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Why clinical trials?

Supported by Visionary & Distinguished Nephrologists and Scientists

“WILL THE BOWEL BE THE KIDNEY OF THE FUTURE”

SYMPOSIUM AT THE INTERNATIONAL SOCIETY OF ARTIFICIAL INTERNAL ORGANS IN EDINBURGH, SCOTLAND. Aug 04, 1999

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Why kidney health supplement to drug pathway?

Change is the law of life in all aspects, whether it is personal or professional, and as well, business strategy matters. Those who look only to the past or present are certain to miss the future opportunities. Hence, timing is most certainly one of the critical elements of operating a profitable business– especially when launching a new enterprise or product, or the repositioning of a company in the marketplace. Generally, in personal or professional life, one can precisely control the timing on several matters or aspects. However, achieving the right timing in a business endeavor is not something that can happen easily or quickly. What one can do, however, is make a concerted effort to anticipate when it might arrive – and be ready to take full advantage of it the moment it does. After twenty-two years of successful business operations as a kidney health dietary supplement company, the timing has finally come for Kibow®. Hence Kibow® is transitioning to a pharmaceutical drug, ultimately reaching out, accomplishing, and achieving the multi-billion-dollar business potential with its novel and breakthrough “Enteric Dialysis®” platform technology. This revolutionary generation of product formulation is a continuation of its two decades of pharma like clinically validated platform technology. The founder and his team – i.e., current employees, the scientific advisors, and board of directors strongly support this transition process, and the entire Kibow® team strongly believes this can be accomplished by January 2023.

Kibow® has mostly financed itself – initially with Founders/Family/Friends and subsequently from highly competitive SBIR phase I and II fast-track dual back to back grant awards from NIDDK-NIH and Qualifying Therapeutic Discovery Project (QTDP) Programs. Additionally, the company also obtained a USAID grant funding allocated to India but used exclusively for the US R&D operations and product development on a conditional basis. The company’s breakthrough happened with its substantial licensing income plus royalties derived (since July 2006) from Vetoquinol SA (VETO, a publicly-traded European veterinary company in France). By 2018, end-market sales for Vetoqiunol’s veterinary product, AZODYL®, reached $10 million in the USA and Canada.

2018

  1.  Harvard Symposium 2018 Poster – Probiotic Supplements prevented Oxonic acid-induced Hyperuricemia and Renal Damage. VIEW (PDF)

2017

  1. ASN 2017 Poster – Possible Improvements in GFR of CKD Patients with Renadyl™-3rd Biennial Survey. VIEW (PDF)
  2. WCN 2017 0450 Poster – Possible Pathways of Gut Microbiome Modulation by Probiotics in Chronic Kidney Disease. VIEW (PDF)
  3. WCN 2017 0453 Poster – Evaluation of the Effect of Two Mixes of Prebiotic Fibers in the Simulator of the Human Intestinal Microbial Ecosystem (SHIME®). VIEW (PDF)

2016Research & Development

  1. ASN 2016 poster. VIEW (PDF)
  2. IPC Budapest 2016 poster. VIEW (PDF)

2015

  1. Commentary: Concept and potential of Enteric Dialysis-Treating the cause not the symptom. VIEW (PDF)
  2. Poster: Probiotics for CKD. The Renadyl™ story. VIEW (PDF)
  3. Poster: Enteric Dialysis-Stabilization of the Gut Microbiome using Probiotics and Prebiotics (Gut-Kidney connection). VIEW (PDF)

2014

  1. Randomized controlled trial of Renadyl™ in Dialysis patients. VIEW (PDF) 
  2. Review of Health status and level of satisfaction of customers with CKD using Renadyl™. VIEW (PDF)
  3. Poster: Probiotics for CKD. The Renadyl™ story. Harvard Medical School.VIEW (PDF)
  4. Poster: Probiotics for CKD. The Renadyl™ story. VIEW (PDF)
  5. Poster: Probiotics for CKD. The Renadyl™ story. VIEW (PDF)

