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..$2 left for dead..army contract/fda approval/etc..da-moon, loaded...
...reloading IMRN$$;;sleeper money maker for the patient imo, gl...
..will buy back little over $2 and lower, gl..
$IMRN Going up! News! March 07, 2024 (GLOBE NEWSWIRE)
Immuron Announces Positive Results Support Travelan® progress to Phase 3 Clinical Trials in the US
Immuron proceeding to Phase 3 registration strategy with the FDA
Travelan® topline clinical trial results demonstrate protective efficacy with single daily dose
https://finance.yahoo.com/news/immuron-announces-positive-results-support-110000104.html
https://www.immuron.com.au/
Great news! Immuron Announces Positive Results Support Travelan® progress to Phase 3 Clinical Trials in the US
52-week high has been SHATTERED!
Watch thing rocket up out the gate IMO
Already read it earlier this am
It has the runs this morning
Immuron Announces Positive Results Support Travelan® progress to Phase 3 Clinical Trials in the US
https://www.otcmarkets.com/stock/IMRN/news/story?e&id=2788683
..crazy lol .. IMRN$ ...
Gonna hold on here.. IMRN$...
IMRN good News Out running hard
imho
That's great news! Thanks.
Immuron Announces FDA Removed Clinical Hold on New Campylobacter ETEC Therapeutic Paves way for Clinical Trial Initiation
Source: GlobeNewswire Inc.
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases, is pleased to announce that the US Naval Medical Research Center (NMRC) has received approval from the US Food and Drug Administration (FDA) to proceed with the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC) developed in collaboration with Immuron. The FDA has removed a clinical hold on the Investigational New Drug (IND) application allowing the NMRC to proceed with its plans to evaluate the efficacy of the hyperimmune product to prevent infectious diarrhoea cause
https://www.sec.gov/Archives/edgar/data/1660046/000121390023012017/ea173668ex99-1_immuron.htm
I guess for those who Travel a lot, some relief.
,,,,,,,We’ll break $3 shortly! FASHOO!!!
,,,,,,,COVER YOU MORONS WEEEEEE!
Immuron Receives FDA Approval for Travelan IND Application
December 23 2022 - 06:00AM
GlobeNewswire Inc.
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Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases, is pleased to announce that it has received approval from the US Food and Drug Administration to proceed with the clinical evaluation of Travelan. The Investigational New Drug (IND) application to evaluate the efficacy of a single dose of Travelan to prevent infectious diarrhea caused by ETEC is now active.
As a result of this approval the company will proceed with the planned clinical trial in the United States. The safety and protective efficacy of Travelan will be tested utilizing a controlled human infection-model clinical trial design.
Immuron is the sponsor of the IND, and the clinical study will be conducted by the Contract Research Organisation Pharmaron CPC, Inc (ASX announcement October 4, 2022) at its FDA inspected clinical research facility located in Baltimore, Maryland in the USA.
The Phase II clinical trial will evaluate the efficacy of a single dose regimen of Travelan® in a controlled human infection model (CHIM) using the enterotoxigenic Escherichia coli (ETEC) strain H10407. The clinical study aims to enrol up to 60 healthy adult subjects each will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan® (30 subjects) or placebo (30 subjects). Recruitment is planned to be initiated in 1H 2023 with headline results from the clinical trial expected to be reported by year end 2023.
Infectious diarrhea is the most common illness reported by travelers visiting developing countries and among US troops deployed overseas. The morbidity and associated discomfort stemming from diarrhea decreases daily performance, affects judgment, decreases morale and declines operational readiness. The first line of treatment for infectious diarrhea is the prescription of antibiotics. Unfortunately, in the last decade, several enteric pathogens have an increasing resistance to commonly prescribed antibiotics. In addition, travelers' diarrhea is now recognized by the medical community to result in post-infectious sequelae, including post-infectious Irritable Bowel Syndrome and several post-infectious autoimmune diseases. A preventative treatment that protects against enteric diseases, is a high priority objective for the US Military.
This release has been authorised by the directors of Immuron Limited.
COMPANY CONTACT:
Steven Lydeamore
Chief Executive Officer
Ph: +61 (0)3 9824 5254
info@immuron.com
For more information visit: http://www.immuron.com
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Making a run here today
Nice:
Immuron Limited (the “Company”) published one announcement (the “Public Notices”) to the Australian Securities Exchange on April 27, 2022 titled:
- “Immuron Q3 Global Sales up 216% YoY”
btw Immuron warrants expire May 12th ..$10 gl...
