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Intarcia Therapeutics, Inc. Announces Interim Results From A Phase 2 Study Of Omega Interferon In HCV

Published: Nov 15, 2005

SAN FRANCISCO, Nov. 15 /PRNewswire/ -- Intarcia Therapeutics, Inc., a privately held, biopharmaceutical company, today announced interim results from a Phase 2 study of omega interferon with or without ribavirin in interferon-naive Genotype 1 chronic HCV patients. The results demonstrate that omega interferon in combination with ribavirin is well tolerated and shows robust antiviral activity as evidenced by an early viral response (EVR) rate of 84%. The 12 week EVR data are being presented today at the 56th annual meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, California by Professor Vladimir Gorbakov with the State Medical Institute of Postgraduate Course, Ministry of Defense, Moscow, Russia.

(Photo: http://www.newscom.com/cgi-bin/prnh/20050301/SFTU126LOGO )

This Phase 2 study of daily subcutaneous omega interferon injections is providing Intarcia with safety and clinical response data in support of further development of omega interferon delivered by continuous release from the DUROS(R) device.

"These early data compare favorably with the published data for alpha interferons and in particular support the use in combination with small molecule antiviral agents such as ribavirin. We are very excited about these results so far," said Peter Langecker, M.D., Ph.D., Chief Medical Officer and Vice President of Clinical Research at Intarcia.

Omega interferon is a naturally occurring, human, glycosylated, type-one interferon manufactured by recombinant technology, with a serum half life of approximately nine to 15 hours. Omega DUROS(R) is a product designed to deliver a continuous and consistent dose of omega interferon for three months via the small DUROS(R) device after a single subcutaneous insertion in the upper arm.

Alice Leung, Chief Executive Officer of Intarcia stated, "We are developing omega interferon to improve the treatment of HCV by offering a more convenient, potentially safer and more efficacious therapy. Based on the data so far, we believe that a continuous release formulation of omega interferon has the potential to become an important therapy for HCV patients."

The ongoing Phase 2 trial is evaluating omega interferon alone and omega interferon in combination with ribavirin in 102 interferon-naïve patients with Genotype 1 chronic HCV infection. This is an open-label, multi-center, active-controlled study conducted in Moscow, Russia. Patients are receiving daily injections of omega interferon (25 mcg) administered by study personnel for up to 48 weeks in order to approximate omega interferon blood levels anticipated from omega DUROS(R). The endpoints for this clinical trial are EVR, defined as a 2-log reduction in HCV RNA after 12 weeks of treatment, and sustained viral response rate (SVR), defined as undetectable HCV RNA six months after the end of 48 weeks of treatment. Overall, EVR has been observed in 84% (56/67) of the patients on omega interferon with ribavirin, 60% (21/35) of the patients on omega interferon alone and 75% (77/102) of the total patients. In addition, 71 of the 77 patients (92%) of patients with EVR had undetectable levels of virus in their blood determined by the Roche AMPLICOR(TM) HCV assay at 12 weeks (lower limit of quantification < 600 IU/mL). The rates of EVR and undetectable HCV RNA in patients on omega interferon or omega interferon plus ribavirin suggest a favorable therapeutic outcome. SVR data, the other endpoint of the study, will be available by the end of 2006.

With this study, Intarcia also took a step towards testing its hypothesis that maintaining continuous drug levels through daily administration of omega interferon may minimize side effects when compared to other interferon therapies. This study to date has shown that omega interferon is well tolerated with only two discontinuations due to adverse events to date. Results of this ongoing Phase 2 study suggest a favorable overall safety profile with no substantial safety issues being identified. Normalization of serum ALT a marker of reduced liver inflammation occurred in 72.6% of patients receiving omega interferon in combination with ribavirin and 53.3% of patients receiving omega interferon alone.

About omega DUROS(R)

Omega DUROS(R) is being developed to improve the treatment of HCV by offering a more convenient and potentially safer and better therapy. Omega DUROS(R) is designed to deliver a continuous and consistent dose of omega interferon for three months via the implantable DUROS(R) device, a drug delivery technology developed by ALZA Corporation and already approved by the FDA for the treatment of patients with prostate cancer.

About Hepatitis C

Hepatitis C is a major global public health problem. According to the World Health Organization, more than 170 million people worldwide are chronically infected with HCV, and three to four million new HCV infections occur annually. The U.S. Centers for Disease Control and Prevention has estimated that in the United States approximately 2.7 million people are chronically infected with HCV and approximately 25,000 patients are diagnosed each year. It is estimated that 10,000 to 12,000 patients die annually in the United States from complications resulting from HCV infection. The current standard of care for treating chronic hepatitis C is combination therapy consisting of pegylated interferon and ribavirin.

About Intarcia

Intarcia Therapeutics, Inc., a privately held biopharmaceutical company, applies a targeted approach to the acquisition, development and commercialization of therapeutic products for use in treating patients with cancer and infectious diseases. Intarcia's lead programs include a combination therapy for the treatment of hormone dependent breast cancer in postmenopausal women and an implant to deliver omega interferon for the treatment of hepatitis C.

Photo: http://www.newscom.com/cgi-bin/prnh/20050301/SFTU126LOGOAP Archive: http://photoarchive.ap.orgPRN Photo Desk, photodesk@prnewswire.comIntarcia Therapeutics, Inc.

CONTACT: James Ahlers, Chief Financial Officer, of Intarcia Therapeutics,Inc., +1-510-652-2600, ext 235

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