Aphton Announces the Initiation of a Phase I/II Trial of Lewis Y-specific Antibody IGN311; Trial to Evaluate Efficacy and Safety of IGN311 in Patients with Malignant Pleural Effusion or Ascites.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 today the enrollment of its first patient in a newly initiated open-label Phase I/II trial of its pipeline compound 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 is 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 tumor-associated antigen tumor-associated antigen Immunology, oncology A molecule–eg, CA 15.3, 19-9, CA-125, that may be associated with specific tumors–eg, lymphomas, carcinomas, sarcomas, melanomas; TAAs may elicit cellular and/or humoral immune responses against the tumor, . Lewis Y is a tumor-related antigen expressed in up to 90% of all epithelial cancers, which include breast, colon, gastric and pancreatic cancers. The endpoints of this study are to evaluate the ability of IGN311 to effectively reduce the number of Lewis-Y positive tumor cells and to decrease the volume of pleural effusions or ascites Ascites Definition Ascites is an abnormal accumulation of fluid in the abdomen. Description Rapidly developing (acute) ascites can occur as a complication of trauma, perforated ulcer, appendicitis, or inflammation of the colon or other , in patients with epithelial cancers. In addition, the study will also evaluate safety, tolerability and pharmocokinetics of the IGN311 antibody. The study is intended to enroll up to 24 patients. "Having recently completed a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I we are enthusiastic to advance the development plan for IGN311 in such a rapid manor," said Patrick Mooney, MD, President and Chief Executive Officer of Aphton Corporation. "We believe that the Lewis Y antigen is an important target in epithelial tumors and we look forward to the progress of this trial." In a Phase I trial reported earlier this month, IGN311 demonstrated a favorable safety and tolerability profile, and a serum half-life of more than 20 days. In addition, data from the trial suggested that the antibody may be capable of significantly decreasing the number of disseminated tumor cells circulating in peripheral blood peripheral blood Cardiology Blood circulating in the system/body . About Pleural Effusion and Ascites Pleural effusion and ascites are characterized by the accumulation of excess fluid within the membranes covering the lung, and in the abdomen, respectively. Both conditions are a common consequence of malignant tumors, caused by the invasion into the pleural space pleural space n. See pleural cavity. Pleural space The space between the pleural membranes that surround the lungs and the chest cavity. Mentioned in: Mediastinoscopy, Pleural Effusion, Thoracic Surgery or into the abdomen of disseminated tumor cells originating from breast, colon, gastric, pancreatic and other cancers. Pleural effusion and ascites can be severe complications in the treatment of cancer patients, and current procedures to manage these conditions are stressful for the patients and of limited efficacy. 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 over-expressed 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 via functional receptors. Strategic Pipeline Aphton continues to focus its efforts on broadening and making progress in its research and development pipeline. An important component of our product portfolio is IGN101, a cancer vaccine 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, and IGN311. Aphton also has a diverse pipeline of pre-clinical and clinical products including active and passive immunotherapies. Aphton believes that immunotherapies may have certain advantages over other targeted therapies by including specificity that may lead to better efficacy and decreased toxicities for patients. 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 designed to induce an immune response against EpCAM-positive tumor cells, and IGN311, a fully humanized antibody humanized antibody Molecular medicine A recombinant DNA product which ↓ non-human monoclonal antibody immunogenicity, by transferring the hypervariable genes of rodent antibodies–which encode peptide segments capable of recognizing the desired epitope, 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 gastrointestinal system: see digestive 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 treating gastrointestinal and other gastrin-sensitive cancers using anti-gastrin monoclonal and other antibodies. 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, including statements about: (1) the development of IGN311 as a potential new therapy for the treatment of Lewis Y positive tumors; (2) Aphton's intent to enter into new and complete ongoing studies with IGN311; (3) the potential of IGN311 to target a broad range of carcinomas, destroy tumor cells, and exert clinical effects by destruction of tumor cells; (4) Aphton's belief regarding the strength of Igeneon's product portfolio and such portfolio's ability to complement Aphton's product portfolio; (5) Aphton's intent to broaden and progress its research and development pipeline; (6) Aphton's belief that immunotherapies have certain advantages over targeted therapies; and (7) Aphton's intent to continue to seek, and its ability to find, a viable partner to financially support the further development of Insegia. These forward-looking statements may be affected by the risks and uncertainties inherent in the drug development process and in Aphton's and Igeneon's business. 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) Aphton's ability to fund the further development of its research and development programs; (2) Aphton's ability to successfully identify and consummate opportunities to broaden and progress its research and development pipeline; (3) scientific developments regarding immunotherapies; (4) Aphton's ability to successfully integrate Igeneon's operations and product portfolio with Aphton's operations and product portfolio; (5) the actual design, results and timing of preclinical and clinical studies for Aphton's products and product candidates; and (6) the ability of Aphton to develop and initiate additional clinical trials of IGN 311 and the future results of IGN 311 in the subsequent clinical trials. |
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