Applied-BioResearch, Inc. – Background
Applied BioResearch, Inc. is a Utah corporation formed on June 15, 2011 to develop, patent and obtain Investigational New Drug (“IND”) approval from the U.S. Food and Drug Administration (the “FDA”) for a new and improved formula that can remove toxic heavy metals from the body. The same molecule has been FDA approved for use in I.V. administration to treat lead poisoning (NDA# 008922). Other potential claims may include the treatment of high levels of lead or other toxic metals, prostate conditions and improvement of cardiovascular markers and heart conditions. Upon approval of the IND application, our Company may offer the opportunity for large pharmaceutical companies to enter into a joint venture, strategic alliance, or partnership with our company or to purchase or license patents and rights to develop the Company’s new formula for the approval of a New Drug Application (NDA) via the accelerated 505(b)2.
World Health Products (“WHP”), a company founded by Mr. Kendal Svedeen in January 2001, developed a chelation suppository, Detoxamin®, which was sold as a dietary supplement. Detoxamin had a ten-year track record of safety along with four clinical trials demonstrating effectiveness for prostate symptoms improvement, effectiveness for heavy metal excretion (removal) and bioavailability (blood level and tissue distribution of the active component). This considerable amount of research has already been completed by WHP and is in the public domain. Sierra Productions, a sole proprietorship owned by the Company’s Consulting Director of Research, Mr. Robert Settineri, has been involved in this research; Mr. Settineri was responsible for design and coordination of all Detoxamin's pre-clinical and clinical studies.
WHP’s current formula achieved sales averaging over two million dollars per year during the past 5 years in business as a dietary supplement and over three million doses have been used to date, with no known major side effects. Over 2500 health care professionals in more than 50 different countries have either recommended the product or sold it directly out of their offices. Over 30 international medical presentations on the science underlying Detoxamin® were given in the past seven years.
In October of 2010, however, the FDA issued warnings letters to 8 chelation distributors (both in suppository and oral form) to halt sales of all EDTA chelation products because the FDA determined they are drugs and not dietary supplements. As a result, WHP ceased distributing Detoxamin.
Based on the FDA decision, a new Company, Applied BioResearch, Inc. was established for the purpose of expanding research and development of a new and improved chelation suppository to be targeted for FDA IND acceptance. The Company believes it has significant and unique advantages in starting the drug application process. Detoxamin®, when previously on the market as a dietary supplement, had an impeccable safety history, a unique mode of administration (rectal suppository), was extensively used by medical professionals, had long history of widespread use with no major side effects, was analogous to IV chelation, had impressive clinical results and a significant bioavailability (ability to be absorbed in the blood stream).