<!– –> A still from Sultan Of Delhi. (courtesy: YouTube) All show and no substance: that is the sum total of Sultan of Delhi. A period crime drama that ambles leaden-footed through the dregs of a troubled city in the years following the carving up of the subcontinent into India and Pakistan, it is a right royal trudge. It is about a Partition riots survivor who seeks to work his way out of the horrors of history and fight for a foothold on a slippery heap where gain and loss, friendship and animosity, go hand in hand. Sultan of Delhi, created and directed by Milan Luthria from a screenplay by co-director Suparn S. Varma, is a blood-soaked tale all right, but its depiction of a city and its underbelly is far from full-blooded. The Hotstar Specials series is ambitious in scale – it is a story of loyalty, ambition and treachery set in the first couple of decades of free India – but the execution is anything but grand. Tepid, if not turgid, the show lacks the energy and momentum to rustle up moments that hit home. Sultan of Delhi makes its lumbering way through a string of gunfights and slugfests, hints of perfunctory romance (and loads of bromance, too), a whole lot of toxic masculinity (of desperate men who believe that the world is theirs for the asking) and an overload of riddles (which are posed by a robber-baron to begin with and then assume the nature of a mind game between him and his accomplices and adversaries). The series revolves around Arjun Bhatia (Tahir Raj Bhasin), who, 17 years after the Partition riots, has learnt to live down his past and go for broke in a dog-eat-dog world. He is a master-mechanic driven by a passion for cars that enable him to zoom into the big league in a hurry. [embedded content] With his loyal friend Nilendu alias Bangali (Anjum Sharma), the young hustler works for Jagan Seth (Vinay Pathak), a businessman with political ambitions. Arjun falls in love with a wealthy man’s daughter Sanjana (Mehreen Pirzada) but his path, as he is to find out soon, isn’t strewn with roses. Sultan of Delhi begins with a meeting of a half a dozen ageing men whose writ runs over the city’s underworld. The convener of the gathering of rogues is Farooq Mastaan (Anil George), who advises the gang lords to work in unison and names Arjun as a first among equals, the man who will henceforth call the shots. A couple of the old fogeys do not take kindly to the prospect of a rookie being handed the reins of their operations. Arjun whips out a gun. Cut. The rest is more hysteria than history, peppered with exploits of men going all out to change their individual and collective destinies. Arjun has his own way of dealing with tricky situations such as the one in the opening sequence. There is worse ahead. His principal foe is Rajinder Pratap Singh (Nishant Dahiya), son of a businessman who made his fortune by profiting from the misery of refugees. The lines separating good and evil are not only blurred but completely eliminated as Rajinder, egged on by Shankari (Anupriya Goenka), the manipulative mistress he has willingly inherited from his father, conspires to push Arjun off the pedestal that Jagan Seth has given him. The lacklustre show does away with the layers that are an integral part of the book it is adapted from – Sultan of Delhi: Ascension, written by Arnab Ray. The narrative vacuum that is created as a result is hard to offset. The titular city, the tumultuous 1960s and the tough men who joust for control over a crime network run by slimy businessmen and smarmy politicians are mere cardboard pieces in a haphazard jigsaw that does not quite add up. Many of the crucial elements of the plot, especially the setting, are short on authenticity. Neither the milieu nor the period creates an impression. Nobody in the show lives in real homes. Everybody owns a mansion that sprawls across of acres of land in the middle of nowhere. One does not see enough of Delhi, barring establishing aerial shots of Qutub Minar at different times of day and night. These feel more like stock footage than fundamental parts of the visual design. The streets, the houses, even a ritzy hotel and its environs – nothing bears any resemblance to what the city might have looked like back then. Early on, Sultan of Delhi offers glimpses of a Lajpat Nagar refugee camp, where a boy ends up with his father after the rest of his family has been wiped out in Lahore. It also takes the audience into Chawri Bazaar, Paharganj and other parts of Old Delhi. They are akin to drop-in settings, as counterfeit as the show’s general depiction of people, places and politics. Parts of Sultan of Delhi play out in Calcutta. Here too, one sees nothing of the city. The show’s understanding of leftist political activism of the 1960s is limited to the presence of a filmmaker simply called Roy Babu. He masterminds bank heists. It isn’t robbery, it is rebellion, the man insists. The money belongs to the poor, he asserts. In Delhi, too, all that it takes for a moneyed man to get an election ticket is a threatening phone call a cocky coquette makes to a political party supremo. The lady believes that she holds all the aces. She isn’t wrong, but the show is determinedly male-dominated and allows her limited play despite the sway she apparently has over the men around her. If only the script had allowed her the room she deserves – Anupriya Goenka plays the role with a mix of controlled intensity and come-hither allure – Sultan of Delhi may have found some meaningful narrative spaces to explore. The script metes out pretty much the same treatment to Mouni Roy, cabaret dancer at a Calcutta nightclub who
