Aphton Announces Closing of Commercialization and Manufacturing Agreements for IGN311 With Celltrion.PHILADELPHIA -- Aphton Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :APHT APHT Advance Physical Test ) announced the formal completion of two agreements with Celltrion, Inc., South Korea for the licensing and commercialization and the product development and manufacturing of Aphton's clinical product candidate IGN IGN Ignored (Status) IGN Institut Geographique National IGN Ignition IGN Instituto Geografico Nacional (Spain) IGN Imagine Games Network IGN In-Game Name (gaming) 311. IGN311, a humanized monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing targeting the Lewis Y antigen, is being developed by Aphton's wholly-owned subsidiary, Igeneon AG, as a potential new therapy for the treatment of cancer. Lewis Y is a tumor-related antigen that is expressed in up to 90% of all epithelial cancers, including breast, colon, gastric, and pancreatic cancers. Under the agreements, Igeneon granted Celltrion a license to commercialize IGN311 in certain Asian countries, including Japan. In return, Igeneon will receive milestone payments and royalties from Celltrion. In addition, Celltrion will provide development and manufacturing services related to the optimization and upscaling of IGN311 and will produce material for further clinical development. Celltrion will have the option to manufacture IGN311 for global commercialization. "We are excited about the close cooperation of both companies and about the progress made in the comprehensive work program laid out in these agreements to advance the development of IGN311," commented Patrick Mooney, MD, Chairman and Chief Executive Officer of Aphton. "This deal validates the concept of our IGN311 anti-Lewis Y antibody, and it allows us to advance the development of this product candidate with a limited impact to our cash flow." About IGN311 IGN311 is a humanized monoclonal antibody against the Lewis Y carbohydrate antigen, a blood-group-related oligosaccharide oligosaccharide: see carbohydrate. oligosaccharide Any carbohydrate with a few (between 3 and about 6 to 10) units of simple sugars (monosaccharides). A wide variety of oligosaccharides are made by partially breaking down polysaccharides. . Lewis Y is overexpressed in up to 90% of all epithelial cancers and its expression on adult normal tissues is very restricted; hence IGN311 has the potential to target a broad range of carcinomas. IGN311 is designed to exert clinical effects by destruction of tumor cells by activation of effector effector /ef·fec·tor/ (e-fek´ter) 1. an agent that mediates a specific effect. 2. an organ that produces an effect in response to nerve stimulation. functions and by selective growth inhibition Growth inhibition (GI) is a medical term pertaining to cancer therapy and the specific reduction in growth of tumors and oncogene cells by a chemical compound, mechanical therapy (e.g. via functional receptors. 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 immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. to fight disease. Through the acquisition of Igeneon AG in March 2005, Aphton acquired late-stage products, IGN101, a cancer vaccine The term cancer vaccine is often used to describe a process whereby a person's immune system is coaxed into recognizing and destroying malignant cells without harming normal cells. designed to induce an immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. against EpCAM-positive tumor cells, as well as IGN311. Aphton has strategic alliances with Xoma for treating gastrointestinal and other gastrin-sensitive cancers using anti-gastrin monoclonal and other antibodies; and Daiichi Pure Chemicals for the development, manufacturing and commercialization of gastrin-related diagnostic kits. Aphton's most advanced product, Insegia(TM), targets the hormone, gastrin 17, in an attempt to treat gastrointestinal cancers. Aphton is currently seeking partners to support the further development of Insegia. For more information about Aphton or its programs please visit Aphton's website at http://www.aphton.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. This press release includes forward-looking statements within the meaning of the federal securities laws, including statements about Aphton's expectations regarding: (1) the potential benefits to Aphton resulting from the licensing and commercialization agreements, including Aphton's belief that the agreements advance the development of IGN311 and that such advancement will have very little impact on Aphton's cash flow; (2) the potential of IGN311 to target a broad range of carcinomas, destroy tumor cells, and exert clinical effects by destruction of tumor cells; (3) the Company's belief in gastrin as a viable target in treating cancer; (4) the Company's expectation regarding the purpose and effectiveness of fully-humanized monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). , IGN101 and IGN311, and its cancer immunotherapy Cancer immunotherapy is the use of the immune system to reject cancer. The main premise is stimulating the patient's immune system to attack the malignant tumor cells that are responsible for the disease. , Insegia; and (5) Aphton's intent to seek partners to further support the development of Insegia. These forward-looking statements may be affected by risks and uncertainties that could cause the actual results to differ materially from those expressed in such forward-looking statements. Aphton undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof. 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. filed with the Commission on March 16, 2005. These risk factors include, but are not limited to: (1) the risks and uncertainties inherent in the drug development process and in Aphton's and Igeneon's business; (2) the ability of Aphton and Celltrion to successfully collaborate in the development of IGN311; (3) the timing or results of ongoing and future clinical trials for IGN311; (4) the ability of Aphton and Celltrion to obtain regulatory approval for IGN311; (5) the ability of Celltrion and any approved third parties to manufacture and supply IGN311 in commercial quantities; (6) the ability of Aphton and Celltrion to gain commercial acceptance for IGN311; (7) the ability of Aphton and Celltrion to fund the development, manufacturing and commercialization of IGN311; (8) Aphton's ability to find a partner who will support the further development of Insegia; (9) intellectual property risks; (10) the impact of competitive products and pricing; and (11) changing economic conditions. |
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