New Discovery for BOTOX®: Increasing the Efficacy of Onabotulinumtoxin A by 200%

by Leigh Mack

Currently, seeking funding for a Phase 2 clinical trial to confirm findings of Phase 1 trial results from 2014.
Tampa, FL United States Drug Development Biotech

All Team Company Patients Physicians Innovation Details Supporters Comments Updates

About our project

The problem we solve: Imagine having to receive shots in your body every 2 to 3 months for the rest of your life for a medical condition? Onabotulinumtoxin A has many FDA approved indications in which patients receive shots of Onabotulinumtoxin A every 2 to 3 months indefinitely for conditions such as: chronic migraines, overactive bladder (bladder dysfunction), upper and lower limb spasticity, cervical dystonia, and primary axillary hyperhidrosis.

About our solution: By changing the diluent from saline to an aqueous based solution with an Ag4O4, crystalline structured silver nanoparticle; the discovery was made that you could extend the efficacy to over 200%.

Progress to date:

Currently, a Phase 1 trial has been completed with 17 healthy participants from 2013 to 2014 resulting in an average efficacy period of 9 months. As of 2016,  No adverse events were reported and no adverse drug reactions were reported. This Phase 1 trial of Onabotulinumtoxin A and Ag4O4 combination has been completed in British Colombia, Canada.

About Our Team

Creator: Leigh Mack

Location: Florida

Education: University of Oxford and USAT Montserrat

Bio: Dr. Leigh J. Mack is an alumni of Indiana State University He is also a graduate of USAT Montserrat; holding both a MD and PhD degrees. Dr. Mack has post graduate training in Nanotechnology (nanomedicine) from University of Oxford. He trained at John Radcliffe Hospital (University of Oxford/NHS) in Trauma Plastics. Dr. Mack is a Certified Principal Investigator (CPI - ACRP); and a Fellow of the Academy of Physicians in Clinical Research. He is currently pursuing a Fellowship with ACC.

Hospital Affiliation: Mack Biotech, Corp, Inaline Corp, Emergency EMCG, Inc.

Title: President

Advanced Degree(s): MD, PhD, FAPCR, CPI

About Team Members

Andrew Willoughby
Inventor, DMD
Biography: Dr. Willoughby graduated with a Doctorate of Dental Medicine (DMD) from the University of Manitoba in 1988 with awards in crown and bridge work and operative dentistry. Dr. Willoughby has a very diverse clinical background and many clinical interests. Dr. Willoughby also has a special interest in helping treat patients who suffer from TMJ and Headache pain as well as restoring badly broken down bites using unique precision attachment partial dentures and over-dentures.
Title: Inventor
Advanced Degree(s): DMD
LinkedIn: https://www.linkedin.com/in/dr-andrew-willoughby-65061148

Keith Moeller
CEO, ND
Biography: Keith is a graduate Brigham Young University and is the Chief Executive Officer of American Biotech Labs, LLC. (ABL) and a owner of Clifton Mining Company. ABL is the manufacturer of the nanoparticle that has been employed in this new discovery.
Title: CEO
Advanced Degree(s): ND

About Our Company

Mack Biotech, Corp.

Location: 401 East Jackson Street
2340
Tampa, FL 33602

Founded: 2016

Website: https://www.mackbio.com

Other link: https://www.mackbio.com/pages/botulinum-toxin-type-a-extender

Product Stage: Prototype/MVP

YTD Sales: $250,000..1M

Employees: 5-10

How We Help Patients

Imagine having to receive shots every 2 to 3 months for the rest of your life for a medical condition? Onabotulinumtoxin A has many FDA approved indications, in which patients receive shots of Onabotulinumtoxin A, every 2 to 3 months indefinitely for a lifetime for conditions such as: chronic migraines, overactive bladder (bladder dysfunction), upper and lower limb spasticity, cervical dystonia, and  primary axillary hyperhidrosis.  We can't fix the conditions, but we possibly extend those shots to just every 8 to 9 months.

How We Help Physicians

This a potential game changer for providers in being able to offer a btter qaulity of life to patients by being able to treat more eefctively at greater intervals.

Innovation Details

Intellectual Property Summary

The inventor Dr. Andrew JM Willoughby has filed two patent applications have been filed with the USPTO for this technology.  The attorney for these patents is David D. McMasters Esq., J.D., North Bend, Washington. 