Federal officials are still looking for the cause of an outbreak of Salmonella Thompson infections. According to an update from the Food and Drug Administration, the outbreak continues to grow, with 67 patients having been confirmed so far. The FDA first reported the outbreak on Oct. 4 but has not reported where the outbreak patients live. Investigators have begun traceback efforts, but the FDA is not reporting what food or foods are being traced. The agency has not yet begun sample collection or on-site inspections. There has been at least one recent Salmonella infection in a South Carolina resident, but it is unknown if the patient is part of the FDA’s current investigation. Recently, at least five Salmonella outbreaks have been linked to cantaloupe, including one this year. A spokesperson with the Centers for Disease Control and Prevention told Food Safety News that the agency is not currently investigating Salmonella infections involving South Carolina residents and cantaloupe. About Salmonella infectionsFood contaminated with Salmonella bacteria does not usually look, smell, or taste spoiled. Anyone can become sick with a Salmonella infection. According to the CDC, infants, children, seniors, and people with weakened immune systems are at higher risk of serious illness because their immune systems are fragile. Anyone who has developed symptoms of Salmonella infection should seek medical attention. Sick people should tell their doctors about their possible exposure to Salmonella bacteria because special tests are necessary to diagnose salmonellosis. Salmonella infection symptoms can mimic other illnesses, frequently leading to misdiagnosis. Symptoms of Salmonella infection can include diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating contaminated food. Otherwise, healthy adults are usually sick for four to seven days. In some cases, however, diarrhea may be so severe that patients require hospitalization. Older adults, children, pregnant women, and people with weakened immune systems, such as cancer patients, are more likely to develop severe illness and serious, sometimes life-threatening conditions. Some people get infected without getting sick or showing any symptoms. However, they may still spread the infections to others. (To sign up for a free subscription to Food Safety News,click here)
A blood test that could detect multiple cancers at their earliest stages has long been a dream of the medical community. Now results from a pilot study, published in The Lancet, suggest that a single blood test might identify the presence of more than 50 cancer types. The experimental test analyzes DNA shed from cancer cells into the bloodstream, looking for telltale genetic “cancer signals.” The goal is to detect these early signs of cancer well before symptoms occur or results are obtained from other diagnostic methods. This kind of test is often called a liquid biopsy. The study is preliminary but included two important findings: Nearly half of the newly diagnosed cancers were identified at an early stage. The test detected many cancer types for which there are no current screening tests endorsed by the U.S. Preventive Services Task Force, the regulatory authority that influences health insurance coverage. “This work is still preliminary, but it is provocative and could represent a future approach to cancer diagnosis and screening,” says Deb Schrag, MD, MPH, Chair of the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSK) and first author of the manuscript published in The Lancet. “We need further research to confirm this approach to screening will translate into meaningful clinical benefits. Early Cancer Detection Results In the study, called PATHFINDER, more than 6,600 patients who did not have signs of cancer agreed to submit a blood sample for testing. If a cancer signal was detected, the test also indicated where the cancer likely started to focus further diagnostic tests that could give a more definitive answer. Overall, a cancer signal was detected in 92 patients — about 1.5% of those screened. In about a third of those patients, cancer was confirmed. The other two-thirds of patients with initial positive results did not turn out to have cancer. “The blood test is not definitive that someone has cancer,” Dr. Schrag says. “The test identifies people for further diagnostic evaluation. About 1 in 3 whose screening test was positive were ultimately confirmed to have a cancer.” Many cancer screening tests, such as mammograms for breast cancer or low-dose computed tomography (CT) scans for lung cancer, can produce false positive results. In that regard, this test was no different, says Dr. Schrag. Like all screening tests, this test generated “false positives,” which then required time, effort, and expense to resolve. However, the percentage of false positives was relatively low when considering the overall number of people being screened, Dr. Schrag notes. Lethal Cancer Types Might Be Caught Early Importantly, the test resulted in early detection for cancer types that are considered rare, including cancers of the bile duct, small intestine, and pancreas, which are not likely to be found during routine physical examination or current screening. The results were based on analyzing DNA circulating in the bloodstream — known as cell-free DNA, or cfDNA. The test is made by the biotech company GRAIL, which sponsored this study. Researchers looked for cancer signals derived from methylation patterns. Methylation, a chemical modification of DNA, is one of the factors that influences gene expression and can be significantly altered in cancer cells. The participants in the PATHFINDER trial were from