Intestinal Fistula

Real-world studies confirm that pairing LONSURF with bevacizumab increases efficacy in patients with metastatic colorectal cancer Increased efficacy with the combination was demonstrated broadly across this population and specifically in Black patients with the disease PRINCETON, N.J., Jan. 24, 2025 /PRNewswire/ -- Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, announced that it will share real-world data about the crucial role of LONSURF® (trifluridine/tipiracil) in a combination treatment for metastatic colorectal cancer (mCRC) during the American Society of Clinical Oncology 2025 Gastrointestinal Cancers Symposium, January 23-25 in San Francisco. In two abstracts, Taiho will present findings from real-world retrospective studies demonstrating that pairing LONSURF with bevacizumab, rather than administering LONSURF alone, improves clinical outcomes for the mCRC patient population, including Black patients. Orally administered LONSURF pairs the chemotherapy trifluridine, a nucleoside metabolic inhibitor, with tipiracil hydrochloride, a thymidine phosphorylase inhibitor that prolongs trifluridine's ability to stay active in the body. In the U.S., LONSURF's indication in mCRC is for use alone or in combination with bevacizumab, an anti-angiogenic drug. "We're pleased to present substantial real-world evidence confirming LONSURF's role as an effective regimen for patients with metastatic colorectal cancer," said Tehseen Salimi, MD, MHA, Senior Vice President and Head of Medical Affairs, Taiho Oncology. "At Taiho Oncology, we are dedicated to improving clinical outcomes and reducing patient burden by analyzing the real-world impact of our treatments and making patients and providers aware of the results." Adding bevacizumab to LONSURF improves clinical outcomes for patients with mCRC The larger of the two studies included 3,680 adult patients with mCRC, 3,151 of whom received LONSURF alone and 529 of whom received LONSURF plus bevacizumab. Researchers pulled data about patients and their treatments from electronic medical records and claims in the ConcertAI RWD360™ dataset. Investigators found that patients who took LONSURF plus bevacizumab, in the usual care setting, experienced a median real-world overall survival of 9.4 months (95% confidence interval [CI] 8.0-10.1) versus 6.4 months (95% CI 6.1-6.6; p<0.0001) in patients who took LONSURF alone, a statistically significant improvement. In addition, in a model that adjusted for certain patient characteristics, the risk of death was significantly decreased in the LONSURF/bevacizumab cohort versus the LONSURF monotherapy cohort, with a hazard ratio of 0.68 (p ˂0.0001) favoring the combination treatment. The investigators also found that the combination regimen, compared with LONSURF alone, significantly prolonged treatment duration (median 3.5 [95% CI: 3.3-3.8] vs 2.4 [95% CI: 2.3-2.6] months, respectively; p<0.0001) and, in the adjusted model, time to next treatment or death (median 5.0 [95% CI: 4.6-5.5] vs 3.9 [95%CI: 3.8-4.1] months; p<0.0001; HR=0.73; p<0.0001). Also using the adjusted model, the team found a decreased risk of treatment discontinuation with the combination regimen (HR=0.65; p<0.0001). Pairing LONSURF with bevacizumab improves real-world overall survival in Black patients with mCRC The second study included 639 Black patients with mCRC, 551 of whom received LONSURF alone and 88 of whom received LONSURF plus bevacizumab. Patient data was collected via United States-based electronic medical records and claims in the ConcertAI RWD360™ dataset. Investigators observed a significant improvement in real-world overall survival with LONSURF plus bevacizumab as compared with LONSURF alone (10.8 vs 6.2 months, respectively; p=0.0001). In addition, in an adjusted model, participants who received the combination treatment experienced a significantly lower risk of death compared with those who received LONSURF monotherapy (HR=0.45; p<0.0001). Researchers also found that treatment duration was significantly prolonged with LONSURF plus bevacizumab compared with LONSURF alone (3.8 vs 2.4 months, respectively; p<0.0001). In the adjusted model, participants who received the combination regimen had about half the risk of discontinuation compared with those who received LONSURF alone (HR=0.51; p<0.0001). "These are the largest real-world studies so far to confirm