Aphton Corporation presents Phase III Clinical Trial Results of G17DT as Monotherapy in Patients with Pancreatic Cancer at ASCO.Business Editors/Health/Medical Writers BIOWIRE2K MIAMI--(BUSINESS WIRE)--June 7, 2004 Aphton Corporation (Nasdaq:APHT APHT Advance Physical Test ) announced today that the positive results of its Phase III trial testing G17DT as a monotherapy for patients with advanced 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. who are unable to tolerate or unwilling to take chemotherapy were presented on Sunday, June 6th at the "Developmental Therapeutics: Immunotherapy" oral session at the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. (ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company ) Annual Meeting in New Orleans. The oral presentation, entitled "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, multicenter, group-sequential trial of G17DT for patients with advanced pancreatic cancer" was given by the study's lead investigator, Andrew D. Gilliam MB ChB, MRCS MRCS Member of Royal College of Surgeons. MRCS abbr. Member of the Royal College of Surgeons , Academic Unit of Cancer Studies, University of Nottingham The University of Nottingham is a leading research and teaching university in the city of Nottingham, in the East Midlands of England. It is a member of the Russell Group, and of Universitas 21, an international network of research-led universities. , Nottingham, UK. Results indicated that G17DT prolonged survival with statistical significance. Overall median survival for patients treated with G17DT was 150 days vs. 83 days for patients treated with a placebo (p=0.030). There was a significantly longer time to deterioration of Karnofsky Performance Score (KPS KPs keratic precipitates. ) in G17DT-treated patients with a median of 138 days vs. 78 days with the patients treated with a placebo (p=0.038). About the study: The primary objective of the trial was to compare overall survival. Secondary objectives included comparative analyses of quality of life, time to deterioration, weight change, tolerability and tumor response. The Phase III trial enrolled 154 chemotherapy naive patients with advanced pancreatic cancer from 22 sites in Europe. Patients were randomly assigned to one of two arms; one arm received G17DT alone, the other arm received identical, matching placebo. An analysis was conducted once the protocol-specified 101 events (deaths) were reached. Baseline demographic data, Karnofsky index for performance status (KPS) and stage distribution of patients recruited in the trial were typical of this disease, and in-line with published epidemiological studies. The 154 chemotherapy naive patients with advanced pancreatic cancer were randomly assigned to one of two arms; 79 patients were randomized to G17DT and 75 patients had the placebo. The arm of patients that received G17DT, had it alone at weeks 0, 1, 3, 26 and 52; the other arm received identical, matching placebo. The following results were presented at ASCO from the study: -- Treatment with G17DT resulted in a median survival of 150 days compared with 83 days for patients treated with the placebo (p=0.030, log rank). -- Patients treated with G17DT showed a significantly longer time to deterioration of Karnofsky score, with a median of 138 days vs. 78 days with the placebo (p=0.038, Wilcoxon). -- Importantly, patients who generated anti-G17 antibodies (G17 responders) lived significantly longer than patients who did not generate anti-G17 antibodies (G17 non-responders), or patients who received placebo. Analysis of the Kaplan Meier plots showed that antibody responders to G17DT had a median survival of 176 days compared to 63 days for non-responders and to 83 days for the placebo group (p=0.003, log rank homogeneity test). -- G17DT treatment was safe and well tolerated. About Pancreatic Cancer It is estimated that approximately 88,000 new cases of pancreatic cancer will be diagnosed in the US and Europe this year. The great majority of patients have advanced disease at the time of diagnosis. Many patients either refuse chemotherapy or cannot tolerate chemotherapy since it adds limited clinical benefit with significant side effects Side effects Effects of a proposed project on other parts of the firm. . Aphton believes that its anti-gastrin targeted immunotherapy approach is a biological alternative with the potential to extend patient survival without adding toxicity. About G17DT Anti-Gastrin 17 (G17DT) targets the hormone gastrin 17 to treat gastrointestinal cancers, including pancreatic, gastric, esophageal and colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. . Aphton's anti-gastrin targeted immunotherapy induces patients to produce antibodies that bind and neutralize the hormones gastrin 17 and gly-gastrin (a gastrin precursor), which are known to be involved in tumor progression in gastrointestinal (GI) cancers. Gastrin is a key hormone in the embryological development of the gastrointestinal (GI) system. Post embryological development, most of the gastrin and gastrin receptor genes throughout the GI system are shut down. Significantly, gastrin