Latest news with #AnnalsofOncology
Business Wire
30-05-2025
- Health
- Business Wire
(radium-223 dichloride) Data in Metastatic Castration-Resistant Prostate Cancer from Phase III PEACE III Trial Published in
WHIPPANY, N.J.--(BUSINESS WIRE)-- Annals of Oncology published full results from the pivotal investigational Phase III PEACE III trial, evaluating XOFIGO ® (radium-223 dichloride) in combination with enzalutamide, an AR pathway inhibitor (ARPI), versus enzalutamide alone in the first-line treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) with bone metastases. 1 XOFIGO is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. 2 Initially presented as a late-breaking abstract during the Presidential Symposium at ESMO 2024, results demonstrated that the addition of XOFIGO to enzalutamide significantly increased radiological progression-free survival (rPFS) for patients with mCRPC with bone metastases, with a 31% reduction in the risk of progression or death (HR 0.69; 95% CI, 0.54-0.87; p=0.0009) compared to enzalutamide alone. 1,3 Patients receiving XOFIGO in combination with enzalutamide had a median rPFS of 19.4 months (95% CI, 17.1-25.3 months) compared to 16.4 months (95% CI, 13.8-19.2 months) with enzalutamide, a 3-month difference in median rPFS. 1,3 The trial was a collaboration between the European Organization for Research and Treatment of Cancer (EORTC), Clinical Trial Ireland (CTI), the Canadian Urological Oncology Group (CUOG), the Latin American Cooperative Oncology Group (LACOG), and French UNICANCER Urogenital Tumor Study Group (GETUG). Additionally, at a preplanned interim analysis the results demonstrated statistically significant overall survival (OS), with a 31% reduction in the risk of death (HR=0.69; 95% CI 0.52-0.90; p=0.0031), with a median OS of 35.0 months (95% CI 28.8-38.9) in the enzalutamide arm compared to 42.3 months (95% CI 36.8-49.1) for XOFIGO plus enzalutamide. 1 The study will continue to the final OS analysis. XOFIGO is the first and only alpha emitting radiopharmaceutical that treats bone metastases in mCRPC approved by the U.S. Food and Drug Administration (FDA). 'PEACE III is the first major Phase III trial to combine an ARPI with radiopharmaceutical that showed statistical significance in meeting the primary endpoint,' said Denis Lacombe, Chief Executive Officer, EORTC. 'The EORTC is proud to be at the forefront of this groundbreaking trial, helping to redefine the development of clinical trials and supporting patient care for difficult to treat diseases.' The results were consistent with the established safety profile of XOFIGO, although authors noted the importance of administering bone protective agents (BPAs) to avoid fractures. Following the release of the ERA-223 results, the PEACE III study was amended in March 2018 making BPAs mandatory at the monthly skeletal-related-event dose. The observed reduction in fractures following this amendment underlined the importance of using a BPA in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastasis also in the era of ARPI's. 4 Grade 3 or higher treatment emergent adverse events (TEAE) were recorded in 65.6% of patients in the combination arm compared to 55.8% of patients who received enzalutamide alone. 1 The most frequent Grade 3 or higher TEAEs were hypertension (34%), fatigue (6%), fracture (5%), anemia (5%), and neutropenia (5%). 1 Fractures (either treatment-emergent or post-treatment, symptomatic or pathologic, or with or without BPA use) were reported in 24.3% of patients in the combination arm and 13.4% of patients in the enzalutamide arm. 1 These results demonstrate the potential for this combination to be a new treatment option for patients with mCRPC and bone metastases who have experienced disease progression on androgen deprivation therapy (ADT). 'There remains an unmet patient need for people living with metastatic castration-resistant prostate cancer who have bone metastases,' said Christine Roth, Global Head of Product Strategy and Commercialization at Bayer's Pharmaceuticals Division. 