outpatient clinics across seven U.S. healthcare systems. Patients were recruited from December 2019 to December 2020, when Dr. Schrag, who joined MSK in 2021, worked at the Dana-Farber Cancer Institute. The study included adults over 50, with and without elevated cancer risk. Elevated risk was based on having one or more of the following: A personal history of cancer at least three years earlier A history of tobacco use Genetic risk A strong family history of cancer Dr. Schrag explains that including patients who already survived one type of cancer was strategic for multiple reasons: These people face increased risk of developing a new cancer type as well as recurrence of the initial cancer. Recruiting high-risk patients decreases the total number of participants required to answer a research question. Cancer survivors are likely to have a deep understanding of what blood testing and imaging studies entail, and they are well-informed to make decisions about participation in this type of research. Cancer survivors are motivated to participate in research if it has even a small chance of helping others avoid the ordeal of cancer treatment. Dr. Schrag cautions that the results from this study are preliminary. Validating the clinical usefulness of liquid biopsy testing to screen for multiple cancers simultaneously will require a randomized trial that recruits a diverse group of patients. New studies are already underway — including one called PATHFINDER2 — to evaluate the test in a larger and more diverse U.S. population. There is also an important randomized trial evaluating cancer detection in people who had the liquid biopsy test compared with those who did not in patients from the U.K.’s National Health Service. Results from this study are expected in a few years. The PATHFINDER results are early but significant: They show the feasibility of a new means of early cancer detection. “This is the brave new world of testing. And although lots more work must be done before this approach becomes standard, it could eventually transform cancer diagnosis and treatment,” Dr. Schrag says.
MADISON, Wis. (WMTV) – The Leukemia and Lymphoma Society held Light the Night on Thursday, an event dedicated to raising awareness and funds for blood cancer research and support. The event was held at the Henry Vilas Zoo for the first time, but the mission of LLS remains the same- no one has to fight blood cancer alone. “Light the night is a national fundraiser for lls that was actually started right here in Wisconsin 30 years ago,” explained LLS board member Steve Stumbris. “The greatest thing about tonight is really gives everybody the courage and strength to ask how they can help and how they can help put an end to blood cancers.” Sports Director Mike Jacques was once again the emcee for the event and was lucky enough to have his picture taken wtih four-time cancer survivor Liam Sanborn. Click here to download the NBC15 News app or our NBC15 First Alert weather app. Copyright 2023 WMTV. All rights reserved.
Eleni Thomas ❘ Published: 2023-10-13T02:23:36 ❘ Updated: 2023-10-13T02:23:50 TikToker Southerspore is going viral on the platform after revealing that he recreated the cordyceps mushrooms using his own flesh and blood, even going so far as giving the fungus a taste on the video. While the Cordyceps mushrooms do exist in the real world, The Last of Us cleverly mixes this reality with a zombie twist, implying that the effects that these mushrooms have been able to affect humans and in turn, transform them into the mindless infected that feature within the apocalypse of the game and television series. Article continues after ad One TikToker named Southerspore has now gone viral on the platform after revealing how he grew cordyceps using his own blood and skin. The video, which currently has over 800k views, has garnered some strong reactions from fans of The Last of Us. Article continues after ad In their bio, the content creator writes that they are a “mushroom man growing gourmet mushrooms.” However, this is the first time that they have ever attempted to recreate The Last of Us’ virus. Article continues after ad “This is cordyceps, the zombie fungus and I grew it off my own blood and skin,” begins Southernspore. The content creator then proceeded to take the fungus out of the jar he had grown it in, cutting it in half and breaking down the process of creating it. He zoomed in on his initial skin flakes he used in the creation and compared it to what it transformed into after merging with the fungus. Subscribe to our newsletter for the latest updates on Esports, Gaming and more. Article continues after ad The microscopic images of the creation show visible differences between the skin before and after the cordyceps. After going through the science behind the creation, he then actually takes the mushroom, stating that it is “strangely sweet” and states that he would “eat it again.” Article continues after ad The video is filled with comments from fans of The Last of Us, many jokingly berating the content creator for fast-tracking the zombie apocalypse. One user wrote “Teaching cordyceps to consume human tissue, what could go wrong?” Others added “Bro tryna speedrun the last of us” and “Bro there’s a whole game on why this shouldn’t happen.” Article continues after ad At the end of the video, he says that he would be willing to do the experiment again. Therefore, we’ll be sure to keep you updated if and when he does and what the results turn out like the next time around. Article continues after ad For all the latest entertainment news and updates, be sure to check out Dexerto’s full coverage here.
