Investor Contact: Media
Contact:
James T. Glover Ian Stone
or David Schull
SVP, Operations & CFO Russo Partners, LLC
Anadys Pharmaceuticals, Inc. (619) 814-3510
(858) 530-3763 ian.stone@russopartnersllc.com
jglover@anadyspharma.com david.schull@russopartnerllc.com
ANADYS PHARMACEUTICALS COMMENCES PHASE I CLINICAL
TRIAL OF ANA773 IN CANCER PATIENTS
SAN DIEGO, February 28, 2008 -- Anadys Pharmaceuticals, Inc. (Nasdaq:
ANDS) today announced that patient dosing has commenced in a Phase I study of
ANA773, the company’s oral TLR7 agonist prodrug,
in patients with advanced solid tumors. This first-in-human trial is a safety
and tolerability study designed to identify pharmacologically active doses and
preliminary antitumor activity as well as to select the dose and schedule
for Phase II trials.
The Phase I trial is a multiple, ascending
dose study conducted at several sites in the
“The extensive preclinical
investigation Anadys has conducted with ANA773 over the last 18 months has
taught us much about the pharmacology of orally administered TLR7 agonists,
including the importance of schedule in sculpting the profile of immune
activation,” said
About ANA773
ANA773 is an orally administered prodrug of a novel TLR7-specific agonist. Pharmacology
studies have shown that ANA773 can elicit desired immune responses and
components of the response can be modulated by both dose and schedule of
administration.
Data presented at the AACR-NCI-EORTC meeting
in October 2007 showed that activation of TLR7 by the biologically active
metabolite of ANA773 initiates a cascade of immune stimulatory events that has
the potential to mediate anti-tumor activity by the induction of cytolytic activity by CD8 T cells against tumor cells and cytolytic activity of NK cells against tumor cells directly
or through antibody-dependent cellular cytotoxicity
(ADCC). Anadys also demonstrated that the immunostimulatory
responses can be modulated by schedule of administration. Earlier in 2007, data
presented at the AACR meeting showed that ANA773 and its active metabolite
stimulate secretion of interferon alpha and other cytokines as well as enhance rituximab-mediated ADCC against transformed B cells.
About TLR7 agonists in
cancer therapy
The potential benefits of the TLR7 mechanism
in cancer therapy arise from the fundamental role of this receptor in immune
activation. The host immune system, once activated, plays an essential role in
controlling the ability of cancer cells to grow, invade and metastasize.
Immunotherapy has had some success in treating selected tumors, and the
potential to harness the immune system as a therapeutic modality remains of
great interest to many oncologists.
TLR7 agonists are of particular interest
because there is precedent for their use in cancer. Small molecule ligands for this receptor have been identified, including
topical imiquimod (Aldara®)
which is approved for the treatment of basal cell carcinoma in the
About Anadys
Anadys Pharmaceuticals, Inc. is a
biopharmaceutical company dedicated to improving patient care by developing
novel medicines in the areas of hepatitis C and oncology. The Company is
developing ANA598, a small-molecule, non-nucleoside inhibitor of the NS5B
polymerase for the treatment of chronic hepatitis C and ANA773, an oral TLR7
agonist prodrug for cancer.
Statements in this press release that are not
strictly historical in nature constitute “forward-looking
statements.” Such statements include, but are not limited to, references
to the planned scope and trial design of the ANA773 clinical trial, the belief
that ANA773 holds promise for the treatment of a range of malignancies, and
that it may have utility when combined with targeted agents, therapeutic
antibodies and/or chemotherapy, Anadys’ ability to identify a dose and
schedule for Phase II investigation by the end of this year and the ability to
develop ANA773 as a therapy for patients with cancer. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors,
which may cause Anadys' actual results to be materially different from
historical results or from any results expressed or implied by such
forward-looking statements. For example, the results of preclinical studies may
not be predictive of future results, and Anadys cannot provide any assurances
that ANA773 will not have unforeseen safety issues, will have favorable results
in future clinical trials or will receive regulatory approval. In addition,
Anadys' results may be affected by risks related to competition from other
biotechnology and pharmaceutical companies, its effectiveness at managing its
financial resources, its ability to successfully develop and market products,
difficulties or delays in its preclinical studies or clinical trials,
difficulties or delays in manufacturing its clinical trials materials, the
scope and validity of patent protection for its products, regulatory
developments involving future products and its ability to obtain additional
funding to support its operations. Risk factors that may cause actual results
to differ are more fully discussed in Anadys' SEC filings, including Anadys'
Form 10-K for the year ended December 31, 2006, and Anadys’ Form 10-Q for
the quarter ended September 30, 2007. All forward-looking statements are
qualified in their entirety by this cautionary statement. Anadys is providing
this information as of this date and does not undertake any obligation to
update any forward-looking statements contained