSK Medicine Development Center for Infectious Diseases. “Despite this disappointing outcome with brecanavir, we remain unwavering in our commitment to find new solutions to meet the challenges of HIV/AIDS.”