image: Steve Gisselbrecht, a research specialist in the genetics division at Brigham and Women’s Hospital, is pictured donating platelets with technician Don Marks in accordance with the more inclusive blood donation process approved by the FDA and adopted at the Kraft Family Blood Donor Center on Oct. 6. Gisselbrecht, who hadn’t been permitted to donate blood products since high school, said “it hurt every time” he learned of an urgent need for blood but knew he would be disqualified from donating due to his sexual orientation. “Being first to donate [under the updated guidelines at the Kraft Center] wasn’t a goal. I just wanted to donate,” he said. “I would have been donating blood this whole time.” view more Credit: Courtesy of Kraft Family Blood Donor Center Boston – The Kraft Family Blood Donor Center, which provides lifesaving blood products to patients at Dana-Farber Cancer Institute and Brigham and Women’s Hospital, announced today that it has finished implementing a more inclusive blood donation process, in alignment with updated guidelines issued by the U.S. Food and Drug Administration (FDA) that will allow many gay and bisexual men to donate blood and platelets. On May 11, 2023, the FDA changed its policy to reflect that deferring prospective blood donors based on sexual orientation is no longer supported by data. The Kraft Family Blood Donor Center announced its strong support of this policy change at that time and has now concluded the technical updates required to welcome many who were previously deemed ineligible to donate. “This policy change is long overdue in welcoming everyone who wishes to contribute to our collective humanitarian mission,” said Richard Kaufman, MD, medical director of the Kraft Family Blood Donor Center and Transfusion Medicine at Brigham and Women’s Hospital. “The Kraft Family Blood Donor Center is proud to join the blood donation centers across the country in its commitment to treating all potential blood donors with equity and respect while ensuring a safe, sufficient blood supply for patients in need.” In alignment with the new donor criteria, The Kraft Family Blood Donor Center will continue to screen eligible donors through an individual risk-based questionnaire, which will be the same for everyone, regardless of sexual orientation, sex or gender. Donors can make an appointment to give blood or platelets by calling 617-632-3206 or emailing [email protected]. Walk-ins are welcome at the center at 35 Binney St. in Boston, MA. ## Caption: Steve Gisselbrecht, a research specialist in the genetics division at Brigham and Women’s Hospital, is pictured donating platelets with technician Don Marks in accordance with the more inclusive blood donation process approved by the FDA and adopted at the Kraft Family Blood Donor Center on Oct. 6. Gisselbrecht, who hadn’t been permitted to donate blood products since high school, said “it hurt every time” he learned of an urgent need for blood but knew he would be disqualified from donating due to his sexual orientation. “Being first to donate [under the updated guidelines at the Kraft Center] wasn’t a goal. I just wanted to donate,” he said. “I would have been donating blood this whole time.” Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.
