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Aphton Reports Activity of IGN101 in Reducing Disseminating Tumor Cells From Patients With Epithelial Cancers

Posted on: Monday, 16 May 2005, 09:00 CDT

Early Data Demonstrated Reduction of Disseminating Tumor in Patients With Cancers of the Colon, Breast and Ovary

Aphton Corporation (NASDAQ:APHT) announced today that preliminary data from an ongoing open-label, multicenter Phase II clinical trial with IGN101 in patients with several types of solid tumors was presented on Sunday at the 2005 Annual Meeting of the American Society for Clinical Oncology (ASCO) in Orlando, Florida.

Investigators presented early data from an ongoing single arm study of IGN101 in patients with various solid tumors. The study, which is intended to accrue 45 patients, has enrolled 17 patients to date. The primary objective of the trial is to assess the ability of IGN101 to decrease circulating tumor cells in peripheral blood. Elevation of circulating tumor cells has been shown to predict short survival in multiple types of cancer, including breast cancer and hormone refractory prostate cancer. Secondary objectives of the trial are the evaluation of safety and tolerability. Vaccinations with IGN101 are given by subcutaneous injection on days 1, 15, 29 and 57. Analyses of circulating tumor cells in peripheral blood were performed on days 1, 29, 57 and 71.

The preliminary data presented from the study demonstrate that the median number of circulating tumor cells has been reduced by approximately 50% in the 17 patients enrolled (from 10.5 at day 1 to 5 cells at day 71). Accrual is continuing into this study.

"While data from this study is early, we are encouraged by the results to date," commented Patrick Mooney, MD, Chairman and Chief Executive Officer. "It is believed that the reduction of circulating tumor cells could not only potentially be a surrogate for efficacy of immunotherapy, but could decrease the potential for the spread, or metastasis, of certain types of cancer."

About IGN101

IGN101 is a cancer vaccine designed to induce an immune response against EpCAM positive tumor cells. IGN101 is an off-the-shelf product consisting of the murine anti-EpCAM monoclonal antibody 17 1-A adsorbed on aluminum hydroxide. EpCAM is a cell surface glycoprotein present in normal epithelial cells and over-expressed in the majority of epithelial cancers. Epithelial cancers account for approximately 70% of all cancers. IGN101 is intended to selectively destroy disseminated and circulating tumor cells and thus may slow or prevent the formation and growth of metastases.

A randomized, double-blind, (placebo-controlled Phase II/III clinical trial is currently being conducted with IGN 101 in patients with advanced non-small cell lung cancer. In the trial, IGN 101 is being evaluated as a monotherapy. Target accrual of 760 patients has recently been reached in this trial, three months ahead of schedule.

About Aphton

Aphton Corporation, headquartered in Philadelphia, Pennsylvania is a clinical stage biopharmaceutical company focused on developing targeted immunotherapies for cancer. Aphton's products seek to empower the body's own immune system to fight disease. Through the acquisition of Igeneon AG in March 2005, Aphton acquired late-stage products, IGN101, a cancer vaccine designed to induce an immune response against EpCAM positive tumor cells, and IGN311, a fully humanized antibody against the Lewis Y antigen. Aphton is currently seeking partners that will support the further development of Insegia (G17DT immunogen), its immunogen targeting the hormone gastrin. Aphton has strategic alliances with sanofi-aventis for the development and commercialization of Insegia related to cancers of the gastrointestinal system and other cancers in North America and Europe; Daiichi Pure Chemicals for the development, manufacturing and commercialization of gastrin-related diagnostic kits; and Xoma for developing humanized monoclonal and other antibodies to treat gastrointestinal and other gastrin-sensitive cancers. For more information about Aphton or its programs please visit Aphton's website at http://www.aphton.com.

Safe Harbor

Except for the factual information herein, the matters discussed herein are forward-looking statements that involve a number of risks and uncertainties and are not a guarantee of future performance. These forward-looking statements may be affected by the risks and uncertainties inherent in the drug development process and in Aphton's business. These forward looking statements include statements about: (1) IGN101's ability to induce a response against EpCam positive tumors; (2) IGN101's ability to selectively destroy disseminated and circulating tumor cells; (3) Aphton's belief that destroying disseminated and circulating tumor cells may slow or prevent the formation and growth of metastasis; (4) Aphton's intention to seek and ability to find a partner for Insegia. This information is qualified in its entirety by cautionary statements and risk factor disclosure contained in Aphton's Securities and Exchange Commission filings, including Aphton's report on Form 10-K filed with the Commission on March 16, 2005. Aphton wishes to caution readers that certain important factors may have affected and could in the future affect Aphton's beliefs and expectations and could cause the actual results to differ materially from those expressed in any forward-looking statement made by or on behalf of Aphton. These risk factors include, but are not limited to, (1) any modifications to the data arising in connection with preparing the registration of IGN101; (2) Aphton's ability to obtain regulatory approval for IGN101 or produce IGN101 in commercial quantities and gain commercial acceptance, (3) Aphton's ability to fund the registration and commercialization of IGN101; (4) intellectual property risks, (5) the impact of competitive products and pricing, and (6) changing economic conditions. Aphton undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof.

Source: Business Wire

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