genes are activated once again in precancerous precancerous /pre·can·cer·ous/ (-kan´ser-us) pertaining to a pathologic process that tends to become malignant. pre·can·cer·ous adj. cells and polyps Polyps A tumor with a small flap that attaches itself to the wall of various vascular organs such as the nose, uterus and rectum. Polyps bleed easily, and if they are suspected to be cancerous they should be surgically removed. and in cancer cells early in the development of its cancer. Gastrin secretion and the expression of gastrin receptors increases as the cancer progresses. Gastrin works by signaling through its receptor, the gastrin receptor (CCK-2/Gastrin-R). In normal adult tissue, gastrin is only produced in the antrum antrum /an·trum/ (an´trum) pl. an´tra, antrums [L.] a cavity or chamber.an´tral cardiac antrum region of the stomach and its receptor is produced only on its target cells found in the normal stomach (Parietal parietal /pa·ri·e·tal/ (pah-ri´e-t'l) 1. of or pertaining to the walls of a cavity. 2. pertaining to or located near the parietal bone. pa·ri·e·tal adj. 1. and ECL (Emitter-Coupled Logic) A digital circuit composed of bipolar transistors in which the emitter ends are wired together. ECL gates switch faster than TTL gates, but consume more power. See TTL, I2L and bipolar. 1. cells). Normally, gastrin is secreted by cells in the stomach, primarily after eating and is responsible for producing approximately 90% of the body's stomach acid. In cancer cells, gastrin acts to signal growth and proliferation, conferring a growth advantage on them. Gastrin expression and the appearance of gastrin receptors have been associated with increasing malignant characteristics of GI tumors and with poorer prognostic outcomes. Specifically, gastrin is known to be in involved in the progression of colorectal, stomach, liver and pancreatic cancers. Recent findings have shown that inhibiting gastrin inhibits cell growth, proliferation and metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases 1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to , leading to programmed cell death pro·grammed cell death n. See apoptosis. programmed cell death proposed system of cell death, often including poly(ADP)-ribosylation, ensures that a cell will not survive if it is so badly damaged that its recovery would harm the (apoptosis). This tilts the balance, from cell growth, to cell suicide. Gastrin also stimulates the secretion and expression of other important growth factors and receptors within and on the surfaces of the cancer cells involved in tumor growth. Hence, inhibiting gastrin inhibits all of the foregoing factors that contribute to tumor growth and spread, resulting in tumor cell death. Aphton's anti-gastrin targeted immunotherapy adds a biological dimension to the treatment of gastrointestinal cancers. Gly-gastrin is also made by the tumors and like gastrin, is involved in the growth stimulation of the cancers. About Aphton Corporation Aphton Corporation is a biopharmaceutical company developing products using its innovative targeted immunotherapy technology for neutralizing hormones that participate in gastrointestinal system gastrointestinal system: see digestive system. and reproductive system reproductive system, in animals, the anatomical organs concerned with production of offspring. In humans and other mammals the female reproductive system produces the female reproductive cells (the eggs, or ova) and contains an organ in which development of the fetus cancer and non-cancer diseases. Aphton has strategic alliances with Aventis Pasteur for treating gastrointestinal system and other cancers with G17DT in North America and Europe; GlaxoSmithKline for reproductive system cancer and non-cancer diseases worldwide; and others This press release includes forward looking statements, including the Company's belief that its anti-gastrin targeted immunotherapy approach has the potential to extend patient survival without adding toxicity. These forward-looking statements may be affected by the risks and uncertainties inherent in the drug development process and in the Company's business. This information is qualified in its entirety by cautionary statements and risk factor disclosure contained in the Company's Securities and Exchange Commission filings, including the Company'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 15, 2004. The Company wishes to caution readers that certain important factors may have affected and could in the future affect the Company'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 the Company. These risk factors include, but are not limited to, (1) any modifications to the data arising in connection with preparing the registration of G17DT; (2) our ability to obtain regulatory approval for G17DT or produce G17DT in commercial quantities and gain commercial acceptance, (3) our ability to fund the registration and commercialization of G17DT; (4) intellectual property risks, (5) the impact of competitive products and pricing, and (6) changing economic conditions. The Company undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion