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Thanks for posting
2023:
BASILEA HALF-YEAR REPORT 202318
OUTLOOK:
BASILEA HALF-YEAR REPORT 202318
OUTLOOK pg 18
Upcoming milestones
H2 2023
In-licensing or acquisition of novel anti-infectives
to complement clinical pipeline
H1 2024
In-licensing or acquisition of novel anti-infectives
to complement clinical pipeline
Interesting they are making announcing corporate goal to acquire or license novel, complementary antiinfectives.
I do not know Basilea well enough to outline all the drugs they may be evaluating, but it is a sure bet Brilacidin is one of them.
JMHO, Farrell
Another recent outbreak of Marburg virus is causing concern. Currently no antiviral treatment is available for Marburg virus. The death rate is as high as 80%.
Marburg virus is a Filovirus. "The Filoviridae consists of 2 genera: Ebolavirus (consisting of 5 species) and Marburgvirus (consisting of 2 species). The specific vectors of these viruses have not been confirmed, but fruit bats are the prime candidates; thus, Filoviridae are not arboviruses. Human-to-human transmission of Ebola virus and Marburg virus occurs readily."
https://www.merckmanuals.com/professional/infectious-diseases/arboviruses,-arenaviridae,-and-filoviridae/overview-of-arbovirus,-arenavirus,-and-filovirus-infections
Brilacidin may have activity against Filoviruses: "...earlier NIH/NIAID-affiliated research of Brilacidin in other acutely infectious virus families, including coronaviruses, alphaviruses, flaviviruses, and filoviruses, with a corresponding scientific paper being prepared for publication."
https://www.ipharminc.com/press-release/2022/8/5/innovation-pharmaceuticals-announces-nihniaid-affiliated-researchers-to-evaluate-brilacidins-treatment-potential-against-monkeypox
https://www.who.int/news-room/fact-sheets/detail/marburg-virus-disease
https://www.cdc.gov/locs/2023/04-06-2023-Lab-Advisory-CDC_Issues_CDC_Issues_Health_Alert_Marburg_Disease_Outbreaks.html
https://www.mirror.co.uk/news/health/deadly-virus-turns-sufferers-into-30520661
cnn.com/2023/04/06/health/cdc-alert-marburg/index.html
"In summary, we identified five molecules,
Hayatinine, Bedaquiline, Brilacidin, Curine, and MMV688271 that completely blocked invasion/schizont rupture at IC50"
Thanks for posting. This finding is consistent with Polymedix's lab findings that some of their small molecule mimetic of defensin, a type of host defense proteins/peptides (HDPs) or antimicrobial peptides had an inhibitory affect against malaria.
This study confirms Brilacidin also possesses antimalarial inhibitory effects. Brilacidin is truly a multifaceted compound with proven antibacterial,antiviral,antifungal and now antiparasitic antimalarial effects.
GLTA Farrell
Sorry I missed your reply.
By focusing on the mortality numbers you ignored a number of significant complications of viral encephalitis plus you did not bother to mention the fact that Brilacidin has been shown to have activity against other viral disorders and other strains of encephalitis.
"Across multiple cell lines and under different testing conditions, research showed Brilacidin inhibited viral replication in a statistically significant manner in encephalitic alphaviruses, including Venezuelan Equine Encephalitis Virus (VEEV), Eastern Equine Encephalitis Virus (EEEV), and Sindbis Virus (SINV). Brilacidin also was shown to inhibit Rift Valley Fever Virus (RVRF), a contagious bunyavirus that can lead to blindness, liver failure, and hemorrhagic fever in infected individuals. Moreover, anti-inflammatory activity was observed, indicating intracellular events are modulated by Brilacidin treatment. Brilacidin is thus able to exert a combined protective effect by decreasing viral and inflammatory load.
The in vitro evaluation of Brilacidin’s antiviral activity was expanded to Echovirus, a non-enveloped picornavirus, to assess Brilacidin’s effect on early viral entry in contrast to its ability to disrupt the lipid membranes of enveloped viruses. Brilacidin was shown to inhibit Echovirus, suggesting Brilacidin possesses additional antiviral mechanisms beyond its ability to directly impact viral envelopes."
https://www.ipharminc.com/press-release/2022/9/14/new-in-vitro-data-supporting-the-broad-spectrum-antiviral-activity-of-innovation-pharmaceuticals-brilacidin-presented-at-2022-military-health-system-research-symposium
Below are some facts relating to Eastern equine encephalitis
No vaccine
No antiviral treatment
41% death rate
50% neurological complications such as: psychosis, memory loss,seizures
"Several complications have been described, more frequently involving the central nervous system resulting in cognitive, motor, or sensory deficits. Associated neurological sequelae include most commonly seizures (63%), but also paralysis, intellectual disability, and behavioral changes. Late diagnosis and intervention can result in multiorgan failure and autonomic dysfunction, and ultimately death.[20][21] A rare case reported hemophagocytic lymphohistiocytosis in a 5 month-old infant secondary to EEE.[22] Behavioral changes are also described, specifically psychosis."
https://www.ncbi.nlm.nih.gov/books/NBK557692/
Venezuiian equine encephalitis can occur as large outbreaks affecting thousands of individuals. It is more common in Central and South America While it is rarely reported in the US. It should be of concern to travelers to endemic areas. One outbreak in South America record 13,000 individual infections.
The disease has a lower death rate and neurological complication rate than EEE, but shares many clinical features.
https://www.ncbi.nlm.nih.gov/books/NBK559332/
:
The FDA process for approving medical devices can be much less stringent than pharmaceuticals.
BeaMedical Technologies {IPIX' has about a 40% position} has received clearance fro the Manta family of surgical lasers
11/2022
"BT BeaMedical Technologies (“BeaMed”), a private company developing a next-generation laser-based platform for epilepsy and cancer surgery, has notified Innovation Pharmaceuticals (OTC: IPIX) (the “Company”) that it has received U.S. Food and Drug Administration (FDA) clearance (K222701) for its MANTA surgical laser family. The clearance is an important milestone for BeaMed in its development of an advanced laser technology with respect to shaping energy and matching it to patient specific anatomy, a novel concept that BeaMed is proving a reality. Innovation Pharmaceuticals made a strategic investment to acquire a minority stake in BeaMed in June 2022."
"he MANTA surgical laser family was cleared by the FDA including five different wavelengths (810nm, 980nm, 1064nm, 1470nm and 1940nm) and soft tissue use in a very wide set of clinical specialties, including Neurosurgery, Spinal Surgery, Urology, Thoracic Surgery, Pulmonary Surgery, Gynecology, General Surgery, ENT/Head and Neck, Plastic Surgery, Orthopedics, Arthroscopy, Ophthalmology, Radiology, and Oral Surgery."
The next approval is for the fiber optic delivery system and integration with MRI imaging.
2/2023
"Having already obtained FDA clearance for the laser component of the StingRay
System, BeaMed expects soon to make additional requisite submissions to the
FDA for clearance of its fiber optics and its software integration package
with Siemens and GE imaging systems."
ttps://www.bloomberg.com/press-releases/2023-02-23/innovation-pharmaceuticals-visits-beamed-new-stingray-laser-system-for-epilepsy-and-brain-tumors-moving-toward-fda-submission
In addition Beamed has signed an agreement with Shina Systems to facilitate development and regulatory approval:
1/2023
"BT BeaMedical Technologies (“BeaMed”), a private company minority-owned by Innovation Pharmaceuticals (OTC: IPIX) (the “Company”) developing a next-generation laser based platform for epilepsy and cancer surgery, has notified the Company that it has entered into a definitive strategic agreement with Shina Systems Ltd. (“Shina”), a company specializing in medical imaging software platforms, in order to build on unique capabilities of Shina and accelerate the development, regulatory clearance, and commercial deployment of BeaMed’s StingRay Laser System for brain surgery."
“This agreement provides us with two key strategic advantages,” said Gil Shapira, Chief Executive Officer of BeaMed. “The first is immediate access to decades of experience and knowledge regarding design and implementation of high end medical imaging platforms including MRI access, 3D image processing and visualization, and superlative usability. The second is acceleration of our development timeline to get through FDA clearance and market launch quickly. This path underscores the execution-focused strategy of BeaMed to successfully bring its innovation to the market efficiently and expeditiously.”
"Shina Systems Ltd. develops and markets clinical image management, PACS and medical imaging analysis application software for almost 3 decades. Shina is recognized for its unique tools and intuitive, clinician-friendly application workflow. Clinically effective and technologically distinguished, Shina’s software is installed in thousands of clinical sites worldwide, including OEM partners from the top 10 global medical imaging and equipment companies."
My guess is that approval could come within months.
GLTA, Farrell
Very interesting. Thanks for posting . More evidence to support Brilacin's anti -infective possibilities...antiviral, anti fungal, antibacterial.
Good luck,
Farrell
Polymedixs performed a great deal of basic research on Brilacidin and its other related compounds . On page 10 of the link below malaria is listed as one of its possible research targets.
https://www.sec.gov/Archives/edgar/data/1341843/000114420413013653/v337514_fwp.htm
In addition Polymedix received a government grant to study its compounds against malaria.
https://www.fiercebiotech.com/biotech/polymedix-receives-nih-grant-to-develop-new-antimicrobials-for-treatment-of-malaria
Farrell
Sintana energy partner ,Galp Energia , has sign a drilling rig for PEL 83 for 2 wells.
https://www.energyvoice.com/oilandgas/africa/rigs-vessels-africa/500815/galp-signs-ojfell-rig-orange-basin-test/
https://sintanaenergy.com/projects/offshore-africa/pel-83/
GLTA,Farrell
Galp has signed up a harsh environment semi-submersible rig for two wells offshore Namibia.
SFL Corp. announced the contract today, worth $50 million, for the Hercules rig. The drilling company reported the contract covered two wells, plus optional well testing.
It expects work to begin in the fourth quarter of 2023, and run for 115 days including mobilisation.
The Hercules is undergoing a special survey in Norway ahead of mobilisation to Canada. After Canada, it will re-cross the ocean and head to Namibia.
Galp entered Namibia in 2012 and now holds the PEL 83 area in the Orange Basin. The operator shot 3D seismic on the block in 2019. Galp relinquished another area, PEL 82 in the Walvis Basin, in 2021.
Galp has an 80% stake in PEL 83, which is next to Shell’s three discoveries at Graff, La Rona and Jonker.
Sintana Energy, partner on PEL 83, has said the licence is thought to hold “mature, oil-prone source rock intervals of Barremian-Aptian (Kudu) shale and Cenomanian-Turonian ages”. The main source rock is a “very thick Barremian-Aptian” of around 300 metres, covering the whole basin, the minnow said.
Must be Hercules
“We are pleased to announce this follow-on contract for the Hercules, which will keep the rig continuously employed until the end of the first quarter of 2024,” said SFL CEO Ole Hjertaker.
“The new contract illustrates the attractiveness and versatility of the Hercules as a harsh environment oil exploration and development rig for the international market. With increasing demand and few available drilling rigs with Hercules’ capabilities, we see additional upside in day rates and contract term from 2024 onwards.”
Odjfell Drilling manages the rig on behalf of SFL. Odjfell CEO Kjetil Gjersdal said the company had been working “tirelessly” to prepare the rig for work in Canada since taking over management and marketing.
“Agreeing this contract with Galp Energia, the third contract for work in Namibia we have agreed within the last year, is very exciting for our company and we look forward to working with SFL and Galp Energia to meet expectations safely and efficiently,” Gjersdal said.
ExxonMobil and SFL signed a contract for the Hercules in November 2022. The rig will begin work in Canada in the second quarter. It has a firm duration of 135 days and an optional extension for another 60 days.
Odjfell also manages the Deepsea Bollsta and Deepsea Mira, which are working in Namibia for Shell and TotalEnergies respectively. The drilling company has cited recent discoveries in Namibia as creating interest in “securing long-term contracts in the area”.
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It's a good point, the risks of fungal diseases increases the closer one is to the equator. I would not be surprised to see a upcoming country such as Brazil, India or Indonesia to be very interested in a new treatment for fungal diseases. The incidence of fungal diseases is increasing in the United States too.
