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The trial is now posted on clinicaltrials.gov (https://clinicaltrials.gov/ct2/show/NCT04784897), which shows seven sites as recruiting and enrolling patients. An eighth site is also now enrolling in addition, and the Company has informed clinicaltrials.gov of the change in status. Fifteen patients have already been dosed in the trial. More sites are coming online, which is expected to further accelerate enrollment and treatment.
The trial doesn’t exclude any variants of SARS-CoV-2, the virus responsible for COVID-19. Virulent coronavirus strains have scoured different countries around the world recently, including highly contagious versions, such as P1 and B.1.1.7. Brazil this week reported that COVID-19 daily deaths reached a new high due to P1. According to Russian news agency Tass, nearly 1,500 coronavirus mutations have been discovered in Russia, a country where seven sites are currently enrolling patients in the Company’s COVID-19 clinical trial. The Company is interested to see what information, if any, might be gleaned from the trial regarding variants considering laboratory studies have indicated Brilacidin to have strong pan-coronavirus treatment potential, remaining unaffected by viral mutations.
PR out!!!
Recruitment and Enrollment Underway at Eight Sites for Innovation Pharma’s Phase 2 Clinical Trial of Brilacidin for COVID-19
Brilacidin
WAKEFIELD, MA – March 5, 2021 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today reports that eight sites are now participating in the Company’s international Phase 2 clinical trial assessing Brilacidin as a novel therapeutic in hospitalized patients with COVID-19.
The trial is now posted on clinicaltrials.gov (https://clinicaltrials.gov/ct2/show/NCT04784897), which shows seven sites as recruiting and enrolling patients. An eighth site is also now enrolling in addition, and the Company has informed clinicaltrials.gov of the change in status. Fifteen patients have already been dosed in the trial. More sites are coming online, which is expected to further accelerate enrollment and treatment.
The trial doesn’t exclude any variants of SARS-CoV-2, the virus responsible for COVID-19. Virulent coronavirus strains have scoured different countries around the world recently, including highly contagious versions, such as P1 and B.1.1.7. Brazil this week reported that COVID-19 daily deaths reached a new high due to P1. According to Russian news agency Tass, nearly 1,500 coronavirus mutations have been discovered in Russia, a country where seven sites are currently enrolling patients in the Company’s COVID-19 clinical trial. The Company is interested to see what information, if any, might be gleaned from the trial regarding variants considering laboratory studies have indicated Brilacidin to have strong pan-coronavirus treatment potential, remaining unaffected by viral mutations.
“We are pleased to see patient recruitment and enrollment in our Brilacidin for COVID-19 clinical trial ramping up,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “COVID-19 is making a resurgence worldwide, with cases up 9 percent last week in Europe and cases no longer decreasing in the United States. Emerging variants are likely partially to blame for this rise. With its unique three-in-one therapeutic profile—antiviral, anti-inflammatory and antibacterial—we believe Brilacidin can play an important role in treating COVID-19. A broad-spectrum therapeutic that can be shown to inhibit coronaviruses would be a valuable countermeasure in fighting coronavirus disease and other viral outbreaks, now and in the future.”
Brilacidin COVID-19 Clinical Trial
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, international, multi-center study with planned enrollment of ~120 subjects with moderate-to-severe COVID-19. Two treatment arms are enrolling patients—active and placebo, with ~60 patients per arm. The trial’s primary endpoint is time to sustained recovery through Day 29, using a clinical status ordinal scale based on that used in the series of National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trials (ACTTs). Additional endpoints include: in-hospital outcomes, all-cause mortality, measurement of disease biomarkers and inflammation-related biomarkers, changes to SARS-CoV-2 viral load, and other key measures.
I have never been one to follow peer pressure but get what you are saying. I might be force to be vaccinated if I want to travel outside the country. I am going to hold out as long as possible.
If Brilacidin does what we think it is going to do we may not need a vaccine. I have every appendage crossed hoping that is the case.
Go Leo & IPIX!
The sad truth, though, is that within a matter of months everyone in the USA is going to have to be vaccinated if they intend to travel or be allowed into many functions as they will be looked at as COVID carriers by those that have taken a vaccine shot(s).
Already in my neighborhood people are wary of those of us that haven't got a shot or said we wouldn't be getting one.
Agreed. I do not want to take any vaccine - ever - and the RBL's are still testing Brilacidin....What else are they going to find out for free?
Brilacidin is in human trials and we have been waiting for this moment for almost a year. Pretty remarkable given the lack of resources Leo has.
Go Leo & IPIX!
Heres the thing you are purposely discounting...
If there is an effective treatment for COVID, then millions upon millions of people that are on the fence about the vaccines (myself included) will decide not to get the shot. That includes this year and for years to come.
Brilliant!
Great post dp70. Now that would be a slap in the face for the US.
Go Leo & IPIX!