'The PEACE III trial underscores our dedication to advancing therapies for patients with prostate cancer and exploring the full potential of XOFIGO.' Bayer has submitted a supplemental New Drug Application (sNDA) to the FDA for XOFIGO for the treatment of patients with mCRPC and who have bone metastases in combination with enzalutamide based on positive results from the Phase III PEACE trial. Bayer will submit applications for marketing authorizations of XOFIGO to additional health authorities as well. The trial is supported by Astellas and Pfizer who manufacture enzalutamide (Xtandi) in collaboration with Bayer. About PEACE III (EORTC GUCG-1333) The PEACE III trial is an international, randomized, open-label, Phase III trial designed to investigate the efficacy and safety of XOFIGO in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. A total of 446 patients were randomized 1:1 to receive either XOFIGO 55 kBq/kg as an intravenous injection monthly for six cycles in combination with enzalutamide 160mg orally daily or enzalutamide 160mg orally daily. The primary endpoint was radiological progression-free survival (rPFS) by investigator assessment. Key secondary endpoints included overall survival (OS), time to subsequent systemic treatment, pain progression, and symptomatic skeletal event. This trial was a collaboration with several cancer cooperative groups: EORTC, CTI, CUOG, LACOG, and GETUG. About Xofigo ® (radium-223 dichloride) Injection 2 Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Important Safety Information for Xofigo ® (radium-223 dichloride) Injection Warnings and Precautions: Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression–notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia–has been reported in patients treated with Xofigo. Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be ≥1.5 × 109/L, the platelet count ≥100 × 109/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 109/L and the platelet count ≥50 × 109/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care Concomitant Use With Chemotherapy: Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued Increased Fractures and Mortality in Combination With Abiraterone Plus Prednisone/Prednisolone: Xofigo is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials. At the primary analysis of the Phase 3 ERA-223 study that evaluated concurrent initiation of Xofigo in combination with abiraterone acetate plus prednisone/prednisolone in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received Xofigo in combination with abiraterone acetate plus prednisone/prednisolone compared to patients who received placebo in combination with abiraterone acetate plus prednisone/prednisolone. Safety and efficacy with the combination of Xofigo and agents other than gonadotropin-releasing hormone analogues have not been established Embryo-Fetal Toxicity: The safety and efficacy of Xofigo have not been established in females. Xofigo can cause fetal harm when administered to a pregnant female. Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with Xofigo Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients' oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo Secondary Malignant Neoplasms: Xofigo contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223 dichloride, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow-up for patients on the trial Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the Xofigo group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy Adverse Reactions: The most common adverse reactions (≥10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%). Please see the full Prescribing Information for Xofigo (radium Ra 223 dichloride). About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 'Health for all, Hunger for none,' the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to © 2025 Bayer BAYER, the Bayer Cross and XOFIGO are registered trademarks of Bayer. Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References Tombal. B., et al. Enzalutamide plus Radium-223 in Metastatic Castration-Resistant Prostate Cancer: Results of the EORTC 1333/PEACE-3 trial. Annals of Oncology. May 30, 2025. DOI: 10.1016/ Gillessen, S., et al. A randomized multicenter open label phase III trial comparing enzalutamide vs a combination of Radium-223 (Ra223) and enzalutamide in asymptomatic or mildly symptomatic patients with bone metastatic castration-resistant prostate cancer (mCRPC): First results of EORTC-GUCG 1333/PEACE-3. European Society of Medical Oncology 2025 (ESMO) LBA1. September 9, 2024. Xofigo ® (radium-223 dichloride) Injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, December 2019. Gillessen S, et al. Decrease in Fracture Rate with Mandatory Bone-protecting Agents in the EORTC 1333/PEACE-3 Trial Comparing Radium-223 Combined with Enzalutamide Versus Enzalutamide Alone: A Safety Analysis. Eur Urol. 2025 Mar;87(3):285-288.