Glta Farrell
Plus the incidence of Candida auris is spreading across the country and the incidence of drug resistance is also spreading.
https://www.cidrap.umn.edu/antimicrobial-stewardship/
https://www.nbcnews.com/health/health-news/cdc-fungal-infection-candida-auris-alarming-spread-rcna75477
https://www.cdc.gov/media/releases/2023/p0320-cauris.html
https://health.ucdavis.edu/news/headlines/cdc-issues-warning-about-increase-of-drug-resistant-candida-auris-infections/2023/03
https://www.washingtonpost.com/health/2023/03/20/candida-auris-fungus-infection/
https://www.statnews.com/2023/02/09/fungal-crisis-is-here-past-time-to-address-it/
https://www.health.pa.gov/topics/Documents/HAN/2023-687-3-31-UPD-C_Auris_update.pdf
https://jamanetwork.com/journals/jama/fullarticle/2803271
It is a big enough of a problem for the Nevada congressional delegation to petition Congress, CDC and GailWilensky for help:
https://susielee.house.gov/media/press-releases/congresswoman-lee-leads-nevada-del
https://www.reviewjournal.com/life/health/fatal-fungus-outbreak-worries-nevada-lawmakers-more-help-wanted-2765479/
https://www.wsws.org/en/articles/2023/04/25/kkkq-a25.html
https://gamefaqs.gamespot.com/boards/261-politics/80420852
GLTA,
Farrell
That is correct. IPIX does not currently have funds for a clinical trial.
What do you think the Nevada congressional group is going request from their colleagues in Washington? My bet is they will ask for research funding, expedited clinical trials and new drugs to treat pan resistant Candida auris.
I believe they will be successful because of the nationwide spread of Candida auris, the high death rate [30-60%] and the lack of effective treatments in patients infected with the pan resistant form.
Plus all the reasons the CDC outlines below:
Centers for Disease Control and Prevention. CDC twenty four seven. Saving Lives, Protecting
General Information about Candida auris
Print
Candida Auris pathogen
Healthcare facilities in several countries have reported that a type of yeast called Candida auris has been causing severe illness in hospitalized patients. In some patients, this yeast can enter the bloodstream and spread throughout the body, causing serious invasive infections. This yeast often does not respond to commonly used antifungal drugs, making infections difficult to treat. Patients who have been hospitalized in a healthcare facility a long time, have a central venous catheter, or other lines or tubes entering their body, or have previously received antibiotics or antifungal medications, appear to be at highest risk of infection with this yeast.
Specialized laboratory methods are needed to accurately identify C. auris. Conventional laboratory techniques could lead to misidentification and inappropriate management, making it difficult to control the spread of C. auris in healthcare settings.
Because of these factors, CDC is alerting U.S. healthcare facilities to be on the lookout for C. auris in their patients.
CDC and partners continue to work closely; click here for the latest information on Candida auris. To learn more about Candida auris, read the Q&A below and:
Fact sheet on Candida auris – Download pdf icon[PDF – 2 Pages]
Recommendations for Laboratorians and Health Professionals
Information for Patients and Family Members
Questions and Answers for Healthcare Personnel
Why is CDC concerned about C. auris infections?
CDC is concerned about C. auris for three main reasons:
It is often multidrug-resistant, meaning that it is resistant to multiple antifungal drugs commonly used to treat Candida infections.
It is difficult to identify with standard laboratory methods, and it can be misidentified in labs without specific technology. Misidentification may lead to inappropriate management.
It has caused outbreaks in healthcare settings. For this reason, it is important to quickly identify C. auris in a hospitalized patient so that healthcare facilities can take special precautions to stop its spread.
What types of infections can C. auris cause?
C. auris has caused bloodstream infections, wound infections, and ear infections. It also has been isolated from respiratory and urine specimens, but it is unclear if it causes infections in the lung or bladder.
How is C. auris infection diagnosed?
Like other Candida infections, C. auris infections are usually diagnosed by culture of blood or other body fluids. However, C. auris is harder to identify from cultures than other, more common types of Candida. For example, it can be confused with other types of yeasts, particularly Candida haemulonii. Special laboratory tests are needed to identify C. auris. For more information, please see the Recommendations for Laboratorians and Health Professionals.
Who is at risk for infection from C. auris?
People who have recently spent time in nursing homes and have lines and tubes that go into their body (such as breathing tubes, feeding tubes and central venous catheters), seem to be at highest risk for C. auris infection. Limited data suggest that the risk factors for Candida auris infections are generally similar to risk factors for other types of Candida infections. These risk factors include recent surgery, diabetes, broad-spectrum antibiotic and antifungal use. Infections have been found in patients of all ages, from preterm infants to the elderly. Further study is needed to learn more about risk factors for C. auris infection.
When was C. auris first reported?
C. auris was first identified in 2009 in Japan. Retrospective review of Candida strain collections found that the earliest known strain of C. auris dates to 1996 in South Korea. CDC considers C. auris an emerging pathogen because increasing numbers of infections have been identified in multiple countries since it was recognized.
How did C. auris get its name?
Auris is the Latin word for ear. Despite its name, C. auris can also affect many other regions of the body and can cause invasive infections, including bloodstream infections and wound infections.
Where have C. auris infections occurred globally?
C. auris infections have been reported from over 30 countries, including the United States. Because identification of C. auris requires specialized laboratory methods, infections likely have occurred in other countries but have not been identified or reported. Click here for a map of countries with reported cases.
How did C. auris infection spread globally?
CDC conducted whole genome sequencing of C. auris specimens from countries in the regions of eastern Asia, southern Asia, southern Africa, and South America. Whole genome sequencing produces detailed DNA fingerprints of organisms. CDC found that isolates within each region are quite similar to one another, but are relatively different across regions. These differences suggest that C. auris has emerged independently in multiple regions at roughly the same time.
Would someone be likely to get a C. auris infection if they travel to any of these countries?
It is unlikely that routine travel to countries with documented C. auris infections would increase the chance of someone getting sick from C. auris. Infections have occurred primarily in patients who were already in the hospital for other reasons. People who travel to these countries to seek medical care or who are hospitalized there for a long time may have an increased risk for C. auris infection.
