Strategy: Conduct a Pre-IND Trial with FDA’s approval with 20 patients. Secure large scale manufacturing and global distribution. Distribute the Treatment while completing the IND.
Background
1) Covid19 has genes in it from Ebola and HIV, as identified by researchers in China.
2) There are two main complications from Covid19:
a) Extremely high viral load
b) Extremely high inflammatory response measured by CRP (C-Reactive Protein)
3) AV1 is an FDA approved drug that has been used for another indication and has
minimal side-effects. Some people have been taking it for over ten years. This drug is now a generic.
4) AV2 is another FDA approved drug that has been used for another indication and also has minimal side-effects. This drug is now a generic.
5) We would be using the 2 FDA approved drugs for off-label use as AV.
6) The initial research involving AV’s drugs being used successfully was by Dr. Prendergast in his study and treatment of HIV and Ebola a few years ago during the crisis in Africa. At that time, Dr. Prendergast was working with NIH and the US Army’s Biological Warfare Lab out of Fort Detrick (MacDiarmid). Dr. Prendergast is one of the leading camel researchers in the world. (FYI-Camels have the best immunologic system of any animal. Only a camel can go up to 6 months without food and water.)
7) Dr. Prendergast has developed several antiviral compounds over the years for Dengue, Zika and other viruses and in addition to HIV and Ebola.
8) Dr. Prendergast developed a compound to treat diabetic wounds. The original patient research regarding this compound was performed several years ago in a 20 patient trial in India used camel plasma to heal the diabetic wounds. Subsequently, the compound was synthesized into a peptide that was manufactured into a compound in a facility in
Florida.
Recently this peptide was used in a patient in Australia who was about to get her foot amputated from complications from diabetes. The peptide dramatically decreased her inflammatory response as measured by her C-Reactive Protein, thereby saving her foot.
9) The combination of AV and the peptide will handle the major issues from Covid19: both the high viral load and inflammatory response.
10) We are filing patents this week in Ireland (Europe), India, US and Australia on the AV compound for the treatment of Covid19.
11) We will file an updated patent on the peptide shortly for the treatment of Covid19.
12) Given the extensive existing data on the FDA approved compound with minimal side-effects, there is little benefit in moving forward with In-Vitro and In-Vivo studies. It is much more beneficial to immediately move to a patient trial in the US to confirm both
the use of the AV and peptide compounds.
13) The AV compounds are being manufactured in limited quantities today as generics. The peptide would need to be mass manufactured and administered simultaneously to treat the people who have a high inflammatory response. However, we would create a treatment that would require AV and the peptide for 4-5 days to ensure the effective treatment of Covid19.
Partners Involved
1. Affinity Bio Partners, LLC, Christina DiArcangelo, CEO: Primary Role: FDA Consultant and CRO
2. PharmEagle, Partners, Steven Beagle, President: Primary Role – Manufacturing and Distribution (In-Charge)
3. Sivina LLC, Shelley Mehta, CEO: Primary Role – Manufacturing and Distribution Network and India CRO
4. Thinq CRO: India (Potential 2nd study)
5. Dr. Vince Bennett, Regional Director of Envision Healthcare: Primary Role – Oversee Treatment Trial
6. Dr. Patrick Prendergast and Dr. Daniel Prendergast: Primary Role – Oversee research and dosing
7. Spectral Analytics, Inc., Steven M. Adler, CEO: Primary Role – Coordination and CFO
8. Rogers Towers, Joe Kincart: Primary Role – Patents
9. Marion & Allen, Roger Marion: Primary Role – Contracts Next Steps Efficacy Confirmation
1) Submitting Pre-IND Application to FDA for off label use in 20 US patients already infected with Covid19 and hospitalized to monitor viral load and inflammatory response reduction over 72 hours to prove efficacy and non-toxicity of AV with the peptide.
2) Dr. Vince Bennett, located in Los Angeles, Regional Director Envision Healthcare, has already agreed to conduct this trial.
3) This study needs close monitoring to make sure no mistakes are made in the administration or viral load monitoring. We will be capturing the data through the DrBot to ensure that we are seeing the data in real-time.
4) There is no need for in- vitro or animal models as both AV compounds are available worldwide from pharmacies and we do not need to utilize above the suggested dosage for AV to demonstrate antiviral efficacy against Covid19.
5) We have data confirming the safety of the peptide.
6) We anticipate we can reduce both the viral load and inflammatory response anywhere from 1-4 days, depending on the severity of the condition.
Project Phases
1) Pre-IND: Manufacture the compound and treat the first 20 patients
2) Expanded Pre-IND: Test an additional 20 patients
3) Manufacture/Distribute by ramping production and distribute worldwide
4) Expanded Pre-IND: Test an additional 20 patients
5) IND: Continue study for formal FDA approval by continuing to track the first 20 patients Pre-IND Information Required by FDA Per the guidance received from the FDA, below is the list of items we need to provide to the FDA for the Pre-IND meeting. Responsible parties are: ABP-Affinity Bio Partners, SA- Spectral
• ABP will draft protocol synopsis and protocol for review by Drs. Prendergast
• Drs. Prendergast to provide any data supporting the proposed use of the product in COVID- 19 or similar viruses.
• Drs. Prendergast to provide detailed justification for the suggested dose: advise using the same dosing as approved by the FDA for the AV compounds.
• In the draft protocol, recommend intensive safety monitoring and a DSMB. This recommendation is based upon the significant safety concerns in this patient population, because of risks associated with the disease and because of the potential for adverse effects from the treatment that might be difficult to recognize. ABP has already established members of the DSMB.
• ABP, SA, and Drs. Prendergast will identify potential endpoints to be studied in either a Phase 2 or the pilot phase of a proposed larger trial may be a reasonable approach until more
information is available to support specific endpoints.
• The size of the trial that would be reasonable may differ depending on the population intended for study (for example, various prophylaxis or treatment populations with different levels of risk) and the safety profile of the drug. In addition, other considerations that may impact the trial size and trial design include whether the drug is an approved drug for another indication that you propose to repurpose for COVID-19 and for which you already have relevant safety data or a new agent with limited human safety data. We are recommending 20 patients.