Sunday, April 16, 2023

Introduction

 

The number of non-human cells in and on the human body exceeds that of human cells.  How is this possible?  When a person dies, bacteria quickly cause decay and putrefaction. How does the body prevent bacterial overgrowth during life?  The answer is the human body makes an antibiotic to control bacterial protein synthesis.  I know what it is, and how to make it.  A short history of antibiotics may be helpful.

Antibiotics, as a class of medicinal compounds, were first discovered by Paul Ehrlich and Sakahiro Hata in 1910.  They synthesized the compound Arsphenamine to treat syphilis.

In 1928, Sir Alexander Fleming discovered a compound he named Penicillin. The compound was secreted by the Penicillium fungus and inhibited bacterial wall protein synthesis. Other drugs were later added to the list of fungal-derived products with antibiotic properties.

During and after 1943, Albert Schotz and Selman Waksmain isolated the antibiotic Streptomycin from the soil bacteria genus Streptomyces. Further research on other members of this genus resulted in the discovery of additional antibiotics.

Most bacterial products successful in humans target bacterial protein synthesis. This is because the protein synthetic apparatus of bacteria differs from that of humans. While both bacterial and human ribosomes are involved in protein synthesis, they differ in their size, composition, and structure. This allows for the development of antibiotics that specifically target bacterial ribosomes without affecting human cells.

 While many bacterial products have antibiotic properties, only a select few are appropriate for human use. The pharmaceutical industry generally demands a Therapeutic Index of 10 or more before exploring a new drug.  My drug, which inhibits MRSA while sparing yeast mitochondria, has a T.I. of 15.

Another facet contributing to the success of an antibiotic is the lack of mutagenicity.  If the compound works by causing mutations in bacterial DNA it will lead to cell death.  This will put pressure on the genome, forcing bacteria to evolve away from the inhibitor, leading to the antibiotic resistance now seen around the world.  The effectiveness of a human antibiotic cannot be attributed to a mutational mechanism, as evidenced by the existence of over 7 billion humans.  The human antibiotic must leave bacterial protein synthesis in stasis without causing bacterial death.  Simultaneously, it must not inhibit human protein synthesis or cause human cell death.  My compound exhibits all of these characteristics at appropriate doses.

Robert Bayless C.V.

 

ROBERT K. BAYLESS

   8710 Chisholm Lane

                                            Austin, Texas  78748

                                      Methylgroup@sbcglobal.net

                                                   512 280 5687

 

I am an antibiotic researcher who has discovered a new class of non-mutagenic protein synthesis inhibitors to control bacterial infections in humans, animals, and plants. I believe that the human body has evolved an antibiotic to control the overgrowth of bacteria found in the everyday environment, and I know what it is and how to make it.

 

EXPERIENCE

 

January 1980 to present: For the last 35 years, I have been involved in an antibiotic research project. In 1985, I founded and ran a basic biochemistry research lab with a Stanford Ph.D., who trained me in the basics of scientific research. We worked together for ten years. I arranged two clinical trials in cats and dogs to investigate the utility of one of our compounds. I then collaborated for ten years with an MD who was the chief of Emergency Medicine at the Austin city hospital. We arranged and performed two human clinical trials using compounds outlined in my six patents. We had a third trial arranged when he retired after the hospital was taken private. I then spent five years studying analytical chemistry with the Ph.D. Director of the Microanalysis Lab at UT Austin.

I have successfully synthesized a member of a new class of antibiotics based on the hypothesis that the human body has evolved a safe, non-mutagenic protein synthesis inhibitor to control bacteria. The spectroscopist and I explored and defined the chemical structure of the antibiotic compound I synthesized as part of my ongoing research. My efforts now are centered on raising the $5 million necessary to obtain US and worldwide patents on the compounds and then license their testing, manufacture, and use to Big Pharma.

  

EDUCATION


 1977:  Pasted the testing and was accepted into Mensa International.

1972-1973: Pace University Graduate School of Business located on the Pleasantville/Briarcliff Campus in upstate New York. I completed one year of a two-year MBA program but left because they did not offer coursework in entrepreneurship.

1965-1969: Earned a B.A. from The University of Connecticut located in Storrs, Connecticut.

