Adventrx in IND for Thiovir
Adventrx Pharmaceuticals has begun cGMP production of the antiviral drug, Thiovir, in preparation for an Investigational New Drug (IND) application filing with the FDA. Thiovir is being manufactured by deCODE genetics'chemistry facility, based in Lemont, IL.
Adventrx Pharmaceuticals has begun cGMP production of the antiviral drug, Thiovir, in preparation for an Investigational New Drug (IND) application filing with the FDA. Thiovir is being manufactured by deCODE genetics'chemistry facility, based in Lemont, IL.
'The successful launch of cGMP manufacturing for Thiovir represents an important step towards moving this compound into the clinic,' said Dr Joan Robbins, Adventrx Pharmaceuticals' chief technical officer. 'In addition to this manufacturing effort, we expect to complete other necessary components for an IND filing with the FDA in the fourth quarter of 2004.'
Thiovir is an orally-delivered prodrug for the broad spectrum antiviral drug, foscarnet, which is an IV-delivered treatment for opportunistic infections in HIV-infected patients. Adventrx intends to study Thiovir as a non nucleoside reverse transcriptase inhibitor (NNRTI) component of HAART (highly active antiretroviral therapy) for treatment of HIV/AIDS.
deCODE's cGMP manufacturing facility, based in Woodridge, Illinois, conducts process chemistry optimization and cGMP manufacturing for pharmaceutical and biotechnology clients as well as for deCODE's proprietary drug development programs.