the findings of the Phase 3 SUNLIGHT trial, which demonstrated that LONSURF paired with bevacizumab, versus LONSURF alone, improved overall survival in patients with treatment-refractory metastatic colorectal cancer," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "Our findings will particularly inform the treatment of Black patients with metastatic colorectal cancer, who are under-represented in clinical trials despite having a much higher incidence and higher mortality of colorectal cancer as compared to other patients, helping to reinforce the importance of a representative patient population throughout clinical development to provide safe and effective treatments for all patients." About the SUNLIGHT Trial SUNLIGHT is a multinational, randomized, active-controlled, open-label, two-arm Phase 3 clinical trial to investigate the efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in patients with refractory mCRC following two chemotherapy regimens. A total of 492 patients were randomly allocated (in a 1:1 ratio) to receive trifluridine/tipiracil in combination with bevacizumab or trifluridine/tipiracil monotherapy. The primary objective was to assess trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in terms of OS (primary endpoint). Key secondary endpoints were PFS, overall response rate (ORR), disease control rate (DCR) and quality of life (QoL), as well as the safety and tolerability of trifluridine/tipiracil used in combination with bevacizumab in comparison with trifluridine/tipiracil monotherapy. The SUNLIGHT trial was conducted by Servier and Taiho Oncology, Inc. For more information on SUNLIGHT, please visit: . About LONSURF LONSURF is an oral nucleoside antitumor agent discovered and developed by Taiho Pharmaceutical Co., Ltd. LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation. INDICATIONS LONSURF is indicated as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine‑, oxaliplatin‑ and irinotecan‑based chemotherapy, an anti‑VEGF biological therapy, and if RAS wild-type, an anti‑EGFR therapy. LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu‑targeted therapy. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Severe Myelosuppression: In the 1114 patients who received LONSURF as a single agent, LONSURF caused severe or life-threatening myelosuppression (Grade 3-4) consisting of neutropenia (38%), anemia (17%), thrombocytopenia (4%) and febrile neutropenia (3%). Three patients (0.3%) died due to neutropenic infection/sepsis; four other patients (0.5%) died due to septic shock. A total of 14% of patients received granulocyte-colony stimulating factors. In the 246 patients who received LONSURF in combination with bevacizumab, LONSURF caused severe or life-threatening myelosuppression (Grade 3-4) consisting of neutropenia (52%), anemia (5%), thrombocytopenia (4%) and febrile neutropenia (0.4%). One patient (0.4%) died due to abdominal sepsis and two other patients (0.8%) died due to septic shock. A total of 29% of patients received granulocyte-colony stimulating factors. Obtain complete blood counts prior to and on Day 15 of each cycle of LONSURF and more frequently as clinically indicated. Withhold LONSURF for severe myelosuppression and resume at the next lower dosage. Embryo‑Fetal Toxicity: LONSURF can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the final dose. USE IN SPECIFIC POPULATIONS Lactation: It is not known whether LONSURF or its metabolites are present in human milk. There are no data to assess the effects of LONSURF or its metabolites on the breastfed child or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LONSURF and for 1 day following the final dose. Male Contraception: Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with LONSURF and for at least 3 months after the final dose. Geriatric Use: Patients 65 years of age or older who received LONSURF as a single agent had a higher incidence of the following hematologic laboratory abnormalities compared to patients younger than 65 years: Grade 3 or 4 neutropenia (46% vs 32%), Grade 3 anemia (20% vs 14%), and Grade 3 or 4 thrombocytopenia (6% vs 3%). Patients 65 years of age or older who received LONSURF in combination with bevacizumab had a higher incidence of the following hematologic laboratory abnormalities compared to patients younger than 65 years: Grade 3 or 4 neutropenia (60% vs 46%) and Grade 3 or 4 thrombocytopenia (5% vs 4%). Renal Impairment: No adjustment to the starting dosage of LONSURF is recommended in patients with mild or moderate renal impairment (CLcr of 30 to 89 mL/min). Reduce the starting dose of LONSURF for patients with severe renal impairment (CLcr of 15 to 29 mL/min) to a recommended dosage of 20 mg/m2. Hepatic Impairment : Do not initiate LONSURF in patients with baseline moderate or severe (total bilirubin > 1.5 times ULN and any AST) hepatic impairment. Patients with severe hepatic impairment (total bilirubin > 3 times ULN and any AST) were not studied. No adjustment to the starting dosage of LONSURF is recommended for patients with mild hepatic impairment. ADVERSE REACTIONS Serious adverse r eactions occurred in 25% of patients. The most frequent serious adverse reactions (≥2%) were intestinal obstruction (2.8%), and COVID-19 (2%). Fatal adverse reactions occurred in 1.2% of patients who received LONSURF in combination with bevacizumab, including rectal fistula (0.4%), bowel perforation (0.4%) and atrial fibrillation (0.4%). The most common adverse reactions or laboratory abnormalities (≥10% in incidence) in patients treated with single-agent LONSURF at a rate that exceeds the rate in patients receiving placebo were anemia (77% vs 33%), neutropenia (67% vs 0.8%), asthenia/fatigue (52% vs 35%), nausea (48% vs 24%), thrombocytopenia (42% vs 8%), decreased appetite (39% vs 29%), diarrhea (32% vs 12%), vomiting (28% vs 14%), abdominal pain (21% vs 19%), and pyrexia (19% vs 14%). The most common adverse reactions or laboratory abnormalities (≥20% in incidence) in patients treated with LONSURF in combination with bevacizumab vs LONSURF alone were neutropenia (80% vs 68%), anemia (68% vs 73%), thrombocytopenia (54% vs 29%), fatigue (45% vs 37%), nausea (37% vs 27%), increased aspartate aminotransferase (34% vs 28%), increased alanine aminotransferase (33% vs 23%), increased alkaline phosphate (31% vs 36%), decreased sodium (25% vs 20%), diarrhea (21% vs 19%), abdominal pain (20% vs 18%), and decreased appetite (20% vs 15%). Please see accompanying full Prescribing Information. About Taiho Oncology, Inc. The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small molecule clinical candidates targeting solid tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company's European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada. For more information, visit , and follow us on LinkedIn and X. Taiho Oncology and the Taiho Oncology logo are registered trademarks of Otsuka Holdings Co., Ltd. or its subsidiaries. Taiho Oncology Contact: Leigh Labrie (609) 664-9878 [email protected] SOURCE Taiho Oncology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NEWTON, Mass.--( BUSINESS WIRE )--Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, has signed agreements with four leading distributors to streamline access to the Leva ® Pelvic Health System. Byram Healthcare Centers, Inc. (“Byram Healthcare”), EVERSANA, J&B Medical and OneSource Medical Group, LLC, now offer the Leva System, recently named to AARP’s 2023 Medical Breakthroughs , making it easier for physicians, healthcare systems and patients to access safe and effective at-home treatment for incontinence supported by multiple clinical trials and published data. Bladder leaks—called urinary incontinence (UI)—affect 78 million women in the U.S. Accidental bowel leakage, called fecal incontinence (FI), affects 12 million women. While UI and FI are the most prevalent pelvic floor disorders among women, they are vastly undertreated. Shame and embarrassment can keep women from seeking treatment. Left untreated, incontinence can affect women’s mental and physical health, quality of life and relationships. It also leads to higher healthcare costs for both women and insurers. For older women, UI is a leading cause of nursing home placement. Pelvic floor muscle training (PFMT)—or “Kegels”—is globally recommended first-line treatment for UI and FI. However, data show few women perform Kegels consistently or effectively enough to relieve incontinence symptoms. The Leva System combines a small FDA-cleared vaginal motion sensor device and integrated software that allows women to visualize pelvic movement in real-time, offering an effective, non-invasive, medication-free way for them to train and strengthen their pelvic floor. As a prescription device, the Leva System offers multiple ways for