Zivo Bioscience, Inc. Announces Results For 90-Day Safety & Toxicology Study, Clearing the Way to Regulatory Compliance For Dried Algae Biomass Product
KEEGO HARBOR, MI / ACCESSWIRE / May 1, 2018 / ZIVO Bioscience, Inc. (OTCQB: ZIVO) a biotech/agtech R&D company engaged in the commercialization of nutritional and medicinal products derived from proprietary algal strains, announces today that a final report for safety/toxicology tests performed late last year was formally issued last week by Product Safety Labs, an independent laboratory based in Dayton, New Jersey. The study is part of the documentation utilized to meet “Generally Recognized As Safe” (GRAS) compliance standards set forth by the FDA. The data and information will be assembled to form a dossier to be reviewed by an independent scientific panel for determination of GRAS status, immediately prior to commercial sales.
ZIVO strain dried algae biomass was administered at three different doses in the diets to rats over a 90-day test period to estimate the safety of the dried algae biomass for human consumption. The study monitored clinical and behavioral signs of toxicity, body weight, food consumption, eye effects, hematology, clinical chemistry, urine analysis, organ weights, and gross and microscopic pathology.
The study indicated no adverse changes attributed to consumption of the dried algae biomass up to the highest dose level of 150,000 ppm.
The safety & toxicology 90-day study is a cornerstone of the GRAS process. Concurrently, the Company is also conducting a product stability study under the direction of Burdock Group Consultants, based in Orlando, Florida. Together with other process and analytical documentation, Burdock Group will convene an independent scientific panel to review all accumulated data to determine the safety of the ZIVO product. Members of that scientific panel have already been selected as the process of collecting, compiling and finalizing data for the GRAS dossier nears its conclusion.
About ZIVO Bioscience, Inc.
ZIVO Bioscience, Inc. (OTCQB: ZIVO) is a Michigan-based biotech company engaged in the investigation of the health and nutritional benefits of bioactive compounds derived from its proprietary algal cultures, and the development of natural bioactive compounds for use as dietary supplements and food ingredients, as well as biologically derived and synthetic candidates for medicinal and pharmaceutical applications in humans and animals, specifically focused on autoimmune and inflammatory response modulation.
Safe Harbor Statement
Except for any historical information, the matters discussed in this press release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements involve risks and uncertainties. A number of factors could cause actual results to differ from those indicated in the forward-looking statements, including the timing of completion of a trial, actual future clinical trial results being different than the results the company has obtained to date, and the company’s ability to secure funding. Such statements are subject to a number of assumptions, risks and uncertainties. Readers are cautioned that such statements are not guarantees of future performance and those actual results or developments may differ materially from those set forth in the forward-looking statements. The company undertakes no obligation to publicly update or revise forward-looking statements, whether as a result of new information or otherwise.
Contact:
Investor Relations
(248) 452 9866 ext. 150
ZIVO Bioscience, Inc.
Investor@zivobioscience.com
SOURCE: ZIVO Bioscience, Inc.
ReleaseID: 498171