Aphton Announces Committee for Orphan Medicinal Products Recommends to European Commission of EU That G17DT Be Granted Orphan Drug Status for Pancreatic and Gastric Cancers.Business Editors & Health/Medical Writers BIOWIRE2K MIAMI--(BUSINESS WIRE)--Jan. 22, 2003 Aphton Corporation (Nasdaq:APHT APHT Advance Physical Test ) announced today that it has received official notification that the Committee for Orphan Medicinal Products (COMP) has recommended to the European Commission (EC) of the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community (EU) that Aphton's anti-gastrin immunogen G17DT be granted Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status for both pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. and gastric (stomach) cancer indications. The documentation has been translated and forwarded to the EC, which acts on behalf of the EU countries, in the languages of English, Dutch, Finnish, French, German, Greek, Italian, Portuguese, Spanish and Swedish. Aphton expects that the recommendations of the COMP will be approved and ratified in a few weeks. Aphton announced in July, 2002 that the US FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. granted Orphan Drug status for its immunogen G17DT for both pancreatic cancer and gastric cancer gastric cancer Stomach cancer, see there indications. It is estimated that approximately 88,000 new cases of pancreatic cancer will be diagnosed in the US and Europe this year. The prognosis for most of these patients is very poor. The great majority of patients have advanced disease at the time of diagnosis and are considered incurable, with a very short survival time. Surgery, when possible, and chemotherapy are the primary treatment options currently available, but have shown only very limited benefit. Aphton believes that its anti-gastrin targeted immunotherapy approach has the potential to extend patient survival without adding toxicity. It is estimated that there are approximately 570,000 patients with gastric cancer in the US, Europe and Japan, alone. The prognosis for the overwhelming majority of these patients is very poor. Patients diagnosed with metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. disease have five-year survival five-year survival Epidemiology The timespan that a person survives with a particular dread disease, in particular CA; 5YS facilitates standardization of survival statistics. See Cancer-free survival. rates of only about three percent. Surgery and chemotherapy are the primary treatment options currently, but have shown only very limited benefit. Aphton believes that its anti-gastrin targeted immunotherapy approach has the potential to extend patient survival without adding toxicity. Aphton Corporation is a biopharmaceutical company in one Phase III and three Phase II clinical trials developing products using its innovative vaccine-like technology for neutralizing hormones that participate in gastrointestinal system and reproductive system cancer and non-cancer diseases worldwide. Aphton has several strategic alliances including strategic alliances with Aventis (NYSE NYSE See: New York Stock Exchange :AVE) for treating gastrointestinal system and other cancers with G17DT in North America and Europe; and GlaxoSmithKline (NYSE:GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ) for reproductive system cancer and non-cancer diseases worldwide; and others. Except for the historical information herein, the matters discussed herein are forward-looking statements that involve a number or risks and uncertainties and are not a guarantee of future performance. Future results may vary significantly based on a number of factors including, but not limited to, intellectual property risks, risks in regulatory and market acceptance of new products and continuing demand for same, the impact of competitive products and pricing, changing economic conditions and other risk factors that are inherent in the drug development process and the company's business including those set forth in Aphton's most recent 10-K and other filings with the Securities and Exchange Commission. It is not possible to predict or identify all such risk factors that could cause actual results to differ from expected or historical results. The company's actual results could differ from these forward-looking statements and the company undertakes no obligation to update publicly any forward-looking statement, except as may be required under applicable securities law. |
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