Anadys Pharmaceuticals Commences Phase I Clinical Trial of ANA773 in Cancer Patients

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Anadys Pharmaceuticals Commences Phase I Clinical Trial of ANA773 in

Cancer Patients

SAN DIEGO, Feb. 28 /PRNewswire-FirstCall/ -- 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 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 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®) 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.