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To: Mr. Big who wrote (47950)	1/27/1999 12:06:00 PM
From: KZAP	Read Replies (4) \| Respond to of 119973

ANTX!!! I know you most likely never heard of it but read the following. You may be interested. Happy investing! <<<<< TOADAY's NEWS... Related QuotesANTX 0.520000 +0.020000 delayed 20 mins - disclaimerWednesday January 27, 10:49 am Eastern Time Company Press Release SOURCE: AntexBiologics AntexBiologics Announces Successful Clinical Trial Results of Helicobacter Pylori Vaccine More than 50 Percent of U.S. Population Over Age 30 Currently Infected With Ulcer-Causing Bacteria GAITHERSBURG, Md., Jan. 27 /PRNewswire/ -- AntexBiologics' orally administered vaccine for Helicobacter pylori (H. pylori), the bacteria responsible for causing gastric ulcers in millions of Americans, has been shown to be safe and promoted a positive immune response in an FDA Phase I clinical trial, the Company announced today. ''Clinical results from human volunteers confirm our preclinical findings in animals that Antex's orally administered Helicobacter vaccine is well tolerated and generates immune responses systemically as well as mucosally, particularly at the site of Helicobacter infections,'' said Dr. Larry Ellingsworth, Vice President, Research and Development at Antex. ''This is the first demonstration in humans that a whole cell vaccine against H. pylori is capable of generating these kinds of immunologic responses. Such responses may be important in fighting these infections in humans.'' Half of the world's population is infected with H. pylori, a bacterial pathogen. More than 50 percent of the U.S. population over the age of 30 are believed to be infected. In developing countries, it is estimated that nearly 100 percent of children 3 years or older are carriers of this pathogen. Infection with H. pylori ranges from asymptomatic to chronic gastritis, and can lead to more serious diseases including peptic ulcers and cancer. Peptic ulcer disease affects 25 million Americans annually. Two forms of cancer are linked to infection with H. pylori, which is the only bacteria classified by the World Health Organization as a class I carcinogen. The American Cancer Society estimates that there are over 25,000 new cases of stomach cancer and over 13,000 deaths per year. Results from this trial will be presented at the Third Annual Winter H. pylori Workshop in Orlando, Florida in February and at The Second Conference of Vaccine Research in Bethesda, Maryland in March. Antex had shown in preclinical models that the H. pylori vaccine was well- tolerated and generated both mucosal and systemic immune responses in vaccinated animals. The animal studies showed that the vaccine works both prophylactically and therapeutically; it prevented infection from H. pylori and cleared H. pylori in previously infected animals. The objective of this two-part clinical trial, conducted at the Center for Vaccine Development in Baltimore, Maryland, was to assess the safety and immunogenicity of Antex's Helicobacter vaccine in humans. The vaccine consists of inactivated H. pylori whole cells (HWC) and a mucosal adjuvant. The First Part of the trial was conducted as an open label study to assess the general safety of the vaccine in uninfected and asymptomatic H. pylori infected volunteers. Each individual received three oral vaccinations, spaced two weeks apart, of escalating doses up to the target dose of 2.5 x 10(10) HWC. Once it waseretermined that there were no adverse events for any of the escalating doses, Part 2 of the trial was conducted. The Second Part was an expanded, placebo controlled, double-blinded study to evaluate the safety and immunogenicity of the vaccine compared to the same amount of HWC alone, adjuvant alone or a placebo. All groups were administered the test sample by the same dosing regimen as in Part 1. Biological samples were taken for laboratory analysis before, during the vaccination period, and during the 6- month period following the third vaccination. The vaccine was generally well-tolerated and caused no serious adverse events. Some individuals experienced self-limiting mild gastrointestinal disturbances only after the first vaccination. The vaccine generated an immune response to H. pylori in both uninfected and asymptomatic H. pylori infected individuals. The asymptomatic infected individuals had the highest response. Vaccination did not exacerbate the H. pylori infection in the asymptomatic volunteers. Helicobacter-specific serum IgG and IgA antibody responses were seen following vaccination. Moreover, fecal and salivary IgA antibody responses were significantly increased in the vaccinated groups compared to volunteers receiving either the HWC alone, the adjuvant alone or the placebo, evidencing that the vaccine induced both systemic and mucosal immune responses. Additionally, the vaccine induced the generation of Helicobacter-specific antibody secreting cells within the gastric antrum and intestinal duodenum, the site of Helicobacter infections. ''We look forward to continuing the clinical development of this vaccine. Additional clinical studies will include establishing the appropriate dosing regimen, evaluating other formulations and initial effectiveness trials,'' stated Dr. Vic Esposito, Chairman and CEO of Antex. AntexBiologics is a biopharmaceutical company dedicated to the discovery, development and commercialization of products to prevent and treat infectious diseases and related disorders. The Company has four vaccine products in clinical development and has strategic alliances with SmithKline Beecham, Pasteur Merieux Connaught, and the U.S. Navy. The Company's common stock is quoted on the OTC Btiletin Board under the ticker symbol: ANTX. Statements contained herein that are not historical facts may be forward- looking statements that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by the Company. Such factors are fully described in the Company's Form 10 KSB filed with the United States Securities and Exchange Commission, and include, but are not limited to: (i) the Company's ability to successfully complete product research and development, including preclinical and clinical studies and commercialization; (ii) the Company's ability to obtain required governmental approvals; (iii) the Company's ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (iv) the Com'sny's ability to develop and commercialize its products before its competitors. SOURCE: AntexBiologics KZAP