Latest news with #MDS
Associated Press
3 days ago
- Business
- Associated Press
Ascentage Pharma Announces Global Registrational Phase III Study of Lisaftoclax for First-line Treatment of Patients with Higher-Risk Myelodysplastic Syndrome Cleared by US FDA and EMA
ROCKVILLE, Md. and SUZHOU, China, Aug. 17, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that it has received clearance by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct GLORA-4 study (NCT06641414), a global registrational Phase III study of lisaftoclax (APG-2575), a proprietary Bcl-2 inhibitor, in combination with azacitidine (AZA), for the treatment of patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS). This marks the second registrational Phase III study of lisaftoclax to receive clearance from both the FDA and EMA. The GLORA-4 study is simultaneously enrolling patients at participating centers in multiple countries, to accelerate the drug's path to potential market authorization. To date, lisaftoclax is the only Bcl-2 inhibitor being advanced in a registrational Phase III trial in higher-risk MDS globally. This study, if positive, may potentially end the longstanding treatment gap in higher-risk MDS, marking yet another major milestone in the global clinical development of lisaftoclax. Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, 'Globally, we still lack targeted therapies for first-line treatment of patients with higher-risk MDS, which represents a huge unmet clinical need. Currently, hypomethylating agents (HMA) and allogeneic hematopoietic stem cell transplantation (allo-HSCT) remain the primary treatment options for higher-risk MDS. In earlier studies, lisaftoclax has demonstrated promising clinical benefit and tolerability. The clearances of the GLORA-4 study by the U.S. FDA and EMA, coinciding with the approval by the China CDE, pave the way for lisaftoclax to potentially become the first Bcl-2 inhibitor approved globally for first-line treatment of higher-risk MDS and the first targeted therapy approved for this indication since the introduction of HMA, which fundamentally reshapes the treatment landscape.' The GLORA-4 trial is being conducted simultaneously in China, the U.S., and Europe. This will significantly accelerate the clinical development of lisaftoclax in MDS and accelerate the drug's path to potential market authorization. Moving forward, we will remain steadfastly committed to our mission of addressing unmet clinical needs in China and around the world, actively advancing our clinical programs for the benefit of more patients.' GLORA-4 is a multi-region, multi-center, randomized, double-blind Phase III trial designed to evaluate the efficacy and safety of lisaftoclax in combination with AZA compared to placebo plus AZA in newly diagnosed adult patients with higher-risk MDS. The study was originally approved by the China CDE in 2024. Currently, the study is enrolling patients globally, with the first patients already enrolled in China and Europe. Guillermo Garcia-Manero, MD, Chair of the Department of Leukemia, The University of Texas MD Anderson Cancer Center (MDACC), and Prof. Xiaojun Huang, MD, an academician of the Chinese Academy of Engineering, director of the Institute of Hematology at Peking University, and director of the Department of Hematology at Peking University People's Hospital, are global co-leading principal investigators of the study. MDS is a myeloid clonal disease originating from hematopoietic stem cells with strongly age-correlated characteristics. Global epidemiological data of MDS show an exponential increase in incidence with age (22/100,000 in the population aged over 65 years), with a median age of diagnosis of 70 years1. More than 75% of patients with MDS present a complex disease profile that includes at least two comorbidities2. The primary risk of MDS is clonal evolution leading to progression to acute myeloid leukemia (AML), with 40-60% of higher-risk patients (high/very high risk, as classified by IPSS-R) progressing to AML within five years3. These patients have a dismal prognosis and a median survival of less than six months4. As the standard first-line therapy for higher-risk MDS, HMAs offer inadequate responses to treatment, with an overall response rate (ORR) of just 30-40%5, a complete response (CR) rate of 10-17%, and a median duration of response of 9-12 months6, 8. While allo-HSCT can offer a potential cure, it is limited by the median age of patients, complex disease profiles, common depletion of the hematopoietic stem cell reserve, and a transplantation-related mortality (TRM) rate of 25-35%. As a result, only 5-10% of eligible patients can receive transplantation7. The five-year survival rate of patients who are classified by the IPSS-R as high-risk remains at 16-24%8, highlighting an urgent unmet medical need for innovative therapies that can change the treatment paradigm. Lisaftoclax is a proprietary, novel, orally administered Bcl-2 selective inhibitor being developed by Ascentage Pharma to treat patients with malignancies by selectively blocking the anti-apoptotic protein Bcl-2 and restoring the normal apoptosis process in cancer cells. Lisaftoclax is already approved in China for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy, including Bruton's tyrosine kinase (BTK) inhibitors. Previously, the Company released the clinical data of lisaftoclax in combination with AZA in treatment-naïve (TN) MDS during the 2024 American Society of Hematology (ASH) Annual Meeting and the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. These data showed an ORR of 75%, much higher than HMAs alone, which demonstrated the clinical benefit of the combination regimen. The combination also showed a favorable safety profile, with a