IRVINE, Calif., March 26, 2004 (PRIMEZONE) -- BioGentech Corp. (OTCBB:BGTH), a pharmaceutical company specializing in over-the-counter anti-allergy medications, announced today the Division of Pulmonary and Allergy Drug Products at the US Food and Drug Administration (FDA) has completed its review of, and has approved the Company to proceed with, Phase III clinical trials for its new allergy drug Prehistin(tm). Based upon this review and approval, BioGentech has initiated Phase III clinical trials to study the ability of Prehistin to mitigate the symptoms of seasonal allergies (seasonal allergic rhinitis). Prehistin is a sub-lingual lozenge requiring no physician visits or injections. A successful outcome to these Phase III trials would open the door for Prehistin to become the first-ever over-the-counter drug whose action would reduce or potentially eliminate the symptoms of season allergies, as opposed to the current paradigm of attacking such symptoms through the use of antihistimines.
Following 15 years of research in double-blind studies, BioGentech's Prehistin represents an exciting new class of allergy drugs based on modulating the body's level of the protein IgE and reducing the overproduction of histamines. In these early double-blind placebo controlled studies, the active ingredient in Prehistin was shown to mitigate symptoms associated with seasonal allergic rhinitis. The Phase III trials will measure the efficacy of Prehistin, a patented treatment for seasonal allergies. The studies, required to complete the Company's New Drug Application (NDA) with the FDA, will be a twin, multi-centered, randomized, double-blind, placebo-controlled trials.
The trials will be conducted by more than 60 investigative physicians who are Board Certified in Allergy and Immunology, and will study the effects of Prehistin on approximately 1,000 allergy sufferers across the Untied States. It is estimated that the study will begin enrollment in the summer of 2004 at approximately 25 sites throughout the United States and take place during the peak pollen (ragweed) season.
Dr. Lyndon E. Mansfield the medical monitor for these studies commented, "We are very pleased with the FDA's encouraging review of our Phase III protocol and are looking forward to beginning the Phase III trials of Prehistin. The development of this product is the first step for a new class of allergy drugs. It is a novel way to lower allergic antibody levels (IgE) associated with the relief of allergy symptoms, and is extremely safe."
Additionally, BioGentech is preparing to implement additional studies based on this science. Currently, the Company is designing protocols to conduct clinical trials for supplementary indications for Prehistin. The indications sought will include perennial allergic rhinitis (year-round, indoor allergies), pediatric dosing, asthma and food allergies.
About BioGentech Corp. -- Prehistin(tm)
Headquartered in Irvine, California, BioGentech Corp. is an over-the-counter pharmaceutical company. Its flagship product, Prehistin, designed to prevent the primary cause of airborne allergies, is scheduled for Phase III clinical trials in the summer of 2004 and initial marketing in the U.S. will commence upon final FDA marketing approval. The U.S. anti-allergy medication market was $7.2 billion in 2003 and is expected to exceed $10 billion by 2010. Prehistin, "the world's first pre-histamine," has shown in previous clinical studies to modulate the body's level of the protein IgE, reducing the overproduction of histamines, the primary cause of airborne allergy symptoms. Prior studies have shown that the active ingredient in Prehistin appears to have essentially no risks of adverse effects to the general population, including sedation and drowsiness found in many of the allergy products currently available.
For further information please visit the website at www.biogentec.com.
Safe Harbor
This news release includes statements that are not historical facts and are considered "forward-looking" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect BioGentech Corp.'s current views about future events. They are identified by their use of terms and phrases such as "believe," "expect," "plan," "anticipate", "possibility" and similar expressions identifying their forward-looking character. Investors should not rely on these forward-looking statements as assurances of future events, because such statements are inherently subject to a variety of risks, uncertainties and other factors that could cause actual results to differ materially from the Company's expectations. The factors that may affect the outcome of such expectations include, but are not limited to factors detailed from time to time in the Company's filings with the Securities and Exchange Commission.