India Today
12-05-2025
- Health
- India Today
Beyond chemo: How a new approach to cancer recovery is changing lives
When Kamala, a 47-year-old woman from New Zealand, was diagnosed with stage 4 ovarian cancer, her hopes for recovery dimmed quickly. Kamala's case is one of only 17 known globally involving squamous cell carcinoma developing from mature cystic two surgeries failed to contain the aggressive tumour, her scans revealed metastases across the pelvic peritoneum, lymph nodes, and lungs. "There was nothing else left for me in New Zealand," she told when Kamala turned to an integrative approach to cancer care in India. At a private oncology centre in Gurugram, she underwent a mix of conventional and personalised therapies, including chemotherapy guided by genetic profiling, nutritional interventions, and the use of natural compounds like vitamin C and curcumin. Three months later, she was declared Kamala's story is extraordinary, it also brings up a growing question in the world of oncology: should more cancer patients consider integrative medicine as part of their recovery?WHAT IS INTEGRATIVE ONCOLOGY?Integrative oncology doesn't aim to replace conventional cancer treatment. Instead, it seeks to complement it by combining chemotherapy, radiation, and surgery with personalised nutrition, mind-body practices, and, in some centres, elements of traditional medicine such as ayurveda."We don't ask patients to skip chemotherapy or surgery. That remains the backbone of treatment," said Dr. Arpan Talwar, co-founder of Art of Healing Cancer. Integrative oncology doesn't aim to replace conventional cancer treatment. Instead, it seeks to complement it. () advertisement"But there are gaps that conventional medicine doesn't always address, like managing side effects, strengthening the immune system, or targeting mutations that don't yet have drugs. That's where integrative strategies come in," he to this approach is precision oncology, the idea that treatment should be guided by a patient's unique genetic profile."We customise everything, from chemotherapy drugs to diet, based on how the tumour's genes behave. If a tumour is feeding on protein, then a high-protein diet could do more harm than good," explained Roshika Tiwari, a Gurugram-based cancer genetic isn't just theory. European research in this area called Molecular Tumor Boards (MTBs) - a multidisciplinary panel that guides treatment decisions based on genetic findings - is gaining European Society for Medical Oncology, in a set of guidelines published in Annals of Oncology, advocates for MTBs in hospitals to personalise care, monitor outcomes, and support decisions on off-label or investigational DOES SCIENCE SAY?There is emerging evidence to support parts of integrative cancer care. Precision medicine, for instance, has shown success in improving treatment response in various cancers by targeting actionable to the US National Cancer Institute, more than 400 cancer-related genes can now be matched to targeted therapies, though hundreds more still lack drugs. More than 400 cancer-related genes can now be matched to targeted therapies, though hundreds more still lack drugs. () Nutrition, too, plays a measurable role in recovery. "Malnutrition and muscle loss are linked to poorer outcomes. We've seen patients complete chemotherapy with fewer interruptions when their diet is personalised and closely monitored," said Shikha Singh, a nutritionist at Fortis Memorial Research Institute's department of hemato-oncology and bone marrow recalled a breast cancer patient who regained weight, energy, and mental well-being through a high-protein, calorie-dense diet tailored to their body's needs, allowing them to finish treatment on experts also warned against falling for fads. "There are plenty of myths, like cutting out all sugar or going vegan to cure cancer. Diet should always be evidence-based and supervised," Dr. Singh CAUTIONDespite some remarkable case studies, integrative medicine in cancer remains a grey area in mainstream natural substances being used, curcumin, antioxidants, ayurvedic herbs, lack large-scale clinical trials to confirm their benefits or interactions with chemotherapy. advertisementHowever, according to experts, the problem is not the idea, it's the lack of regulation. Combining alternative therapies with conventional treatment requires proper doctors also raise concerns about commercial clinics promoting unproven combinations of herbal remedies and dietary changes as "cures."While genomic testing is becoming more accessible, it remains expensive and largely confined to urban centres in India, and "there's a long way to go before we can democratise precision oncology," Tiwari said.A NEED FOR INTEGRATION, NOT POLARISATIONGlobally, integrative oncology is gaining recognition, not as a replacement but as a companion. Major cancer centres in Europe and the US are experimenting with yoga therapy, nutritional genomics, and stress-reduction programs, especially for patients in advanced Mandeep Singh, founder of Art of Healing Cancer, believes that the future of cancer care should be interdisciplinary. While genomic testing is becoming more accessible, it remains expensive and largely confined to urban centres in India. () advertisement"We already use substances like turmeric or vitamin C. The question is: can we use them in precise doses, backed by genetic science, alongside conventional treatment? That's what we're trying to figure out," said Dr. Singh. The expert suggested the potential of supportive care approaches such as nutrition and mental health in improving quality of life during cancer treatment. But clear, evidence-based frameworks are still missing for wider WE TURN TO INTEGRATIVE MEDICINE?For patients like Kamala, integrative medicine was life-changing. For others, it may be supplementary, or even real question isn't whether integrative oncology works for everyone, it's whether we're ready to design cancer care around the individual, not just the includes allowing for experimentation, as long as it's rooted in more large-scale studies emerge, experts recommend caution, collaboration, and clarity.