Maybe they learned a lesson?..develop Covid pill lol IMRN$..
Sold when director left $4.70..buyer today $3.55 IMRN$...
Covid pill in development same as RVVTF$, gl...
Quiet here, good! ..waiting IMRN$...
Everybody asleep here..one day get woken up imo.. IMRN/W$...
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Immuron Reports Neutralizing activity Against SARS-CoV-2
Key Points:
? | Immuron’s IMM-124E used to manufacture Travelan® and Protectyn® demonstrates antiviral activity against the COVID-19 virus in laboratory studies |
? | Immuron’s technology platform offers a potential new oral therapeutic approach to target SARS-CoV-2 in the GI Tract |
Melbourne, Australia, July 21, 2020: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercialising oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, today is pleased to announce that IMM-124E used to manufacture the company’s flag ship commercially available and over-the-counter gastrointestinal and digestive health immune supplements Travelan® and Protectyn® has demonstrated neutralizing activity against the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19.
The cytopathic effect inhibition cell-based assay was established and performed by 360 biolabs, a Melbourne based Contract Research Organization using the SARS-CoV-2 hCoV-19/Australia/VIC01/2020 virus obtained from Melbourne’s Peter Doherty Institute for Infection and Immunity. The in-vitro assessment of the neutralization of SARS-CoV-2 was performed on four production lots of product used to manufacture Travelan® and Protectyn®. The In-vitro susceptibility of the virus to IMM-124E was determined using the quantitative assay which measures virus replication in the presence of increasing concentrations of the product compared to replication in the absence of the product. The effective concentration of IMM-124E was reported as the concentration of the product at which virus replication is inhibited by 50 percent (EC50) or 90 percent (EC90).
All four production lots produced mean EC50 values of 40.5 to 91.9 ug/mL and inhibited viral replication at concentrations which there was no observed cell toxicity. The concentration of IMM-124E at which virus replication was inhibited by 90 percent (EC90) produced mean EC90 values ranging from 48.7 to 155.4 ug/mL for all four lots tested again at concentrations at which there was no observed cell toxicity. A commercially available high protein milk powder product was used as a placebo in the studies and produced EC50 values greater than the observed cellular cytotoxicity concentration of >4800 ug/mL. The control milk powder inhibited viral replication at doses >25,000 ug/mL and more importantly did not inhibit viral replication at doses which it was cytotoxic to cells.
Another major finding made during the study was that cell viability in the presence of IMM-124E was greatly enhanced when compared to placebo. IMM-124E improved cell viability by 180 to 260% relative to controls. These results indicate that IMM-124E at concentrations which inhibited SARS-CoV-2 replication improved cell viability.
The Type B meeting with the FDA discussed the Chemistry, Manufacturing and Controls including the proposed release testing specifications of the product as well as the planned clinical studies evaluating the safety and efficacy of the product which the company is developing to prevent Campylobacter and ETEC mediated moderate to severe diarrhea.
The FDA were recently provided a Pre- Investigational New Drug (IND) package for the new Hyper-immune therapeutic which specifically targets Campylobacter jejuni capsule and Enterotoxigenic Escherichia coli (ETEC) colonization factor antigen 1. Following FDA review the agency provided a written response to the non-clinical questions posed in the briefing documentation as well as providing additional guidance and comments to support the planned IND submission.
“This is an important milestone in the development of any new drug for therapeutic evaluation. The information obtained from this review will assist in the development of the IND application and provides a clear roadmap forward for conducting the two planned clinical studies next year,” said Dr. Jerry Kanellos, CEO of Immuron Ltd. “The company is also please to inform shareholders that the manufacturing program is proceeding as planned. We have completed the second immunisation campaign and are on schedule to harvest the Hyper-immune colostrum in September this year which will be used to manufacture the drug product that will be used to treat moderate to severe campylobacteriosis and ETEC infections.”
This release has been authorised by the directors of Immuron Limited.
COMPANY CONTACT:
Dr Jerry Kanellos, Ph.D.
Chief Executive Officer
Ph: +61 (0)3 9824 5254
info@immuron.com
For more information visit: http://www.immuron.com
www.immuron.com
Level 3, 62 Lygon Street,
Carlton South, Victoria
AUSTRALIA 3053
Phone: + 61 (0)3 9824 5254
Facsimile: + 61 (0)3 9822 7735
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