Virax seeks to reactivate IND for cancer drug
Virax Holdings (ASX:VHL) is ready to fast-track the process of reactivating the Investigational New Drug (IND) application in the US for its newly acquired cancer drug GGTI-2418.
The company has received a technical assessment report from Ground Zero Pharmaceuticals, which was appointed in June to help manage the IND process.
The report will allow Virax to request IND reactivation. Virax then plans to request a meeting with the FDA to discuss the GGTI-2418 development program and anticipates that the meeting could be held 30 days post-request.
GGTI-2418 is a first-in-class cancer immunotherapeutic originally developed out of a collaboration between Yale University and the Moffitt Cancer Center in the US.
Virax acquired the exclusive worldwide rights to the treatment in June, when it completed the acquisition of Pathway Oncology.
Virax is developing the treatment in breast cancer and multiple myeloma and aims to conduct a phase Ib/II breast cancer trial in 2015 as part of the IND process.
“Re-opening the IND application is a critical step toward next-stage clinical trials. We are determined to exploit this highly encouraging clinical and commercial opportunity,” Virax managing director Dr Robert Crombie commented.
Virax Holdings (ASX:VHL) shares were trading unchanged at $0.006 as of around 2.30 pm on Wednesday.
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