Anadys Highlights ANA773 Data to be Presented at ASCO

SAN DIEGO, May 25, 2011 /PRNewswire/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS), a biopharmaceutical company focused on developing medicines for the treatment of hepatitis C, announced today that it will present data from a previously conducted cancer study of ANA773, the Company's oral immuno-modulator that acts via the TLR-7 pathway, at the 2011 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.  The data from the completed Phase I study is being presented on June 4, 2011 in a poster titled "Phase I Open Label, Dose Escalation Study of ANA773 Tosylate, an Oral Prodrug of a Toll-Like Receptor-7 Agonist, in Patients with Advanced Solid Tumors".  The poster will be available on the Company's website at www.anadyspharma.com as of the date of presentation.  

In the Phase I cancer study, ANA773 showed a favorable safety and tolerability profile at doses that had desired effects on the innate immune system.  A confirmed partial response was achieved in a patient with melanoma and prolonged stable disease was observed in additional patients.  A maximum tolerated dose (MTD) was not reached in this study.  These results suggest that ANA773 may provide clinical benefit to cancer patients.  

"The clinical activity seen with ANA773 in this Phase I oncology study is quite promising," said James L. Freddo, M.D., Anadys' Senior Vice President, Drug Development and Chief Medical Officer.  "While Anadys is focusing its development efforts in the area of hepatitis C, we continue to believe that ANA773 holds promise for the treatment of a range of cancer types, particularly in combination with other agents such as monoclonal antibodies that rely on immune mechanisms for activity."  

About the Concluded Phase I study of ANA773 in Cancer

Patients with advanced solid tumors were treated with ANA773 every-other-day (QOD) for 14 days, followed by a 14 day rest period, on continuous 28 day cycles.  20 patients participated in the study and were treated at dose levels of either 50mg, 100mg, 200mg, 400mg or 800mg (all QOD), with a minimum of three patients enrolled at each dose level. The endpoints for the study included safety, pharmacokinetics, biomarkers of immune activation and preliminary assessment of tumor response by RECIST.  

Next Steps for ANA773 Development

Anadys is advancing development of ANA773 in a separate indication, chronic hepatitis C virus infection, or HCV.  Anadys is currently preparing for a Phase IIa study of ANA773 in combination with ribavirin in HCV patients, which it expects to initiate in Europe this quarter.  The Company expects to receive 28-day data from the Phase IIa HCV study during the fourth quarter of this year.

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. 

About Anadys

Anadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C.  The Company believes hepatitis C represents a large unmet medical need in which meaningful improvements in treatment outcomes may be attainable with the introduction of new medicines.  Anadys is conducting a Phase IIb study of ANA598, the Company's DAA, added to current standard of care for the treatment of hepatitis C.  The Company is also preparing to resume clinical development of ANA773, the Company's oral, small-molecule inducer of endogenous interferons that acts via the Toll like receptor 7, or TLR7, pathway in hepatitis C.

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 belief that ANA773 and the TLR7 mechanism hold promise for the treatment of cancer, as well as Anadys' expected timing and plans for the development of ANA773 for the treatment of hepatitis C.  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 and early clinical studies may not be predictive of future results, and Anadys cannot provide any assurances that ANA598 or ANA773 will not have unforeseen safety issues, will have favorable results in ongoing or future clinical trials or will receive regulatory approval.  In addition, Anadys' results may be affected by competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to enter into transactions around its product candidates, difficulties or delays in its clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments 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-Q for the quarter ended March 31, 2011.  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 in this document as a result of new information, future events or otherwise.

SOURCE Anadys Pharmaceuticals, Inc.