Researchers have developed a more convenient way of measuring omega-3 fatty acid levels in the blood, an important biomarker of disease risk. The faster, simpler test will make it easier for healthcare professionals to obtain critical information about cardiovascular and cognitive health. Omega-3 fatty acids have been linked to health benefits, but our bodies don’t produce enough naturally, so we need to get it from what we eat. Two key omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), can only be derived from certain sources, such as oily fish and seafood, enriched foods and supplements. The omega-3 index (O3I) is the sum of the EPA and DHA found in the membranes of red blood cells. It is a novel biomarker of cardiovascular disease, sudden cardiac death, inflammation, and cognitive dysfunction, independent of traditional risk factors. However, existing tests to measure the O3I require a large amount of blood to be drawn and time-consuming, complicated laboratory work to analyze the omega-3 fatty acid content. As a result, most clinicians don’t routinely measure the O3I. Now, researchers from McMaster University in Canada have developed a simpler, more convenient test for this important biomarker. “Testing for the O3I is a complicated procedure, so it’s not routinely available for patient screening despite the popular use of fish supplements and promising clinical evidence of the many health benefits from optimal omega-3 fatty acid nutrition,” said Philip Britz-McKibbin, corresponding author of the study. “This should make it much more convenient to do routine testing since dosage levels and product formulations differ widely in their exact omega-3 fatty acid composition.” The researchers used multisegment injection-nonaqueous capillary electrophoresis-mass spectrometry (MSI-NACE-MS) to identify circulating phospholipids, particularly phosphatidylcholines (PCs), as surrogate biomarkers of the O3I. MSI-NACE-MS provides faster results and requires only small volumes of blood to be taken. Study participants were given between three and five grams of fish oil, EPA, or DHA supplements daily. The researchers found that serum or plasma concentrations of two circulating PCs provided the strongest correlation to the O3I, reflecting local changes in red blood cells after receiving supplements for a minimum of 28 days. In high-dose fish oil and EPA-only trials, PC (16:0_20:5) was the most responsive phospholipid, whereas PC (16:0_22:6) was selective to DHA-only supplementation. They found that the sum of both PCs in fasting serum or plasma samples was positively correlated to the O3I following fish oil, EPA- and DHA-only supplementation. Overall, DHA was found to be more effective in improving the O3I in the study sample compared to EPA. “In general, if you have an O3I below 4% you may have a higher risk for a cardiovascular-related event,” said Britz-McKibbin. “Conversely, individuals with an O3I above 8% have a lower risk. But since O31 is a modifiable risk factor, you can change it through diet.” The newly discovered biomarkers of the O3I will make it easier to study omega-3 fatty acids from the perspective of population health. “By directly measuring only two specific biomarkers in a blood sample, we can rapidly assess the omega-3 index without time-consuming and costly sample workup protocols prior to analysis,” Britz-McKibbin said. The researchers will next work on identifying a biomarker present in urine, which would eliminate the need to draw blood entirely. The study was published in the Journal of Lipid Research. Source: McMaster University
<!– Hide Mobile side –> SOUTH BEND, Ind. – The need for blood never goes down. Over 60% of the American population is eligible to donate blood, but only about 3% does, according to America’s Blood Centers. After blood drives pretty much halted altogether during the pandemic, blood banks are still working to fully bounce back. The South Bend Medical Foundation (SBMF) now has a new center open on Ireland Rd. in the Erskine Village shopping plaza. This location, on South Bend’s South Side, was chosen to be centrally located where most of the city’s donors are. The South Bend Medical Foundation previously had locations on Lafayette Boulevard downtown and Edison Road in Mishawaka. Those two locations have closed, so now, the regular blood centers are on Ireland Road and Douglas Road in St. Joseph County. SBMF is the primary donor for local area hospitals. For all of October, which is Breast Cancer Awareness Month, SBMF will donate $5 per donor to Hello Gorgeous!, a nonprofit that benefits those battling breast cancer. Nationally, the American Red Cross is pushing for more schools to bring blood drives back. Roughly 25% of donations used to come from educational organization’s blood drives. That figure dipped as low as 10% during the pandemic, according to Kristin Marlow, executive director of the American Red Cross Northwest Indiana chapter. “It’s bounced back to about 20%, but compared to 25, that 5% makes a huge difference,” Marlow said. She said it’s important to establish the next generation of blood donors! “When we get young donors at the high school age, at the college age, we find that it really increases the opportunity for them to be longevity donors,” Marlow said. “They also tend to advocate for the need for blood a little bit more actively.” Share this article:
