Pharming's C1 inhibitor effective in preventing AMR in animal model of transplant rejection
(Thomson Reuters ONE) -
Leiden, The Netherlands, April 1, 2010. Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today publication
of preclinical evidence that its recombinant human C1 inhibitor (rhC1INH) was
effective in a primate model in preventing antibody-mediated rejection (AMR)
following kidney transplantation.
Following transplantation, some patients make specific antibodies against the
donor kidney that cause activation of the classical complement system. This
process known as antibody-mediated rejection, results in inflammatory damage to
the transplanted kidney that can lead to organ failure and graft loss. Over the
past decade, AMR has been increasingly recognized as a serious transplantation
complication that can lead to loss of the transplanted organ. Current treatments
for AMR are non-specific and have suboptimal efficacy.
In the published study, Dr. Gilles Blancho and colleagues from the Institute of
Transplantation - Urology - Nephrology (ITUN) in Nantes, France, demonstrated
that Pharming's rhC1INH prevented AMR in a baboon AMR model by blocking the
activation of the classical complement system in the treated animals, whereas
untreated animals developed AMR by the second day following transplantation.
Histopathological results indicated that the classical complement pathway was
effectively inhibited during treatment as evidenced by the lack of specific
complement deposition in the kidney, which is also the hallmark of AMR in
humans. The results also confirmed the group's earlier positive findings with
rhC1INH at inhibiting cytotoxicity. These results are published in Kidney
International (advance online publication, 24 March 2010) by Dr Tillou et al.
"The data we observed in this stringent model of AMR suggest that rhC1INH may be
even more efficient in less severe experimental or clinical situations", said
Dr. Blancho. "AMR remains an unsolved issue in transplantation and rhC1INH could
be an effective complementary treatment for this challenging problem."
"These results support the significant potential for rhC1INH in
antibody-mediated rejection, which is a serious transplantation complication",
commented Dr. Bruno Giannetti, COO of Pharming. "Earlier this year, preclinical
evidence was published indicating rhC1INH could also be effective in preventing
delayed graft function following kidney transplantation. We intend to initiate
clinical studies in patients for both of these indications later this year."
About transplantation
In the United States alone, over 79,000 patients are waiting for an organ
transplant (35,000 in the EU). Each month, nearly 3,000 new patients are added
to this waiting list. However, only 25,000 solid organs are available and
transplanted each year, including kidney, liver, lung and heart transplants. In
addition, complications may arise following organ transplantation, such as
antibody-mediated rejection (AMR) and delayed graft function (DGF).
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of genetic
disorders, ageing diseases, specialty products for surgical indications, and
nutritional products. Pharming's lead product Rhucin® has completed clinical
development for acute attacks of Hereditary Angioedema and a Market
Authorization Application is under review with the EMA. Prodarsan® is in early
stage clinical development for Cockayne Syndrome and human lactoferrin for use
in food products The advanced technologies of the Company include innovative
platforms for the production of protein therapeutics, technology and processes
for the purification and formulation of these products, as well as technology in
the field of DNA repair (via DNage). Additional information is available on the
Pharming website,http://www.pharming.com
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:
Marjolein van Helmond, Pharming Group NV, T: +31 (0)71 52 47 431 or +31 (0)6
109 299 54
[HUG#1400134]
Press Release (PDF): http://hugin.info/132866/R/1400134/355534.pdf
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Datum: 01.04.2010 - 01:30 Uhr
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