Latest news with #Kersten
Business Wire
23-04-2025
- Business
- Business Wire
CEL-SCI to File for Regulatory Approval of Multikine in Saudi Arabia—Pursuing Local Partnerships for Commercialization and Manufacturing to Serve Middle East and North Africa Market
VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced that it met with the Saudi Food and Drug Authority (SFDA) to discuss the development of Multikine cancer immunotherapy* (Leukocyte Interleukin, Injection), the vast amount of Multikine data available to support a marketing application for its use as a treatment of head and neck cancer, and the possible pathways to a marketing application in Saudi Arabia. Our data was well received by the SFDA in a recent meeting. In consideration of their response, our intention is to file for Conditional Approval of Multikine with Breakthrough Therapy designation based on our completed Phase 3 data. Share Based on discussions with the SFDA, CEL-SCI is preparing to submit a regulatory filing for the approval of Multikine as a neoadjuvant (pre-surgical) treatment of newly diagnosed previously untreated locally advanced head and neck cancer. The submission will be made based on all data from CEL-SCI's concluded 928-patient randomized controlled Phase 3 study and is expected to be filed as a Conditional Approval with Breakthrough Therapy designation. The SFDA's usual response time for a complete submission for such an application is thought to be approximately 60 days after filing. 'Our data was well received by the SFDA in a recent meeting. In consideration of their response, our intention is to file for Conditional Approval of Multikine with Breakthrough Therapy designation based on our completed Phase 3 data,' stated CEL-SCI CEO Geert Kersten. 'In alignment with the Saudi Kingdom's Vision 2030 initiatives, we are currently evaluating potential partnerships with local Saudi companies to commercialize Multikine, conduct clinical trials in Saudi hospitals and to establish a local Multikine manufacturing facility that would serve the entire Middle East and North Africa (MENA) market. We envision such a partnership encompassing funding, regulatory support, post-approval commercial launch, and distribution,' Kersten concluded. The Kingdom of Saudi Arabia's Vision 2030 includes a National Biotechnology Strategy, which is poised to position the Kingdom as a regional and global biotech hub with a far-reaching impact in biomanufacturing and medical innovation. The National Biotechnology Strategy aims to establish an advanced local bio-manufacturing platform to boost the Kingdom's self-sufficiency in producing biologics and biosimilars, enable global export opportunities, drive growth of the broader biotech sector in the Kingdom, and reduce healthcare costs. The incidence of head and neck cancer in the MENA region is expected to double by 2030, from incidence levels cited in a 2012 study. This rate of increase is two times higher than that of the projected worldwide incidence rate. In the Gulf Cooperation Council countries (GCC) of Saudi Arabia, Bahrain, Oman, Kuwait, Qatar, and the United Arab Emirates, the incidence risk of head and neck cancer is estimated to be 1.6%. About CEL-SCI Corporation CEL-SCI believes that boosting a patient's immune system before surgery, radiotherapy and chemotherapy have damaged it, should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital, inability to finalize a partnering agreement and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2024. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. * Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
South China Morning Post
02-04-2025
- Sport
- South China Morning Post
Hong Kong cyclists storm to Tour of Thailand glory, as Australian coach makes golden start
Hong Kong road endurance coach Ben Kersten has overseen the first triumph of his reign, after the city's women's team won the three-day Tour of Thailand. Advertisement Star athlete Ceci Lee Sze-wing was second in the individual race, behind fourth-time winner Jutatip Maneephan. Lee claimed the white jersey awarded to the best young rider. Kersten, the former Australian Cycling Academy managing director, was appointed last month. Soon after, he led a six-strong men's contingent to the five-stage Tour of Taiwan, where 70th-placed Cheung Shi-ho was Hong Kong's best performer. In Thailand, however, Australian Kersten masterminded success for the quintet of Lee, Leung Wing-yee, Leung Bo-yee, Yang Qianyu and Kwan Tsz-kwan. 'It's a positive start for Ben with Hong Kong … it's his first time with the women's team, he's an experienced coach, and he gave them good plans and a lot of confidence,' said Herve Dagorne, the Hong Kong head coach, who had sought reassurances before his team travelled on the situation in Thailand following last week's deadly earthquake in the country. Advertisement 'On every stage, the team worked very hard together and followed the strategy, so it's encouraging for [November's] National Games, when the race will also be flat. It's good for the team's morale – they will come back feeling confident.'