Intensive care units can collect less blood for lab tests and thereby reduce transfusions for critically ill patients who may have blood drawn multiple times a day, suggests a large study that says switching to lower-volume tubes can preserve the blood supply and reduce strain on already fragile patients. Researchers note that 90 per cent of blood collected by a standard test tube — which can draw up to six millilitres — is wasted because only 0.5 ml of blood is needed for a typical lab test. They compared the use of regular and lower-volumetubes for tests involving 27,000 patients at 25 intensive care units in Quebec, Ontario, New Brunswick and Manitoba between 2019 and 2021, minus a five-month delay during the pandemic. The study, published Thursday in the Journal of the American Medical Association (JAMA), found that using a tube that collects about half the amount provides more than enough blood for a typical lab test. The switch also saved one blood transfusion for every 10 patients in ICUs. The alternate tubes are physically identical to standard tubes but allow for a smaller draw because they contain less anticoagulants, which prevent blood from clotting, said lead author and hematologist Dr. Deborah Siegal of The Ottawa Hospital. She said it’s one of the reasons standard tubes can’t be partly filled. Lower-volume tubes also generate a weaker vacuum pullso automatically draw less blood, she added. Siegal said about 40 per cent of the sickest patients have repeated lab tests, resulting in significant blood loss thatcontributes to anemia, or low red blood cells. That leads to more blood transfusions. Smaller-volume tubes are used mostly in children anddon’t cost more, said Siegal. “Literally, the hospital staff went to storage areas in the intensive care units, swapped out the old tubes for the new tubes and put on a new bar code,” Siegal said of the study, which she started while at the Population Health Research Institute at McMaster University and Hamilton Health Sciences. “This was embedded right into practice by people actually doing the job of looking after patients.” The study shows it’s time to change protocols in ICUs and elsewhere to prevent excessive blood draws from patients who end up having more transfusions, she added. “Ninety per cent of the blood that they take is thrown into the garbage. This is a way to reduce transfusion so that (blood) is available for people who need it, for surgeries or cancer treatment. There are ongoing shortages of blood in Canada. This is a worldwide problem.” Patients in the study received more than 36,000 blood transfusions. The small-volume tubes may have saved about 1,500 units of blood, Siegal said. One unit of blood equals half a litre. Using standard tubes to draw blood from critically ill ICU patients has long been criticized as a wasteful practice. It was even dubbed “ICU vampirism” by Mayo Clinic researchers in a report published a decade ago in the British Journal of Haematology. They suggested hospitals adopt restrictive blood draw protocols. Ashley Ruelland of Ottawa agrees. She had countless lab tests and more than 100 blood transfusions over a two-month ICU stay after suffering multiple injuries in a head-on crash in March 2015. Ruelland said doctors ordered blood tests for various reasons, including to determine whether her organs were functioning properly, if she was getting enough nutrients and if she had infections. “And they were testing for anemia, which seems counterproductive, while I was getting the blood transfusions,” said Ruelland, whose vehicle was struck when she wasdriving the bride-to-be and another friend to a bachelorette party. “It seems like a no-brainer,” Ruelland said of the suggestion that hospitals transition to smaller-volume tubes. “When I heard about this study I thought of how much less stressful it would have been on my body to have had less blood taken. When I was not sedated, seeing the amount of blood leaving my body was also traumatic after what happened to me.” Dr. Jeannie Callum, a hematologist and director of transfusion medicine at the Kingston Health Sciences Centre in Ontario, said that while blood transfusions are life-saving, they can have negative consequences, including infections and allergic or flu-like reactions. Callum said she knew about some of the study’s findings several months ago and has helped to gradually transition all units at the hospital from standard to “pediatric tubes.” “Last week, the entire hospital got done, everything — outpatients and in-patients, everybody,” said Callum, who initially faced some pushback from staff who worried the move might compromise test results. But she said her experience working with Siegal had convinced her that if such a switch was beneficial in ICUs, it could also be used in other units. Staff at Kingston also spoke with some researchers aboutthe JAMA study, Callum added. “The paper is a game changer for hospitals because now they know there’s no downside. You’ve got to have a pretty good reason for not doing this.” This report by The Canadian Press was first published Oct. 12, 2023. Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.