  

                                                   PATENTS

 1)   Treating AIDS and HIV Infection with Methionine  United States 5,292,773    Issued March 8, 1994  2 inventors:  Robert Bayless and  Gerald P. Hirsch,  Ph.D.


2)   Treating AIDS and HIV Infection with Methionine Compositions.          Continuation-in-part of above patent.     United States  5,430,064     Issued July 4, 1995   2 inventors:  Robert Bayless and Gerald P. Hirsch, Ph.D.


3)   Treating Inflammatory Pain with Methionine     United States  5,053,429 Issued Oct. 1, 1991   2 inventors:  Robert Bayless  and Gerald P. Hirsch,  Ph.D.


4)   Antioxidant Compositions and Methods Ameliorating Inflammatory Symptoms of Respiratory Disease     United States 4,927,850     Issued May 22, 1990        2 inventors:  Robert Bayless and Gerald P. Hirsch,  Ph.D.


5)   Calcium Homeostasis Compositions and Methods for Controlling Calcium Metabolism   United States 4,902,718    Issued February 20, 1990                                     2 inventors:  Robert Bayless and Gerald. P. Hirsch, Ph.D.


6)   Methods for Inhibiting Inflammatory Ischemic, Thrombotic and Cholesterolemic Disease Response with Methionine Compounds              United States 5,084,482 Issued January 28, 1992        2 inventors:  Robert Bayless and Gerald P. Hirsch, Ph.D.

 

REFERENCES

Earl Matthew  M.D.                                             Paul Lebourgeois  M.D.

earlmatthewmd@yahoo.com                                           Paul@Lebourgeois.org

Thursday, April 2, 2015

Antibiotic Executive Summary

       

 

                  ANTIBIOTIC EXECUTIVE SUMMARY

 

In 1985, my late business partner, Gerald Hirsch, Ph.D. biochemist, and I developed a theory describing a hypothetical antibiotic.  We established The Lithox Corporation to exploit this new technology.  We spent four years trying to synthesize the molecule, but were unsuccessful, and we closed The Lithox Corporation in 1989. 

 

       After 15 years working on the idea, I finally succeeded through trial and error.  My 74th attempt yielded the correct synthetic method.  Here is a summary of my work.

 

                         A NEW ANTIBIOTIC COMPOUND             

 I have discovered a new chemical entity with antibiotic properties that works by inhibiting the production of protein in bacteria.  This stops bacterial growth without killing them. This compound should have low toxicity to humans because it does not interfere with human protein synthesis, which differs from that of bacteria.

 

Since protein synthesis in bacteria is carried on outside of DNA, the compound does not target DNA synthesis or functions.  This means that bacteria should not develop resistance to the compound as they do with antibiotics that target DNA. This characteristic is significant.  Because of the lethal properties of many existing antibiotics, bacteria have developed resistance.  Antibiotic-resistant bacteria, including the flesh-eating MRSA, are increasingly prevalent in hospitals and doctor’s offices world-wide, posing significant risks to patients.  Although some current treatments exist for this problem, they can be difficult to administer, toxic to humans, or have expired patent protection.  This new compound has the potential to solve these problems and offer significant revenues to pharmaceutical companies.

 

This antibacterial compound can be used for humans for internal infections and external skin infections, veterinarian use—both in food animals and pets—and agricultural use to treat bacterial infections in plants.  It can also be used as a topical spray, and in wound coverings to prevent or treat bacterial infections, and many other uses where anti-bacterial capability is desired.

 

            The inventor, who already holds several patents, has developed a novel method to create the molecule, the compound he created has not been described in the scientific literature, and the antibacterial properties of the compound are unanticipated in the literature. These factors make the compound novel and useful, which is necessary for patentability.

 

           The initial testing on bacteria, including MRSA, has been completed, and produced positive results as expected. The next stage includes wider in vitro tests, chemical characterization, and animal testing.  Patent filings would follow.

 

            The market potential, considering the wide variety of uses, is huge. My goal is to create an entity that subcontracts the necessary testing, files patents, and licenses the patents to various companies who will then complete the testing appropriate to their respective markets, and commercialize the compound.

