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Strategies & Market Trends : Three Amigos Stock Thread -- Ignore unavailable to you. Want to Upgrade?

To: lostmymoney who wrote (13225)	1/28/1999 9:22:00 AM
From: John R Resseger	Respond to of 29382

Mike I spoke with Tom Norton, of SPECTRUM Science Public Relations, 202-955-6222, for AntexBiologics/ ... about 20 minutes ago. He wanted to know what investment firm or media group I was involved in. I said, You don't think an investment firm would touch a BEE board stock? He said .... We have been getting an awful lot of calls from them! He said Dow Jones had picked up the story. He said they also faxed the story to the Washington Post Business section. Antex is in the DC area. This is the story AntexBiologics Announces Successful Clinical Trial Results of Helicobacter Pylori Vaccine PR Newswire - January 27, 1999 11:04 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 was determined 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 Bulletin Board under the ticker symbol: ANTX. /Web site: antexbiologics.com If some one out there knows of other companies that are working on this or other vaccines Antex is working on, please temper my enthusiasm.