Silence Therapeutics to Receive $1.9m Milestone Payment as
2008-07-30 12:03:45.70 (New York)
Pfizer and Quark Commence Phase II Trial
LONDON, July 30 /PRNewswire/ -- Silence Therapeutics plc (AIM: SLN), a
leading European RNAi focused biotechnology company, today announces that its
partner, Quark Pharmaceuticals Inc. ("Quark") together with Pfizer, has
commenced a Phase II clinical trial with RTP-801i-14 (PF-4523655), a small
interfering RNA (siRNA) therapeutic product based on Silence's AtuRNAi
technology. Its initiation triggers a $1.9 million milestone payment to
Silence from Quark.
The study is designed to evaluate the effectiveness of the candidate in
improving visual acuity compared to laser treatment in patients with diabetic
macular oedema. The Phase II study is being funded and is conducted by Pfizer
Inc. in collaboration with Quark. Pfizer in-licensed RTP-801i-14 from Quark in
a deal announced in 2006 for the treatment of age-related macular degeneration
(AMD) and other ophthalmologic and non-ophthalmologic indications.
Diabetic macular oedema results in the macula swelling and surrounding
blood vessels dilating to compensate for this. The dilated vessels are
generally leaky, resulting in fluid build-up in the macula, which in turn
causes the macula to swell and cease to function. Diabetic macular oedema is
the most common cause of visual impairment in patients with non-proliferative
retinopathy. Approximately 14% of people with diabetes have diabetic macular
oedema with prevalence increasing to 29% for people with diabetes who use
insulin for more than 20 years.
In December 2004 Quark and Silence Therapeutics AG signed a Collaboration
Agreement on the development of siRNA molecules for the gene target RTP-801,
which resulted in RTP801i-14, a 19 base pairs long blunt-ended AtuRNAi (siRNA)
molecule and also provided Quark with a license to AtuRNAi technology. In
addition a second agreement (Option and License Agreement) was signed in April
2005, and expanded in 2007, to provide Quark with options for non-exclusive
licenses to develop additional molecules against further specific targets
using Silence Therapeutics' proprietary AtuRNAi technology.
Iain Ross, Chairman and CEO of Silence Therapeutics, commenting on today's
announcement said, "It is great news that our partners Quark and Pfizer are
continuing to make good clinical progress with RTP-801i-14, a compound which
we discovered together in our collaboration with Quark. The commencement of
the first Phase II clinical trial utilizing our chemistry is a very
significant milestone for Silence, and the advancement of this compound
represents a further strong validation of our proprietary AtuRNAi technology."
The Company also announces today that its operating company Silence
Therapeutics AG has been awarded a research grant from the German Federal
Ministry of Education and Research. The BioChancePlus grant program provides
individual grants to support innovative research initiatives in Germany. The
grant, which totals €1.5 million over three years, was awarded to Silence
Therapeutics AG in recognition of the company's pioneering research and
development projects in the field of RNAi.
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
CONTACT:
Iain Ross, Chairman & Chief Executive Officer, or Melvyn Davies, Finance
Director, both of Silence Therapeutics plc, +44(0)20-7307- 1620; or European
Contacts: David Dible or Heather Keohane, both of Citigate Dewe Rogerson,
+44(0)20-7638-9571; or Thomas Christely, Chief Executive Officer, or Klaus
Giese, Chief Scientific Officer, both of Silence Therapeutics AG, +49(0)30-9489-
2800; Nominated Advisers: Chris Collins of Nomura Code Securities Limited,
+44(0)20-7776-1200; or U.S. Contacts: Tim Allison, +1-978-745-4200 ext. 102, or
Lisa Rivero, +1-978-745-4200 ext. 106, both of LaVoie Group for Silence
Therapeutics |