Have C. auris infections occurred in the United States?
Cases of C. auris infections have been reported in the United States. As laboratories continue to look for this fungus, it is likely that more cases will be reported. Click here for a map of cases in the United States.
What should someone do if they suspect they have a C. auris infection?
CDC recommends that anyone who believes they have any fungal infection or healthcare-associated infection see a healthcare provider.
Are C. auris infections treatable?
Most C. auris infections are treatable with a class of antifungal drugs called echinocandins. However, some C. auris infections have been resistant to all three main classes of antifungal medications, making them more difficult to treat. In this situation, multiple classes of antifungals at high doses may be required to treat the infection. Treatment decisions should be made in consultation with a healthcare provider experienced in treating patients with fungal infections.
Can a person die from infection with C. auris?
Yes. Invasive infections with any Candida species can be fatal. We don’t know if patients with invasive C. auris infection are more likely to die than patients with other invasive Candida infections. Based on information from a limited number of patients, 30–60% of people with C. auris infections have died. However, many of these people had other serious illnesses that also increased their risk of death.
How does C. auris spread?
C. auris can spread in healthcare settings through contact with contaminated environmental surfaces or equipment, or from person to person. More work is needed to further understand how it spreads.
How can the spread of C. auris be prevented?
Please see the Recommendations for Laboratorians and Health Professionals.
What is CDC doing to address C. auris?
CDC is providing guidance for clinicians and infection control personnel. For more information, please see the Recommendations for Laboratorians and Health Professionals. CDC also is working with state and local health agencies, healthcare facilities, and clinical microbiology laboratories to ensure that laboratories are using proper methods to detect C. auris and know the limitations of certain tests for detecting C. auris.
JMO but things are looking up for Brilacidin
Good luck,
Farrell
I am sure you noted in my post I placed clinical trial before the mention of compassionate use.
" Could a clinical trial be coming? Compassionate use? "
FYI below is IPIX's description of compassionate use
"Expanded Access and Compassionate Use
Innovation Pharma is dedicated to developing innovative therapies in areas of unmet need.
To learn more about our clinical trials, including possible opportunities to participate in ongoing or upcoming studies, visit ClinicalTrials.gov—a government-run database listing private and publicly-funded clinical studies conducted around the world.
As part of drug development, the FDA allows for potential Expanded Access/Compassionate Use of an Investigational New Drug before any regulatory approval might be achieved. This opportunity applies only to patients with serious or life-threatening conditions who are unable to participate in a clinical trial and have exhausted alternative treatment avenues.
For FDA regulations on Expanded Access/Compassionate Use, please visit the FDA website."
Patients and physicians should refer to the following information before contacting us about potential Expanded Access/Compassionate Use opportunities."
Expedited clinical trials can happen quickly when the current treatments for infectious disease are ineffective leading to contagion, severe illness, disability or even death.
The Nevada politicians are right to be very concerned.
Farrell
Farrell
Resistant Canidida auris is spreading in Las Vegas ,Florida and California
From the CDC:
"Combination antifungal treatment yielded promising results in laboratory testing but has not been evaluated in clinical settings. Investigational drugs have been tried against C. auris and may be considered for patients with echinocandin-resistant "
Brilacidin in combination with other antifungals may prove to be a key medication for Candida auria. Could a clinical trial be coming? Compassionate use?
The situation with panresistant Candida auris sounds desperate.
"Brilacidin converted CAS from a fungistatic into a fungicidal drug, enabling it to overcome both drug resistance and biofilm formation. Brilacidin exerted, to a lesser degree, synergistic effects with VOR in A. fumigatus. Further in vitro testing showed Brilacidin synergized with CAS in C. albicans, C. auris and C. neoformans. In an A. fumigatus immunosuppressed mouse model in invasive pulmonary aspergillosis, Brilacidin plus CAS cleared infection in the lungs by almost 95 percent, compared to ~50 percent when each compound was administered individually."
https://www.biospace.com/article/releases/innovation-pharmaceuticals-announces-publication-
CDC Recommendations for treatment of Candida auris infections
"Consultation with an infectious disease specialist is highly recommended when caring for patients with C. auris infection.
Even after treatment for invasive infections, patients generally remain colonized with C. auris for long periods, and perhaps indefinitely. Therefore, all recommended infection control measures should be followed during and after treatment for C. auris infection.
Adults and children ≥ 2 months of age
Based on the limited data available to date, an echinocandin drug at a dose listed below is recommended initial therapy for treatment of C. auris infections.
Dose information for Adults and Children ≥ 2 months of age
Dose information for Adults and Children ≥ 2 months of age
Echinocandin Drug Adult dosing Pediatric dosing
Anidulafungin loading dose 200 mg IV,
then 100 mg IV daily not approved for use in children
Caspofungin loading dose 70 mg IV,
then 50 mg IV daily loading dose 70mg/m2/day IV, then 50mg/m2/day IV
(based on body surface area)
Micafungin 100 mg IV daily 2mg/kg/day IV with option to increase to 4mg/kg/day IV in children at least 40 kg
Most strains of C. auris found in the United States have been susceptible to echinocandins although reports of echinocandin—or pan-resistant cases are increasing. This organism appears to develop resistance quickly. Patients on antifungal treatment should be carefully monitored for clinical improvement. Follow-up cultures and repeat susceptibility testing should be conducted. Both recurrent and persistent C. auris bloodstream infections have been documented.
Switching to a liposomal amphotericin B (5 mg/kg daily) could be considered if the patient is clinically unresponsive to echinocandin treatment or has persistent fungemia for >5 days.
Data are lacking about the most appropriate therapy for pan-resistant strains. Combination antifungal treatment yielded promising results in laboratory testing but has not been evaluated in clinical settings. Investigational drugs have been tried against C. auris and may be considered for patients with echinocandin-resistant ."
https://www.cdc.gov/fungal/candida-auris/c-auris-treatment.html
GLTA Farrell
The FDA has the ability to sponsor public/private studies for serious infectious diseases.
https://www.nih.gov/research-training/medical-research-initiatives/activ
I agree, compassionate use of Brilacidin would be appropriate in the sick patients not responding to standard care.
IMO an urgent FDA study is needed with the death rate for the standard treatment being so high.
Farrell
CDC page regarding Candidia auris
https://www.cdc.gov/fungal/candida-auris/tracking-c-auris.html
Brilacidin for Candidia auris would be a good study for the George Mason and Rutgers biodefense labs.
GLTA, Farrell
If anyone wants to see the whole article you can by paying $6.00 US.
https://www.africaintelligence.com/
Wow, up 24% in one day; over 57 % from the low.
Go IPIX
Farrell
Exciting news which will lead to more information relatively soon.
GLTA, Farrell
Thanks for posting and reminding us of the early PMX research on Brilacidin which confirmed its anti fungal qualities.
GLTA Farrell
Nice find again. Thanks
I thought this comment was interesting,too.
"Today we're only spending exploration capex in São Tomé and Namibia. By 2025, if not before
that, we will know a lot more about these two assets."
From the transcript:
https://www.galp.com/corp/Portals/0/Recursos/Investidores/4Q_Results_2022/4Q22%20Presentation%20Transcript.pdf
Farrell
On a more positive note, IPIX reported $238,000 for “reimbursement for Brilacidin manufacturing expenses”.
Good find...Alpha Sigma did report they are making plans for a Stage 2 trial.
From the last 10Q:
"Phase 1 studies in healthy volunteers using Brilacidin in a proprietary Alfasigma formulation have successfully completed, and Alfasigma notified the Company in late September 2022 that a Phase 2 multinational clinical trial is estimated to start in 2H2023. "
The other possibility is Brilacin for OM, additional viral or fungal research, but no announcements have been made about a partner for stage 3 OM trial.
Interesting the price ticked up on increased volume after a lackluster 10 Q
GLTA, Farrell
Clinical trials .gov shows 23 studies using some type of nasal spray. Most of these are repurposed approved steroid inhalers , but the list include hydroxychloroquine, one antiviral, thyme oil , heparin and other investigational drugs.
May be Brilacidin will get a shot.
Time will tell,
GLTA, Farrell
Who knows, perhaps the Brilacidin nasal swab and nasal spray could shake out a partner to fund a clinical trial for both against a placebo control.
BTW did you notice the contents of the nasal spray in the article you posted?. It looks like the ingredients for a middle eastern dish. I was expecting an antiviral pharmaceutical.
Thanks for posting
Farrell
Full article from 2021 describing swab system for treatment of early Covid 19. I could find no mention of Brilacidin in this article, but he seemed to believe Brilacidin was important enough to mention it in his patent along with articles from the early research of brilacidin.
The patent application specifically references this article:
Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture
by Allison Bakovic
1, Kenneth Risner
1 [ORCID] , Nishank Bhalla
1, Farhang Alem
1 [ORCID] , Theresa L. Chang
2 [ORCID] , Warren K. Weston
3, Jane A. Harness
3 and Aarthi Narayanan
https://www.americanpharmaceuticalreview.com/Featured-Articles/584544-Simple-and-Economical-Multifunctional-Therapeutic-Swab-Device-System-for-Treating-Upper-Respiratory-Infections-Including-COVID-19-on-a-Mass-Scale/
https://www.mdpi.com/1999-4915/13/2/271
More on Subhash Dhawab:
Experience
BIOMEDICAL SCIENTIST (INDEPENDENT) Graphic
Senior FDA Research & Regulatory Scientist (Retired)
BIOMEDICAL SCIENTIST (INDEPENDENT)
Jan 2019 - Present4 years 2 months
United States
• Independent science writer
• Invited reviewer of manuscripts for peer-reviewed scientific journals
• Can provide guidance on research and regulatory projects related to in vitro diagnostics, vaccines, and therapeutics
• Can provide short-term or long-term contractual and consulting services for advancing research and regulatory projects
• Can provide editorial assistance
Published six articles and filed a patent application (U.S. and PCT Patent Pending) after retiring from the US FDA in December 2018
FDA Graphic
Senior FDA Research & Regulatory Scientist
FDA
Apr 1993 - Dec 201825 years 9 months
United States
Senior Investigator and Chief, Viral Immunology Section, Laboratory of Molecular Virology
Laboratory Research:
• Directed a comprehensive research program to conduct investigation on HIV-1 and other viruses, including Ebola, Zika, and poxvirus. Other administrative responsibilities included planning, coordinating research with outside collaborators, management, and supervision of research fellows and students.
Product Regulation:
• Provided guidance and…
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Senior National Research Council Associate
Department of Cellular Immunology, Walter Reed Army Institute of Research, Washington, D.C.
Apr 1991 - Mar 19932 years
United States
Investigated HIV-1 pathogenesis regarding how HIV infection is localized to the peripheral and central nervous systems. The major outcome of this highly productive research program revealing marked invasiveness by HIV-infected macrophages defined a previously unknown mechanism for facilitating their escape from the vascular system. These studies yielded a novel experimental modality for designing therapeutic strategies to retard the progression of HIV infection.
Departments of Biochemistry and Pharmacology, Georgetown University Medical Center, Washington, D.C. Graphic
Research Associate (1984-1986)/Research Assistant Professor (1990-1991)
Departments of Biochemistry and Pharmacology, Georgetown University Medical Center, Washington, D.C.
1984 - 19917 years
United States
Work focused on understanding the biochemical and pharmacologic aspects of the neuronal nicotinic receptors which influence the function of nearly all peripheral organs. The major outcome of this work revealed varying distribution of high affinity nicotinic receptors, indicative of the differential sensory functions in the central nervous system, and provided valuable insights into the regulation of nicotinic receptors and in developing new therapeutic modalities for treating neurological…
National Institute of Dental Research, National Institutes of Health, Bethesda, MD Graphic
Senior Staff Fellow
National Institute of Dental Research, National Institutes of Health, Bethesda, MD
Apr 1987 - Apr 19903 years 1 month
United States
Developed a method to identify HTLV-I-binding cell types in heterogeneous leukocyte populations. This work discovered B cells, in addition to T cells, as a new target for HTLV-I infection and provided future directions for evaluating HTLV-I pathogenesis.
