On behalf of Peptide BioSciences, Inc. (PBI), our team is requesting consideration to be admitted into Operation Warp Speed and is seeking Emergency Use Authorization to treat humans infected with the SARS-CoV-2 virus.
PBI’s lead therapeutic, Immune Complex Inhibitor (ICI), is a highly disruptive technology that holds the promise to perform as a ubiquitous therapeutic in a manner that heretofore has never been achieved.
PBI believes it has a solution to the COVID-19 pandemic, both in treating existing cases and in preventing future infections, with a single protocol that could be sold over the counter (OTC) in a nasal spray or transdermal patch to prevent the coronavirus, and as a prescription drug administered in a clinical setting to treat even the most advanced COVID-19 patients with comorbidities, administered via intramuscular (IM) and intravenous (IV) modes of delivery.
We believe that only ICI is positioned to facilitate this administration’s bold agenda for Operation Warp Speed, to address both the human toll and the socioeconomic fallout from the coronavirus pandemic, with efficacy results delivered before the consequential November election and production fulfillment by the end of the year.
Operation Warp Speed has prioritized vaccine development as its primary mandate. For myriad reasons, beyond the fundamental hurdles and logistics relating to cost, development timeline and massproduction, PBI strongly believes that vaccines will not be the solution. Vaccines are developed specific to one genomic sequence, yet viruses are constantly mutating with each host they inhabit, and at least 30 different genetic variations of SARS-CoV-2 have been identified since the first confirmed case in Wuhan, Hubei, China on December 1, 2019, a genomic strain now termed ‘G614.’
In a full peer-reviewed study published on July 2, 2020, researchers at Sheffield University Genomics Group identified a new genome mutation variant called ‘D614G.’ Dynamic tracking of variant frequencies revealed a recurrent pattern of G614 increase at multiple geographic levels, that has become dominant in circulating strains globally. D614G is associated with higher viral loads in the upper respiratory tract of patients with Covid-19 and is more infectious under laboratory conditions, but not identified with increased disease severity.
Unlike vaccines, ICI could be efficacious against any virus and all viral mutations, its efficacy will apply regardless of the viral strain and how the genomic DNA mutates over time, and it does not depend on adaptive immunity or require an immune response. Furthermore, ICI could be efficacious in thwarting all infectious diseases caused by viruses, bacteria, parasites, protozoa, amoebas, fungi, etc., which could also pose bioterrorism threats.
It is now widely understood and universally accepted that acute and chronic inflammation is the root cause of disease. ICI has demonstrated an absolute interruption of the disease inflammatory cytokine cascade, at its inception, and represents a fundamentally new method of directly inhibiting the pathogenesis, or onset, of literally hundreds of diseases and conditions. Indeed, clinicians have now observed the inflammatory manifestations of COVID-19 express systemically, beyond the Acute Respiratory Distress Syndrome (ARDS) in the lungs, to nearly every organ and system in the body.
Nontoxic and safe, with no negative side effects or complications, ICI is inexpensive to produce through recombinant synthesis. After administration, ICI takes effect throughout the entire body in less than an hour, including crossing the blood-brain barrier, and data consistently supports that it will be efficacious on everyone, with no ‘non-responders.’ There are no deleterious interactions with other drugs or alcohol, and there is no potential for overdose or recreational use or abuse.
Studies have indicated that ICI may both treat and prevent diseases as seemingly disparate as autoimmune, immune-mediated and other inflammatory diseases; all infectious diseases; diseases of the central nervous system (CNS); some cancers; and to prevent the rejection that occurs in tissue and organ transplantation. Furthermore, ICI may be efficacious as a prophylactic and therapeutic for use in veterinary medicine, which would be critical in securing the global food supply.
In this unprecedented moment, there is no margin for error. In parallel to spending unlimited funds to investigate and stockpile vaccines and therapies that may or may not work on the coronavirus, it would seem prudent to invest a relatively small amount of time and money to explore a novel approach, that could pay huge dividends beyond the pandemic, when the COVID-19 crisis subsides.
There exists an opportunity to identify a protocol that may both prevent and treat COVID-19, regardless of the viral strain and how the genomic DNA mutates over time, through a mechanism that does not require an immune response, while simultaneously solving the mystery of every other disease and infection that involves an inflammatory component.
A post-COVID-19 “new normal,” could be one where ICI is inexpensively and abundantly available, and widely distributed directly to the public; where people can have confidence and peace of mind that they may resume their lives, without the threat of contracting the virus or exposing loved ones who may be most vulnerable; where businesses and air travel may safely resume, without the restrictions and protocols that preclude any semblance of normalcy and expectation of profitability; where it is possible for a single nontoxic protective protocol to enable people to board a plane and be protected against any contagion that might be recirculating within the cabin, while simultaneously preventing the onset of countless other diseases and conditions, including Alzheimer’s, rheumatoid arthritis and other hereditary diseases to which people may be genetically predisposed.
