Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
PR Newswire; Wednesday November 12, 2:37 pm Eastern Time
This patent covers the use of Verex's novel controlled release drug delivery system for the administration of zidovudine (AZT), the first line treatment for HIV and AIDS in North America and Europe, and the only treatment currently used in much of the rest of the world.
James M. Dunn, M.D., president of Verex, commented, "We are quite pleased with the issuance of this patent which we believes continues to substantiate the progress that we have made in our HIV and AIDS treatment program. In the past year we have completed Phase III clinical trials on this controlled release formulation and we expect to file an NDA with the FDA late this year or in early 1998."
Patents for this product are currently pending in 26 foreign countries and the Company expects issuance of these patents in the first quarter of 1998.
Clinical trials on the Verex product have shown it to be at least as efficacious as the currently available form of zidovudine in the U.S., Retrovir(R), while being better tolerated and having significantly less side effects in the areas of headaches, nausea and fatigue.
Most significant, however, is the difference in the development of resistance to AZT between the two products. In one of Verex's clinical studies it was found that 10 of 76 (13.2%) patients on Retrovir(R) developed resistance during an 18 week study, as measured by codon 215 mutation, while only 1 of 72 (1.4%) patients on the controlled release Verex product developed resistance. Dose modeling done by some of the leading scientists in AIDS research have shown that use of immediate release zidovudine in a twice daily regimen may actually increase the incidence of resistance compared to 5-6 times per day dosing. The Verex formulation does not have this problem because, taken twice a day, it actually keeps the phosphoralated zidovudine in the affected cells at therapeutic levels 24 hours a day, thereby severely limiting the opportunity for resistance to develop.
Combinational therapy, in most cases, includes AZT as one of a two, three or even four drug combination. Resistance and cross resistance between the various compounds has become a major problem, which should be greatly aided by Verex's low-resistance AZT formulation.
Verex Laboratories, Inc. is a publicly held drug development company founded in 1980 to develop and commercialize its proprietary technologies for safer, more convenient and more compliant delivery of known therapeutic agents.
This press release contains, among other things, certain statements of a forward-looking nature relating to Verex's ability to advance its clinical development and research programs. Such statements involve a number of risks and uncertainties including the timing and results of clinical studies and determinations by the U.S. Food and Drug Administration, as well as the Risk Factors listed in the Company's SEC filings including, but not limited to, those contained in Verex Laboratories, Inc.'s Annual Report on Form 10-K for the year ended June 30, 1997. This filing is available upon request from the Company.
SOURCE: Verex Labratories, Inc.
Copyright (c) 1997/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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