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Anadys Pharmaceuticals Commences Phase I Clinical Trial Of ANA773 In Cancer Patients
Anadys Pharmaceuticals,
Inc. (Nasdaq: ANDS) 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 United States. In addition to safety and tolerability,
patients will be monitored for pharmacodynamic responses indicative of
immunological stimulation. Initially, patients will be dosed every other
day. The company also expects to investigate additional schedules during
this first clinical trial and anticipates that up to 60 patients will be
enrolled in the study.
"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 James Freddo, M.D.,
Anadys' Chief Medical Officer. "We believe ANA773 holds promise for the
treatment of a range of malignancies and may have utility when combined
with targeted agents, therapeutic antibodies and/or chemotherapy. We are
excited about having initiated this first clinical study."
Steve Worland, Ph.D., Anadys' President and Chief Executive Officer,
said, "This is an important milestone for Anadys. The initiation of this
trial marks the resumption of our clinical investigation of oral TLR7
agonists and moves us closer toward our objective of developing ANA773 as a
novel therapy for patients with cancer. We anticipate identifying the dose
and schedule for Phase II investigation by the end of this year."
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(R)) which is approved for
the treatment of basal cell carcinoma in the United States. Imiquimod and
other TLR7 agonists have also demonstrated early clinical activity against
other tumor types, including melanoma and chronic lymphocytic leukemia.
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.
Safe Harbor Statement
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
Anadys Pharmaceuticals, Inc.
http://www.anadyspharma.com
Anadys produse farmaceutice începe faza I de studiu clinic la pacienþi cu cancer ANA773 - Anadys Pharmaceuticals Commences Phase I Clinical Trial Of ANA773 In Cancer Patients - articole medicale engleza - startsanatate