Biotech company Pharming Group NV has confirmed that a randomized, cross-over double blind, placebo controlled study in healthy volunteers which shows that its recombinant human Lactoferrin (rhLF) is safe, based on the assessment of clinical data, gastro-intestinal tolerance and adverse event reporting.

Twenty-four healthy subjects with an age-range of 25 to 49 years participated in the study. These volunteers consumed recombinant human Lactoferrin at a daily dose of 0, 300 or 1000 mg, in combination with 10 grams of skimmed milk powder. Each treatment was consumed for a period of two weeks. There was no difference between treatment and placebo and it was concluded that consumption of rhLF is safe. The study was supported by a grant from the Dutch Food and Nutrition Delta (FND).These results are consistent with a previous clinical study, undertaken by Pharming in 2002 under a pharmaceutical development plan, in which intravenous use of rhLF was tested to a dose of 60 mg/kg in healthy volunteers. Pre-clinical safety studies showed that doses up to 2000 mg/kg/day were safe.

Human Lactoferrin is a natural protein that helps to fight and prevent infections. The protein is present in substantial quantities in mother’s milk and plays an important role in the defense system of infants. The protein is also present in various body fluids and continues to play an important role against a wide range of bacterial, fungal and viral pathogens in adults.

Out-licensing discussions aimed at finding partners interested in further developing the Lactoferrin franchise are ongoing.

Bruno Giannetti, COO of Pharming said, “With this study in human volunteers we now complete an extensive dossier of safety studies on Pharming’s recombinant human Lactoferrin. We conclude that these latest results confirm previous findings and together provide a very good basis to use rhLF as a food ingredient and support for our ongoing discussions with potential partners and buyers for the project.”

Pharming Group NV is developing innovative products for the treatment of unmet medical needs. RUCONEST is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum (SOBI).