Ondansetron Hydrochloride

RedHill has been selected to provide a presentation to further elaborate on opaganib's potential to U.S. government representatives at the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense's (JPEO-CBRND) "Host Directed Therapeutics Industry Day" -- Based on reviews, feedback, and discussion, the judges selected for presentation those therapeutics that demonstrated capability in the prophylaxis, post-exposure prophylaxis, and the treatment of exposure to viruses, bacteria and toxins. The meeting is scheduled to take place October 29-30, 2024, at the United States Patent and Trademark Office in Alexandria, VA -- The JPEO-CBRND manages U.S. government investments in chemical, biological, radiological, and nuclear (CBRN) defense equipment and medical countermeasures (MCMs). The JPEO-CBRND's mission is to provide integrated, layered, chemical, biological, radiological, and nuclear defense capabilities to the Joint Force across combined Joint all-domain operations -- With multiple U.S. government collaborations for chemical and MCMs and pandemic preparedness, opaganib is a novel, host-directed, potentially broad-acting, orally administered small molecule, clinical-stage drug with demonstrated safety and efficacy profiles, being developed for various oncology, viral infections, inflammatory diseases, and chemical and nuclear/radioprotection indications TEL-AVIV, Israel and RALEIGH, N.C., Oct. 28, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the Company has been selected to further elaborate on opaganib's[1] potential in a presentation to U.S. government representatives at the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense's (JPEO-CBRND) "Host Directed Therapeutics Industry Day". The meeting is scheduled to take place October 29-30, 2024, at the United States Patent and Trademark Office in Alexandria, VA. The JPEO-CBRND manages U.S. government investments in chemical, biological, radiological, and nuclear (CBRN) defense equipment and medical countermeasures (MCMs). The JPEO-CBRND mission is to provide integrated, layered, chemical, biological, radiological, and nuclear defense capabilities to the Joint Force across combined Joint all-domain operations. Based on reviews, feedback, and discussion, the judges selected for presentation those therapeutics that demonstrated capability in the prophylaxis, post-exposure prophylaxis, and treatment of exposure to viruses, bacteria and toxins. "Opaganib is already the subject of multiple ongoing collaborations with several U.S. government agencies. However, selection for presentation at this important governmental investment event provides a significant opportunity to highlight the growing body of evidence in support of opaganib's potential as an oral, host-directed, broad-acting viral, chemical and nuclear countermeasure ," said Guy Goldberg, RedHill's Chief Business Officer. About Opaganib (ABC294640) Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential indications, including several cancers, diabetes and obesity-related disorders, gastrointestinal acute radiation syndrome (GI-ARS), Sulfur Mustard exposure, COVID-19, Ebola and other viruses as part of pandemic preparedness. Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS). Several U.S. government countermeasures and pandemic preparedness programs have selected opaganib for evaluation for multiple indications, including Acute Radiation Syndrome (ARS), Ebola virus disease and others. Funding bodies include the Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. government Department of Health & Human Services' National Institutes of Health and the Administration for Strategic Preparedness and Response's (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA). Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study. Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in Microorganisms. Opaganib has received several orphan-drug designations from the FDA in oncology and other diseases and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission. Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications. Disclaimer: The views and opinions of authors expressed herein do not necessarily state or reflect those of the U.S. government and shall not be used for advertising or product endorsement purposes. Reference herein to any specific commercial products, process, or service by trade name, trademark, manufacturer, or otherwise, does not constitute or imply its endorsement, recommendation, or favoring by the U.S. government and shall not be used for advertising or product endorsement purposes. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[2]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first -in -class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for chemical and medical countermeasure and pandemic preparedness use, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease. More information about the Company is available at / X.com/RedHillBio. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include, among others, statements regarding the potential of opaganib. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, and that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law. Category: R&D [1]Opaganib is an investigational new drug, not available for commercial distribution. [2]Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Logo: SOURCE RedHill Biopharma Ltd. 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The comprehensive cancer center’s experts will spotlight scientific data on how dietary choices, psychosocial support, massage therapy and mind-body calming practices can improve outcomes and the quality of life of people touched by cancer LOS ANGELES--(BUSINESS WIRE)--Researchers from City of Hope ® , one of the largest and most advanced cancer research and treatment organizations in the United States, ranked among the nation’s top 5 cancer centers by U.S. News & World Report and a national leader in providing cancer patients with best-in-class, integrated supportive care programs, will present new data on integrative oncology research and clinical trials at the 21st International Conference of the Society for Integrative Oncology taking place Oct. 25 to 27. Integrative oncology is a patient-centered field of cancer care that combines conventional cancer treatments with complementary, evidence-based therapies to improve outcomes and quality of life. The hybrid conference hosted by City of Hope in Costa Mesa, California, will include more than 170 oral and poster abstracts evaluating supplements and herbal therapies, traditional medicine such as acupuncture, lifestyle choices like diet and exercise, mind-body practices, and use of artificial intelligence and machine learning in integrative oncology. “City of Hope and other experts will share the best science that’s occurring in the field of integrative oncology, which aims to optimize health, quality of life and clinical outcomes,” said Richard T. Lee , M.D., Cherng Family Director’s Chair for the Center for Integrative Oncology at City of Hope, medical director of supportive and integrative medicine at City of Hope Orange County and co-chair of the SIO conference. “City of Hope is leading a national effort to make evidence-based integrative oncology a routine and interwoven part of optimal cancer care and survivorship. City of Hope is bringing together leaders in the field to create the most holistic approach to cancer care.” A $100 million gift from Panda Express Co-CEOs Andrew and Peggy Cherng has enabled City of Hope to lead efforts to accelerate research, therapeutic development and clinical trials for the advancement of evidence-based integrative oncology practices so that cancer patients nationwide and their doctors have access to safe, proven approaches. Some of the leading-edge data City of Hope will present include the following oral abstracts. Massage therapy during infusion lessens the side effects of chemotherapy in a pilot study Presentation time and location: Saturday, Oct. 26 in the Plaza Ballroom from 3 to 4:15 p.m. Christy DiCristofano, a City of Hope massage therapist, led a pilot study assessing the therapeutic effects of massage on cancer patients. The research team surveyed 232 individuals who collectively received 500 hand and/or foot massages while undergoing an infusion. They found that massage therapy is a beneficial additional treatment for symptoms induced by chemotherapy. The therapy had no reported side effects and proved useful in managing symptoms, such as anxiety, pain, shortness of breath, nausea and neuropathy, which is marked by shooting pain, numbness or tingling. Further research is needed to comprehensively evaluate the benefits of this intervention during infusion. Increasing white button mushroom intake could slow the progression of prostate cancer Presentation time and location: Sunday, Oct. 27 in the Lido Room from 10:45 a.m. to noon Bidirectional translational research led by Xiaoqiang Wang, M.D., Ph.D., City of Hope staff scientist, and Shiuan Chen , Ph.D., professor and chair of City of Hope’s Department of Cancer Biology and Molecular Medicine and the Lester M. and Irene C. Finkelstein Chair in Biology, revealed that consuming white button mushrooms can alter androgen levels and boost anti-cancer immunity. The comprehensive research included preclinical experiments, mouse models and prostate cancer patients participating in an ongoing phase 2 clinical trial. The physician-scientists collected blood samples from both mouse models and humans, analyzing myeloid-derived suppressor cells that are responsible for squelching immune responses and assisting tumor growth. They found that consuming white button mushrooms enhances anti-tumor immunity and slows prostate cancer progression. They expect to learn more once the phase 2 clinical trial is completed. Can intermittent fasting decrease the side effects of radiotherapy and enhance its efficacy? Presentation