Department of Physiology, Duke University Medical Center, Durham, NC Graphic
Research Associate
Department of Physiology, Duke University Medical Center, Durham, NC
Jun 1982 - Dec 19831 year 7 months
United States
Studies focused on the assembly of the low-density lipoprotein (LDL) with particular emphasis on its differential capacity to bind various lipids. These studies provided useful insights into the understanding of the mechanism for apo-LDL interaction with its two major lipid counterparts -- cholesterol and phospholipid -- in defining its role in hyperlipidemic-related cardiovascular disorders.
Education
Central Drug Research Institute, Lucknow, India Graphic
Central Drug Research Institute, Lucknow, India
Ph.D.Biomedical research
1977 - 1981
Publications
Dhawan, S. Is COVID-19 mRNA Vaccination Safe in HIV-1 and Other Retroviral Infections? Am. Pharma. Rev. (Published on December 22, 2022)
American Pharmaceutical Review December 22, 2022
ABSTRACT: Translocation from the cytoplasm to nucleus and integration of reverse-transcribed SARS-CoV-2 spike mRNA into the genomic DNA of COVID-19 mRNA-vaccinated individuals positive for HIV-1 or other retroviral infections HIV-1 or other retroviral infections raise a possibility of generation of a new type of retrovirus. Such retrovirus expressing both HIV-1 receptor-binding domain (gp120) and SARS-CoV-2 receptor-binding domain (SARS-CoV-2-spike protein) could not only have the potential to bind and infect HIV-1 receptor CD4-positive cells but also to CD4-negative-SARS-CoV-2 receptor ACE2-positive cells that are widely distributed in the peripheral vascular and the central nervous system. This perspective raises concerns about these realistic possibilities that need to be scientifically addressed and evaluated in COVID-19 mRNA vaccine recipients infected with retroviruses, including those who are at high risk of acquiring new retroviral infections.
See publicationExternal link
Dhawan, S. Therapeutic potential of inducible endogenous cytoprotective heme oxygenase-1 in mitigating SARS-CoV-2 infection and associated inflammation. Antioxidants 2022, 11: 662.
MDPI March 30, 2022
ABSTRACT: The inducible cytoprotective enzyme heme oxygenase-1 (HO-1) has gained significant recognition in recent years for mediating strong cellular resistance to a broad range of viral infections, regardless of the type of viruses, viral strains, or mutants. HO-1 is not a typical antiviral agent that targets any particular pathogen. It is a “viral tropism independent” endogenous host defense factor that upon induction provides general cellular protection against pathogens. By virtue of HO-1…
See publicationExternal link
Dhawan, S. Simple and economical multifunctional therapeutic swab device system for treating upper respiratory infections, including SARS-CoV-2, on a mass-scale. Am. Pharma. Rev. 2022, 25: 20-24. [March 2022 issue; U.S. and PCT Patent Pending].
American Pharmaceutical Review March 24, 2022
ABSTRACT: New tools are urgently needed to control the current out-of-control COVID-19 pandemic which can be further complicated by annually emerging influenza infections, especially in the winter months. This article offers a simple and economical Therapeutic Swab Device System comprising multifunctional drugs for their direct application to nasal cavity, oral cavity, nasopharynx and posterior pharynx that are the primary sites of upper respiratory infection, including SARS- CoV-2. This system…
See publicationExternal link
Huang. H. et al. Hemin activation abrogates Mycoplasma hyorhinis replication in chronically infected prostate cancer cells via heme oxygenase-1 induction. FEBS Open Bio. 2021, 11:2727-2739.
Wiley August 10, 2021
ABSTRACT: Mycoplasma hyorhinis (M. hyorhinis) lacks a cell wall and resists multiple antibiotics. We describe here the striking > 90% inhibitory effect of hemin, a natural inducer of the cytoprotective enzyme heme oxygenase-1 (HO-1), on M. hyorhinis replication in chronically infected LNCaP prostate cancer cells. The role of HO-1 in interrupting M. hyorhinis replication was confirmed by HO-1-specific siRNA suppression of hemin-induced HO-1 protein expression, which increased intracellular M.…
See publicationExternal link
Dhawan S. Significance of innate immunity in mitigating SARS-CoV-2 infection. Am. Pharma. Rev. 2021, 24:48-49, 2021.
American Pharmaceutical Review June 18, 2021
ABSTRACT: Continuously surging numbers of global COVID-19 cases caused by rapidly emerging SARS-CoV-2 mutants forming more contagious and deadly viral strains force our scientific capacity to find creative ways to control the pandemic. While current SARS-CoV-2 vaccines are quite effective in reducing the severity of the disease, hospitalization and deaths, none is yet known to provide complete protection from acquiring SARS-CoV-2 infections and to prevent reinfections of the recovered adults or…
See publicationExternal link
Dhawan S. Innate cellular immunity for suppressing viral infections. Curr. Trends Immunol. 2021, 22: 19-21.