Yahoo
12-03-2025
- Health
- Yahoo
Breast cancer death rates across Europe are expected to drop in 2025. How do countries compare?
Death rates due to breast cancer in 2025 are set to decrease for women across most age groups in Europe, according to a new study. The new projections for this year show that breast cancer mortality will drop in every age group except for women over 80, for whom death rates will only decrease in the United Kingdom and Spain. Published in the journal Annals of Oncology, the study also says that breast cancer death rates will fall by 4 per cent in the EU compared to 2020 and 6 per cent in the UK. It's based on data from the World Health Organization (WHO) and United Nations databases for the EU, its five most populous countries (Germany, France, Poland, Spain, and Italy), and the UK. The fall in breast cancer mortality is largely due to improvements in screening, diagnosis, and treatment, Carlo La Vecchia, a professor of medical statistics and epidemiology at the University of Milan in Italy and lead author of the study, told Euronews Health. 'What's surprising with breast cancer is the proportion of decline… in all European countries and in all age groups under 80,' La Vecchia said. The increase for elderly women, however, is because they are screened less often than younger women, he said. Related Why US experts are now recommending breast cancer screenings for women in their 40s They also 'seem to not have the same benefits from the improvements of treatment compared to younger women,' he said, adding that 'we have to work on that, to understand whether this is justified or not'. The research found that between 1989 and 2025, there were an estimated 6.8 million averted cancer deaths in EU countries, including more than 370,000 breast cancer deaths. In the UK, meanwhile, there were 1.5 million avoided cancer deaths, including nearly 200,000 breast cancer deaths, researchers found. The researchers estimate that overall cancer death rates have declined in EU countries by 3.5 per cent for men and 1.2 per cent for women since 2020. The overall number of deaths, however, have increased due to population growth and ageing, they added. The death rates in the UK, meanwhile, have fallen even more by 10.1 per cent among men and 6.3 per cent among women. They predict that there will be 1.28 million cancer deaths in the EU and 173,000 in the UK in 2025. Looking at more than 10 different types of cancers, the researchers found that death rates will fall in the EU except for pancreatic cancer in men and women and lung and bladder cancer in women. In the UK, cancer death rates will fall except for bowel cancer and uterus cancer in women. Researchers say that risk factors such as smoking, diabetes, being overweight, and obesity may contribute to this rise. Some of this is related to when certain generations, such as women born in the 1950s, began smoking, La Vecchia said. 'The generations born after the 1970s, they smoked less, and stopping smoking has become more frequent in women too,' he said. 'Still, there is a lot to do for lung cancer,' he added. One of the negative signs is an increase in colorectal cancer deaths among young people in the UK and other countries, he said, adding in a statement that this is 'mainly due to increased prevalence of overweight and obesity in the young who are not covered by colorectal cancer screening'. In terms of limiting risk factors, he recommends stopping smoking, limiting alcohol, and controlling overweight and obesity, and called for increased screening and early diagnosis of cancers.
Euronews
12-03-2025
- Health
- Euronews
Breast cancer death rates across Europe are expected to drop in 2025. How do countries compare?
