Latest news with #Lm
Newsweek
21-05-2025
- Health
- Newsweek
Sausage Recall in 3 States As Listeria Warning Issued
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. A Louisiana-based meat processor is recalling around 100 pounds of sausage products because of potential listeria contamination. Bourgeois Smokehouse, located in Thibodaux, Louisiana, announced the voluntary recall of its ready-to-eat smoked andouille sausage on Tuesday. The affected items were shipped to Rouses Market retail locations in Alabama, Louisiana and Mississippi. Newsweek has contacted Bourgeois Smokehouse via email for comment. Why It Matters The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) warns that consumption of food contaminated with listeria can cause listeriosis, an infection that can be particularly serious for certain groups. Listeriosis can cause fever, muscle aches, headaches, stiff neck, confusion, loss of balance and convulsions, diarrhea and other gastrointestinal symptoms. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. The infection can also be fatal in older adults and people with weakened immune systems. A photo of the Bourgeois Smokehouse sausage product that has been recalled. A photo of the Bourgeois Smokehouse sausage product that has been recalled. Bourgeois Smokehouse What To Know The recall was initiated after a sample of the sausage product tested positive for Listeria monocytogenes during a routine FSIS inspection. The recalled sausages were produced on May 12, 2025. They do not bear an establishment number or the USDA mark of inspection because they were wrapped and labeled in-store at the time of purchase. They have been available for purchase at Rouses Market stores in Alabama, Louisiana and Mississippi since May 13. The FSIS has given the recall a Class I classification, meaning that there is a "reasonable probability that the use of the product will cause serious, adverse health consequences or death." As of Tuesday, there have been no reports of illness linked to the recalled product. What People Are Saying FSIS, said in a January 2024 report on controlling Listeria monocytogenes in ready-to-eat meat and poultry products: "[Ready-to-eat (RTE)] products are of particular concern for contamination with [Listeria monocytogenes (Lm) because they may support the growth of the pathogen during refrigerated storage. In addition, since RTE products are often consumed without further cooking, there is a greater possibility of the occurrence of foodborne illness from these products if they become contaminated." It added: "Lethality treatments such as cooking meat and poultry products generally eliminate Lm; however, RTE products can be re-contaminated by exposure to the environment after the lethality treatment during peeling, slicing, repackaging, and other processing steps. By controlling sanitation in the post-lethality processing environment or implementing interventions in their products, establishments can ensure that their RTE products do not become contaminated with Lm." What Happens Next The FSIS says that anyone experiencing symptoms of listeriosis after consuming these products should seek medical attention. Consumers are advised to check their refrigerators and freezers and discard any products matching the recall details. They can also be returned to the place of purchase. FSIS has encouraged any consumers with questions to contact Bourgeois Smokehouse at 985-447-1604 or bourgeoissmokehouse@
Business Wire
07-05-2025
- Business
- Business Wire
OS Therapies Announces Issuance of U.S. Patent #12,239,738 Protecting Commercial Manufacturing Market Exclusivity for OST-HER2 in Rare Pediatric Cancer Osteosarcoma and Full Listeria Cancer Immunotherapy Platform into 2040
NEW YORK--(BUSINESS WIRE)--OS Therapies (NYSE-A: OSTX) ('OS Therapies' or 'the Company'), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced the issuance of United States Patent #12,230,738 protecting proprietary commercial manufacturing methods for the Company's listeria monocytogenes (Lm) cancer immunotherapy platform technology into 2040. The Company is seeking to gain FDA approval for lead asset OST-HER2 in the treatment of pediatric recurrent, fully-resected, lung metastatic osteosarcoma by the end of 2025. Phase 3-stage OST-AXIL for HPV, Phase 2-stage OST-503 for NSCLC & GBM, Phase 1-stage OST-504 for Prostate cancer, 8 pre-clinical stage immunotherapy candidates are also protected under this patent. The patent also covers OST-HER2's use in canine osteosarcoma. 'The issuance of this patent covering commercial manufacturing for the entire listeria monocytogenes platform breathes new life into our pipeline, giving us the exclusive ability to develop this exciting field of cancer immunotherapy,' said Paul Romness, CEO of OS Therapies. 'Potential FDA approval of OST-HER2 in Osteosarcoma would bring a Priority Review Voucher valued at least $150 million. This non-dilutive capital will allow us to expand OST-HER2 use into metastatic & frontline osteosarcoma, and other HER2 positive cancers. The issuance of this patent resets the clock in terms of creating value from the over $250 million previously invested in the platform. Additionally, this positions OS Therapies to develop three (3) clinical and eight (8) pre-clinical assets that could improve the standard of care in a variety of cancers.' OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to sell immediately. The most recent PRV sale valued at $150 million occurred in February 2025. The osteosarcoma treatment market was estimated at $1.2 billion in 2022 according to Data Bridge Market Research. Approximately 50% of patients are diagnosed with a lung metastasis at some point following chemotherapy. The Company believes the market opportunity for OST-HER2 in the prevention of lung metastases is over $500 million. Human and Canine OST-HER2 patients are featured in the upcoming movie Shelter Me: The Cancer Pioneers. The movie focuses on canine/human comparative oncology, a field that compares treatment of cancers in dogs to those in people, and covers developing treatments for rare forms of cancer. The movie airs live and via streaming on PBS May 15, 2025. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for osteosarcoma and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency. The Company has demonstrated positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a BLA to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and grant of a priority review voucher and other risks and uncertainties described in 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' in the Company's registration statement on Form S-1 filed with the Securities and Exchange Commission (the 'SEC') on November 12, 2024, as amended on November 27, 2024, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
