PRO 140 potential too broad for orphan designation

The FDA has not granted orphan drug designation (ODD) to CytoDyn for its PRO 140 therapy as it appears to have the potential to treat more than just the subset of multi-drug resistant HIV patients for which the designation was requested.

PRO 140 is currently being evaluated, in combination with other antiretroviral agents, in Phase IIb/III trial for the ODD application. Additionally, the company is conducting a 300-patient Phase IIb/III trial with PRO 140 as a single-agent maintenance therapy for HIV-infected patients.

In previous Phase I and II clinical trials, PRO 140 was shown to be able to significantly reduce viral burden in HIV patients. The Phase IIb trial results demonstrated the therapy can prevent viral escape in patients during several months of interruption from conventional drug therapy. The company intends to continue development of PRO140 as a therapeutic anti-viral agent in patients with HIV and will pursue non-HIV indications.

CytoDyn is a biotechnology company that is focused on the clinical development and potential commercialisation of humanised monoclonal antibodies for the treatment and prevention of HIV infection.