low incidence of severe hematologic toxicities and neutropenia-related infections. In addition, the proportion of patients requiring dose adjustments was low and there were no treatment-related mortalities within 60 days9, 10. Professor Huang commented, 'Despite the significant advancement in the treatment of hematologic malignancies, higher-risk MDS remains a major clinical challenge because of a range of factors. First, the current standard of care treatment with HMAs only offers limited efficacy, with just about one-third of patients achieving a response to treatment. Second, no breakthrough therapies have emerged globally in the two decades since the introduction of HMAs. As a result, there is an unmet clinical need for targeted therapies for higher-risk MDS. The compelling response rate and manageable safety profile observed in earlier studies of lisaftoclax are very encouraging. We hope this global Phase III study has the potential to provide new insights that could benefit how we treat and manage higher-risk MDS.' Dr. Garcia-Manero commented, 'Higher-risk MDS is more prevalent in older populations and thus presents unique clinical challenges. These patients often have multiple comorbidities and depleted hematopoietic reserves, making them less tolerant of treatment with particularly high requirement for safety. Preliminary clinical data of lisaftoclax demonstrated notable clinical benefit, with low rates of treatment-related dose adjustments and mortalities while maintaining significant response rates. We hope these characteristics of lisaftoclax will make it a potentially superior treatment option for patients.' References: About Ascentage Pharma Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The company has built a rich pipeline of innovative drug candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53 and next-generation kinase inhibitors. The lead asset, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or POLARIS-2, of olverembatinib for CML, as well as global registrational Phase III trials for patients with newly diagnosed Ph+ ALL and SDH-deficient GIST. The second lead asset, lisaftoclax, is the first China-approved third-generation Bcl-2 inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy, including Bruton's tyrosine kinase (BTK) inhibitors. The Company is currently conducting 4 global registrational Phase III trials: the GLORA study of lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL who were previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed elderly and unfit patients with AML; and the GLORA-4 study in patients with newly diagnosed higher-risk MDS. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma's opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma's filings with the SEC, including those set forth in the sections titled 'Risk factors' and 'Special note regarding forward-looking statements and industry data' in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, the sections headed 'Forward-looking Statements' and 'Risk Factors' in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company's management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma's current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contact Information Investor Relations: Hogan Wan, Head of IR and Strategy Ascentage Pharma [email protected] +86 512 85557777 Stephanie Carrington ICR Healthcare [email protected] +1 (646) 277-1282 Media Relations: Jon Yu ICR Healthcare [email protected] +1 (646) 677-1855
Borneo Post
4 days ago
- General
- Borneo Post
Memorial proposed in Serian to honour professor who documented Bidayuh life
Minos (fourth left) MDS councillors and officials are joined by some of the Mentu Tapu folks as they visit the hall that Geddes helped to build. KUCHING (Aug 17): A memorial and gallery to honour the late Prof William Geddes, the New Zealand academic who documented Bidayuh life in the 1950s, is being proposed at Kampung Mentu Tapu in Serian. Serian District Council chairman Dato Peter Minos said the council, together with Kedup assemblyman Datuk Martin Ben, is considering the initiative in recognition of Geddes' invaluable contributions to the Bidayuh community. He explained that Geddes had written the book 'Nine Dayak Nights' based on his experiences living with the Bidayuh community at Mentu Tapu. 'Geddes lived in Kampung Mentu Tapu from around 1950 to 1951 while conducting research on the Bidayuhs, then known as the Land Dayaks, on behalf of the British colonial government. 'His book Nine Dayak Nights and accompanying report remain classic references on Bidayuh culture and traditions,' Minos said in a statement. He noted that Geddes' works captured the community's history, customs and character with great depth and accuracy. As such, he strongly believes that setting up the memorial, albeit a modest one for a start, would be a fitting tribute for Geddes. 'This is the least we can do for this great man who did a good turn for the Bidayuhs. We must never forget our roots, and remembering Geddes is part of remembering our history,' he stressed. According to Minos, he was told Geddes returned to Kampung Mentu Tapu briefly in the 1970s and 1980s, and even helped build a small village hall, which still stands today, though no longer in use. He pointed out that although Geddes passed away many years ago, villagers of Mentu Tapu still remember him fondly. Minos, who visited the village recently, said the people expressed their gratitude to the professor for putting their community on the map. 'They told me, 'Geddes made our village famous. We really thank him for that.' It shows the depth of their appreciation and respect,' he said. Bidayuh life Kampung Mentu Tapu lead Peter Minos Prof William Geddes Serian
Medscape