Antibiotic Business Plan

            BUSINESS PLAN FOR DEVELOPMENT AND MARKETING 

                                             OF A NEW ANTIBIOTIC

 

THE PATENT IS THE PRODUCT

                                                By Robert Bayless, inventor.

 

Following positive Phase III test results for both a new anti-fungal and a new antibiotic, Pfizer, Inc. bought a small company, Vicuron Pharmaceuticals, for $1.9 billion in cash in 2005. Pfizer could justify such a purchase premium because total worldwide antibiotic sales in 2000 exceeded $25 billion. A single blockbuster drug can generate $1 billion in sales in the first year, allowing large drug firms to recoup their investment immediately.

Project Summary: This project to create, patent, and market a patent describing a new antibiotic requires a total investment of $5 million over five years to maximize future patent yields. Identifying, testing, and preparing the patent should take four years, followed by filing the patent and marketing it to drug firms in year five. When a drug firm commits to a licensing deal, they typically pay upfront money, and royalty payments in the range of 5% to 10% of total revenue continue for the patent's life. Setting up a joint venture between a major drug firm and the patent holder increases the potential for a higher return to the original investors compared to a license or acquisition.

Background: In 1983, Robert Bayless began researching new antibiotics to treat bacterial infections with the late Dr. G.P. Hirsch, Ph.D. He and Dr. Hirsch established The Lithox Corporation in 1985 to further refine this research. After four years of work, they were unable to synthesize a stable product that could withstand the rigors of synthesis, purification, and analysis. They filed and were granted six U.S. patents disclosing the use of an amino acid as an antioxidant to treat various ailments. In 2001, while continuing his study alone, Bayless discovered a novel synthesis method for a new antibiotic. After considerable research and work, he filed a series of Disclosure Documents, culminating in the 2014 disclosure   The disclosed products need to be synthesized and identified using a variety of standard analytical techniques, biological tests conducted both in vitro and in animals, and patents filed describing such products and their uses.

 

Challenges:

The U.S. pharmaceutical industry is facing challenges. Worldwide, branded pharmaceutical sales are projected to exceed $706 billion in 2012. However, about 9% of patents expire annually, resulting in a loss of roughly $60 billion in protected revenues to the generic market each year. For instance, in 1984, only 19% of U.S. prescriptions were filled with generics; by 2015, that number had risen to 88%. The generic market comprises approximately $67 billion in sales each year, with profit margins that are razor-thin compared to those of patent-protected drugs. Global animal pharmaceutical sales average around $14 billion per year, with large volumes but minuscule profits. Consequently, large drug firms actively seek patented products for human use that will ensure a price-protected market for the future.

Primary target markets for a new antibiotic include:

Internal use to treat bacterial infections in humans, including respiratory infections.

External use to treat bacterial skin infections in humans.

Inhalation use to treat bacterial lung infections in humans.

Internal use to treat bacterial infections in food and non-food animals.

External use to treat bacterial skin infections in food and non-food animals.

Systemic use to treat bacterial infections in food and non-food plants.

Topical sprays to treat bacterial infestations in food and non-food plants.

Cleaning fluids and sprays to disinfect surfaces.

Disinfection of foods and liquids, including water and blood.

Use in wound coverings to prevent and treat bacterial infections.

 

Top of Form

Top of Form

 Market Strategy:

 Bayless proposes to market patent-pending drugs to large pharmaceutical firms with the resources to conduct clinical trials and finance the FDA regulatory process necessary to sell drugs in the United States. However, large drug firms refuse to sign Non-Disclosure Agreements in order to review new drug entities in the pre-patent stage because of concerns that their ongoing research may impinge on the new material. By designating the drugs as patent-pending, the drug firms can review the material without such concerns. Additionally, since it takes on average 12 years and costs $24 million to bring a New Chemical Entity (NCE) to the preclinical/nonclinical patented stage, large drug firms can skip a significant part of the time delay and uncertainty of the drug discovery process (refer to Attachment "C" for an in-depth discussion of drug discovery and development costs). The cost difference between the $24 million incurred on average by large firms to develop a patented drug in-house and the $5 million cost outlined by this document constitutes the value-added available to investors in this plan.