clinicians to connect more women with first-line treatment and support them throughout 12 weeks of therapy. “Several recent studies show that women do not regularly receive recommended first-line treatment for incontinence,” said Steven G. Gregg, PhD, executive director of the National Association For Continence (“NAFC”). “While concerning, it’s not surprising. While PFMT is effective, first-line treatment for urinary incontinence, doing Kegels correctly and consistently is hard, and most women don’t have access to specialized physical therapy, which can help. The Leva System makes PFMT accessible by supporting a women’s success as she improves her incontinence symptoms. NAFC applauds all efforts to make access to clinically proven treatment options for incontinence more available for women.” "Women dealing with bladder and bowel leaks are reaching out for support," shared Eileen Maus, CEO of Axena Health. "Pelvic floor muscle training is a globally recommended solution that Leva makes more accessible to women. Through these strategic distributor agreements, we've orchestrated a seamless network, supporting swift access to Leva for patients. We're excited to collaborate with healthcare leaders who share our commitment to offering women non-invasive, drug- and surgery-free options for incontinence treatment." About the Leva ® Pelvic Health System The Leva Pelvic Health System is a prescription medical device available in the United States that offers an innovative, non-invasive, medication-free way for women to train and strengthen their pelvic floor muscles—at home in just five minutes a day—to treat urinary incontinence (UI) and chronic fecal incontinence (FI). Combining a small FDA-cleared vaginal motion sensor device and integrated software, the Leva System offers precise visualization of pelvic movement in real-time, enables progress tracking and allows active clinician involvement, all of which support women’s success. Recognizing that level-one evidence shows pelvic floor muscle training is most effective when performed under the supervision of a skilled healthcare provider, the Leva System is available by prescription only, allowing physicians the opportunity to treat UI and chronic FI on a broad scale and with continued involvement in patient success. The Leva System has multiple clinical trials and published data from globally recognized medical centers supporting its efficacy in treating UI, including two studies in Obstetrics and Gynecology (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists (ACOG). In May 2023, Axena Health announced a global study to examine the burdens of incontinence for women in low- and middle-income countries. The findings will guide the development of new treatment options based on the Leva System that are culturally acceptable and available within local healthcare pathways. About Axena Health Axena Health, Inc. is a women-led company dedicated to improving the lives of women with pelvic floor disorders. Axena Health’s flagship product, the Leva ® Pelvic Health System , offers a novel, effective, first-line treatment for urinary incontinence (UI) and chronic fecal incontinence (FI), underreported conditions affecting over 78 million and 12 million women in the U.S. alone. Axena Health's technology enables non-invasive, drug-free treatment via precise visualization of movement in real time during pelvic floor muscle training, while monitoring usage and progress. For more information, please visit www.axenahealth.com or www.levatherapy.com , follow Axena Health on LinkedIn and follow Leva Pelvic Health System on Instagram and TikTok. Important Indication and Other Information for the Leva® Pelvic Health System The Leva ® Pelvic Health System is intended for (1) strengthening of pelvic floor muscles, (2) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women and (3) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence ( > 3-month uncontrolled passage of feces) in women. Treatment with the Leva System is by prescription and is not for everyone. Please talk to your prescriber to see if Leva System is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use the Leva System while pregnant, or if you think you may be pregnant, unless authorized by your doctor. For a complete summary of the risks and instructions for the Leva System, see its Instructions for Use available at www.levatherapy.com .