Research Trends
ABSTRACT: Innate immunity is our first-line, generic/non-specific host defense mechanism against viral infections, regardless of the type of virus. This component of anti-viral immunology could potentially provide initial protection of host cells against viral infections, but it is generally overlooked as a potential candidate for pharmacological enhancement. Although immunization against individual pathogens provides protection against specific infections and reduces disease severity, the…
See publicationExternal link
Dhawan S. Necessity for the evaluation of stimulated cellular immunity against SARS-CoV-2 infection. Curr. Trends Immunol. 2021, 22: 43-47, 2021
Research Trends
ABSTRACT: Innate immunity is the first-line of non-specific host defense mechanism against pathogens, regardless of the type of strains and mutants. This pivotal component of viral immunology, extremely critical for protecting host cells against infections, has largely been overlooked for SARS-CoV-2 infection. While effective immunization against SARS-CoV-2 reduces the severity of the disease, constantly emerging viral mutants and variant strains continue to pose difficult challenges for…
See publicationExternal link
These are most recent publications
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Patents
"Therapeutic swabs for treating upper respiratory infections" (U.S. and PCT Patent Pending, 2021). Sole Inventor - Subhash Dhawan
Filed August 31, 202117462070
The present invention offers a Therapeutic Swabs Device System as the first therapeutic approach intended to deliver plurality of antiviral, antimicrobial, cytoprotective, anti-inflammatory, and low- or non-anticoagulant drugs to the nasal and oral cavities, nasopharynx, and posterior pharynx, the primary sites of upper respiratory infections. This invention enables an ideal multiprong therapeutic approach for effective targeting of serious upper respiratory infections in humans and in…
Projects
Independent scientific writer • Provides guidance on research and regulatory projects related to in vitro diagnostics, vaccines, and therapeutics • Provides scientific editorial assistance • Amateur self-taught keyboard player
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More activity by Subhash
#covid #inflammation #resolution #HeatShockResponse Chronic suppression of the physiological #resolution of #inflammation via heat shock proteins…
#covid #inflammation #resolution #HeatShockResponse Chronic suppression of the physiological #resolution of #inflammation via heat shock proteins…
Liked by Subhash Dhawan
January 23, 2023 REPOSTING MY COMMENTS ON Lori Peterson's VERY IMPORTANT LinkedIn POST TWO OR MORE WEEKS AGO. My apologies Dr. Amesh Adalja, but I…
January 23, 2023 REPOSTING MY COMMENTS ON Lori Peterson's VERY IMPORTANT LinkedIn POST TWO OR MORE WEEKS AGO. My apologies Dr. Amesh Adalja, but I…
Shared by Subhash Dhawan
I have mentioned the AI Frame Problem previously. This is a great demonstration of it. The dad is AI, the kids are just plain old I. I programing…
Your intuition was correct there most likely is a connection:
Subhash Dwawan...now retired
Viral immunologist with a Ph.D. in biomedical research and more than 25 years of experience with the United States Food and Drug Administration (FDA) regulatory processes. Served as a Principal Investigator and Chief of the Viral Immunology Section to direct and manage an independent research program involving infections: HIV-1, Ebola virus, West Nile virus, Zika virus, and mycoplasma. Actively participated in the FDA review process of 510(k), IDE, IND, and BLA submissions related to in vitro diagnostics, and conducted several US and foreign pre-approval/pre-licensure inspections of manufacturing facilities. Chaired or served as a member on several internal FDA regulatory committees, represented FDA as an ad hoc external committee member for developing guidance for diagnosis and monitoring of infectious diseases, and presented invited and keynote addresses at domestic and international conferences.
See page 2 section 0032
"An embodiment of the present invention relates to utility of brilacidin, a peptide or a biomimetic antimicrobial polymer derived from a host protein defensin exhibiting antiviral and antibacterial activities."
Quite clever. What will they think up next?
Think of the lives that could be saved. I will join you in praying for its success.
GLTA,
Farrell
IPIX's scientific adviser, William DeGrado Phd, is finding success with a company he helped develop, Pliant Pharmaceuticals. Dr DeGrado is one of the world leading researchers on protein science. He performed some of the basic research on Pliant's new drug for pulmonary fibrosis which recently reported a successful mid phase clinical trial.
More details below:
https://ir.pliantrx.com/news-releases/news-release-details/pliant-therapeutics-announces-positive-data-integris-ipf-phase
https://finance.yahoo.com/news/pliant-therapeutics-plrx-surges-44-152103262.html
https://ir.pliantrx.com/press-releases
https://pliantrx.com/scientific-founders/
Good luck,
Farrell
Good to hear the progress in SW African oil fields.Thanks for posting.
Farrell
Not so strange articles regarding the Kevetrin's P53 modulating properties against malignancies:
https://pubmed.ncbi.nlm.nih.gov/32945487/
Kumar A, Hiran T, Holden SA, Chafai-Fadela K, Rogers S, Ram S, Menon K. Kevetrin™, a novel small molecule, activates p53, enhances expression of p21, induces cell cycle arrest and apoptosis in a human cancer cell line. Cancer Res. 2011;71:4470.
Kumar A, Holden SA, Chafai-Fadela K, Ram S, Menon KE. Kevetrin targets both MDM2-p53 and Rb-E2F pathways in tumor suppression. Cancer Res. 2012;72:2874
Kumar A, Brennan DP, Chafai-Fadela K, Holden SA, Ram S, Shapiro GI, Menon GI. Kevetrin induces p53-dependent and independent cell cycle arrest and apoptosis in ovarian cancer cell lines representing heterogeneous histologies. Cancer Res. 2017;77:322.
Shapiro G, Supko JG, Cho DC, Hilton JF, Hadfield M, Pruitt-Thompson S, Bordoli-Trachsela E, Zvereva N, Wolanski A, Sato-DiLorenzo A, et al. A phase I, dose-escalation, safety, pharmacokinetic, pharmacodynamic study of thioureidobutyronitrile, a novel p53 targeted therapy, in patients with advanced solid tumors. J Clin Oncol. 2013;31(Suppl 15):TPS2627. doi: 10.1200/jco.2013.31.15_suppl.tps2627. - DOI
https://www.annalsofoncology.org/article/S0923-7534(19)34531-4/fulltext#back-bb0215
GLTA, Farrell
From Basilea Pharmaceuticals 5/22/2022
It appears Brilacidin is on Basileas radar as an antibiotic. The new Brilacidin antifungal findings should only make Basilea more interested.
JMO
GLTA, Farrell
https://www.edisongroup.com/publication/renewed-focus-on-anti-infectives/30855/
"To increase focus and momentum in the anti-infective pipeline we expect Basilea to actively engage in licensing and/or transaction deals for further clinical-stage, anti-infective assets. Here, we envisage the company proceeding with licensing or the outright purchase of assets that are indicated against resistant bacteria/fungi and/or in Phase II or III and/or possess a novel mechanism of action. Examples of such assets are displayed in Exhibit 9. We note that these are examples that fit the above criteria but are however not to our knowledge current acquisition or licensing targets for Basilea.