 

Patents:

 Patents are legal monopolies granted within the capitalist system that provide up to 20 years of exclusive ownership for a given technological advance. European patents must be filed before U.S. patents issue to protect European rights, so the timing of patent filing is of great importance. Investors should consult patent counsel to fully understand the patent process.


Funding Proposal:

To interest a major drug firm in a licensing deal, the following steps must be accomplished (please refer to Attachment “B” for the complete Research Plan proposal):

 Step I: Set up a corporate entity to pursue the patent (please see Corporate Structure for details).

 Step II: Prepare and file a provisional U.S. patent. Although Bayless has already written one, it requires review and editing by patent counsel before filing.

 Step III: Synthesize compounds, identify chemicals, and conduct biological testing. Once the Provisional Patent is filed, approach companies to subcontract the synthesis, analysis, and in vitro and animal testing required to support a patent filing.

 Step IV: File U.S. Patent application(s) based on the results. Filing provides patent pending protection. Filing foreign patents must occur before the U.S. patent issues. Steps II and III run concurrently.

Step V: Begin marketing the patent(s) to major drug firms.

 

       TYPICAL PHARMACEUTICAL LICENSING DEALS ANNOUNCED IN 2006:

 

GlaxoSmithKline has agreed to purchase all outstanding shares of Praecis Pharmaceuticals for $54.8 million. Praecis has an anticancer drug in development.

 Genmab has entered into a worldwide agreement with GlaxoSmithKline to commercialize a human monoclonal antibody for the treatment of leukemia. Genmab received a license fee of $102 million, and GSK agreed to invest $357 million in Genmab. Additionally, Genmab received tiered royalties on worldwide sales.

Exelixis has entered into a worldwide agreement to develop cancer treatments with Bristol-Myers Squibb. Exelixis received $60 million in cash, $20 million for each drug candidate selected by BMS, and royalties on worldwide sales.

Altus Pharmaceuticals has entered into an agreement with Genentech to commercialize their version of human growth hormone. Genentech paid $15 million upfront and purchased $15 million of Altus' stock. Commercialization milestones trigger up to an additional $110 million in payments.

Kosan Biosciences has established a worldwide license agreement with Pfizer for a drug to treat gastrointestinal diseases. Kosan received $12.5 million upfront, and Pfizer will initiate a Phase I trial. If commercialization is successful, Kosan will receive $250 million, as well as royalties on worldwide sales.

AstraZeneca paid a $20 million milestone payment to Targacept following the successful completion of clinical studies of a cognitive-enhancing drug.

MedImmune signed an agreement with Japan Tobacco with the intent to develop a monoclonal antibody to treat lupus. JT received upfront payments, as well as royalties on marketed products. MedImmune received exclusive development and marketing rights everywhere in the world except Japan. 

Crucell has signed a cross-licensing agreement with Merck, allowing Merck to use Crucell's technology in the vaccine field. In exchange, Crucell will receive access to Merck's large-scale vaccine manufacturing technology.

Albany Molecular Research has entered into a two-year collaboration with Bristol-Myers Squibb. This collaboration includes upfront payments, research funding, and milestone payments.

Top of Form

 

Attachment B: Research Plan

                                  

 

                                   

 

THE PATENT IS THE PRODUCT

                             RESEARCH PLAN FOR PATENT FILING

 

          U.S. Patent law establishes a blueprint for research aimed at patenting a new chemical compound with medicinal properties in humans.  The compound must be novel, which means that it must be chemically identified, and then a patent search, as well as a Chemical Abstract search, must show that no similar compound has been synthesized and characterized anywhere in the world in the last 150 years.  The specific tests to positively identify a given compound will vary according to the atomic structure of the compound, but general categories of compounds require similar tests.

A patentable compound must have demonstrable utility, which in the case of medicinal compounds, has been defined by court ruling to mean both in vitro tests and successful animal tests.  An U.S. Appeals Court ruling has established that reduction to practice for a medicinal compound occurs only after successful completion of appropriate animal tests, so any patent filing submitted without such data will fail on grounds of non-utility. Clinical trials showing utility in humans are not necessary to obtain a valid U.S. patent. 

