An Antex Biologics vaccine against a bacteria that causes stomach ulcers and that has been associated with cancer will be moved into a second stage of human tests next year, after getting positive Phase I test results, the company said yesterday.
The vaccine, known as Helivax, resulted in no serious side-effects when 45 healthy volunteers drank five doses over an unspecified period of days, the Gaithersburg company said.
The vaccine also stimulated the production of antibodies, a sign of potential effectiveness.
"There are no other vaccines" on the market against Helicobacter pylori, a bacterium that is a predominant cause of peptic ulcers and is classified as a carcinogen by the World Health Organization, said V.M. "Vic" Esposito, Antex's chairman and chief executive.
"I'm unaware of anyone that's ahead of us."
Antex estimates the total market for vaccines used to treat and prevent disease caused by Helicobacter pylori at more than $1 billion.
The company, which has no products on the market, has three vaccines in clinical trials, including one designed to prevent ear infections in infants and children that is licensed to Aventis Pasteur.
The three-phase human trials are required by the Food and Drug Administration to prove a drug's safety and effectiveness.
Antex has retained the rights to Helivax and Campyvax, its third vaccine in human testing.
Campyvax, designed to prevent traveler's diarrhea caused by Campylobacter jejuni, has completed a Phase II test and will be supported through Phase III by the Defense Department, the company has said.
Antex estimates the worldwide market for that vaccine at more than $300 million.
The completion of the Phase IB trial of Helivax announced yesterday comes on the heels of a Phase IA trial in which volunteers took either three doses of the vaccine or a placebo. The company continues to evaluate the most recent trial results for Helivax at the cellular level.
"We're looking at [raising] funds for these trials and all trials," Esposito said of Phase II trials for Helivax.
Antex reported $7.4 million in cash and cash equivalents at the end of its second quarter June 30 and raised $3 million through a securities sale in July. The company spent about $1.9 million in the quarter on operating expenses.
Shares of Antex dropped 1 cent yesterday to close at $1.39 in trading on the American Stock Exchange.