time and location: Friday, Oct. 25 in the Mesa Verde Room from 2:30 to 3:45 p.m. Several clinical and preclinical studies suggest that time-restricted eating, more commonly called intermittent fasting, may enhance anti-tumor response, decrease side effects and improve quality of life during systemic therapy. Ziyi Huang, M.D., City of Hope research fellow, and Yun Rose Li , M.D., Ph.D., assistant professor of radiation oncology at City of Hope, are leading an ongoing randomized phase 2 trial testing whether patients with pelvic malignancies who practice time-restricted eating could experience reduced levels of radiotherapy-induced side effects and enhanced radiotherapy efficacy. The time-restricted eating group are asked to fast for 12 to 14 hours on radiotherapy days. Researchers collect diet logs, stool, urine and blood samples alongside patient- and clinician-reported toxicities. Thus far, the results are encouraging and support the tolerability and feasibility of intermittent fasting during pelvic radiotherapy, especially among patients with prostate cancer. Enrollment in the trial is expected to be completed in spring 2025. Nurses can videoconference cancer patients to provide supportive care and improve quality of life Presentation time and location: Saturday, Oct. 26 in the Plaza Ballroom from 3 to 4:15 p.m. Psychosocial support services can be limited in small urban and rural areas. Up to 70% of patients with advanced cancer experience elevated levels of fear of cancer progression characterized by intrusive thoughts, distress and difficulty making future plans. Anne Reb , Ph.D. N.P., assistant professor of nursing research and education at City of Hope, and Betty Ferrell , Ph.D., M.S.N., CHPN, City of Hope director and professor of nursing research and education, led a pilot study to assess the feasibility and preliminary effects of a nurse-guided videoconferencing intervention to manage fear of cancer progression levels in patients with Stage 3 or 4 gynecologic or lung cancer. Some 82% of the 30 study participants completed all five nurse-led videoconferencing sessions and reported using the tools the nurses introduced like attention training and detached mindfulness to focus, connect with what is most important to them and gain control over daily life stressors. The intervention showed improvement in fear and other quality-of-life outcomes. Feasibility and acceptability was established in this small sample size and suggestions for improvement were established. The potential risk of drug interactions with cannabis use Presentation time and location: Saturday, Oct. 26 in the Plaza Ballroom from 11:30 a.m. to 12:45 p.m. In one of the first studies to assess cannabis-related drug interactions in patients receiving cancer treatment, Elyssa Kim, B.S., former City of Hope research assistant, and Richard T. Lee , M.D., City of Hope clinical professor of supportive and integrative medicine, found that a significant proportion of cannabis users are at risk of moderate to major potential medication interactions. Of the 313 participants, 61 were actively using a form of cannabis to address insomnia (46%), pain (41%) and mood (39%). The most common medications whose effectiveness could be compromised due to cannabis use were noted to be medications for pain or inflammation (acetaminophen, dexamethasone), anti-nausea (ondansetron) and even chemotherapy (paclitaxel, doxorubicin). Researchers say that more states are legalizing cannabis and more cancer patients turn to cannabis to alleviate cancer symptoms, but we need more data on the therapeutic effects and pitfalls of cannabis use during cancer treatment. A mix of mindfulness meditation, gentle exercise and spirituality is linked to improved emotional well-being among breast cancer survivors Presentation time and location: Saturday, Oct. 26 in the Lido Room from 11:30 a.m. to 12:45 p.m. Breast cancer survivors often report experiencing anxiety, depression, poor sleep and cognitive impairment. Frank Munoz, a City of Hope chaplain, conducted a pilot study of meditative movement effects on this patient population, taking blood samples to measure serotonin-related (HTR1F and SLC6A4) and mood/cognitive function-related (BDNF, IL6 and IL1b) gene expression levels. The intervention resulted in a biological change in scores of anxiety, depression, sleep quality and cognitive function. This small study, which demonstrated changes in gene expression, suggests that meditative movement such as tai chi and meditation may help breast cancer survivors recover from persistent mental and emotional symptoms. About City of Hope City of Hope’s mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the U.S., and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines , as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope™ . For more information about City of Hope, follow us on Facebook , X , YouTube , Instagram and LinkedIn . Contacts Zen Logsdon 626-409-9367 zlogsdon@coh.org