 There also exists the patent concept of broad versus narrow patents.  A broad patent is granted to a novel group of compounds in which a new area of chemical entities with novel properties has been discovered.  A narrow patent is granted where a new use for a known compound is sought.  Broad patents have more commercial value than narrow patents.  With broad patents, the rule is:  show three examples, and claim the world.  Therefore, a search for closely related compounds with biological activity is mandatory if a broad patent is desired.  Effectiveness against a range of organisms allows broad claims of utility against entire classes of organisms.

 With these considerations in mind, a sequential course of action would include the following steps:

  Year One:

 Set up the corporate structure to retain the rights to any patents filed by the corporate entity.  Retain a patent lawyer to review the provisional patent as already written by Bayless.  A prior art search and opinion as to the patentability of the drug discovery is the first step.  A provisional patent should then be filed, as revised by the attorney.  Provisional patents are used a place-holders.  If the actual patent filing goes beyond the provisional patent in scope, the Patent Office will disallow the broader claims, so the provisional patent should be as broad as possible.  Provisional patents are good for one year.  If the actual patent is not filed within the one-year period, a second or third provisional patent can be filed, but the priority filing date of the first or second provisional patent is lost. 

Cost: $50,000.

  

SYNTHESIS OF COMPOUNDS: 

Once the provisional patent is filed, a preclinical drug discovery company that specializes in synthesis and testing of compounds will be located and hired (See Southern Research Institute at end for example).   An NDA should be signed by the companies selected, but the provisional patent does not have to be shared with them until after a deal is signed.  Once the legal requirements are in place, synthesis of active ingredients, using both Method One and Method Seventy-Four, will be conducted with the original compound as well as its analogs, as selected by Bayless.  Following synthesis, precipitation and/or freeze-drying, the purification of active ingredients will occur.  Synthesis of compounds will be an on-going process that may require two to four years to complete.  Research is not a linear process, but a series of hop-scotch steps forward and back and sideways, making it hard to forecast how long is long enough.

            Cost:  $950,000.

 

 Year Two:     

           Biological testing should begin.  As compounds are synthesized, they should be tested in vitro against a range of micro-organisms in order to select metabolically active compounds for further review.          A biological testing lab will have to be selected and hired to conduct such tests.  (See Accugen Labs for example at end)  Here again, the extent of in vitro testing necessary to evaluate synthesized compounds is difficult to forecast at this time.  The obvious endpoint is when sufficient testing is completed to support a broad patent.  The patent attorney should have input here.

    IN VITRO BIOLOGICAL TESTS:

          1.     Tests of synthesized compounds should be run to identify which of

them possess inhibitory properties.  Growth Inhibition Curves in liquid media

against a range of bacteria will accomplish this task.

         2.     Toxicity screens of active compounds in yeast will reveal toxicity profiles and 

               provide the Therapeutic Index on each candidate and allow the selection those 

               that are both active and non-toxic.

 

3.     Additional tests, including Minimum Inhibitory Concentration determinations as well as Growth Inhibition Curves in liquid media, and Zone of Inhibition tests using solid media against a range of pathogenic Gram-positive and Gram-negative organisms, both aerobic and non-aerobic, will establish which compounds are worth the time and expense of characterization.

        Cost:  $1,000,000.

 

 Year Three:

           Compounds which have in vitro activity against bacteria, and a satisfactory                           Therapeutic Index, will then be characterized by an Analytical Chemist.  The same                lab that does the synthesis may perform the characterization, or a different lab may              be selected.

 

ANALYTICAL METHODS:

           Once the activity and toxicity profiles of active compounds have been established, chemical characterization should occur.  By following this sequence, only active compounds go through the expense of lab identification.  Following identification, a Chemical Abstract search by the patent attorney will confirm the novelty of the group of compounds.  Typical tests for this group of compounds include:

           1.     Ultraviolet spectroscopy with water as solvent.

2.     Paper chromatography,

      using the ascending technique with propanol-ethanol-water (40:40:20). 

3.     Infrared spectroscopy to determine the molecular composition of the compounds. 

4.     Nuclear magnetic resonance to determine the structure of the compounds. 

5.   Mass spectrometry for detection and identification of components.

                   Cost:  $1,000,000.