I think Leo was smart to look to overseas to make progress getting Brilacidin approved. I would not be surprised if they end up manufacturing it and distributing throughout Russia, eastern Europe, some Middle East countries, etc. Maybe then IPIX will get the USA’s attention and speed things up here!
IMO Arthur P. Bertolino was the driving force towards P and might be why Leo never went with Brilacidin at the time.
Should have could haves. Its all in the past and the past can never be changed. I am sure there are a lot of things that everyone would change if we could change the past. I am just looking at the immediate future.
Go Leo & IPIX!
BP's current drug patents have expiration dates. If they don't have any new drugs, they won't generate any new revenue. If they are all trying to prevent small biotechs from developing better drugs by suppressing their stock prices, then you won't see any new partnership deals. On the contrary, new partnership deals are happening.
Investors should ask themselves a logical explanation why Leo hasn't been able to find a partner for B-ABSSSI and B-OM. B-ABSSSI received QIDP and completed a successful Phase 2b trial about 7 years ago. B-OM received Fast Track designation and completed a successful Phase 2b trial about 4 years ago. Both drugs address a billion dollar market.
If your reasoning is Leo wants to prove other indications such as COVID, UC, Crohn's Disease, and acne before considering to partner the whole platform, then the patent expiration date is quickly approaching. B's patent expires in early 2030s if I remember correctly. BPs will consider how many years of market exclusivity are left after each indication runs a lengthy Phase 3 and is approved by the FDA. For each year B-ABSSSI and B-OM sit on the shelf, billions of potential revenue is lost by the BP and IPIX. Can Leo really make up the lost revenue with upfront and milestone payments from a future deal?
Had Leo decided to run B-ABSSSI Phase 3 either by himself or with a partner, IPIX could be generating revenue by now. Also B could be used to treat COVID-19 patients off-label.
I understand what you are say and you could very well be right. I am starting to believe that they are holding this down on purpose in order to send the share price into the stratosphere when/if we get the right news. I believe the share price will not make any meaningful increase until we get the right news. I hope that I am wrong and unfortunately nothing makes sense on the OTC.
IPIX is closer to the right news then ever.
Go Leo & IPIX!
his is being done for criminal intent not the almighty dollar.
They could make ten times the money by letting it run but are deliberately holding the price down for chump change.
Their actions are being done to hurt the company, nothing more.
Strangleholding a potential exciting CV therapeutic is something to be proud of...Amazing
Why even make this argument or take issue? FatAlbert1986 said "manipulation" and that's all.
Go Leo & IPIX!
If the problem is naked shorting where the MMs don't bother to locate available shares to borrow prior to shorting, why would they care if your shares are locked up? They aren't borrowing shares now to begin with, they just pull them from air.
One more nail in the coffin!
Go Leo & IPIX!
Leo Ehrlich, Chief Executive Officer of Innovation Pharmaceuticals, commented, “Infectious disease experts have noted the next phase in the global fight against COVID-19 will be in developing potent antivirals that directly act on the SARS-CoV-2 virus—which is what Brilacidin has been shown to do in pre-clinical studies. The Company looks forward to continuing its scientific collaborations with government and academic researchers to further inform Brilacidin’s treatment potential as a broad-spectrum antiviral drug candidate targeting coronaviruses, regardless of mutation or strain.”
The article is accessible at the link below.
· Bakovic, A.; Risner, K.; Bhalla, N. (et al). Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture. Viruses 2021, 13, 271; https://doi.org/10.3390/v13020271
https://www.mdpi.com/1999-4915/13/2/271/
Brilacidin’s ability to disrupt viral integrity suggests Brilacidin likely is not subject to resistance developing due to coronavirus variants—unlike current COVID-19 treatments, such as monoclonal antibodies and convalescent plasma, and first-generation COVID-19 vaccines. This mechanism of action supports Brilacidin as a clearly differentiated antiviral in clinical development.
PR OUT
March 2, 2021
Innovation Pharmaceuticals Announces Publication of Peer-Reviewed Scientific Article in the Journal Viruses on the Anti-SARS-CoV-2 Properties of Brilacidin
Brilacidin
· Emerging mutations to the coronavirus are unlikely to affect Brilacidin’s ability to inhibit the virus
· Brilacidin currently is being evaluated in a Phase 2 clinical trial in hospitalized COVID-19 patients
WAKEFIELD, MA – March 2, 2021 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced the publication of a peer-reviewed scientific article—Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture—in the journal Viruses.
The article is accessible at the link below.
· Bakovic, A.; Risner, K.; Bhalla, N. (et al). Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture. Viruses 2021, 13, 271; https://doi.org/10.3390/v13020271
https://www.mdpi.com/1999-4915/13/2/271/
In the paper, Brilacidin was shown to exert potent inhibitory effects on SARS-CoV-2 in cell culture by decreasing viral load in different cell types, including ACE2 positive human lung cells, and, importantly, in both the Washington and Italian strains of the coronavirus. Testing of Brilacidin against additional SARS-CoV-2 strains is planned.
