Aphton Corp. Announces Start of Phase III Clinical Trials Program for GI Cancers with Gastrimmune.WOODLAND, Calif.--(BUSINESS WIRE)--July 23, 1996--Aphton Corp. (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 that it has started its Phase III Clinical Trials Program with Gastrimmune(TM) for treatment of cancers of the gastrointestinal (GI) tract. It has been demonstrated by Aphton scientists, and by other researchers as well, that the hormone Gastrin 17 (G17), which Gastrimmune(TM) blocks, is a major growth promoter of several cancers. These include colorectal, stomach, pancreatic and liver cancer. Stomach Cancer Patients with stomach cancer Stage II (tumor in mucosa and muscle layer) and Stage III (tumor penetration into adjacent lymph nodes) will be treated. This will be a multicenter, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double- blind, placebo-controlled trial involving 760 patients. The end-point will be survival 18 months after recruitment of the patients, which is projected to take six to eight months. An interim analysis of the data will be carried out midway through the trial. The study will be conducted principally in the United Kingdom. Colon Cancer: Resectable re·sect·a·ble adj. Suitable for resection. Liver Metastases Metastasis (plural, metastases) A tumor growth or deposit that has spread via lymph or blood to an area of the body remote from the primary tumor. Mentioned in: Malignant Melanoma A Phase III trial with patients with colon cancer with surgically removable liver metastases is being prepared. Aphton scientists recently reported at the meeting in San Francisco, Calif., of the American Gastroenterological Society of the strong dependence on G17 of both primary liver cancer and metastases to the liver, as well as G17's role in liver regeneration. Gastrimmune(TM) will be administered to the patients prior to the surgical removal of the liver tumors, to inhibit G17's promotion of growth of micrometastases which are not removed. Aphton also plans to take advantage of recent changes in the US regulatory process. The 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. announced that for life-threatening diseases, including cancers, product sales will be allowed early ("expanded access") based on surrogate marker measurements, concurrent with conducting a trial with definitive end points. Aphton is preparing such trials for colon cancer, liver cancer and pancreatic cancer. It should be noted that Gastrimmune(TM), which has completed Phase I/II trials, induced neutralizing antibodies in the patients in large excess of those needed to block not only endogenous gastrin (G17), but also both forms of gastrin generated by the tumor cells. Aphton Corp. is a biopharmaceutical company developing products using its innovative vaccine-like technology for neutralizing hormones that participate in other diseases, as well. These diseases include: Gastroesophageal Reflux Disease gastroesophageal reflux disease (GERD) Disorder characterized by frequent passage of gastric contents from the stomach back into the esophagus. Symptoms of GERD may include heartburn, coughing, frequent clearing of the throat, and difficulty in swallowing. (GERD GERD gastroesophageal reflux disease. GERD abbr. gastroesophageal reflux disease GERD ); ulcers (both peptic and pain-killer induced); endometriosis; and prostate, breast and endometrial cancers. In addition, Aphton has exclusive worldwide manufacturing, distribution and sales rights for an immunocontraceptive product, also utilizing vaccine-like technology, which is in a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II funded by the World Health Organization (WHO). CONTACT: Aphton Corp. J. L. Whitmore, 305/374-6717 |
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