Pharming confirms safety profile of recombinant human Lactoferrin in a food safety study in healthy human volunteers
(Thomson Reuters ONE) -
Leiden, The Netherlands, July 16, 2012. Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that a
randomized, cross-over double blind, placebo controlled study in healthy
volunteers has shown that Pharming's 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."
About Pharming Group NV
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 (OMX: SOBI). RUCONEST(®) is partnered with Santarus, Inc
(NASDAQ: SNTS) in North America where the drug is undergoing Phase III clinical
development. The product is also being evaluated for follow-on indications in
the areas of transplantation and reperfusion injury. The advanced technologies
of the Company include innovative and validated platforms for the production of
protein therapeutics, technology and processes for the purification and
formulation of these products. A feasibility study, using the validated
transgenic rabbit platform, aimed at the development of recombinant Factor VIII
for the treatment of Haemophilia A is underway with partner, Renova Life, Inc.
Additional information is available on the Pharming website, www.pharming.com.
To download the Pharming Group Investor Relations App, click here.
This press release contains forward looking statements that involve known and
unknown risks, uncertainties and other factors, which may cause the actual
results, performance or achievements of the Company to be materially different
from the results, performance or achievements expressed or implied by these
forward looking statements.
Contact
Sijmen de Vries, CEO: T: +31 (0)71 524 7400
Karl Keegan, CFO: T: +31 (0)71 524 7400
FTI Consulting
Julia Phillips/ John Dineen, T: +44 (0)207 269 7193
Press release (PDF):
http://hugin.info/132866/R/1626847/520564.pdf
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originality of the information contained therein.
Source: Pharming Group N.V. via Thomson Reuters ONE
[HUG#1626847]
Unternehmensinformation / Kurzprofil:
Datum: 16.07.2012 - 07:00 Uhr
Sprache: Deutsch
News-ID 165260
Anzahl Zeichen: 4814
contact information:
Town:
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Kategorie:
Business News
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