Already with over a half-million deaths in the U.S. and over two million deaths worldwide attributable to COVID-19, the emergence of more transmissible and more virulent variants of the novel coronavirus is causing added concern. Last week, the U.S. FDA issued industry guidance outlining recommendations for developing vaccines, drugs and diagnostic tools based on variants.
Brilacidin’s ability to disrupt viral integrity suggests Brilacidin likely is not subject to resistance developing due to coronavirus variants—unlike current COVID-19 treatments, such as monoclonal antibodies and convalescent plasma, and first-generation COVID-19 vaccines. This mechanism of action supports Brilacidin as a clearly differentiated antiviral in clinical development.
Leo Ehrlich, Chief Executive Officer of Innovation Pharmaceuticals, commented, “Infectious disease experts have noted the next phase in the global fight against COVID-19 will be in developing potent antivirals that directly act on the SARS-CoV-2 virus—which is what Brilacidin has been shown to do in pre-clinical studies. The Company looks forward to continuing its scientific collaborations with government and academic researchers to further inform Brilacidin’s treatment potential as a broad-spectrum antiviral drug candidate targeting coronaviruses, regardless of mutation or strain.”
Currently, Brilacidin is being evaluated in a global Phase 2 clinical trial in hospitalized COVID-19 patients.
Brilacidin and COVID-19
Brilacidin, which has received FDA Fast Track designation for the potential treatment of COVID-19, is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Pre-clinical testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). In a human lung cell line against SARS-CoV-2, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin antiviral research to date has been limited to laboratory-based experiments. Additional pre-clinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1ß, TNF-a and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Collectively, these data support Brilacidin as a unique 3-in-1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate, with pan-coronavirus treatment potential. The Company has initiated a randomized, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of COVID-19 in moderate-to-severe hospitalized patients.
Hence the delay in the 10Q - legal advice on disclosure?. It is fun speculating. The next release might be a doozy.
Go Leo & IPIX!
The Russian change of the clinical trial end date from March 2021 to Sept. 2021 suggest the possibility of a transition from a P-2 to P-3.
What I find "unbelievable" is your apparent inability to follow reasoned speculation.
Message in reply to:
CallMeCrazy Really Sept? And you consider a slip of 6 months good news. Unbelievable.
Citadel....
Looks like a pretty scientific process that will be able to determine if Brilacidin works for the covid19 human trials. Thanks farrell90.
ACTT developed by the NIAID seems to be the outline Brilacidin will be following for Brilacidin for Covid19 Phase2. Until the study guidelines are published on Clinicaltrials.gov it is useful to review the ACTT.
GLTA,Farrell
From todays PR:
" The trial’s primary endpoint is time to sustained recovery through Day 29, using a clinical status ordinal scale based on that used in the series of National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trials (ACTTs). Additional endpoints include: in-hospital outcomes (e.g., duration of hospitalization, time to discharge), all-cause mortality, measurement of disease biomarkers (e.g., CRP, ferritin) and inflammation-related biomarkers (e.g., IL-1ß, IL-6, IL-10, total IL-18, TNF-a), changes to SARS-CoV-2 viral load, as well as other key measures.
8 point ordinal scale:
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant
Brilacidin will follow some of the the NIAID Adaptive Treatment Trial guidelines for Covid 19 studies as outlined in the links below:
https://clinicaltrials.gov/ct2/show/NCT04280705 ACTT1}
https://clinicaltrials.gov/ct2/show/NCT04401579 {ACTT2}
https://clinicaltrials.gov/ct2/show/NCT04492475 {ACTT3}
In addition to the study parameters outlined in the PR the following are included in the ACTT 3 and most likely many of these will be incorporated in the Brilacidin for Covid19 protocol when it is released on clinicaltrials.gov:
1 "There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms."
2 "Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. "
3. "All subjects will undergo a series of efficacy, safety, and laboratory assessments. Safety laboratory tests and blood (serum and plasma) research samples and oropharyngeal (OP) swabs will be obtained on Days 1 (prior to infusion) and Days 3, 5, 8, and 11 (while hospitalized). OP swabs and blood (serum only) plus safety laboratory tests will be collected on Day 15 and 29 (if the subject attends an in-person visit or are still hospitalized)."
4." The primary outcome is time to recovery by Day 29 for patients with baseline ordinal score 4, 5 and 6. A key secondary outcome evaluates treatment-related improvements in the 8-point ordinal scale at Day 15. Each stage may prioritize different secondary endpoints for the purpose of multiple comparison analyses."
5.Primary Outcome Measures :
" Time to recovery for patients with baseline ordinal score 4, 5, and 6 [ Time Frame: Day 1 through Day 29 ]
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care."
