Contact Information: Contact: MDRNA, Inc.: Peter Garcia Chief Financial Officer (425) 908-3603 pgarcia@mdrnainc.com Westwicke Partners (Investors): Stefan Loren, Ph.D. (443) 213-0507 sloren@westwicke.com John Woolford (443) 213-0506 john.woolford@westwicke.com McKinney|Chicago (Media): Alan Zachary (312) 944-6784 x 316 or (708) 707-6834 azachary@mckinneychicago.com
MDRNA, Inc. Presents Positive Efficacy and Tolerability Data in Non-Human Primates With Proprietary siRNA Compounds
New Data Demonstrates Evidence of Potent Anti-Tumor Activity Against Multiple Gene Targets in Multiple Rodent Oncology Models
| Source: MDRNA, Inc.
BOTHELL, WA--(Marketwire - December 3, 2009) - MDRNA, Inc. (NASDAQ : MRNA ), a leading
RNAi-based drug discovery and development company, today announced
presentation of data related to its non-human primate and oncology programs
at the Informa Life Science 10th Annual Conference, EuroTIDES, taking place
in Amsterdam, The Netherlands. Michael V. Templin, Ph.D., Vice President of
Discovery Research and Pharmaceutical Development at MDRNA, Inc., today
presented data on efficacy and tolerability in non-human primates with the
Company's novel UsiRNA construct and DiLA2 delivery platforms for the
development of RNAi-based therapeutics.
Dr. Templin stated that the non-human primate program, which began four
months ago, resulted in the significant knockdown of a primate liver gene
following a single intravenous (systemic) dose of 0.3 mg/kg. No increase
in ALT and AST levels were observed at 24 or 48 hours post-dose nor was
there elevation in other liver enzymes or kidney function markers. In
addition, there were no alterations in hematology parameters and no
apparent induction of cytokines.
Dr. Templin also presented new data from the Company's oncology
therapeutics programs. In models of liver and bladder cancer, UsiRNAs
against Survivin and PLK-1, two genes considered to play critical roles in
tumor growth, have demonstrated potent anti-tumor effects when delivered
with the Company's proprietary DiLA2 liposome formulations via systemic
(liver cancer) and local (bladder cancer) administration. In orthotopic
(within the liver) liver cancer, > 60% knockdown of survivin mRNA was
found, and compared to negative controls a 65% decrease in tumor weights
occurred in UsiRNA-treated mice. This was similar to the tumor growth
inhibition in positive control Avastin® (bevacizumab)-treated mice.
Potent anti-cancer activity was also demonstrated for bladder cancer with
up to 90% reduction in survivin mRNA. There was a dose-dependent decrease
in bioluminescence of up to 90%, indicating significant reduction in tumor
burden compared to vehicle and scrambled UsiRNA controls. Importantly, in
each model, the mechanism was confirmed to be via RNA interference.
"Our non-human primate program is fundamental to the continued development
of our oncology programs and the overall advancement of our RNAi drug
discovery platform," said J. Michael French, President and Chief Executive
Officer of MDRNA. "These data further corroborate the potency and
tolerability of our UsiRNA/DiLA2 compounds. With the rapid advancement of
our non-human primate program over the last few months, we are encouraged
with the positive progress and feel strongly that we have a robust approach
to the development of RNAi-based therapeutics."
The presentation given by Dr. Templin is posted on the Company website
homepage at: www.mdrnainc.com.
About MDRNA, Inc.
MDRNA is a biotechnology company focused on the development and
commercialization of therapeutic products based on RNA interference (RNAi).
Our goal is to improve human health through the development of RNAi-based
compounds and drug delivery technologies that together provide superior
therapeutic options for patients. Over the past decade, we have developed
substantial capabilities in molecular biology, cellular biology, lipid
chemistry, peptide chemistry, pharmacology and bioinformatics, which we are
applying to a wide range of RNAi technologies and delivery approaches.
These capabilities plus the in-licensing of key RNAi-related intellectual
property have rapidly enabled us to become a leading RNAi-based
therapeutics company with a pre-clinical pipeline in oncology. Through our
capabilities, expertise and know-how, we are incorporating multiple RNAi
technologies as well as peptide- and lipid-based delivery approaches into a
single integrated drug discovery platform that will be the engine for our
clinical pipeline as well as a versatile platform for establishing broad
therapeutic partnerships with biotechnology and pharmaceutical companies.
We are also investing in new technologies that we expect to lead to safer
and more effective RNAi-based therapeutics while aggressively building upon
our broad and extensive intellectual property estate. By combining broad
expertise in siRNA science with proven delivery platforms and a strong IP
position, MDRNA is well positioned as a leading RNAi-based drug discovery
and development company.
MDRNA Forward-Looking Statements
Statements made in this news release may be forward-looking statements
within the meaning of Federal Securities laws that are subject to certain
risks and uncertainties and involve factors that may cause actual results
to differ materially from those projected or suggested. Factors that could
cause actual results to differ materially from those in forward-looking
statements include, but are not limited to: (i) the ability of MDRNA to
obtain additional funding; (ii) the ability of MDRNA to attract and/or
maintain manufacturing, research, development and commercialization
partners; (iii) the ability of MDRNA and/or a partner to successfully
complete product research and development, including preclinical and
clinical studies and commercialization; (iv) the ability of MDRNA and/or a
partner to obtain required governmental approvals; and (v) the ability of
MDRNA and/or a partner to develop and commercialize products that can
compete favorably with those of competitors. Additional factors that could
cause actual results to differ materially from those projected or suggested
in any forward-looking statements are contained in MDRNA's most recent
periodic reports on Form 10-K and Form 10-Q that are filed with the
Securities and Exchange Commission. MDRNA assumes no obligation to update
and supplement forward-looking statements because of subsequent events.