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Saturday, 01/30/2021 4:11:41 PM

Saturday, January 30, 2021 4:11:41 PM

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From Ferrell90 post https://investorshub.advfn.com/boards/read_msg.aspx?message_id=160761379

This is just the Covid 19 related activity that Brilacidin has undergone:

-2/18 Initial announcement of Brilacidin for Covid 19
-2/24 Material transfer agreements to virology labs
-2/28 Brilacidin sent to Regional Biodefense Labs {RBL)for study
-3/2 Brilacidin PDF outlines scientific rationale for use against Covid19
-3/9 Brilacidin studies planned at RBL
-3/12 Testing to begin 3/16
-4/1 Brilacidin effective against Covid19 in Vero monkey cells
-4/6 Early discussions of human trials
-4/20 Screening of 11,552 compounds shows Brilacidin a leading drug against Covid19 by inhibiting the M-protease
-4/27 Initial research confirms anti Covid properties more research planned
-5/5 PHRI studies announced
-5/19 Brilacidin reduces Covid 75% in preincubtion Vero cell study
-5/26 Brilacidin reduces Covid in human renal cell line; blocks viral cell entry
-6/11 Brilacidin study to include MERS and SARS pan corona virus testing; Grant application application made
-6/17 Brilacidin inhibits Covid 97% in infected Human respiratory cells
-7/7 Brilacidin active against Covid 19 before during and after Covid infects cells
-7/13 Human clinical trial planning/manufacture of Brilacidin announced
-7/20 Brilacidin at low dosage is effective against Covid19; lower than ABSSI dose
-8/4 Brilacidin shown effective against entire Covid life cycle
-8/24 Brilacidin Selectivity index among highest reported
-8/26 Dr Degrado announced as science advisor
-9/15 Brilacidin synergistic with remdesivir;reduces viral load almost 100%
-10/2 Pre IND meeting; Brilacidin human clinical trials
-10/30 RBL preprint article released; Selectivity index 426 one of highest achieved
-11/2 FDA pre IND response received;CRO secured
-11/16 Overseas CTA submitted;Brilacidin viral resistance unlikely
-11/30 New research for Brilacidin as a pancoronavirus treatment
FDA application submitted

-12/21 Brilacidin for phase 2 Covid study approved

new since Farrell90's article:

http://www.ipharminc.com/press-release/2021/1/14/innovation-pharmaceuticals-brilacidin-for-the-treatment-of-covid-19-receives-fda-fast-track-designation

--1/14/21 Brilacidin receives FDA Fast Track Status for treatment of Covid19

http://www.ipharminc.com/press-release/2021/1/29/innovation-pharmaceuticals-phase-2-clinical-trial-of-brilacidin-for-treating-covid-19-scheduled-to-begin-next-week

--1/29/21 Innovation Pharmaceuticals’ Phase 2 Clinical Trial of Brilacidin for Treating COVID-19 Scheduled to Begin Next Week
( the week of Feb 1st..this coming week.. )

---------------------------

Taken from: https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1.full

Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2 ( a study conducted by the government RBL lab at George Mason University ..not a study by in-house Innovation Pharma staff ..3rd party unbiased validation..)

--Highlights

Brilacidin potently inhibits SARS-CoV-2 in an ACE2 positive human lung cell line.

Brilacidin achieved a high Selectivity Index of 426 (CC50=241µM/IC50=0.565µM).

Brilacidin’s main mechanism appears to disrupt viral integrity and impact viral entry.

Brilacidin and remdesivir exhibit excellent synergistic activity against SARS-CoV-2.

--Brilacidin inhibits SARS-CoV-2 replication (Vero Cells)

--Brilacidin appears to impact entry of SARS-CoV-2 (Vero cells)

--Brilacidin appears to disrupt the integrity of the SARS-CoV-2 virion

--The outcomes of this experiment revealed a higher inhibition of SARS-CoV-2 (72% inhibition), alluding to an inhibitory activity exerted upon the virus directly (Figure 2D). Using the same assay (for 10µM brilacidin), the intracellular viral genomic copy numbers were assessed by semi-quantitative RT-PCR at 24 hours post infection, which demonstrated a 29% decrease in the viral genomic copies with brilacidin treatment; this extent of inhibition of intracellular RNA copies assessed at later timepoints in infection is not unexpected for an inhibitor with likely activity exerted during the early entry and post-entry steps.