6. Secondary Outcome Measures :
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in C-reactive protein (CRP) [ Time Frame: Day 1 through Day 29 ]
Change from baseline in creatinine [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in d-dimer concentration [ Time Frame: Day 1 through Day 29 ]
Change from baseline in hemoglobin [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in international normalized ratio (INR) [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in platelets [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in total bilirubin [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in white blood cell count (WBC) with differential [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change in National Early Warning Score (NEWS) from baseline [ Time Frame: Day 1 through Day 29 ]
The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6). Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6). An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of invasive mechanical ventilation [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of non invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of oxygen use [ Time Frame: Day 1 through Day 29 ]
Measured in days
Incidence of discontinuation or temporary suspension of study product administration [ Time Frame: Day 1 through Day 10 ]
For any reason. Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change from baseline in the ordinal scale [ Time Frame: Day 1 through Day 29 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Participant's clinical status at Day 15 by ordinal scale for patients with baseline ordinal score 4 and 5 [ Time Frame: Day 15 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Percentage of subjects reporting each severity rating on an 8 point ordinal scale [ Time Frame: Days 3, 5, 8, 11, 22, and 29 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]
Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]
Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]
The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Time to recovery for patients with a baseline ordinal score of 4 and 5 [ Time Frame: Day 1 through Day 29 ]
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Possible, but I can't believe that Leo would make that mistake twice unless he was forced to do so. Maybe that is why he went to Russia. I have faith that this will turn out good for longs. We should know soon.
Go Leo & IPIX!
Or to payoff the CRO to say the SOC was the B arm for a few of the trial sites. I kinda wonder if that happened with P. As on of the large data sets from a trial site results were near identical to P but said those patients were the SOC, killing the P efficacy results. Maybe it was a mistake. In any case that may me realize that double blind trials are ripe for corruption and I don’t think they really make a difference.
Hopefully it will be obvious which patient got Brilacidin but I wonder if the double blinded was to slow down information leakage to the entity(s) that have been trying to destroy IPIX.
Go Leo & IPIX!
How is that comparable or fair in a double blinded trial that both the SOC and B arms wouldn’t be identical. To know which one to stop at 3 days would mean you knew which patients got B versus SOC. Just doesn’t make sense to me.
Great point, it will be super interesting to see how this plays out.
Go Leo & IPIx!
We know it only took one IV dose in the successful ABSSSI trial. The MOA is the same to penetrate the cells outer layer.
Very good information. I appreciate the information farrell90.
ACTT developed by the NIAID seems to be the outline Brilacidin will be following for Brilacidin for Covid19 Phase2. Until the study guidelines are published on Clinicaltrials.gov it is useful to review the ACTT.
GLTA,Farrell
From todays PR:
" The trial’s primary endpoint is time to sustained recovery through Day 29, using a clinical status ordinal scale based on that used in the series of National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trials (ACTTs). Additional endpoints include: in-hospital outcomes (e.g., duration of hospitalization, time to discharge), all-cause mortality, measurement of disease biomarkers (e.g., CRP, ferritin) and inflammation-related biomarkers (e.g., IL-1ß, IL-6, IL-10, total IL-18, TNF-a), changes to SARS-CoV-2 viral load, as well as other key measures.
8 point ordinal scale:
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant
Brilacidin will follow some of the the NIAID Adaptive Treatment Trial guidelines for Covid 19 studies as outlined in the links below:
https://clinicaltrials.gov/ct2/show/NCT04280705 ACTT1}
https://clinicaltrials.gov/ct2/show/NCT04401579 {ACTT2}
https://clinicaltrials.gov/ct2/show/NCT04492475 {ACTT3}
In addition to the study parameters outlined in the PR the following are included in the ACTT 3 and most likely many of these will be incorporated in the Brilacidin for Covid19 protocol when it is released on clinicaltrials.gov:
1 "There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms."
2 "Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. "
3. "All subjects will undergo a series of efficacy, safety, and laboratory assessments. Safety laboratory tests and blood (serum and plasma) research samples and oropharyngeal (OP) swabs will be obtained on Days 1 (prior to infusion) and Days 3, 5, 8, and 11 (while hospitalized). OP swabs and blood (serum only) plus safety laboratory tests will be collected on Day 15 and 29 (if the subject attends an in-person visit or are still hospitalized)."
4." The primary outcome is time to recovery by Day 29 for patients with baseline ordinal score 4, 5 and 6. A key secondary outcome evaluates treatment-related improvements in the 8-point ordinal scale at Day 15. Each stage may prioritize different secondary endpoints for the purpose of multiple comparison analyses."
5.Primary Outcome Measures :
" Time to recovery for patients with baseline ordinal score 4, 5, and 6 [ Time Frame: Day 1 through Day 29 ]
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care."