Clinical Information

Currently, a Phase 1 trial has been completed with 17 participants from  2013 to 2014 resulting in an average efficacy period of 9 months. As of 2016  No adverse events were reported and no adverse drug reactions were reported. This Phase 1 trial of Onabotulinumtoxin A and Ag4O4 combination has been completed in British Colombia, Canada.

Dr. Andrew JM Willoughby, DMD, discovered a new formulation for BOTOX® (onabotulinumtoxinA) that extends the effective time to over nine months.  Dr. Willoughby, a reconstructive and cosmetic based dentist with numerous accreditations and over 30 years of clinical experience.  Dr. Willoughby found in 2013, that he could extend the effective time of BOTOX®  by over 200%.  During 2013 and 2014, a phase 1 (limited) clinical trial was conducted involving 17 healthy, adult participants. The trial involved diluting Botox with a new buffer solution (“diluent”) comprised of a nanometallic silver hydrosol.  Dr. Willoughby, found this new buffer solution to be a type of “BOTOX® Bacteriostatic” material.  

The results of this discovery were monumental.  After closely following the 17 participants for over a year after the initial treatments two exceptional observations were made:

1. The “BOTOX® Bacteriostatic” effect lasted up to 200+% longer with participants/patients previously injected with just Botox. This meant less injections to maintain to the same amount of desired muscle relaxation.

2. The “BOTOX® Bacteriostatic” (diluted) solution appeared to remain stable and preserve it's efficacy for upwards of 3-4 months while refrigerated.

As of the publication of this press release zero adverse events have been reported by all 17 participants.

Dr. Willoughby believes that the pharmacology and cellular mechanism of action behind these results are twofold: 1) it involves the stimulation of the lysol oxidase cascade and connective tissue metabolism which is essential in the physiologic rest potential of every muscle injected with Botox and 2) the manner in which the NMSH molecule is able to encapsulate and preserve a purified protein such as Onabotulinumtoxin A.

Currently, Dr. Willoughby along with Leigh J. Mack, MD, PhD, FAPCR CPI are organizing a formal Phase 2, double blind, factorial clinical trial with 120 participants.  A clinical trial start date in 2nd quarter of 2017 is anticipated.

Dr. Mack believes a possible mechanism of action and the reason for extension of efficacy. The Onabotulinumtoxin A is not being removed by the body as quickly - this may be a reason why:

150-kDa core BoNT is the only part capable of stimulating the formation of neutralizing antibodies.  More specifically,  Flagellin is a constituent protein of the bacterial locomotor apparatus that interacts with the Toll-Like Receptor 5 (TLR5) which initiates a immune response.  Ag4O4 Silversol’s two trivalent bonds , within the particle, creates a small magnetic field that disrupts this communication and hinders the biochemical communication of TLR5 communication.  The toll-like receptors then do not send information recognizing the flagellin.  This in turn stops MyD88 leading to subsequent activation of IRAK4, IRAK1, TRAF6, and eventually IκB kinases. Activation of IκB kinases contributes to the nuclear localization of NF-κB (a proinflammatory cytokine). NF-κB induces many downstream gene expressions, which initiates the canonical proinflammatory pathway. 

Currently we are in the process of funding a full Phase 2 clinical trial in British Columbia for a specific maxillofacial condition.  If you are interested in knowing more or interested in investing please contact us directly.  IRB approval of protocol is in review currently. We are working on consent forms and SOPs for the trial.

 

BOTOX® is a registered trademark of Allergan, Inc., Irvine CA. This study was neither funded or approved by Allergan, Inc., Irvine CA.

Regulatory Status

Currently pre NDA meetings are being scheduled along with pre clinical trial meeetings with Health Products and Food Branch (HPFB) of Health Canada.  These pre clinical trial meetings shall be complete by March, 2017.

How we will use the funds raised

Funding for Phase 2 clinical trial and new drug application fees.

Thank You

Everyone who has reviewed the science and the data from this research has found it facinating and "paradigm shifting" for this industry. We believe this will bring better patient care and better quality of life for those people who use Onabotulinumtoxin A to treat many muscle based medical conditions.  Pleae help us with the next stage of research so we can solidify the efficacy of this discovery. 

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Leigh Mack
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University of Oxford and USAT Montserrat

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