PBI successfully tested ICI in the dengue and Zika viruses, and in May 2020, it concluded in vitro and in vivo coronavirus studies, and the results were highly compelling. In vitro tests performed in mammalian (human and primate) cell lines revealed that ICI not only reduces inflammatory cytokines in response to SARS-CoV-2 viral infection in cell culture, but it demonstrated as high as a 20-fold reduction in infectivity. Thus, mammalian cells are 2,000% less likely to become infected after direct exposure to the active virus.
ICI substantially reduced inflammatory cytokines in a lipopolysaccharide (LPS) induced ARDS mouse model, with a statistically significant decrease in numerous cytokines involved in the inflammatory response, including a 990% reduction in IL-6, a 260% reduction in IL-12 p40/p70, a 60% reduction in fractalkine, a 177% reduction in exotoxin, and a 427% reduction in TIMP-1. This data demonstrated that ICI is downregulating cellular cytokine response to exogenous stimuli. Sectioned tissues from kidney, heart, lung, and brain and tests performed on blood serum demonstrated an overwhelming level of decreased inflammation relative to untreated controls (Please see the attached images of the untreated and treated tissues).
The Director of PBI’s Infectious Disease Program, Srisakul Kliks, Ph.D., is a world-renowned immunologist, virologist, microbiologist and bacteriologist, whose groundbreaking work focused on the viral genetic and biologic variations and their impact in the pathogenesis of dengue and HIV. Dr. Kliks worked extensively under Dr. Scott B. Halstead, MD, who discovered the Antibody Dependent Enhancement (ADE) phenomenon that occurs in numerous infectious viral diseases such as dengue and Zika, and COVID-19.
On July 1, 2020, it was reported by a pathologist at NYU Langone Health that there is a correlation between COVID-19 and dengue and rare cells called megakaryocytes, which produce platelets that control clotting. Drs. Kliks and Halstead are the world’s foremost experts on the dengue virus.
PBI has now set forth a concise, short-range program that would include prioritized human trials, a plan for the design of an ICI recombinant expression construct, and the development of a large-scale ICI cGMP recombinant synthesis production pipeline that will provide unlimited quantities of ICI. This accelerated pathway to U.S. and global commercial availability of ICI could be accomplished before the end of the year.
ICI’s potential to proactively prevent a host of diseases, drastically lower the cost of disease treatment and chronic disease management, effectively streamline system efficiencies, enable improved health and wellbeing outcomes, and support human productivity, could provide this administration the tools to solve the far-reaching effects of this pandemic and those of potential bioterrorism threats in the future, fix the broken healthcare system, restore the unprecedented U.S. economy and secure the nation’s food supply. Furthermore, the humanitarian importance, political significance and global goodwill that will coalesce around ICI’s unprecedented metrics, can be utilized to strategically restructure diplomatic relationships and renegotiate imbalanced trade deals globally.
PBI’s Chairman of the Board, Malcolm R. Currie, Ph.D., is the scientific and technology luminary responsible for many of the 20th century’s most iconic and life-altering innovations, including DirecTV; Global Positioning Systems (GPS); lasers; early satellite communications electronics; electric propulsion; ion beam propulsion; semiconductor implantation; stealth technologies; the AMRAAM and cruise missiles; and the early smart weapons which constitute the foundation of our national security systems today.
Dr. Currie was the United States Under Secretary of Defense in two presidential administrations, and received regular classified briefings on bioterrorism and biologic agents from Fort Detrick, the center of the U.S. biological weapons and defense program. Of all of Dr. Currie’s meritorious achievements, he believes that his role with PBI may one day be his greatest legacy.
Operation Warp Speed has been tasked and empowered to fast-track the development of a comprehensive solution to address the full spectrum of consequences from this insidious plague, and to prepare for the onslaught of future bioterrorism threats. ICI’s broad-based applications, efficacies and efficiencies, are more closely aligned with this administration’s panoramic vision and overarching objective for this initiative, and uniquely classify it as a candidate for Operation Warp Speed I have attached information on PBI and its numerous disease indications, a general scientific mechanism of action presentation for ICI, PBI’s patent application filed June 1, 2020, entitled ‘Methods for Treating Coronavirus Infection,’ a request received by PBI to treat a COVID-19 patient with rheumatoid arthritis under Right to Try.
If you need any additional information, please do not hesitate to contact me on SMS: 0435 317 886.
Peptide BioSciences, Inc. (PBI) No none responders. It works every time. Covid 19 Vaccine – 100% rate of success: Heart, Kidney & Lung treatment.