6. Secondary Outcome Measures :
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in C-reactive protein (CRP) [ Time Frame: Day 1 through Day 29 ]
Change from baseline in creatinine [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in d-dimer concentration [ Time Frame: Day 1 through Day 29 ]
Change from baseline in hemoglobin [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in international normalized ratio (INR) [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in platelets [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in total bilirubin [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in white blood cell count (WBC) with differential [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change in National Early Warning Score (NEWS) from baseline [ Time Frame: Day 1 through Day 29 ]
The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6). Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6). An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of invasive mechanical ventilation [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of non invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of oxygen use [ Time Frame: Day 1 through Day 29 ]
Measured in days
Incidence of discontinuation or temporary suspension of study product administration [ Time Frame: Day 1 through Day 10 ]
For any reason. Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change from baseline in the ordinal scale [ Time Frame: Day 1 through Day 29 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Participant's clinical status at Day 15 by ordinal scale for patients with baseline ordinal score 4 and 5 [ Time Frame: Day 15 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Percentage of subjects reporting each severity rating on an 8 point ordinal scale [ Time Frame: Days 3, 5, 8, 11, 22, and 29 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]
Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]
Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]
The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Time to recovery for patients with a baseline ordinal score of 4 and 5 [ Time Frame: Day 1 through Day 29 ]
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
From what I can see the current standard of car in US for Covid-19 is administered for 5 days. I find it interesting Brilacidin will be administered for 3 days with an optional 5. Is this because of the efficacy it showed in the RBLs labs testing...
Go Leo & IPIX!
I am very satisficed with Leo and his decisions to date. Can't wait for Brilacidin Covid19 human trial results.
Go Leo & IPIX!
Seems like some who don’t own shares are more concerned then those who own many shares as to the status of the trial. Why might that be I am inclined to ask??
I absolutely agree 100%. Leo, please continue to keep us in the dark to eliminate the share price manipulation and let Brilacidin run its course.
Go Leo & IPIX!
Keeping stockholders a bit uninformed vs possibly giving vital data to those that want to see IPIX decimated.
I know which side I favor.
IMO Leo has done his job giving investors all they need to know regarding the science of Brilacidin (peer review article), the results of the RBLs, and that B was Fast Tracked and approved for a P2 human trial. It is my opinion that is about all stockholders NEED to know, thought they may WANT to know far more.
If IPIX was a BP, what kind of news would one have expected to be given above what IPIX investors were told? I don't think much more, if even as much.
Also, I speak to a number of heavily invested players and they seem pretty happy with how things are progressing and PRs being issued. They don't complain about being given fluff PRs, ambiguous PRs, late PRs, etc they accept what is given and believe mgt has a reason to only put out what they do. As such, I feel complaints about the PRs are pretty much pure FUD.
I would love to be a fly on the IPIX mgt wall, but that is not the case. I don't really see what Leo has held back that has made investors buy/sell their shares and incur major losses. As to traders, I don't worry about them as they have their charts and other games to make their decisions.
Thank you farrell90, as always your post are very informative and factual.
Go Leo & IPIX!
ACTT developed by the NIAID seems to be the outline Brilacidin will be following for Brilacidin for Covid19 Phase2. Until the study guidelines are published on Clinicaltrials.gov it is useful to review the ACTT.
GLTA,Farrell
From todays PR:
" The trial’s primary endpoint is time to sustained recovery through Day 29, using a clinical status ordinal scale based on that used in the series of National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trials (ACTTs). Additional endpoints include: in-hospital outcomes (e.g., duration of hospitalization, time to discharge), all-cause mortality, measurement of disease biomarkers (e.g., CRP, ferritin) and inflammation-related biomarkers (e.g., IL-1ß, IL-6, IL-10, total IL-18, TNF-a), changes to SARS-CoV-2 viral load, as well as other key measures.
8 point ordinal scale:
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant
Brilacidin will follow some of the the NIAID Adaptive Treatment Trial guidelines for Covid 19 studies as outlined in the links below:
https://clinicaltrials.gov/ct2/show/NCT04280705 ACTT1}
https://clinicaltrials.gov/ct2/show/NCT04401579 {ACTT2}
https://clinicaltrials.gov/ct2/show/NCT04492475 {ACTT3}
In addition to the study parameters outlined in the PR the following are included in the ACTT 3 and most likely many of these will be incorporated in the Brilacidin for Covid19 protocol when it is released on clinicaltrials.gov:
1 "There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms."
2 "Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. "
3. "All subjects will undergo a series of efficacy, safety, and laboratory assessments. Safety laboratory tests and blood (serum and plasma) research samples and oropharyngeal (OP) swabs will be obtained on Days 1 (prior to infusion) and Days 3, 5, 8, and 11 (while hospitalized). OP swabs and blood (serum only) plus safety laboratory tests will be collected on Day 15 and 29 (if the subject attends an in-person visit or are still hospitalized)."
4." The primary outcome is time to recovery by Day 29 for patients with baseline ordinal score 4, 5 and 6. A key secondary outcome evaluates treatment-related improvements in the 8-point ordinal scale at Day 15. Each stage may prioritize different secondary endpoints for the purpose of multiple comparison analyses."
5.Primary Outcome Measures :
" Time to recovery for patients with baseline ordinal score 4, 5, and 6 [ Time Frame: Day 1 through Day 29 ]
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care."