2013

  1. Dose Escalation, Safety and Impact of Renadyl™_CKD-III-IV.  VIEW (PDF)
  2. Poster:Dose escalation, safety and impact of Renadyl™ on CKD 3 and 4 patients-Preliminary outcomes. VIEW (PDF)
  3. Poster:Dose escalation, safety and impact of Renadyl™ on CKD 3 and 4 patients. VIEW (PDF)
  4. Poster:Effect of Renadyl™ on NF-kB levels in hemodialysis patients. VIEW (PDF)
  5. Poster:Effect of Renadyl™ on sCD30 levels in hemodialysis patients. VIEW (PDF)
  6. Poster:Effect of Renadyl™ on uremic toxins in hemodialysis patient. VIEW (PDF)

2012

  1. Probiotics, Prebiotics and Synbiotics: Gut and Beyond VIEW (PDF)
  2. Open-Label Dose Escalation Study of Kibow® Biotics (Renadyl™) in Chronic Kidney Failure Stage III and IV Patients at Thomas Jefferson University began in May 2011 and completed on December 2012. VIEW (PDF)
  3. Double-blind, randomized, placebo controlled, cross-over study of Kibow® Biotics in Chronic Kidney Failure Patients on Dialysis (Renadyl™) at SUNY-Downstate Medical Center began in April 2011 and completed on December 2012. VIEW

2011

  1. Observational Study of Kibow® Biotics (Renadyl™) in Chronic Kidney Failure Patients (Jefferson).  VIEW
  2. Observational Study of Kibow® Biotics (Renadyl™) in Chronic Kidney Failure Patients on Dialysis (SUNY-Downstate Medical Center).   VIEW

2010

  1. Pilot Study of Probiotic Dietary Supplementation for Promoting Healthy Kidney Function in Patients with Chronic Kidney Disease.   VIEW
  2. Poster: Probiotic Dietary Supplementation in Chronic Kidney Disease Patients (CKD III and IV) – Preliminary Observations and Combined Data Analysis of a 6-month Pilot Scale, Randomized, Double Blind and Crossover Study Design in Argentina, Canada, Nigeria and USA.  VIEW (PDF)
  3. Poster: Kibow®’s Pathway Through a Drug Like Validation for a Probiotic Dietary Supplement Targeted for Helping Maintain a Healthy Kidney Function    VIEW (PDF)
  4. Poster: Case Study of a Patient with Juvenile Diabetes and Nephropathy using a Probiotics as a Dietary Supplement for a Continuous Three Year Period   VIEW (PDF)

2009

  1. Poster: Dietary Supplementation with Probiotic Formulation (Kibow® Biotics) on CKD III and IV patients – a Short Term Pilot Scale Study in Canada.     VIEW (PDF)
  2. Editorial: “Can the bowel substitute for the kidney in advanced renal failure?     VIEW
  3. Probiotic dietary supplementation in patients with stage 3 and 4 chronic kidney disease: a 6-month pilot scale trial in Canada.     VIEW
  4. Poster: Probiotics for Kidney health – Gut Based Uremic Toxin Removal – “Enteric Dialysis™”     VIEW (PDF)
  5. Enteric Dialysis™ – Brief introduction and its potential for CKD applications.     VIEW

2008

  1. Development of Room Temperature Stable Probiotics for CKD Applications.     VIEW (PDF)
  2. Pilot Scale Human Clinical Trials with a Scientifically Validated Probiotic Formulation – Kibow® Biotics- With CKD Stage III and IV Patients (Mid-term and partial data analysis from Canada).     VIEW (PDF)
  3. Oral ingestion of probiotics and fecal analysis in CKD III and IV patients – Preliminary observations.     VIEW (PDF)

2007

  1. Pilot Clinical Trial of Probiotic Bacteria (Kibow® Biotics) in Chronic Kidney Disease (CKD). VIEW (PDF)
  2. Progress in devising a bowel based probiotic therapy for uremia.     VIEW (PDF)