Breast cancer death rates are expected to drop across European countries, here's a look at how different women's age groups compare. ADVERTISEMENT Death rates due to breast cancer in 2025 are set to decrease for women across most age groups in Europe, according to a new study. The new projections for this year show that breast cancer mortality will drop in every age group except for women over 80, for whom death rates will only decrease in the United Kingdom and Spain. Published in the journal Annals of Oncology, the study also says that breast cancer death rates will fall by 4 per cent in the EU compared to 2020 and 6 per cent in the UK. It's based on data from the World Health Organization (WHO) and United Nations databases for the EU, its five most populous countries (Germany, France, Poland, Spain, and Italy), and the UK. The fall in breast cancer mortality is largely due to improvements in screening, diagnosis, and treatment, Carlo La Vecchia, a professor of medical statistics and epidemiology at the University of Milan in Italy and lead author of the study, told Euronews Health. 'What's surprising with breast cancer is the proportion of decline… in all European countries and in all age groups under 80,' La Vecchia said. The increase for elderly women, however, is because they are screened less often than younger women, he said. Related Why US experts are now recommending breast cancer screenings for women in their 40s They also 'seem to not have the same benefits from the improvements of treatment compared to younger women,' he said, adding that 'we have to work on that, to understand whether this is justified or not'. The research found that between 1989 and 2025, there were an estimated 6.8 million averted cancer deaths in EU countries, including more than 370,000 breast cancer deaths. In the UK, meanwhile, there were 1.5 million avoided cancer deaths, including nearly 200,000 breast cancer deaths, researchers found. Overall cancer mortality predictions The researchers estimate that overall cancer death rates have declined in EU countries by 3.5 per cent for men and 1.2 per cent for women since 2020. The overall number of deaths, however, have increased due to population growth and ageing, they added. The death rates in the UK, meanwhile, have fallen even more by 10.1 per cent among men and 6.3 per cent among women. They predict that there will be 1.28 million cancer deaths in the EU and 173,000 in the UK in 2025. Looking at more than 10 different types of cancers, the researchers found that death rates will fall in the EU except for pancreatic cancer in men and women and lung and bladder cancer in women. In the UK, cancer death rates will fall except for bowel cancer and uterus cancer in women. ADVERTISEMENT Researchers say that risk factors such as smoking, diabetes, being overweight, and obesity may contribute to this rise. Some of this is related to when certain generations, such as women born in the 1950s, began smoking, La Vecchia said. 'The generations born after the 1970s, they smoked less, and stopping smoking has become more frequent in women too,' he said. 'Still, there is a lot to do for lung cancer,' he added. One of the negative signs is an increase in colorectal cancer deaths among young people in the UK and other countries, he said, adding in a statement that this is 'mainly due to increased prevalence of overweight and obesity in the young who are not covered by colorectal cancer screening'. ADVERTISEMENT In terms of limiting risk factors, he recommends stopping smoking, limiting alcohol, and controlling overweight and obesity, and called for increased screening and early diagnosis of cancers.
Yahoo
10-02-2025
- Business
- Yahoo
Cosmos Health Advances Cancer Treatment Innovation with Two New AI-Driven Patent Filings for Gliomas and Hematologic Malignancies; $25 Billion+ Global Market
CHICAGO, IL / / February 10, 2025 / Cosmos Health Inc. ("Cosmos Health" or the "Company'') (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today the filing of two new patent applications, covering groundbreaking developments in the treatment of glioma, an aggressive brain cancer, and hematologic malignancies, a complex group of blood cancers. The patent application for glioma has been filed under number N2039647, while the second application, numbered N2039645, focuses on hematologic malignancies, including multiple myeloma. These filings mark significant additions to the Company's intellectual property portfolio and represent a milestone in its collaboration with Cloudpharm and the National Hellenic Research Foundation, with further support from the pharma patent expert team at NLO. These advancements build on promising preclinical discoveries, predictive insights, and simulations generated by Cosmos Health's AI-powered Cloudscreen drug repurposing platform. Recent in vitro studies have validated the therapeutic potential of a repurposed marketed drug for both indications, with inventors establishing a novel mechanism of action unique to each cancer type. This dual focus represents a critical step in addressing the unique challenges of these cancers and underscores Cosmos Health's commitment to developing transformative solutions for patients in need. These findings pave the way for continued preclinical and clinical development, offering new hope in the fight against challenging oncological diseases. Gliomas Gliomas are a diverse group of primary brain and spinal cord tumors originating from glial cells. According to Annals of Oncology, gliomas account for approximately 