6. Secondary Outcome Measures :
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in C-reactive protein (CRP) [ Time Frame: Day 1 through Day 29 ]
Change from baseline in creatinine [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in d-dimer concentration [ Time Frame: Day 1 through Day 29 ]
Change from baseline in hemoglobin [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in international normalized ratio (INR) [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in platelets [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in total bilirubin [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change from baseline in white blood cell count (WBC) with differential [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Change in National Early Warning Score (NEWS) from baseline [ Time Frame: Day 1 through Day 29 ]
The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6). Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]
Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6). An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of invasive mechanical ventilation [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of non invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Measured in days.
Duration of oxygen use [ Time Frame: Day 1 through Day 29 ]
Measured in days
Incidence of discontinuation or temporary suspension of study product administration [ Time Frame: Day 1 through Day 10 ]
For any reason. Assessed overall and by baseline ordinal scale category (categories 4 and 5 versus category 6).
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change from baseline in the ordinal scale [ Time Frame: Day 1 through Day 29 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Participant's clinical status at Day 15 by ordinal scale for patients with baseline ordinal score 4 and 5 [ Time Frame: Day 15 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Percentage of subjects reporting each severity rating on an 8 point ordinal scale [ Time Frame: Days 3, 5, 8, 11, 22, and 29 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]
Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]
Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]
The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Time to recovery for patients with a baseline ordinal score of 4 and 5 [ Time Frame: Day 1 through Day 29 ]
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or new or increased requirement for home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Great analogy!
Leo, Please turn the corkscrew and drive it deeper...
Very happy that only the basic information needed to be PRd was issued and nothing more.
I think Leo has learned "You say it best when you say nothing at all."
Leo has the big corkscrew and he has used it. Now turn it ever so much deeper, Leo.
This is eye opening to me. I am very happy you are posting your thoughts on this. It makes total sense.
Go Leo & Brilacidin!
That is correct. Russia’s SOC is different then in our US hospitals.
So this can be Huge on multiple levels since if Brilacidin can Show synergistic value both with our local US Standard of Care and also with the Overseas SOC, we can see huge $’s in my opinion since Remdesivir is widely only being used in the US as SOC and you can see they brought in billions last year.
I like the new Leo!
Go Leo & IPIX!
The last PR was:
A month ago, and,
On the last Friday of the month
Hmm.
Very nice find Here Today and thanks for bringing that too my attention.
The Phase 2 Brilacidin for COVID-19 clinical trial is a randomized, double-blind, placebo-controlled, international, multi-center study with planned enrollment of ~120 subjects with moderate-to-severe COVID-19. Two treatment arms are enrolling patients—active and placebo, with ~60 patients per arm. The study protocol provides for 3 days of study drug administration.
• Active Arm (Brilacidin): Standard of Care + daily Brilacidin IV infusion for 3 days
• Control Arm (Placebo): Standard of Care + daily Saline IV infusion for 3 days
After an interim review, by an independent Data Monitoring Committee (DMC), dosing may be extended to 5 days.
Notice that they are testing Brilacidin while in USE with the Standard of Care!!!! Huge development!!!!
I have been long since 2013 and am glad Leo did not mention when the trials started. That will keep the mm's guessing!
Way too go Leo! Make Brilacidin great!
Innovation Pharma Provides Study Details for Ongoing Phase 2 Clinical Trial of Brilacidin in Hospitalized COVID-19 Patients
WAKEFIELD, MA – February 26, 2021 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today provides additional study details for its ongoing Phase 2 clinical trial assessing Brilacidin as a novel therapeutic in hospitalized patients with COVID-19. Patients are being treated, with recruitment and enrollment progressing at trial sites.
PR OUT
Innovation Pharma Provides Study Details for Ongoing Phase 2 Clinical Trial of Brilacidin in Hospitalized COVID-19 Patients
WAKEFIELD, MA – February 26, 2021 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today provides additional study details for its ongoing Phase 2 clinical trial assessing Brilacidin as a novel therapeutic in hospitalized patients with COVID-19. Patients are being treated, with recruitment and enrollment progressing at trial sites.
Innovation Pharma is developing Brilacidin, a defensin-mimetic, under Fast Track designation from the U.S. Food and Drug Administration (FDA).
The Phase 2 Brilacidin for COVID-19 clinical trial is a randomized, double-blind, placebo-controlled, international, multi-center study with planned enrollment of ~120 subjects with moderate-to-severe COVID-19. Two treatment arms are enrolling patients—active and placebo, with ~60 patients per arm. The study protocol provides for 3 days of study drug administration.
• Active Arm (Brilacidin): Standard of Care + daily Brilacidin IV infusion for 3 days
• Control Arm (Placebo): Standard of Care + daily Saline IV infusion for 3 days
After an interim review, by an independent Data Monitoring Committee (DMC), dosing may be extended to 5 days.
