New Data from Silence's Atu027 Anticancer Trial Published at ASCO
LONDON, May 17, 2012/PRNewswire-FirstCall/ --
- Atu027, a First in Class RNAi Therapy, Demonstrates Potential
- Antitumour Activity in Cancer Patients and Possible Biomarker
Identified
Silence Therapeutics to Announce New Data from Phase I Study of
Atu027 in
Solid Tumours At 2012 ASCO Annual Meeting
Silence Therapeutics plc (AIM: SLN) ("Silence" or the "Company"), a
leading global RNA interference (RNAi) therapeutics company, today
announces that top line data from its ongoing Phase I trial of
Atu027 [http://silence-therapeutics.com/pipeline ] show that of the
33 patients treated in the first 10 cohorts of the study, 10
patients experienced stable disease after three months. Two
patients with neuroendocrine cancers had disease stabilisation for
nine and 12 months respectively, including partial regression of
liver metastases in one patient. Another patient with breast cancer
demonstrated regression of liver metastases. Importantly, among
various biomarkers tested, sVEGFR-1 plasma levels decreased
significantly upon treatment further confirming a potential
biological effect of Atu027.
Silence will publish the latest data from its ongoing Phase I study
of Atu027
[http://silence-therapeutics.com/pipeline/pre-clinical-development
], its lead internal therapeutics candidate, at the 2012 American
Society of Clinical Oncology ("ASCO") Annual Meeting in Chicago,
Illinois, 1-5 June 2012. Further data from the ongoing Phase I
Atu027 clinical study will also be the subject of a presentation
with the following details:
Abstract Title:
Anti-metastatic activity of Atu027, a liposomal small
interfering RNA formulation, targeting protein kinase
N3 (PKN3): Final results of a phase I study in
patients with advanced solid tumours.
Abstract
#: 98347
Presentation
Date/Time:
Mon, June 04, 2012 / 16:00 - 18:00
Location:
Networking Lounge, Level 3, North
Presenters: Klaus
Giese
[http://silence-therapeutics.com/about-us/management],
Ph.D., chief scientific officer of Silence, and Dr.
Dirk Strumberg, Professor of Medicine and Director,
Department of Hematology and Medical Oncology,
University of Bochum, Marienhospital Herne, the
study's principal investigator
Attendees
Please contact c.jahn@silence-therapeutics.com
for
further information
Silence's open label, single-centre, dose-finding Phase I study of
Atu027 [http://silence-therapeutics.com/pipeline ] in subjects with
advanced solid cancer is ongoing. The study was designed to
evaluate up to a total of 11 escalating doses of Atu027 and enroll
approximately 33-36 patients. Across the nine completed dose
levels, Atu027
[http://silence-therapeutics.com/pipeline/pre-clinical-development
] was generally well tolerated with no dose-limiting toxicities
observed. Additionally, as consistent with preclinical data,
preliminary Phase I pharmacokinetic (PK) data showed dose-dependent
increase in plasma siRNA and lipid levels.
Silence expects to complete the ongoing Phase I clinical trial of
Atu027, one of the most clinically advanced RNAi therapeutics
[http://silence-therapeutics.com/platform-technologies/rna-interference
] in the area of oncology, in July 2012. The full ASCO abstract for
the Phase I Atu027 study is now available online at: http://chicago2012.asco.org.
"I am delighted that with Atu027 we potentially have a first in
class RNAi therapeutic for treating solid tumours. Cancer therapy
[http://silence-therapeutics.com/pipeline/pre-clinical-development
] needs innovative treatments such as Atu027. The new data at ASCO
demonstrates that Atu027 can be safely administered at doses above
those believed to be effective. Moreover, the data also strongly
indicate that Atu027 is impacting the disease course and in
particular providing disease stabilisation." said Tony Sedgwick,
Ph.D., chief executive officer of Silence Therapeutics.
"Identification of sVEGR-1 as a possible biomarker is also a
significant new advancement and we look forward to sharing more
complete findings from the ongoing Phase I study at ASCO in
June."
About Atu027
Atu027 is a liposomal siRNA [http://silence-therapeutics.com ]
formulation targeting PKN3 for the treatment of advanced solid
cancer. PKN3 is a key regulator during angiogenesis and
lymphangiogeneis, while also acting as a major regulator of
metastasis and motility during pathological processes. Accordingly,
Silence believes that inhibition of PKN3 with Atu027 may lead to a
reduction in nutrient and oxygen supply to solid tumors, as well as
interfering with tumor formation, endothelial cell motility and
metastasis.
Notes for editors
About Silence Therapeutics plc (http://www.silence-therapeutics.com)
Silence Therapeutics plc (AIM: SLN) is a leading biotechnology
company dedicated to the discovery, development and delivery of
targeted, systemic RNA interference (RNAi) therapeutics for the
treatment of serious diseases. Silence offers one of the most
comprehensive short interfering RNA (siRNA) therapeutic platforms
available today based on a strong intellectual property portfolio
and large clinical safety database. Silence's clinical siRNA
product pipeline is one of the broadest in the industry. The
Company possesses multiple proprietary siRNA delivery technology
platforms including AtuPLEX(TM), DACC and DBTC. AtuPLEX enables the
broad functional delivery of siRNA molecules to targeted diseased
tissues and cells, while increasing their bioavailability and
intracellular uptake. The DACC delivery system allows functional
delivery of siRNA molecules selectively to the lung endothelium
with a long duration of target mRNA and protein knock-down. The
DBTC delivery system enables functional delivery of siRNA molecules
selectively to liver cells including hepatocytes. Additionally, the
Company has a platform of novel siRNA molecules based around its
AtuRNAi chemical modification technology, which provides a number
of advantages over conventional siRNA molecules. Silence's unique
RNAi assets also include structural features for RNAi molecules and
specific design rules for increased potency and reduced off-target
effects of siRNA sequences.
The Company's lead internal drug candidate is Atu027, a liposomal
formulation in clinical development for systemic cancer indications
and one of the most clinically advanced RNAi therapeutic candidates
in the area of oncology. Atu027 incorporates two of the Company's
technologies, AtuRNAi and AtuPLEX(TM). Silence is currently
conducting an open-label, single-centre, dose-escalation Phase I
study with Atu027 in patients with advanced solid tumors involving
single, as well as repeated, intravenous administration.
Encouraging interim safety and pharmacokinetic data were presented
at the American Society of Clinical Oncology Annual Meeting in June
2011. The study is expected to be completed in July 2012.
The Company's RNAi therapeutic platform has received key validation
through multiple partnerships with pharmaceutical companies
including AstraZeneca, Dainippon Sumitomo, Pfizer/Quark, and
Novartis/Quark. Silence is actively pursuing the establishment of
additional partnerships. Silence Therapeutics has operations in
both Berlin and London.
For further information, please contact:
Silence Therapeutics
Tony Sedgwick / Max Herrmann
T: +44-20-7491-6520
a.sedgwick@silence-therapeutics.com
m.herrmann@silence-therapeutics.com
M: Communications
Mary-Jane Elliott / Sarah Macleod /
Claire Dickinson
T: +44-20-7920-2330
silencetherapeutics@mcomgroup.com
[healthcare@mcomgroup.com ]
Singer Capital Markets
Shaun Dobson / Claes Spang
T: +44-20-3205-7500
shaun.dobson@singercm.com
claes.spang@singercm.com
Source: Silence Therapeutics Plc
Posted: May 2012