6 days ago
- Health
- Medscape
Leukemia Relapse: PD-1 Inhibition Shows Mixed Results
TOPLINE: Programmed death-1 (PD-1) inhibition with pembrolizumab led to durable remission in 31.3% of patients with early acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) relapse after hematopoietic cell transplantation (HCT). Mixed CD3 chimerism predicted response, but 37.5% developed severe graft-vs-host disease (GVHD). METHODOLOGY: A prospective phase 1B clinical trial enrolled 16 patients with AML (n = 12) and MDS (n = 4) who experienced relapse after HCT, with a median time to relapse of 5.5 months and median pretreatment bone marrow blast percentage of 21.5%. Participants received 200 mg pembrolizumab intravenously every 21 days for up to four cycles (induction), with responding patients eligible for maintenance therapy up to 1 year. Primary objectives included assessment of safety, overall response rate to pembrolizumab with or without subsequent chemotherapy, and rates of GVHD or clinically significant immune-mediated toxicity. Response evaluation occurred through bone marrow examination on day 35 (after cycle 2) and day 77 (after cycle 4), with complete remission defined as bone marrow blasts less than 5% and absence of circulating blasts. TAKEAWAY: The overall response rate was 31.3%, consisting of three complete remissions (18.8%) and two partial remissions (13.5%), with a median response duration of 610 days. Patients with mixed CD3 chimerism showed significantly higher response rates compared to those with full donor chimerism (50% vs 0%; P = .03). Severe (grades 3-4) GVHD developed in 37.5% of patients, with most cases resistant to corticosteroids and contributing to death in 25% of participants. The 1-year overall survival was 37.5% and event-free survival was 31.3%, with AML patients showing 1-year overall survival of 50.0%. IN PRACTICE: 'PD-1 inhibition led to durable remission in on -third of the patients experiencing early relapse after HCT, suggesting that this approach may augment the GVL [graft-vs-leukemia] response. Responses were exclusively observed in the setting of mixed CD3 donor chimerism. Immune toxicities (GVHD) were a barrier to successful treatment outcome,' the authors of the study wrote. 'The results of the study highlight the challenge of attempting to dissect the graft-vs-leukemia effect from immunologic toxicity in patients with HCT,' Roman M. Shapiro and Robert J. Soiffer, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, said in a press release. SOURCE: The study was led by John M. Magenau, Transplantation and Cell Therapy Program, University of Michigan Rogel Cancer Center in Ann Arbor, Michigan. It was published online on August 12 in Blood Advances. LIMITATIONS: According to the authors, the small sample size limited their ability to determine the extent to which pembrolizumab could separate graft-vs-leukemia effects from GVHD. The researchers note that, while some patients achieved response without GVHD, the limited cohort size may have confounded interpretation of significant variables, including response patterns in patients with high blast percentage, very early relapse, monosomal karyotype, or TP53 mutations. DISCLOSURES: Magenau declared receiving support through a National Institutes of Health career development award (K23AI123595) and a Rogel Cancer Center Scholarship. The study was supported by a research grant (54053) from the Investigator-Initiated Studies Program of Merck Sharp & Dohme LLC. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Time of India
7 days ago
- Time of India
RTI reply exposes irregularities in Panayarakunnu farmers society
Thiruvananthapuram: An RTI reply by cooperative department has exposed grave financial irregularities surrounding Panayarakunnu Farmers Social Welfare Cooperative Society. The RTI query was filed by one of the depositors who was allegedly cheated by the administrative panel members. The society was reportedly functioning without following most of the provisions of the state cooperative rules. The monthly deposit scheme (MDS) was supposed to be passed by general body of the society and approved by the department for running chit funds and other schemes, but this was not done, the report stated. A sum of Rs 61.40 lakh was supposed to be collected from customers through MDS. However, the society did nothing to collect the money despite being directed to do so. In the monthly expense register, a huge sum was found given as 'secretary advance' and 'president advance'. A society is not supposed to grant loans and run MDS on the guarantee of cheques, but the Panayarakunnu society granted loans to several people on such a guarantee. A total of Rs 5.65 crore was collected by the society as deposits, but it was supposed to collect only Rs 25 lakh from loan arrears. The society did not keep enough funds in line with the deposits collected and was not in a position to clear the deposits of customers, the report said. The society diverted the deposit amounts for MDS and other investments. Loans were granted without proper guarantees. By appointing more staff and collection agents than the permitted limits, the society spent over Rs 10 lakh on paying them commission and wages. Issues spotted in the audits were not rectified properly and the stock register was not maintained. Even in benami names, the accused took loans for their personal needs, but not even a single penny was paid back, the report added. Meanwhile, depositors alleged that neither police nor the department took any action against the accused on their complaints. Stay updated with the latest local news from your city on Times of India (TOI). Check upcoming bank holidays , public holidays , and current gold rates and silver prices in your area.
