IRVINE, Calif., April 29, 2004 (PRIMEZONE) — BioGentech Corp. (OTCBB:BGTH), a pharmaceutical company specializing in over-the-counter anti-allergy medications, announced today that it has entered into an agreement with Irvine based ClinDatrix, Inc. for the implementation, management and analysis of clinical investigations of BioGentech’s flagship product, Prehistin, for their upcoming Phase III trials.
The Phase III trials will measure the efficacy of Prehistin, a patented treatment for seasonal allergies. 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 United States. It is estimated that the studies 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. The studies, required to complete BioGentech’s New Drug Application (NDA) with the FDA, will be twin, multi-centered, randomized, double-blind, placebo-controlled trials.
Dr. Louise M. Murphy, President and CEO of ClinDatrix, Inc., said of the agreement, “We at ClinDatrix are excited to be working with BioGentech on this very promising product. Our role as CRO is to provide project management, clinical monitoring, and data management services for the upcoming Phase III clinical investigations of Prehistin. It is not often that the opportunity arises to conduct investigations on a product with a proven safety record and minimal side effects that, at the same time, shows promise of a high degree of efficacy. ClinDatrix is pleased to be able to play such a critical role in the execution and analyses of these trials.”
Chaslav Radovich, President and CEO of BioGentech, commented, “The ClinDatrix team has significant experience with clinical investigations in which key efficacy data is collected via subject diaries then retrieved, entered and tabulated as quickly as possible in order to provide the data basis for strategic decisions. We feel that their strengths as a company mesh well with the requirements of BioGentech for these investigations and we are looking forward to a productive and successful partnership. Positive results from the Phase III trials will open the door for Prehistin to become the first-ever over-the-counter anti-allergy drug that helps to prevent the symptoms of seasonal allergies.”
About ClinDatrix, Inc.
ClinDatrix, Inc., www.clindatrix.com, a clinical research organization based in Irvine, CA, is dedicated to providing detailed, in-depth reviews of clinical protocols together with their supporting CRFs; verifying documents; and capturing data required for the clinical project per protocol on the accompanying CRFs. Working in partnership with the client, ClinDatrix designs CRFs to accurately and completely capture the data required by the clinical protocol. ClinDatrix is committed to providing world class, full service clinical research capabilities to the biotechnology, medical device, and pharmaceutical industries.
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.
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