Replies to post #12415 on iBio Inc (IBIO)

[doebop]

ZMapp: Under contract with DOD’s Defense Threat Reduction Agency (DTRA) and BARDA, ZMapp’s antibodies are produced in specially grown tobacco plants and have only been produced in limited quantities. BARDA is sponsoring the manufacturing of ZMapp for Phase 1-2 clinical studies. ZMapp has shown evidence of antiviral activity in animal models of infection. Clinical studies are expected to start in early 2015 at NIAID. Other clinical studies are slated to begin in affected African countries in early 2015. This therapeutic candidate has been used under an emergency investigational new drug (eIND) application in Ebola-infected patients in the United States, Africa, and elsewhere. Mapp Biopharmaceutical produces ZMapp.

[OhManIDied]

NIH, DOD, and HHS’ Biomedical Advanced Research and Development Authority (BARDA) are supporting production of tens of thousands of doses of these vaccines on a pilot scale for planned trials. BARDA with FDA assistance is supporting the rapid scale-up and optimization of vaccine manufacturing for these vaccine candidates to ensure that the capacity exists to produce millions of vaccine doses in a timely way if mass vaccination campaigns are able to occur in 2015 in Africa.

In addition to these vaccine candidates, there are three other candidates supported during early stage development by NIH and DOD that are a few months away from the start of Phase 1 clinical trials.

Ebola Therapeutics Development. Additionally, the U.S. Government is supporting the development of several investigational candidate therapeutics to treat patients infected with the disease. Some have already been employed in patients in the United States and Africa.

ZMapp: Under contract with DOD’s Defense Threat Reduction Agency (DTRA) and BARDA, ZMapp’s antibodies are produced in specially grown tobacco plants and have only been produced in limited quantities. BARDA is sponsoring the manufacturing of ZMapp for Phase 1-2 clinical studies. ZMapp has shown evidence of antiviral activity in animal models of infection. Clinical studies are expected to start in early 2015 at NIAID. Other clinical studies are slated to begin in affected African countries in early 2015. This therapeutic candidate has been used under an emergency investigational new drug (eIND) application in Ebola-infected patients in the United States, Africa, and elsewhere. Mapp Biopharmaceutical produces ZMapp.

Thanks again for the link.

IBIO

[TheMotivatedTrader]

Great post. Thanks for sharing.