Tourism Breaking News
12-08-2025
- Sport
- Tourism Breaking News
Jordan at the forefront of adventure tourism with Marathon Des Sables 2025
In a major announcement for Jordan's tourism sector, Minister of Tourism and Antiquities, Lina Annab, and CEO of the Global Marathon Des Sables (MDS), Cyrilie Gauthier, held a press conference in Amman to officially launch the fifth international edition—and the first ever in the Middle East—of the Marathon des Sables, scheduled to take place in Wadi Rum from 1 to 8 November 2025. The desert ultramarathon, organized by the Jordan Tourism Board (JTB) and Experience Jordan Adventures, and renowned as one of the world's most challenging endurance races, will bring together approximately 650 runners from across the European Union, marking a significant boost to Jordan's tourism season in November and highlighting the unique landscapes of Wadi Rum. In her remarks to the press, Minister Annab said, 'Hosting the Marathon des Sables for the fifth time in Jordan firmly cements our country's position as a premium adventure travel destination. Over the past decade, Jordan has made significant strides in shaping its adventure tourism landscape, investing in trails, infrastructure, and authentic experiences that connect visitors with our nature, culture, and heritage. From the world-renowned Jordan Trail, which spans more than 650 kilometers through diverse terrains and communities, to this iconic race set against the magnificent backdrop of Wadi Rum, Jordan continues to spotlight the richness and variety of its outdoor offerings.' The minister underlined that marathon tourism 'has become a strategic pillar in our destination planning. It aligns with global trends in wellness and 'live tourism,' offering immersive, shareable experiences that resonate with cultural athletes, runners who view the sport as a way to connect, explore, and reflect shared values.' 'Events like the Marathon des Sables bring athletes whose immersive experiences turn them into storytellers,' she explained, adding, 'Each participant leaves with a deep emotional connection to Jordan—its heritage, its people, and its natural beauty. Wadi Rum offers a demanding physical course set within a landscape that invites reflection, cultural connection, and a sense of spiritual awe. Beyond the race, runners will also have the opportunity to experience the timeless wonder of Petra and the healing stillness of the Dead Sea, two of Jordan's most iconic and transformative landscapes.' Highlighting the marathon as a remarkable opportunity to showcase what Jordan has to offer beyond the racecourse, she said, 'It is an immersive and unforgettable experience, one that transcends geography and time, and remains etched in our guests' memory.' Minister Annab concluded by extending her 'heartfelt gratitude to the organizers of the Marathon des Sables for their continued trust in Jordan, and to all the extraordinary runners joining us from around the world. We look forward to welcoming them this November and wish each participant the very best of luck on this extraordinary journey.' For his part, the CEO of MDS stated, 'MDS Jordan has become the crown jewel of our global series—one of the most successful destinations in the history of MDS. Its extraordinary landscapes, unmatched hospitality, and the emotional connection it creates with runners from around the world have set a new benchmark for what adventure racing can be. But this is only the beginning. We have ambitious plans for Jordan. We believe this is the right country to grow, innovate, and build a long-term vision where sport, culture, and tourism intersect in a powerful way. Jordan has all the ingredients to become a global hub for our endurance events, and we are proud to be part of that journey. Managing Director of the Jordan Tourism Board, Dr. Abdelrazzak Arabiyat, stated: 'We at the Jordan Tourism Board are proud to support world-class events like the Marathon des Sables. This event not only highlights Jordan's stunning landscapes, but also reflects our ongoing efforts to position the Kingdom as a leading destination for adventure tourism. Through such events, we welcome responsible travelers who are seeking authentic connections with nature, culture, and history. Events like this help visitors discover the true spirit of Jordan and the richness that makes our country truly unique.' Commenting on the occasion, CEO of Experience Jordan Adventures, Ayman Abd-AlKareem, said, 'As the official local partner, Experience Jordan Adventures is proud to continue hosting this iconic race, which brings together hundreds of international runners in a celebration of endurance, connection, and discovery.' He stressed the team's commitment to sustainability and community partnership in Wadi Rum, expressing gratitude for the ongoing support of the Ministry of Tourism, Aqaba Special Economic Zone Authority (ASEZA), and the Jordan Tourism Board in strengthening Jordan's position as a leading adventure travel destination. As a host of the Marathon des Sables, Jordan marks a milestone in its emergence as a leading destination for international sporting and adventure tourism. More than just a race, it offers a transformative experience that blends endurance, culture, and exploration against the breathtaking backdrop of Wadi Rum's desert landscapes. As global interest in adventure travel continues to rise, MDS Jordan positions the country at the forefront of this growing sector, attracting high-value international visitors and supporting the national tourism strategy by showcasing Jordan's natural beauty, heritage, and hospitality on the world stage.