2006

  1. Progress in devising a bowel based probiotic therapy for uremia.     VIEW (PDF)
  2. In Vitro and In Vivo Assessment of Intraintestinal Bacteriotherapy in Chronic Kidney Disease.     VIEW (PDF)
  3. Effect of feeding Kibow® Biotics to cats and dogs in kidney failure.     <ahref=”https://kibowpharma.com/pdf/abstact2.pdf” target=”_blank” rel=”noopener”>VIEW (PDF)
  4. Preliminary clinical evaluation of Kibow® Biotics, a probiotic agent, on feline azotemia.     VIEW (PDF)

2005

  1. Are Clinical Trials Warranted for a Dietary Supplement with Probiotics?  VIEW
  2. Initial Safety Studies of a Probiotic for Renal Insufficiency.     VIEW
  3. Probiotics reduces Azotemia in Gottingen Minipigs  VIEW
  4. Probiotic Amelioration of Azotemia in 5/6th Nephrectomized Sprague-Dawley Rats  VIEW (PDF)
  5. Short term effect of temperature on Kibow® Biotics   VIEW
  6. Evaluation of Commercial Probiotic Products for Azotemia    VIEW

2004

  1. An introduction to Probiotics and its potential in Clinical applications.     VIEW
  2. Comparative microbial viability analysis in two delivery formats-Gel caps or mixed with food/diet.     VIEW
  3. Gut-Based Uremia Therapy: In vitro R&D Investigations of an Oral Probiotic Microbial Formulation with the Aid of a Simulated Human Intestinal Microbial Ecosystem (SHIME) Biochemical Reactor.     VIEW
  4. Gut-Based Uremia Therapy: Oral Bacteriotherapy Effectively Reduces Severity of Azotemia in 5/6th Nephrectomized Mini Pigs.     VIEW
  5. Gut based Uremia therapy: Continued in vitro and in vivo R&D investigations on the application of oral probiotic bacteriotherapy towards Chronic Kidney Disease (CKD) patients.     VIEW
  6. Significance of dosage for effective clinical application of probiotics. VIEW
  7. Mode of Delivery and Dosage are important factors for Uremia Therapy with Probiotics VIEW
  8. Probiotic Formulation in vitro effect on Phenol and p-Cresol levels VIEW
  9. Initial Trial of Probiotic Bacteria as Therapy for Uremia in Dogs. VIEW
  10. Kibow® Biotics is preferred and superior to yogurt for uremia applications VIEW
  11. Model of Chronic Renal Failure in Miniature Pigs VIEW
  12. Oral Probiotic treatment for Uremia in a Porcine Model of Chronic Renal Failure VIEW
  13. Substitution of the kidney function by the bowel in Azotemia VIEW

2003

  1. Artificial Swallowable Kidney Formulation VIEW
  2. Oral Bacteriotherapy Effectively Reduces Severity of Azotemia in 5/6th Nephrectomized Rats  VIEW
  3. Streptococcus thermophilus KB19 is a Potential component of a Probiotic Regimen Applicable in Enteric Dialysis for Uremia  VIEW
  4. Rate of Urea Hydrolysis by Streptococcus thermophilus KB19 is comparable to Soil Bacterium Bacillus pasteurii and Genetically Engineered Urealytic E.coli VIEW
  5. Probiotics Extend Survival in Untreated 5/6 Nephrectomized Rats: Possible Use for Probiotics as An Adjunct in Chronic Renal Failure (CRF)® VIEW

2002

  1. Probiotics to Eliminate Nitrogenous Metabolites     VIEW
  2. A Novel Synbiotic for Augmenting Kidney Function     VIEW
  3. Urea Hydrolysis and Ammonia Uptake by Bacillus pasteurii     VIEW
  4. Urease Activity in Commercial Yogurt     VIEW
  5. Bacillus pasteurii: A Small Microbe with Huge Potential     VIEW
  6. A Nutraceutical Approach to Pre-Dialysis     VIEW
  7. Viability of Probiotics in Gastric Juice and Artificial Intestinal Fluid     VIEW

2001

  1. Gut Based Uremia Therapy: Simultaneously Eliminate Urea, Creatinine and Uric Acid 2010.     VIEW

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