ROCKVILLE, Md. and SUZHOU, China, Oct. 12, 2023 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has approved a global pivotal registrational Phase III study designed to evaluate a key drug candidate in Ascentage Pharma’s pipeline, Bcl-2 inhibitor APG-2575 (Lisaftoclax), in combination with the Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib, versus immunochemotherapy in treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), aiming to validate the combination regimen as a first-line treatment for CLL/SLL. This approval marks another major milestone in the clinical development of the drug candidate following the clearance from the US Food and Drug Administration (FDA) in August 2023 for the global registrational Phase III study in patients with CLL/SLL who have received prior therapies. This global multi-center, randomized-controlled, open-label, pivotal Phase III confirmatory trial (APG2575CC301) is designed to evaluate the efficacy and safety of APG-2575 (lisaftoclax) combined with acalabrutinib versus immunochemotherapy in treatment-naïve patients with CLL/SLL. CLL/SLL is a hematologic malignancy caused by mature B-cell neoplasms. It primarily affects older populations and is among the most common leukemia subtypes in adults, accounting for a quarter of all leukemia cases in the Western World, with over 100,000 new diagnoses reported globally each year1. In China, CLL/SLL is occurring at a rapidly rising incidence rate, with a younger age of onset and higher aggressiveness2, thus posing a serious threat to public health in the country. Advancements in basic research and targeted therapies have brought significant survival benefit to patients with CLL/SLL. However, CLL/SLL still presents major clinical challenges and urgent medical needs for new treatment options that can offer both efficacy and safety. APG-2575 (Lisaftoclax) is a novel, orally administered small-molecule Bcl-2 selective inhibitor being developed by Ascentage Pharma to treat the patients with malignancies by selectively blocking the antiapoptotic protein Bcl-2 and hence restoring the normal apoptosis process in cancer cells. With strong global best-in-class potential, lisaftoclax is the first Bcl-2 inhibitor in China and the second anywhere globally that has demonstrated compelling clinical activity and entered a pivotal registrational study. At present, lisaftoclax is being evaluated in multiple clinical studies across the world and more than 300 patients with CLL/SLL have already been treated with the drug either as a monotherapy or in combinations. Interim results suggest that lisaftoclax offers potent efficacy to patients with CLL/SLL and has the potential as a safe, efficacious, and convenient treatment option. The preliminary results from a global Phase II study have already showed therapeutic potential of lisaftoclax in combination with acalabrutinib, with an objective response rate (ORR) of 98% in patients with relapsed/refractory (R/R) CLL/SLL, an ORR of 100% in treatment-naïve patients with CLL/SLL, and an excellent safety profile that is on par with that of lisaftoclax monotherapy. In the study, lisaftoclax was initiated on a daily ramp-up that simplified the dosing schedule and allowed patients receive the treatment dose more quickly3. Moreover, the study adopted a dosing regimen that was improved on that of existing Bcl-2 inhibitor plus BTK inhibitor combinations as it eliminated the lead-in for the BTK inhibitor, thus allowed patients to begin receiving the combination therapy more quickly. Those results were being released as an Oral Presentation at the 2022 American Society of Hematology (ASH) Annual Meeting. “In earlier studies, lisaftoclax combined with acalabrutinib has already demonstrated impressive efficacy and safety, validating the combination regimen’s therapeutic potential and its promise as a patient-centric treatment strategy,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “We are very encouraged by this approval for the global registrational Phase III study of lisaftoclax combined with acalabrutinib. In terms of the dose ramp-up schedule for the Bcl-2 inhibitor and no lead-in of the BTK inhibitor, this trial adopts an innovative and optimized dosing regimen that is more convenient and allows for a faster onset of actions compared to studies of similar combinations. Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will vigorously advance those clinical programs of lisaftoclax to expedite the drug’s journey to market for the benefit of more patients.” References 1. Yao, Y., Lin, X., Li, F. et al. The global burden and attributable risk factors of chronic lymphocytic leukemia in 204 countries and territories from 1990 to 2019: analysis based on the global burden of disease study 2019. BioMed Eng OnLine 21, 4 (2022). https://doi.org/10.1186/s12938-021-00973-6 2. 刘澎. 复旦大学附属中山医院慢性淋巴细胞白细胞/小淋巴细胞淋巴瘤诊疗规范(v1.2018)[J].中国临床医学, 2018, 25(1). 3. Davids M, Chanan-Khan A, Mudenda B, et al. Lisaftoclax (APG-2575) Safety and Activity As Monotherapy or Combined with Acalabrutinib or Rituximab in Patients (pts) with Treatment-Naïve, Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (R/R CLL/SLL): Initial Data from a Phase 2 Global Study. Blood (2022) 140 (Supplement 1): 2326–2328. 4. Ailawadhi S, Chen Z, Huang B, Paulus A, Collins MC, Fu LT, Li M, Ahmad M, Men L, Wang H, Davids MS, Liang E, Mekala DJ, He Z, Lasica M, Yannakou CK, Parrondo R, Glass L, Yang D, Chanan-Khan A, Zhai Y. Novel BCL-2 Inhibitor Lisaftoclax in Relapsed or Refractory Chronic Lymphocytic Leukemia and Other Hematologic Malignancies: First-in-Human Open-Label Trial. Clin Cancer Res. 2023 Jul 5;29(13):2385-2393. About Ascentage Pharma Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK. Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of 9 clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company