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THIS INFORMATION IS FOR NON-US HEALTHCARE PROVIDERS ONLY

The Study Drugs

Ropeginterferon α-2b (AOP2014) versus Hydroxyurea

AOP2014

Ropeginterferon α-2b (AOP2014) at 50mcg to max 500 mcg, given every other week as one subcutanous injection

Importantly, in contrast to other pegylated Interferons that require weekly administration, AOP2014 is administered only once every 14 days with the potential for monthly administrations. Ultimately, this is expected to result in improved tolerability, convenience and compliance and, as a consequence, better long-term treatment outcomes.

AOP2014 was already awarded Orphan Drug status in 2011.

Hydroxyurea

Hydroxyurea capsules (500 mg each). Daily intake of doses from 500 mg daily to 3000 mg daily.

Hydroxyurea (hydroxycarbamide) is an orally active antineoplastic agent. Although the mechanism of action has not yet been clearly defined, hydroxycarbamide appears to act by interfering with synthesis of DNA. After oral administration the drug is readily absorbed from the gastrointestinal tract. Peak plasma concentrations are reached in 2 hours; by 24 hours the serum concentrations are virtually zero. Hydroxyurea crosses the blood-brain barrier and is well distributed throughout the body.[1]

[1] Hydrea 500 mg Hard Capsules, Summary of Product Characteristics (UK), date of revision - June 2015