Yahoo
11-03-2025
- Business
- Yahoo
Afternoon Briefing: Real ID ‘supercenter' will open to handle rush
Good afternoon, Chicago. Rancor among the staff at the Civilian Office of Police Accountability was the driving force behind the recent effort to remove the agency's former chief administrator, Andrea Kersten, records obtained by the Tribune show. The Community Commission for Public Safety and Accountability — the city body overseeing the leaders of COPA, the Chicago Police Department and police board — wrote Kersten on Jan. 28 to tell her of a planned no-confidence vote regarding her overseeing COPA. Persistent complaints and concerns about oversight within COPA, the agency's workplace culture, the quality of investigations, as well as Kersten's own public statements and appearances were chief among the reasons highlighted by CCPSA. Here's what else is happening today. And remember, for the latest breaking news in Chicago, visit and sign up to get our alerts on all your devices. Subscribe to more newsletters | Asking Eric | Horoscopes | Puzzles & Games | Today in History The Illinois secretary of state's office is opening a Real ID 'supercenter' in Chicago's Loop to meet a growing demand for the document ahead of a federal May 7 deadline. Read more here. More top news stories: Multiple businesses hit in early morning smash and grab Suburban businessman created phony immigration narratives to win asylum for foreign clients, feds say From the tiny North Chicago Housing Authority to the behemoth Chicago Housing Authority, local housing agencies are seeing their voucher recipients struggle and fail to find housing. Read more here. More top business stories: New names could be in store for Metra lines, as agency sues Union Pacific during takeover of UP routes Southwest Airlines breaks with another tradition and checked bags will cost you now After a bumpy patch in mid-February, the Illini finished the regular season with three straight convincing victories: against Iowa, at then-No. 15 Michigan and the finale at home against the Boilermakers, who had won five straight in the rivalry. Read more here. More top sports stories: Chicago White Sox notes from camp: Evaluating shortstop options — and Sean Burke's 'sharp' breaking stuff 5 takeaways from the Chicago Blackhawks' 3-0 loss, including Artyom Levshunov's debut and Spencer Knight's chin music Thanks to a $10 million gift from an anonymous donor, Chicago's Museum of Contemporary Art says it plans to greatly expand its live performance offerings in its 300-seat Edlis Neeson Theater, a much-admired performance space with a substantial seating capacity and an enviable location off the Magnificent Mile. Read more here. More top Eat. Watch. Do. stories: Lyric Opera's 2025-26 season includes 'Madama Butterfly' and Billy Corgan revisiting 'Mellon Collie' Out of Space and ARC music fests announce their 2025 lineups The president says the increase of the tariffs set to take effect tomorrow is a response to the price increases that the provincial government of Ontario put on electricity sold to the United States. Read more here. More top stories from around the world: Trump administration to resume military aid to Ukraine and intelligence sharing Ann Coulter questions effort to deport Columbia student Mahmoud Khalil
Chicago Tribune
11-03-2025
- Politics
- Chicago Tribune
Afternoon Briefing: Real ID ‘supercenter' will open to handle rush
Good afternoon, Chicago. Rancor among the staff at the Civilian Office of Police Accountability was the driving force behind the recent effort to remove the agency's former chief administrator, Andrea Kersten, records obtained by the Tribune show. The Community Commission for Public Safety and Accountability — the city body overseeing the leaders of COPA, the Chicago Police Department and police board — wrote Kersten on Jan. 28 to tell her of a planned no-confidence vote regarding her overseeing COPA. Persistent complaints and concerns about oversight within COPA, the agency's workplace culture, the quality of investigations, as well as Kersten's own public statements and appearances were chief among the reasons highlighted by CCPSA. Here's what else is happening today. And remember, for the latest breaking news in Chicago, visit and sign up to get our alerts on all your devices. Real ID 'supercenter' opens in Loop this week to handle rush ahead of May 7 deadline The Illinois secretary of state's office is opening a Real ID 'supercenter' in Chicago's Loop to meet a growing demand for the document ahead of a federal May 7 deadline. Read more here. Housing authorities look for solutions as voucher recipients fail to lease units with rental subsidies From the tiny North Chicago Housing Authority to the behemoth Chicago Housing Authority, local housing agencies are seeing their voucher recipients struggle and fail to find housing. Read more here. More top business stories: Big Ten Tournament preview: Illinois heads to Indianapolis on a roll — while Northwestern sneaks into field After a bumpy patch in mid-February, the Illini finished the regular season with three straight convincing victories: against Iowa, at then-No. 15 Michigan and the finale at home against the Boilermakers, who had won five straight in the rivalry. Read more here. More top sports stories: Chicago White Sox notes from camp: Evaluating shortstop options — and Sean Burke's 'sharp' breaking stuff 5 takeaways from the Chicago Blackhawks' 3-0 loss, including Artyom Levshunov's debut and Spencer Knight's chin music With a major new donation, the MCA will ramp up live performance in its theater Thanks to a $10 million gift from an anonymous donor, Chicago's Museum of Contemporary Art says it plans to greatly expand its live performance offerings in its 300-seat Edlis Neeson Theater, a much-admired performance space with a substantial seating capacity and an enviable location off the Magnificent Mile. Read more here. More top Eat. Watch. Do. stories: Lyric Opera's 2025-26 season includes 'Madama Butterfly' and Billy Corgan revisiting 'Mellon Collie' Out of Space and ARC music fests announce their 2025 lineups The president says the increase of the tariffs set to take effect tomorrow is a response to the price increases that the provincial government of Ontario put on electricity sold to the United States.
