U.S. AtuRNAi Patent Allowance Builds on European Equivalent Granted in 2007, Expanding Commercial Protection LONDON, July 31
LONDON, July 31 /PRNewswire/ -- Silence Therapeutics plc (AIM: SLN), a
leading European RNAi focused biotechnology company, today announced that the
United States Patent and Trademark Office has allowed the Company's core RNAi
patent application. The Patent Office issued a 'Notice of Allowance' for
patent application 10/633,630, "Interfering RNA Molecules," which covers
stabilized, small interfering RNA (siRNA) molecules with defined positional
modifications. The claims cover siRNA molecules that are "blunt ended," as
well as molecules with one or more "overhangs" and specifically cover Silence
Therapeutics' proprietary siRNA molecules, known as "AtuRNAi".
The company also announced today it has received a Notice of Acceptance
from the Australian Patent Office for patent application No. 2003260370
entitled "Further novel forms of interfering RNA molecules." The European
equivalent of the US and Australian patent applications was granted by the
European Patent Office in January 2007.
Iain Ross, Chairman & CEO of Silence Therapeutics, said, "This is a major
milestone for Silence, our partners and investors. This patent allowance
protects our AtuRNAi technology and our proprietary siRNA molecules in the
United States, the largest pharmaceutical market in the world. Silence
already has a strong, proprietary position in the RNAi space and this
allowance builds further on our global patent portfolio. With the U.S. patent
allowance, we are now significantly better positioned to achieve our goal of
becoming one of the leading companies in the field of RNAi therapeutics and
delivery."
Silence considers its AtuRNAi to be best-in-class siRNA molecules based on
important advantages over conventional siRNA molecules, including increased
stability against nuclease degradation and an increased serum half-life, while
retaining therapeutic activity. AtuRNAi molecules form the basis of Silence's
therapeutic research and development collaboration with AstraZeneca, as well
as the Company's license and collaboration agreements with Quark
Pharmaceuticals Inc. In addition, Silence is developing an internal,
proprietary pipeline of systemically delivered AtuRNAi molecules that are
initially focused on oncology indications.
Silence's intellectual property portfolio includes patents and patent
applications covering essential chemical modification to stabilize siRNA
molecules in vitro and in vivo, as well as systemic siRNA delivery systems.
These include AtuPLEX, Silence's proprietary systemic delivery system that
enables the functional delivery of novel siRNA therapeutic molecules to
targeted tissues and cells.
About Silence Therapeutics plc (www.silence-therapeutics.com)
Silence Therapeutics plc (AIM: SLN) is a leading European RNAi focused
biotechnology company. RNAi can selectively 'silence' genes linked to the
onset of disease. RNAi is a Nobel Prize winning technology and one of the
most promising areas of drug discovery and development today.
Silence Therapeutics has developed a platform of novel short interfering
RNA ('siRNA') molecules, AtuRNAi, which provide a number of advantages over
conventional siRNA molecules, including increased stability against nuclease
degradation. In addition, the Company has developed a proprietary systemic
delivery system, AtuPLEX. This system enables the functional delivery of siRNA
molecules to targeted diseased tissues and cells, while increasing their
bioavailability and intracellular uptake.
Silence's lead internal product, Atu027, is a proprietary AtuRNAi molecule
in preclinical development for systemic cancer indications. Atu027 has
successfully completed single and repeat dose toxicology and geno-toxicology
studies, as well as a 28-day toxicology study using multiple dosing regimens.
Silence plans a regulatory filing in 2008 to commence clinical trials for
Atu027.
In March 2008, Silence Therapeutics announced a collaboration with
AstraZeneca (LSE: AZN) focused on the development of a range of novel delivery
approaches for siRNA molecules. Under the terms of the agreement both Silence
Therapeutics and AstraZeneca will be allowed to commercialize the truly novel
delivery systems that the two partners develop together.
In July 2007, Silence Therapeutics formed its first research and
development collaboration with AstraZeneca to develop novel AtuRNAi
therapeutics against five specific targets, including those in respiratory
indications. This collaboration was the first industry validation of the
potential application of Silence Therapeutics' proprietary AtuRNAi molecules
and solidified the Company's leadership position in field of RNAi
therapeutics.
The Company's AtuRNAi technology also has been sublicensed to Pfizer via
Quark's license to them of the compound RTP-801i-14 for the treatment of age-
related macular degeneration (AMD) and a number of other indications. This
compound entered the clinic in early 2007. Silence Therapeutics also has
licensed to Quark rights to the AtuRNAi structure for Quark's proprietary
compound, AKIi-5, which is in a Phase I human clinical study for treatment of
acute kidney injury. In May 2008 the U.S. Food and Drug Administration (FDA)
approved an Investigational New Drug application (IND) from Quark for another
siRNA therapeutic product based on Silence's unique proprietary chemistry.
The product, DGFi, which uses the same AtuRNAi molecule as AKIi-5, was
discovered and is being developed by Quark for use in prevention or treatment
of delayed graft function in kidney transplantation.
Silence Therapeutics is based in London, UK, and Berlin, Germany, and is
listed on AIM.
About RNAi
RNA interference (RNAi), is a Nobel Prize winning technology and one of
the most exciting areas of drug discovery today. It represents a completely
new approach to selectively 'silence' or inactivate disease relevant genes and
as such it has the potential to create a new class of therapeutic products.
RNAi could therefore offer a therapeutic approach to a broad range of diseases
(cancer, infectious diseases, inherited diseases), many of which have been
regarded as incurable and are not addressed by current therapeutics, therefore
providing a large market opportunity.
Forward-Looking Statements
This press release includes forward-looking statements that are subject to
risks, uncertainties and other factors. These risks and uncertainties could
cause actual results to differ materially from those referred to in the
forward-looking statements. All forward--looking statements are based on
information currently available to Silence Therapeutics and Silence
Therapeutics assumes no obligation to update any such forward-looking
statements.
SOURCE Silence Therapeutics plc