Exhibit 9: Anti-infective assets currently in development
Asset
Company
Indication
Drug class
MOA
Market status
Afabicin
Debiopharm
ABSSSI, bone and joint infections
Benzofuran naphthyridine
Fatty acid synthesis inhibitor
Phase II
Brilacidin (iv)
Innovation Pharmaceuticals
MRSA infections, gram-negative infections.
Defensin mimetic
Host Defence Protein (HDP) regulator
Phase II
CRS3123
Crestone Inc.
Clostridium difficile infection
Diaryldiamine
Methionyl-tRNA synthetase inhibitor
Phase II
Zoliflodacin
Entasis Therapeutics
Gonorrhoea
Spiropyrimidinetrione
type II topoisomerase inhibitor
Phase III
Olorofim
F2G
Invasive aspergillosis
Coccidioidomycosis
Invasive moulds
Orotomide
dihydroorotate dehydrogenase inhibitor
Phase II
Source: Edison Investment Research, Evaluate Pharma
With the anticipated divestment of the oncology pipeline during CY22, we see deals of this kind as a potential near/mid-term value driver for Basilea, considering its experience in the area."
Trago Energy, Namibian Affiliate of Sintana, Completes Transaction in Respect to Its Interests in PEL 90
10:57 am ET October 4, 2022 (Globe Newswire) Print
GlobeNewswireOctober 04, 2022
TORONTO, Oct. 04, 2022 (GLOBE NEWSWIRE) -- Sintana Energy Inc. (TSX-V:SEI) (OTCQB:SEUSF) ("Sintana" or the "Company") is pleased to announce that Trago Energy (Pty) Limited ("Trago"), a Namibian affiliate of the Company, has completed a transaction (the "Transaction") with Chevron Namibia Exploration Limited, a wholly-owned subsidiary of Chevron, in respect of its interest in Petroleum Exploration License 90 ("PEL 90") located in the Orange Basin in Namibia.
Trago will retain a 10% interest in PEL 90 ON Block 2813B. Chevron will carry Trago through initial exploration activities including 3D seismic and drilling of the first exploration well. Post the carry period, Trago will be responsible with approved expenses associated with its interest. Additional terms of the transaction have not been publicly disclosed.
PEL 90 represents one of the most exciting exploration opportunities in the Orange Basin sitting directly above TotalEnergies' Venus-1 oil discovery.
"We are very happy to partner with Chevron in the Orange Basin," said Knowledge Katti, Chairman and CEO of Trago and a Director of Sintana. "This transaction in our emerging, globally significant deepwater province brings partnership with an aligned, highly experienced and committed deep water drilling operator.
"This partnership demonstrates the continuing emergence of Namibia as an important hydrocarbon province, and the timeliness of our entry in March of this year," said Robert Bose, President and Director of Sintana. "We look forward to the near-term exploration activity on PEL 90."
ABOUT SINTANA ENERGY:
The Company is engaged in petroleum and natural gas exploration and development activities in Colombia's Magdalena Basin and five large, highly prospective, onshore and offshore petroleum exploration licenses in Namibia. Sintana's exploration strategy is to acquire, explore, develop and produce superior quality assets with substantial reserves potential.
On behalf of Sintana Energy Inc.,
Great news. Chevron to partner with Sintana in Orange basin PEL 90.
Trago Energy, Namibian Affiliate of Sintana, Completes Transaction in Respect to Its Interests in PEL 90
10:57 am ET October 4, 2022 (Globe Newswire) Print
GlobeNewswireOctober 04, 2022
TORONTO, Oct. 04, 2022 (GLOBE NEWSWIRE) -- Sintana Energy Inc. (TSX-V:SEI) (OTCQB:SEUSF) ("Sintana" or the "Company") is pleased to announce that Trago Energy (Pty) Limited ("Trago"), a Namibian affiliate of the Company, has completed a transaction (the "Transaction") with Chevron Namibia Exploration Limited, a wholly-owned subsidiary of Chevron, in respect of its interest in Petroleum Exploration License 90 ("PEL 90") located in the Orange Basin in Namibia.
Trago will retain a 10% interest in PEL 90 ON Block 2813B. Chevron will carry Trago through initial exploration activities including 3D seismic and drilling of the first exploration well. Post the carry period, Trago will be responsible with approved expenses associated with its interest. Additional terms of the transaction have not been publicly disclosed.
PEL 90 represents one of the most exciting exploration opportunities in the Orange Basin sitting directly above TotalEnergies' Venus-1 oil discovery.
"We are very happy to partner with Chevron in the Orange Basin," said Knowledge Katti, Chairman and CEO of Trago and a Director of Sintana. "This transaction in our emerging, globally significant deepwater province brings partnership with an aligned, highly experienced and committed deep water drilling operator.
"This partnership demonstrates the continuing emergence of Namibia as an important hydrocarbon province, and the timeliness of our entry in March of this year," said Robert Bose, President and Director of Sintana. "We look forward to the near-term exploration activity on PEL 90."
ABOUT SINTANA ENERGY:
The Company is engaged in petroleum and natural gas exploration and development activities in Colombia's Magdalena Basin and five large, highly prospective, onshore and offshore petroleum exploration licenses in Namibia. Sintana's exploration strategy is to acquire, explore, develop and produce superior quality assets with substantial reserves potential.
On behalf of Sintana Energy Inc.,
Sorry to ruffle your feathers. I just posted the article to add context to the previously posted article.
Farrell
In return [For a 1 year extension of the EEZ drilling contract} the oil companies [Total and Angol }agreed to plough an additional $250,000 into social programs [in STP].
https://www.upstreamonline.com/exploration/totalenergies-lands-licence-extension-offshore-sao-tome-principe-as-shell-eyes-wildcat/2-1-1076338
Farrell
Beautiful review.
Should be stickied; Moderators?
GLTA Farre
TPOOX.tecovirimat the only drug approved for smallpox seems to be the only other antiviral being studied for monkeypox besides Brilacidin.
The FDA is looking at very few options for treating the current viral epidemic of monkey pox as welll as other viral disorders.
https://clinicaltrials.gov/ct2/results?cond=monkeypox&term=&cntry=&state=&city=&dist=
https://www.niaid.nih.gov/diseases-conditions/monkeypox-treatment
Good luck,
Farrell