( Brilacidin not only greatly reduces viral entry into cells, but unexpectedly, appears to reduce the amount of virus produced in the cell itself. It appears to work to kill the virus outside the cell and reduce the virus' ability to produce geonomic copies of itself by 29% )

--Brilacidin exhibits potent inhibition of SARS-CoV-2 in a human cell line (Calu-3 cells)

--in human cells 95-97 reduction of viral load (Viral load, also known as viral burden, viral titre or viral titer, is a numerical expression of the quantity of virus in a given volume of fluid;)..and by 33% inside the cell inhibiting the virus ability to make copies of itself --it both kills virus outside the cell and inhibits the virus from being able to replace as much of the virus as was killed by limiting production of new virus from the virus that already got into a cell to escape Brilacidin... ( note mine ) :)

"However, when the experiment was modified to include a brilacidin-treated inoculum – with direct pre-incubation of the virus with brilacidin for 1 hour prior to infection, and with infection carried out in the presence of the compound – the extent of inhibition dramatically increased, resulting in 95% and 97% reduction of infectious viral titer at the 10µM and 20µM concentration of the compound respectively (Figure 3B). Quantification of intracellular viral RNA by semi-quantitative RT-PCR at 24 hours post infection (for 10µM brilacidin) demonstrated a 33% decrease in the viral genomic copies upon brilacidin treatment."

--Selectivitiy Index determination for brilacidin against SARS-CoV-2 in a human cell line (Calu-3 cells)

"The Selectivity Index, a ratio that compares a drug’s cytotoxicity and antiviral activity, is a measure of how likely a drug is to be safe and effective when translated to human testing in the clinic." ( per Google ..note mine)

Quantification of the inhibitory response – when the virus was directly pre-incubated with brilacidin prior to infection; cells were treated prior to infection; brilacidin was present during infection; and infected cells were maintained in the presence of brilacidin post-infection (assay as in Figure 3B) – demonstrated brilacidin achieved 90% inhibition at a concentration of 2.63µM and 50% inhibition at 0.565µM, yielding a Selectivity Index of 426 (CC50=241µM/IC50=0.565µM).


Brilacidin has already been successfully tested in over 400 individuals for other indications and has been proven safe. It is planned to be tested against other virus

-----------------

Other Innovation Pharam drugs in the pipeline, besides Brilacidin:

from:https://www.globenewswire.com/news-release/2018/02/08/1336046/0/en/Innovation-Pharmaceuticals-Concludes-Successful-Phase-2a-Trial-of-Kevetrin-for-Ovarian-Cancer-Intra-Tumor-Modulation-of-p53-Observed.html

BEVERLY, Mass., Feb. 08, 2018 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals Inc., (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces the closure of its Phase 2a clinical trial (see NCT03042702) of Kevetrin for the treatment of late-stage Ovarian Cancer (OC). The Company initiated the trial for the purpose of demonstrating modulation of the key tumor-suppressor protein p53, which was achieved in analysis of the first patients at the lowest dose of Kevetrin (see December 27, 2017 press release).

Throughout pre-clinical testing and two successful clinical trials, Kevetrin has demonstrated promising signs of efficacy as an anti-cancer agent and a favorable pharmacokinetic profile that includes a very short half-life and good bioavailability. It is believed that these characteristics make Kevetrin an ideal candidate for oral delivery (capsule or tablet), which will facilitate convenient and frequent dosing, perhaps even multiple times daily, to maximize the therapeutic benefit of the compound. With the positive observation of intra-tumor p53 modulation, the Company will now allocate resources to focus its efforts on completing development of an oral formulation, including performing bridging toxicology work.

The Company is adhering to a value-building strategy born from discussions with larger pharmaceutical companies interested in Kevetrin, one of the world’s most advanced p53 drug candidates. Securing the right development partner for Kevetrin remains an important objective.

“This study delivered multiple insights into how Kevetrin modulates the p53 protein and affects related molecular pathways,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Moreover, if we successfully transition to oral dosing of Kevetrin, we believe the therapeutic effect will be maximized, providing important benefits to cancer patients in need—beyond the ultimate convenience of oral delivery. An effective orally-delivered p53-modulating drug has the potential to transform cancer care and we are proud to be at the forefront toward achieving this goal.”

