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$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
IMRN 10Q 2/26
IMRN under $2
Immuron achieves record quarterly Travelan® sales
Highlights:
- Record quarterly Travelan® sales of $1,550,240
- Total sales of A$1,565,767 in Q1, FY24
- $1,508,933 increase on Q1, FY23 sales
- 130% higher than pre-pandemic period Q1, FY20 sales
Melbourne, Australia, October 11, 2023: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce record quarterly sales (unaudited net sales) of its over-the-counter gastrointestinal and digestive health immune supplement Travelan®.
Australia
Immuron previously reported (August 9, 2023) that short term stock outages of Travelan® in some wholesalers and pharmacies in the June 2023 quarter was resolved following receipt of GMP Clearance from the Therapeutic Goods Administration (TGA). Immuron has since supplied product to wholesalers who in turn have supplied retail pharmacies.
Sales of Travelan® increased to AUD $1,339,160 in Q1, FY24, compared to AUD $25,565 in Q1, FY23. Sales increased by $940,991 (236%) on the pre-pandemic peak period (Q1, FY20).
This increase partially reflects 3 months (May, June, July) of backorders accrued while awaiting GMP Clearance from the TGA.
Immuron anticipates continued demand for replenishment of Travelan® as retail pharmacies sell to consumers. Australian Bureau of Statistics: short term resident returns in July 2023 were 48% higher than July 2022 and approaching pre-pandemic levels (89% of July 2019)1. Cumulative short term resident returns in the 12 months to July 2023 were 77% of those in the pre-pandemic period 12 months to July 2019. 1
USA
Sales of Travelan® increased to AUD $211,080 in Q1, FY24, compared to AUD $16,614 in Q1, FY23. Sales were lower by $20,499 (-9%) on the pre-pandemic peak period (Q1, FY20).
International Trade Administration Total U.S. citizen international visitor departures from the United States in June 2023 increased 20.2% compared to June 2022 and were 99.4% of total departures in June 2019. 2
..crazy lol .. IMRN$ ...
IMRN under $2
Finally something going up.. IMRN$...
…skip
,,,,,,,We’ll break $3 shortly! FASHOO!!!
,,,,,,,COVER YOU MORONS WEEEEEE!
thanks for the heads up
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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