The trial’s primary endpoint is time to sustained recovery through Day 29, using a clinical status ordinal scale based on that used in the series of National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trials (ACTTs). Additional endpoints include: in-hospital outcomes (e.g., duration of hospitalization, time to discharge), all-cause mortality, measurement of disease biomarkers (e.g., CRP, ferritin) and inflammation-related biomarkers (e.g., IL-1ß, IL-6, IL-10, total IL-18, TNF-a), changes to SARS-CoV-2 viral load, as well as other key measures.
The study protocol will be registered and posted on www.clinicaltrials.gov.
Brilacidin and COVID-19
Brilacidin, which has received FDA Fast Track designation for the potential treatment of COVID-19, is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Pre-clinical testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). In a human lung cell line against SARS-CoV-2, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin antiviral research to date has been limited to laboratory-based experiments. Additional pre-clinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1ß, TNF-a and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Collectively, these data support Brilacidin as a unique 3-in-1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate, with pan-coronavirus treatment potential. The Company has initiated a randomized, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of COVID-19 in moderate-to-severe hospitalized patients. A peer-reviewed article in Viruses supporting Brilacidin’s COVID-19 treatment potential can be accessed at the link below.
• Bakovic, A.; Risner, K.; Bhalla, N. (et al). Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture. Viruses 2021, 13, 271; https://doi.org/10.3390/v13020271
https://www.mdpi.com/1999-4915/13/2/271/
Global COVID-19 Cases and Mortality
An online tool tracking COVID-19 cases and mortality, both in the U.S. and globally, can be found on the Company’s website (http://www.ipharminc.com), and at the following link:
https://ipixcovid19tracker.com/
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
http://www.ipharminc.com/email-alerts/
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019, who have recently completed a Phase 1 study with their formulation. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection. Brilacidin, based on promising in vitro antiviral activity against SARS-CoV-2, is being evaluated in a Phase 2 clinical trial as a potential treatment for COVID-19. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations and has successfully completed a Phase 2 trial in Ovarian Cancer. More information is available on the Company website at www.IPharmInc.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its impact on SARS-CoV-2 (COVID-19) and other coronaviruses, as well as obtaining government regulatory approvals. Other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks but not limited to risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals for Brilacidin and Kevetrin in the US and other jurisdictions; that prior test results may not be replicated in future studies and trials, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACTS
Innovation Pharmaceuticals Inc.
Leo Ehrlich
info@ipharminc.com
Innovation Pharma Provides Study Details for Ongoing Phase 2 Clinical Trial of Brilacidin in Hospitalized COVID-19 Patients
WAKEFIELD, MA – February 26, 2021 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today provides additional study details for its ongoing Phase 2 clinical trial assessing Brilacidin as a novel therapeutic in hospitalized patients with COVID-19. Patients are being treated, with recruitment and enrollment progressing at trial sites.
Innovation Pharma is developing Brilacidin, a defensin-mimetic, under Fast Track designation from the U.S. Food and Drug Administration (FDA).
The Phase 2 Brilacidin for COVID-19 clinical trial is a randomized, double-blind, placebo-controlled, international, multi-center study with planned enrollment of ~120 subjects with moderate-to-severe COVID-19. Two treatment arms are enrolling patients—active and placebo, with ~60 patients per arm. The study protocol provides for 3 days of study drug administration.
• Active Arm (Brilacidin): Standard of Care + daily Brilacidin IV infusion for 3 days
• Control Arm (Placebo): Standard of Care + daily Saline IV infusion for 3 days
After an interim review, by an independent Data Monitoring Committee (DMC), dosing may be extended to 5 days.
The trial’s primary endpoint is time to sustained recovery through Day 29, using a clinical status ordinal scale based on that used in the series of National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trials (ACTTs). Additional endpoints include: in-hospital outcomes (e.g., duration of hospitalization, time to discharge), all-cause mortality, measurement of disease biomarkers (e.g., CRP, ferritin) and inflammation-related biomarkers (e.g., IL-1ß, IL-6, IL-10, total IL-18, TNF-a), changes to SARS-CoV-2 viral load, as well as other key measures.
The study protocol will be registered and posted on www.clinicaltrials.gov.
Brilacidin and COVID-19
Brilacidin, which has received FDA Fast Track designation for the potential treatment of COVID-19, is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Pre-clinical testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). In a human lung cell line against SARS-CoV-2, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin antiviral research to date has been limited to laboratory-based experiments. Additional pre-clinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1ß, TNF-a and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Collectively, these data support Brilacidin as a unique 3-in-1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate, with pan-coronavirus treatment potential. The Company has initiated a randomized, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of COVID-19 in moderate-to-severe hospitalized patients. A peer-reviewed article in Viruses supporting Brilacidin’s COVID-19 treatment potential can be accessed at the link below.