About Kevetrin and p53

Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by modulating p53, a protein frequently referred to as the “Guardian of the Genome” due to its critical role in controlling cell mutations. In the majority of cancers, and regardless of origin, type, and location, the p53 pathway is mutated, preventing the body from performing its natural anti-tumor functions. Conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, a Phase 1 clinical trial (see NCT01664000) of Kevetrin in treating advanced solid tumors has been successfully completed, with patients showing good toleration and encouraging signs of potential therapeutic response (see ASCO 2015, ASCO 2013). Additional pre-clinical work supporting Kevetrin’s anti-cancer activity has recently been presented at scientific conferences (see EHA 2017, AACR 2017). The Company has initiated a Phase 2a trial of Kevetrin (see NCT03042702) in late stage, platinum-resistant/refractory ovarian cancer. Patients receive more frequent dosing (3 times per week) at higher levels and then receive standard of care treatment after trial conclusion. Efforts also are underway to develop Kevetrin as an oral anti-cancer agent that can be administered daily, potentially multiple times per day. The FDA has awarded Kevetrin Orphan Drug status for ovarian cancer, pancreatic cancer, and retinoblastoma, qualifying it for developmental incentives and a potential extra 7 years of market exclusivity upon drug approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood retinoblastoma


--------------------

As has been stated many times, the reason the stock is trading at such low prices ( currently .24xx cents ) is the abuse of naked shorts and not, as claimed by those who seek to dismiss kevetrin's proven cancer killing effects and Brilacidin's proven anti-biotic action against MRSA and potential life-saving effect on COVID19 victims in favor of those who are naked shorting ( making up shares that don't exist and selling them into the market ..not legally borrowing shares..) the stock. One can easily see that larger pharmaceutical companies with billions of dollars invested in drugs that have shown to be ineffective against COVID19 and less and less effective against drug resistant bacteria are the ones who stand to gain from their hoped-for bankruptcy of Innovation Pharmaceuticals via their naked shorting...which never shows up in the legal short reports by FINRA. The minute the stock price rises, there is immediate massive selling by parties interested in seeing the stock price crash. The ask price is dropped mysteriously even undercutting the bid price on a regular basis on 'news day' in spite of...

Even before COVID19, Brilacidin was already known as a potent anti-biotic:

From wikipedia: https://en.wikipedia.org/wiki/Brilacidin ( a write-up that has not been updated in ages..)

"Brilacidin, a non-peptide chemical mimic, is an arylamide foldamer designed to replicate the amphiphilic properties of antimicrobial peptides while solving the problems encountered by peptide-based antimicrobials.[10] Brilacidin, a broad-spectrum antibiotic, has potent Gram positive activity and Gram negative coverage,[11] and is highly effective in treating the 'superbug' methicillin-resistant Staphylococcus aureus (MRSA). Brilacidin has low cytotoxicity against mammalian cells while selectively targeting bacteria, directly and rapidly disrupting their membranes, resulting in the bacteria's death. Due to this unique mechanism of action (mimicking the host's natural immune response, proven to be successful in fighting off infections over millions of years of evolution), bacterial antibiotic resistance is less likely to develop.[12][13][14][15]

Potential significance
There has not been a new drug approval from a new class of antibiotics since 1987. While six antibiotics have been approved over the last year, they are all adaptations of existing antibiotic classes.[16] None of the recently approved novel antibiotics represent entirely new classes.[17] Novel antibiotics are crucial as antibiotic resistance poses a global health risk. The World Health Organization, warning of a "post-antibiotic era" has stated that antimicrobial resistance (AMR) is a "problem so serious that it threatens the achievements of modern medicine".[18]"


Innovation Pharma has a new class of drug in both Kevetrin and Brilacidin and is being fought tooth and nail in every possible way to slander it and dismiss its miraculous accomplishments. Yet despite theses obstacles, Brilacidin in particular begins phase 2 in human trials this coming week.

Do your own due diligence. Be aware of the obstacles. This drug is needed right now. The vaccines are failing and the virus is mutating. Other hyped drugs have not worked as advertised. It appears that it doesn't matter how the virus mutates, Brilacidin's action of disrupting the virus's integrity is not at all dependent on a particular mutation of the virus and is in fact being investigated as a solution of all coronavirus' ( thus the term "pan-coronavirus" ) which includes SARS 1 which to this day does not have an effective vaccine.

God bless All
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