30% of all central nervous system tumors and about 80% of all malignant brain tumors. The annual incidence of malignant gliomas is estimated to be around 3 to 5 cases per 100,000 individuals, with a slight predominance in males. These tumors can develop at any age but are most commonly diagnosed in individuals in their fifth and sixth decades of life. Hematologic Malignancies Hematologic malignancies encompass a diverse group of cancers affecting the blood, bone marrow, and lymphatic system, including leukemia, lymphoma, and multiple myeloma. These diseases account for a significant portion of cancer diagnoses worldwide, with varying incidence rates across different regions. While advancements in targeted therapies and immunotherapies have improved treatment outcomes, hematologic malignancies remain among the most challenging diseases in oncology. Global Market Overview According to Market Research Future, both the glioma and hematologic malignancies treatment markets are experiencing significant growth, driven by advancements in therapeutic options such as innovations in neuro-oncology and immunotherapies, alongside the increasing prevalence of these diseases. This growth is further supported by rising healthcare expenditure and government initiatives aimed at enhancing accessibility and fostering continued innovation. The global glioma treatment market was valued at approximately $3.58 billion in 2024 and is projected to reach $5.1 billion by 2032, reflecting a compound annual growth rate (CAGR) of 5.20% during the forecast period, while the global hematologic malignancies treatment market was valued at $22.23 billion in 2022 and is expected to reach $41.7 billion by 2032, with a CAGR of 6.5%. Together, these trends underscore the critical need for ongoing research and investment to address these complex and life-threatening conditions. Greg Siokas, CEO of Cosmos Health, stated: "These filings mark significant additions to our intellectual property portfolio and help us accelerate our efforts in advancing innovative treatments for complex and challenging diseases. By utilizing our AI-powered Cloudscreen platform, we are enhancing drug discovery and repurposing efforts to address significant unmet medical needs. By focusing on glioma and hematologic malignancies, including multiple myeloma, we are reinforcing our commitment to delivering transformative solutions for patients. This milestone underscores the strength and success of our collaboration with Cloudpharm and the National Hellenic Research Foundation." About Cosmos Health Inc. Cosmos Health Inc. (Nasdaq:COSM), incorporated in 2009 in Nevada, is a diversified, vertically integrated global healthcare group. The Company owns a portfolio of proprietary pharmaceutical and nutraceutical brands, including Sky Premium Life®, Mediterranation®, bio-bebe®, C-Sept® and C-Scrub®. Through its subsidiary Cana Laboratories S.A., licensed under European Good Manufacturing Practices (GMP) and certified by the European Medicines Agency (EMA), it manufactures pharmaceuticals, food supplements, cosmetics, biocides, and medical devices within the European Union. Cosmos Health also distributes a broad line of pharmaceuticals and parapharmaceuticals, including branded generics and OTC medications, to retail pharmacies and wholesale distributors through its subsidiaries in Greece and the UK. Furthermore, the Company has established R&D partnerships targeting major health disorders such as obesity, diabetes, and cancer, enhanced by artificial intelligence drug repurposing technologies, and focuses on the R&D of novel patented nutraceuticals, specialized root extracts, proprietary complex generics, and innovative OTC products. Cosmos Health has also entered the telehealth space through the acquisition of ZipDoctor, Inc., based in Texas, USA. With a global distribution platform, the Company is currently expanding throughout Europe, Asia, and North America, and has offices and distribution centers in Thessaloniki and Athens, Greece, and in Harlow, UK. More information is available at as well as LinkedIn and X. Forward-Looking Statements With the exception of the historical information contained in this news release, the matters described herein, may contain 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. Statements preceded by, followed by, or that otherwise, include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could", are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. These statements, involve unknown risks and uncertainties that may individually or materially impact the matters discussed, herein for a variety of reasons that are outside the control of the Company, including, but not limited to, the Company's ability to raise sufficient financing to implement its business plan, the impact of the COVID-19 pandemic and the war in Ukraine, on the Company's business, operations and the economy in general, and the Company's ability to successfully develop and commercialize its proprietary products and technologies. Readers are cautioned not to place undue reliance on these forward- looking statements, as actual results could differ materially from those described in the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's filings with the SEC, which are available at the SEC's website ( The Company disclaims any intention or obligation to update, or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Relations Contact: BDG Communicationscosm@ 207 0971 653 SOURCE: Cosmos Health Inc. View the original press release on ACCESS Newswire
