Sirna Therapeutics Reports Final Results from Phase 1 Study on Its RNAi-Based Therapeutic for Age-Related Macular Degeneration
August 10 2006 - 9:19AM
PR Newswire (US)
100% Visual Acuity Stabilization observed in All Patient Groups
Eight Weeks after a Single Dose of Sirna-027 SAN FRANCISCO, Aug. 10
/PRNewswire-FirstCall/ -- Sirna Therapeutics, Inc. (NASDAQ:RNAI), a
leading RNAi-based therapeutics company, reported the final results
from its recently completed Phase 1 trial for Sirna-027, a novel
therapeutic for age-related macular degeneration (AMD). Single
ascending doses of Sirna-027 were safe and well tolerated, and all
26 patients (100%) showed visual acuity stabilization eight weeks
after a single injection. In addition, at the same time point, five
of 26 patients (19%) experienced clinically significant improvement
in visual acuity, indicated by an increase of at least three lines
on an eye chart. Three months after a single injection, 24 of 26
patients (92%) showed visual acuity stabilization, with four of 26
patients (15%) experiencing clinically significant improvement in
visual acuity; only two of 26 patients (8%) experienced a reduction
in visual acuity of three lines or more. Importantly, a decrease in
foveal thickness was observed in some patient groups, which is an
indication of biological activity of Sirna-027. "This is the first
demonstration of biological activity of a chemically optimized
siRNA in humans," said Sirna Chief Medical Officer Roberto
Guerciolini, M.D. "These data represent an important milestone
toward the demonstration of the potential therapeutic benefit of
Sirna-027 and the clinical validation of RNAi as a therapeutic
modality." The potential for a long-lasting effect on visual acuity
after a single dose of Sirna-027 could be due to the unique
catalytic mechanism of short interfering RNA (siRNA), and could
make this compound amenable to a more favorable dosing regimen than
other approved products. "Less frequent dosing in this devastating
disease should greatly improve patient convenience, compliance, and
quality of life," said Dr. Guerciolini. The Phase 1 study evaluated
the safety, tolerability, and biological effect of single-ascending
doses of Sirna-027 in patients with AMD. A total of 26 patients
with active disease were enrolled to receive a single intravitreal
injection of Sirna-027 ranging from 100-1,600 micrograms. In
September 2005, Sirna and Allergan, Inc., a global leader in eye
care, established a Strategic Alliance in eye diseases which
includes Sirna-027 for AMD. Under the terms of the Agreement,
Allergan assumed all developmental and commercialization costs for
Sirna-027. Sirna and Allergan expect to initiate the Phase 2 trial
during the second half of 2006. About Sirna Therapeutics Sirna
Therapeutics is a clinical-stage biotechnology company developing
RNAi-based therapies for serious diseases and conditions, including
age- related macular degeneration (AMD), hepatitis B and C,
dermatology, asthma, respiratory syncytial virus (RSV),
Huntington's disease, diabetes and oncology. Sirna Therapeutics
completed its Phase 1 clinical trial for Sirna- 027 in AMD in 2005
and with its strategic partner, Allergan, Inc., will move Sirna-027
into Phase 2 clinical trials in the second half of 2006. Sirna has
selected a clinical compound for hepatitis C virus, Sirna-034,
which the Company plans to bring into Phase 1 clinical trials by
the end of 2006. Sirna has established an exclusive multi-year
strategic alliance with GlaxoSmithKline for the development of
siRNA compounds for the treatment of respiratory diseases. Sirna
has a leading intellectual property portfolio in RNAi covering over
250 mammalian gene and viral targets and over 200 issued or pending
patents covering other major aspects of RNAi technology, including
the microRNA technology. More information on Sirna Therapeutics is
available on the Company's web site at http://www.sirna.com/. Safe
Harbor Statement Statements in this press release which are not
strictly historical are "forward-looking" statements which should
be considered as subject to many risks and uncertainties. For
example, most drug candidates do not become approved drugs. The
development of Sirna-027 and Sirna-034 as well as Sirna's other
programs are still at a relatively early stage. All of these
programs, and Sirna's ability to obtain milestone and royalty
payments for them, are subject to significant risks and unknowns,
are highly contingent upon future successes, and require
significant funding. In addition, patent applications may not
result in issued patents, and issued patents may not be enforceable
or could be invalidated. Other risks and uncertainties include,
among others, Sirna's early stage of development and short
operating history, Sirna's history and expectation of losses and
need to raise capital, Sirna's need to obtain clinical validation
and regulatory approval for Sirna-027, Sirna-034 and Sirna's other
product candidates, any of which could have negative results,
Sirna's need to engage collaborators, Sirna's need to obtain and
protect intellectual property, and the risk of third-party patent
infringement claims. These and additional risk factors are
identified in Sirna's Securities and Exchange Commission filings,
including Forms 10-K and 10-Q and in other SEC filings. Sirna
undertakes no obligation to revise or update any forward- looking
statements in order to reflect events or circumstances that may
arise after the date of this release. Contacts: Stephan Herrera,
Executive Director, Investor Relations, Sirna Therapeutics, Inc.,
415-512-7200 DATASOURCE: Sirna Therapeutics, Inc. CONTACT: Stephan
Herrera, Executive Director, Investor Relations, of Sirna
Therapeutics, Inc., +1-415-512-7200 Web site: http://www.sirna.com/
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