 

 Year Four:

                Once the compounds have been synthesized, tested in vitro, and characterized, they should be tested in animals to provide evidenced for utility.  An animal testing facility will have to be located to conduct such testing. (See Idexx BioResearch for example at end).

 

ANIMAL TESTING:

Animal models for human disease exist, and appropriate animals should be selected to demonstrate the ability of the compounds to prevent death from pathogenic bacteria. Typically, animal testing first involves establishing dosing levels, and then challenging the animal with pathogenic bacteria while providing the drug to see if the animal survives. 

Therefore:

          1.   Determine maximum tolerated oral dose in the mouse and rabbit. 

2.     Perform Staphylococcus aureus (MRSA) and Escherichia coli (diarrhea) challenge test in mouse and rabbit, and Francisella tularensis (Tularemia) and Pasteurella mutocida (cholera) tests in rabbits.  Dogs, cats, and pigs are also candidates for testing.

  

ADDITIONAL IN VITRO TESTS:

     3.  Inhibition screening on at least three normal human cell lines to provide a                                 Therapeutic Index for human cells.                                                                  

     4.   Inhibition screening on lung, breast, and prostate human tumor cell lines.

     5.     Inhibition tests on at least three species of protists in liquid media. 

     6.   Inhibition tests on Canine Distemper, Measles, and Ebola viruses in vitro.

                  Cost:  $1,000,000.

 

 Year Five:

     Patent Filing.

 Once the various synthesis, purification, analytical and biological techniques are completed, U.S. patent(s) must be filed.  Estimated time to completion from the original filing: three years.  PCT patent(s) must be filed within one year of a U.S. patent application.

Once the patent is filed, potential licensing partners can be contacted.  A marketing manager should be hired to lead this effort.  Only major pharmaceutical companies have the financial means to carry a drug candidate through the FDA process to market.  Up-front money is usually paid at signing, with royalty payments as negotiated.  Joint ventures with major pharmaceutical companies should be investigated as a possible alternative.  Out-right sale is also possible, although licensing and royalties generally result in more money to investors over time.   

                    Cost:  $1,000,000.

 

 

         SOUTHERN RESEARCH INSTITUTE

 

BIRMINGHAM, Ala. —Southern Research Institute conducts both contract research and basic research for clients, providing preclinical drug discovery, development, and clinical trial support services in cancer, infectious diseases, and CNS/neurological disease to pharmaceutical and biotechnology companies. Scientists conduct translational science to invent small molecules and advance them from the design stage to the clinic. Services available include medicinal chemistry, molecular biology, biochemistry, high-throughput screening and a full set of in-house GLP development services including toxicology, ADME/PK, animal models, formulations, and bioanalytical services.

About Southern Research

Southern Research Institute is a not-for-profit 501(c)(3) scientific research organization founded in 1941 that conducts preclinical drug discovery and development, advanced engineering research in materials, systems development, and environment and energy research. More than 550 scientific and engineering team members support clients and partners in the pharmaceutical, biotechnology, defense, aerospace, environmental and energy industries. Southern Research is headquartered in Birmingham, Ala., with facilities in Wilsonville, Ala., Frederick, Md., and Durham, NC and offices in Huntsville, Ala., New Orleans, La., and Washington, DC.

ACCUGEN LABS

Accugen is a FDA registered, independent contract microbiology laboratory. We offer full microbiological testing and analyze products from a wide variety of industries. Our microbiological testing laboratory is comprised of a highly experienced team of microbiologists who are experts in testing ASTM, AOAC, AATCC, FDA, EPA, USDA, USP, CTFA, JIS, ISO and other methods of analysis. Our competent professionals have decades of experience in routine microbiological analysis, special microbiology, research microbiology, and a variety of other microbiological testing. We are considered leading authorities in microbial testing. Accugen has provided impeccable microbiological services to pharmaceutical, disinfectant, cosmetic, food, personal care, household, medical device, antimicrobial, paint, paper, plastic, textile and other miscellaneous industries. At Accugen, we understand the challenges presented by a changing market place and our goal is to maintain the cost effective and highest quality microbiological testing services.

 

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