• Bakovic, A.; Risner, K.; Bhalla, N. (et al). Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture. Viruses 2021, 13, 271; https://doi.org/10.3390/v13020271
https://www.mdpi.com/1999-4915/13/2/271/
Global COVID-19 Cases and Mortality
An online tool tracking COVID-19 cases and mortality, both in the U.S. and globally, can be found on the Company’s website (http://www.ipharminc.com), and at the following link:
https://ipixcovid19tracker.com/
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http://www.ipharminc.com/email-alerts/
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019, who have recently completed a Phase 1 study with their formulation. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection. Brilacidin, based on promising in vitro antiviral activity against SARS-CoV-2, is being evaluated in a Phase 2 clinical trial as a potential treatment for COVID-19. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations and has successfully completed a Phase 2 trial in Ovarian Cancer. More information is available on the Company website at www.IPharmInc.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its impact on SARS-CoV-2 (COVID-19) and other coronaviruses, as well as obtaining government regulatory approvals. Other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks but not limited to risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals for Brilacidin and Kevetrin in the US and other jurisdictions; that prior test results may not be replicated in future studies and trials, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACTS
Innovation Pharmaceuticals Inc.
Leo Ehrlich
info@ipharminc.com
Great post!
Go Leo & IPIX!
IPIX is no longer a start-up. It's been on the biotech scene for more than a decade. Any "financier" would only offer a predatory lending for a biotech on an OTC with a stock price hovering in the low pennies. If our CEO was not also one of the largest shareholders, the company would have already been sold off for peanuts, giving himself/herself an out of the door bonus...the interest of a majority of shareholders be damned.
It is interesting how these doubts are raised when the stock starts going down after a faux rally in the price. Investors claiming a large stake in the company now say they have taken a little off the table sowing more doubt.
What has changed really? The trials which will make (or break) this company have just started. I consider that as a positive. We are in a good financial position per the latest 10Q, which I would also consider positive. A partner for UP just announced the end of P1 and the initial stages for a P2. Again a positive. P2 for UC through the oral route will start this year. Hmmm...that again sounds positive to me.
The runway for day traders is getting shorter and shorter by the week. Therefore, the desperation is palpable. After all this stock has been a lunch money cash cow for more than a decade, and the thought of losing it may be disconcerting to some. So one last slog to get a final pay-off before the great reset.
The big advantage of keeping us real shareholders in the dark is that it keeps the crew who has been trying to destroy this company also in the dark. They are obviously very organized and strategic and I think Leo's biggest fault to this point is that he has not known how to deal with it. I believe he has strategic plan now.
Leo, I have been invested in your company since 2013 and have not sold a share yet. Please keep me in the dark until you are ready to release the kraken.
Go Leo & IPIX!
Why did Leo not release the Alfasigma news? That is completely different than the covid trials. Sorry...Not the same IPIX, something different.
The good news is crashco is that Leo is no pushover and will get Brilacidin to market so that it can heal people. I will not sell!
Go Leo & IPIX!
It is tragic. And exacerbated by a market that rewards profit above development of new and novel drugs. The structure of a market that discourages investment in high risk, low return indications is a shame. Permitting manipulation and overt attacks against companies introducing novel treatments is reprehensible and criminal.
GLTA(Longs), good health to all infected, goodwill to those who would risk careers and capital to bring new hope to mankind.
Thanks.
JFM.
Brad...imo...you are absolutely correct:
Quote:
The Captain of our ship is Leo Ehrlich whom we rely on to steer us to reap the rewards of a successful Brilacidin trial for COVID-19. That’s right the same drug he bought for $5million.
...an astute and some would say "genius" move!
Leo's new "stealth" approach to releasing minimal information (via disclosure in 10Q) could be pointing (speculating) to another...ASTUTE MOVE...and more positive news on the horizon.
The question becomes what has caused Leo to radically modify his M.O. ... not doing a traditional expansive PR, on obviously good news (commencement of trials in U.S. and Russia). The anwer might be in four questions...
1. Could the LEO M.O change due to stategic calculated shift? Likely...another clever move...Keep the details close to the vest...and naked and legal shorts in the dark...until BOOM! Brilacidin explodes onto the scene...OK good...but there could be more..
2. Could the regulatory authority (FDA) desire to keep the information on trial developments and their results...under wraps because they know how explosive and fundamentally ground-breaking in the treatment of all viruses and bacteria?
3. Could IPIX be in a quiet period by agreemengt, while negotiating with BP on all or part of a deal involving Brilacidin (or entire company)?
4. Could we be witnessing a combination of 2 & 3?
IMO...we will see $2.00 (and likely much more) before and if ever, we see $0.20 again
...of course all IMO
I agree crashco and that is what I thought when I was reviewing the stages of development chart. http://www.ipharminc.com/stages-of-development It appears that we have other phase 2 trials about to start along with the current covid19 human trials that are set to complete very shortly.
Looking forward to seeing the results.
This should be an exciting year for those who have been holding IPIX.
Go Leo & IPIX!