Kibow Biotech to Exhibit and Discuss its Proposed Unique Cross Over Design, Multi-Site RCT Protocol on its "Enteric Dialysis®" Technology and Renadyl™ at the Annual ASN 2019 - Kidney Week Conference - Washington DC.
NEWTOWN SQUARE, Pa., Nov. 6, 2019 /PRNewswire/ -- Kibow® Biotech is proud to announce its 15th consecutive year of participation in the ASN Conferences and draw the attention of American Society of Nephrology (ASN), National Kidney Foundation (NKF), Dept of Human and Health Services (HHS), and related healthcare professionals on its continued 22 years of operations as a pioneer in the use of Pro/Prebiotics in people with failing kidneys. This year, the annual ASN kidney week is being held at the Walter E. Washington Convention Center, Washington DC. (https://www.asn-online.org/education/kidneyweek/2019/meeting-overview.aspx).
Recently, a new program has been initiated called "KIDNEYX". This program, established in April 2018, is a joint public-private partnership between the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN). Medicare alone spends more than $64 billion each year to care for people with CKD and an additional $34 billion to care for people with ESRD.
According to KidneyX announcement, "For the past 50 years, advances in treatments for kidney diseases and kidney failure have been modest, with few significant innovations reaching people who live with kidney disease. Several barriers may be limiting kidney health innovation, including 1) lack of capital, 2) risks associated with early-stage research and development, and 3) low levels of meaningful input from other medical, scientific, or technological fields."
For more information, please refer to the following two links:
http://www.kidneyx.org/ and https://www.hhs.gov/idealab/kidneyx/rfi1/
The president has also endorsed the NKF/HHS initiative in issuing a special executive order on July 10, 2019, as a top priority in addressing the burden of treatment of CKD/ESRD:
https://www.kidneyfund.org/news/news-releases/akf-applauds-trump-administration-for-making-kidney-disease-a-national-health-priority.html?utm_campaign=news&utm_medium=email&utm_source=luminate190710&utm_term=16418.0&utm_content=button
In this year's event, with greater awareness and exposure on poor outcomes and the high-cost burden of Chronic Kidney Disease (CKD) and End Stage Renal Disease (ESRD) treatment, the company's personnel will interact with and update nephrology professionals on new developments. They will discuss the crucial role of the gut-kidney connection, dysbiosis, and modulation of the Gut Microbiome with its innovative "Enteric Dialysis®" technology.
Although marketed and sold in the USA and several other countries as a dietary supplement product since 2010, Renadyl™ is the first and only kidney health supplement with its proprietary and patented Probiotics/Prebiotics formulation researched and developed with the type of rigor applied to drug development for Kibow's revolutionary "Enteric Dialysis®" technology concept.
With 22-years of R&D, pharma like and pilot-scale clinical trial validation, Kibow® Biotech has opted to diversify and create a separate pharmaceutical company (Kibow Pharmaceuticals, LLC – a Delaware Corporation).
Thus, the new pharmaceutical company will pursue all its efforts in obtaining the needed Investigational New Drug (IND) approval process. Subsequently, the company will perform the mandated clinical trials under the Center for Biological Evaluation Research (CBER). The pharma company will perform the required clinical trials with CKD patients stage IV and with patients undergoing hemodialysis in conjuncture to the patients' individual standard care of therapy. This will be under the CBER/US FDA as a Live Biotherapeutic drug for CKD and ESRD applications, in conjunction with individual patient's standard care of therapy.
For additional validation and to provide sufficient evidence to justify medical reimbursement of its kidney health supplement product to a drug category, the company is planning to conduct a unique cross over, multi-site randomized controlled clinical study for a period of one year in the USA and possibly in other countries. Slowing the progression of CKD with an inexpensive alternative technology can help reduce healthcare expenses, not only in the USA, but worldwide.
This kind of multi-site clinical trial that includes a well-established kidney function endpoint (https://www.kidney.org/news/new-endpoints-ckd-clinical-trials-gaining-traction-regulators) will ultimately pave the way for the acceptance and referral of the product as a drug by all healthcare professionals, caregivers, and payers. The use of such products would significantly reduce the healthcare cost of treating CKD worldwide.
Forward-looking statements: This press release contains forward-looking statements that reflect management's current views of future events, including the status of development of the dietary supplement formulation, Renadyl™, for kidney health in the USA, and the possibility of its approval as a drug in some other countries according to respective governmental authorities.
About Uremic Toxin Reduction Technology – also known as "Enteric Dialysis®": Kibow's novel "uremic toxin removal technology" addresses the diffusion of various uremic toxins into the bowel as a consequence of failing kidney function. The Company's patented and proprietary dietary supplements, Renadyl™ (for humans) and Azodyl® for cats and dogs with moderate to severe kidney failure (a veterinary formulation licensed to Vetoquinol http://www.vetoquinolusa.com/) consists of a combination of three specific probiotic microbial strains and chosen prebiotics.
Kidney health supplement with a pharma-like validation: Kibow® Biotech is not a pharmaceutical company. Kibow® products are not drugs and may not be considered as a treatment nor a therapy. The dietary supplement formulation of Renadyl™ is not meant to cure, prevent, or mitigate any disease. Actual results may differ significantly from the above forward-looking statements due to several factors. These include but are not limited to the possibility that Renadyl™ may not reduce levels of uremic toxins in each and every individual, due to differences that exist between individuals that cannot be controlled such as genetics and lifestyle factors, as well as environmental factors that would include proper storage of the product and conditions of transport of the product in the chain of commerce. Other factors that could cause or contribute to differences in actual results include, but are not limited to whether or not the Company or any of its collaborators will be able to develop drug pathway using the technologies of the Company; whether the cash resources of the Company will be sufficient to fund operations as planned; reliance on key employees, especially senior management; the uncertainty of the Company's future access to capital; the risk that the Company may not secure or maintain relationships with collaborators; and the Company's dependence on intellectual property. The Company expressly disclaims any intent or obligation to update these forward-looking statements except as required by law.
Investor & Media Contact:
Terrence O. Tormey - CEO
(610) 353-5130 or Email: [email protected]
SOURCE Kibow® Biotech, Inc.
SOURCE Kibow Biotech
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