Mesenchymal stem cells (MSCs) have broad therapeutic potential for treating inflammation and degenerative diseases. Mesenchymal stem cells have been isolated and identified from many other sources of human tissues, widely distributed in virtually all tissues (including fetal and adult), such as bone marrow, blood, umbilical cord, placenta, fat, amnion, amniotic fluid, dental pulp, skin, menstrual blood, and so on. Mesenchymal stem cell therapy works in both direct and indirect ways. The direct actions include homing, directed differentiation, multipotent differentiation, and paracrine effects. The indirect actions involve the bidirectional regulation of immune responses and inflammation, antioxidative stress, antifibrosis, antiapoptosis, hematopoiesis support, participation in or promotion of angiogenesis, activation of the proliferation and differentiation of endogenous stem cells, and the dedifferentiation of diseased tissue organs' normal cells, as well as anti-aging, and anti-scar formation. The application of mesenchymal stem cell therapy in clinical practice is very broad, including the treatment of hematological diseases, neurological diseases, digestive diseases, cardiovascular diseases, respiratory diseases, skeletal system diseases, endocrine system diseases, immune system diseases, urogenital diseases, as well as anti-aging and immune enhancement. With the continuous investment in future scientific research, it is believed that there will be increasingly more difficult and complex diseases starting to explore the use of mesenchymal stem cells for treatment, and an increasing number of new drugs based on mesenchymal stem cells will be approved for clinical trials and even applications. Mesenchymal Stem Cell Therapy Competitive LandscapeAccording to Patsnap Synapse, as of 8 Oct 2023, there are a total of 339 Mesenchymal stem cell therapy drugs worldwide, from 320 organizations, covering 11 targets, 299 indications, and conducting 1254 clinical trials. 👇Please click on the picture link below for free registration or login directly if you have freemium accounts, you can browse the latest research progress on drugs , indications,  targets, organizations, clinical trials, and clinical results related to this drug type. Phase II Clinical Trial of Mesenchymal Stem Cell Therapy Medicinal: ADR-001ADR-001 is a mesenchymal stem cell therapy drug that targets ADAR. Mesenchymal stem cells are multipotent cells that can differentiate into various cell types, including those found in the immune system, urogenital system, and digestive system. ADAR, or adenosine deaminase acting on RNA, is an enzyme involved in RNA editing. The therapeutic areas for ADR-001 include immune system diseases, urogenital diseases, and digestive system disorders. Immune system diseases encompass a wide range of conditions that affect the body's immune response, such as autoimmune diseases and immunodeficiency disorders. Urogenital diseases refer to disorders affecting the urinary and reproductive systems, including conditions like urinary tract infections and infertility. Digestive system disorders involve issues with the gastrointestinal tract, such as inflammatory bowel disease and liver diseases. The active indications for ADR-001 are liver cirrhosis, glomerulonephritis, and IGA. Liver cirrhosis is a chronic liver disease characterized by the replacement of healthy liver tissue with scar tissue, leading to impaired liver function. Glomerulonephritis is a group of kidney diseases that cause inflammation in the glomeruli, the tiny filters in the kidneys. IGA refers to immunoglobulin A, an antibody that plays a role in the immune response. Elevated levels of IGA can be associated with certain diseases, including kidney and liver disorders. Rohto Pharmaceutical Co., Ltd. is the originator organization of ADR-001. They are responsible for the development and research of this drug. The highest phase of development for ADR-001 is Phase 2, indicating that it has undergone initial testing for safety and efficacy in a limited number of patients. In summary, ADR-001 is a mesenchymal stem cell therapy drug developed by Rohto Pharmaceutical Co., Ltd. It targets ADAR and is being investigated for its potential in treating immune system diseases, urogenital diseases, and digestive system disorders. The active indications for ADR-001 include liver cirrhosis, glomerulonephritis, and IGA. Currently, ADR-001 is in Phase 2 of development, suggesting that further clinical trials are required to assess its effectiveness and safety. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. Approved Mesenchymal Stem Cell Therapy Medicinal: StempeuticsMesenchymal stem cell therapies, specifically Stempeutics, are a type of drug used in the field of biomedicine. These therapies are designed to treat various medical conditions related to the digestive system, nervous system, cardiovascular system, endocrinology and metabolism, as well as skin and musculoskeletal diseases. The active indications for Stempeutics include osteoarthritis, diabetic foot, and rectal fistula. These conditions are targeted by the drug to provide therapeutic benefits and alleviate symptoms associated with them. In terms of its development stage, Stempeutics has reached the highest phase of approval, indicating that it has successfully undergone rigorous testing and evaluation. The first approval of Stempeutics was granted in August 2020 in India. This means that India was the first country/location to approve the drug for use in patients. This approval signifies that the regulatory authorities in India have reviewed the clinical data and determined that the drug meets the necessary standards for safety and effectiveness. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. Overall, Stempeutics is a mesenchymal stem cell therapy that has been approved for the treatment of osteoarthritis, diabetic foot, and rectal fistula. It has shown promising results in clinical trials and has received approval in India. The drug holds potential for addressing various medical conditions related to the digestive system, nervous system, cardiovascular system, endocrinology and metabolism, as well as skin and musculoskeletal diseases.