BBC News
11-03-2025
- Health
- BBC News
'Meat intolerance': Can our bodies forget how to digest flesh?
Some people who stop eating meat have reported unpleasant effects when they return to it. Can your body forget how to digest flesh? Eating less meat is one of the simplest ways to reduce your carbon footprint. If everyone in the UK moved to a low-meat diet, eating less than 50g, or one Cumberland sausage's worth of meat a day, it would save as much carbon as if eight million cars were parked for good, researchers have calculated. Data from the UK government shows that meat consumption is dropping – between 1980 and 2022, consumption of beef, pork, and lamb fell by 62% – and though the reasons cited vary, and may have more to do with rising costs than an environmental conscientiousness, more and more people are clearly experimenting with saying no to meat. But if you go a long time without eating it, does that change your body's ability to digest it? Vegetarians and vegans sometimes post on social media, asking whether going back to meat could cause stomach pain, bloating, and other symptoms. Others weigh in with their own experiences, and a great, late-night whirlwind of curiosity and cramps is born. However, there isn't much research on whether consuming meat after a long break can trigger an upset stomach, says Sander Kersten, a professor of nutrition at Cornell University in the US. "A lack of evidence doesn't mean it doesn't exist, it's just that people haven't studied it," he reflects. "That's not always a satisfying situation or answer, but it's just what you have to deal with sometimes." It is possible – though it is very rare – to be allergic to meat. Alpha-gal syndrome, in which the immune system recognises animal proteins as invaders, can lead to anaphylaxis and death. But this allergy, which can crop up after a lifetime of cheerful meat eating, is not related to switching to a low-meat diet. You can, for example, develop the condition after a tick bite. For many who are avoiding meat, discovering that they have unknowingly consumed it can be emotionally painful – it can feel like a personal violation, says Kersten, who is a vegetarian himself. "That would make some people extremely sad," he explains. " I don't know if that would lead to physical symptoms. It certainly could trigger a lot of anger." But when you consider the biology of digestion, it is not as plausible as you might imagine that the body could, over a long period of time, lose the ability to digest meat. Meat is generally very easily digested, unlike the fibre in fruits, vegetables, and legumes. To break that up, our bodies require help from our microbiome, whose microbes do possess the enzymes necessary for digesting it. Moreover, the enzymes used to digest plant proteins are the same as those used on meat proteins. These enzymes recognise and sever particular chemical bonds in proteins. Whether they come from plants or animals, the proteins are made of building blocks called amino acids. Enzymes can generally break them up no matter where they came from. This process is different from the case of, say, animal milk sugars like lactose. To digest lactose, your body requires a specific enzyme called lactase, and people who do not produce enough of the enzyme, making them lactose intolerants, can suffer a tummy upset after eating dairy products. But with meat proteins, it does not make sense to think of the body somehow ceasing to make the enzymes necessary to digest a hamburger comfortably – they're always there, breaking down any protein that comes through, be it from pea, soybeans, or steaks, says Kersten. The human gut microbiome does morph and change depending on what its host eats, though. Sometimes this means that the specific types of bacteria there change; sometimes it's just that the microbes make other enzymes. While there are differences between the microbiomes of omnivores and vegetarians and vegans, they do not seem to be radically divergent, so long as the omnivores consume a variety of plants, research has found. Microbiomes can shift quickly as a result of dietary changes, however – one study in which people switched to a fully animal-based diet showed that a shift away from their baseline microbiome was visible within a day (it swiftly reverted back to normal once the diet ended). Subjects were encouraged to report any discomfort they felt, but nothing made it into the paper. More like this:• How a month of abstinence can lead to meat disgust• The rise and fall and possible rise of the oyster• The complicated history of gelatine If anything, it's the sudden consumption of large amounts of fibre after a long hiatus that could cause digestive problems. It's better to ease into such dietary changes. "Depending on the fibre, you can have some pretty strong reactions to it," says Kersten. In short, worrying about your body somehow losing the ability to digest meat shouldn't impair any plans you have to extend Veganuary into the spring. If you're among those who've had an upset stomach after eating meat following a long hiatus, a loss of enzymes is not likely to be the culprit, though this phenomenon remains understudied, Kersten says. "The body is quite adaptable," he continues. "It can do more than you think." --
