Harringtonine injection for the treatment of castration-resistant prostate cancer after second-line treatment, a prospective single-arm, open-label clinical study

Start Date01 Jun 2023

Sponsor / Collaborator

Southeast University Affiliated Zhonda Hospital

100 Clinical Results associated with Harringtonine

100 Translational Medicine associated with Harringtonine

100 Patents (Medical) associated with Harringtonine

1,515

Literatures (Medical) associated with Harringtonine

31 Dec 2024·Bioengineered

Establishment and characterization of a highly metastatic hepatocellular carcinoma cell line

Article

Author: Huang, Jiacheng ; Zhang, Yu ; Wang, Menglan ; Yu, Anning ; Hu, Zhenhua ; Bu, Chiwen ; Sun, Mengqing ; Qiao, Yiting ; Zhou, Jie ; Zheng, Huilin

The prevalence of alcohol-related hepatocellular carcinoma (HCC) has been increasing during the last decade. Cancer research requires cell lines suitable for both in vitro and in vivo assays. However, there is a lack of cell lines with a high in vivo metastatic capacity for this HCC subtype. Herein, a new HCC cell line was established, named HCC-ZJ, using cells from a patient diagnosed with alcohol-related HCC. The karyotype of HCC-ZJ was 46, XY, del (p11.2). Whole-exome sequencing identified several genetic variations in HCC-Z that occur frequently in alcohol-associated HCC, such as mutations in TERT, CTNNB1, ARID1A, CDKN2A, SMARCA2, and HGF. Cell counting kit-8 assays, colony formation assays, and Transwell assays were performed to evaluate the proliferation, migration, and sensitivity to sorafenib and lenvatinib of HCC-Z in vitro. HCC-ZJ showed a robust proliferation rate, a weak foci-forming ability, a strong migration capacity, and a moderate invasion tendency in vitro. Finally, the tumorigenicity and metastatic capacity of HCC-Z were evaluated using a subcutaneous xenograft model, an orthotopic xenograft model, and a tail-veil injection model. HCCZJ exhibited strong tumorigenicity in the subcutaneous xenograft and orthotopic tumor models. Moreover, HCC-ZJ spontaneously formed pulmonary metastases in the orthotopic tumor model. In summary, a new HCC cell line derived from a patient with alcohol-related HCC was established, which showed a high metastatic capacity and could be applied for in vitro and in vivo experiments during pre-clinical research.Highlights• An alcohol-related HCC cell line, HCC-ZJ, was established• HCC-ZJ was applicable for in vitro functional experiment and gene editing• HCC-ZJ was applicable for in vivo tumor growth and spontaneous metastasis models.

01 Nov 2024·Infectious Disorders - Drug Targets

Insight into the Natural Biomolecules (BMs): Promising Candidates as Zika Virus Inhibitors

Review

Author: Singh, Alka ; Semwal, Amit ; Garg, Ruchika ; Dobhal, Kiran

Abstract:Zika virus (ZIKV) is among the relatively new infectious disease threats that include SARS-CoV2, coronavirus, monkeypox (Mpox) virus, etc. ZIKV has been reported to cause severe health risks to the fetus. To date, satisfactory treatment is still not available for the treatment of ZIKV infection. This review examines the last five years of work using natural biomolecules (BMs) to counteract the ZIKV through virtual screening and in vitro investigations. Virtual screening has identified doramectin, pinocembrin, hesperidins, epigallocatechin gallate, pedalitin, and quercetin as potentially active versus ZIKV infection. In vitro, testing has shown that nordihydroguaiaretic acid, mefloquine, isoquercitrin, glycyrrhetinic acid, patentiflorin-A, rottlerin, and harringtonine can reduce ZIKV infections in cell lines. However, in vivo, testing is limited, fortunately, emetine, rottlerin, patentiflorin-A, and lycorine have shown in vivo anti- ZIKV potential. This review focuses on natural biomolecules that show a particularly high selective index (>10). There is limited in vivo and clinical trial data for natural BMs, which needs to be an active area of investigation. This review aims to compile the known reference data and discuss the barriers associated with discovering and using natural BM agents to control ZIKV infection.

01 Nov 2024·European Journal of Pharmacology

Harringtonine metabolites: 5'-de-O-methylharringtonine and cephalotaxine, targeting spike protein and TMPRSS2 to double block membrane fusion of SARS-CoV-2 and its variants

Article

Author: He, Langchong ; Gao, Jiapan ; Zhang, Yuxiu ; Ma, Weina ; Ma, Xiaoyu ; Lei, Panpan ; Ren, Bingxi ; Hu, Shiling

Membrane fusion is the main pathway for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to invade host cells. Harringtonine (HT), derived from cephalotaxus fortunei Hook. f., has been recognized as an effective antagonist of SARS-CoV-2. It can directly block the active binding of spike (S) protein to host angiotensin converting enzyme 2 (ACE2), as well as hinder the enzymolysis of transmembrane serine proteases 2 (TMPRSS2). This study examined the potential of HT metabolites, 5'-de-O-methylharringtonine and cephalotaxine, as the membrane fusion inhibitors for SARS-CoV-2. 5'-De-O-methylharringtonine was synthesized and subsequently characterized by high resolution mass spectrometry and nuclear magnetic resonance to be structurally consistent, with a purity of 92.677% determined by reverse phase high performance liquid chromatography. Both 5'-de-O-methylharringtonine and cephalotaxine can specifically bind to SARS-CoV-2 S protein and TMPRSS2 using cell membrane chromatography. They can form hydrogen bonds with key sites that correlated highly with the enhanced binding affinity of SARS-CoV-2 and its variants to ACE2 or nafamostat to TMPRSS2. Moreover, 5'-de-O-methylharringtonine and cephalotaxine can inhibit pseudotyped virus entry and membrane fusion in a dose-dependent manner, with enhanced effectiveness upon elevated expression of TMPRSS2. Importantly, they displayed low cytotoxic effects on human normal cell lines. Our study suggested that 5'-de-O-methylharringtonine and cephalotaxine were of low toxicity and safety for humans as potential antagonists of SARS-CoV-2 and its variants, which deserve further validation in a biosafety level 3 facility.

News (Medical) associated with Harringtonine

29 Nov 2023

·www.prnewswire.com

Astellas' Fezolinetant Reduces Frequency and Severity of VMS Associated with Menopause in Women Considered Unsuitable for Hormone Therapy

Phase 3b DAYLIGHT study being presented at ESG 2023 demonstrated fezolinetant 45 mg achieved statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms due to menopause and patient-reported sleep disturbance at 24 weeks Women considered unsuitable included those with contraindications, who are averse to taking, have stopped taking or have conditions that suggest caution in using hormone therapy Results will support health technology assessment and reimbursement dossiers throughout Europe TOKYO, Nov. 29, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will present 24-week results from the Phase 3b DAYLIGHT clinical trial examining the efficacy and safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause in women considered unsuitable for hormone therapy, in an oral presentation on November 30 at the 15th Congress of the European Society of Gynecology in Amsterdam, The Netherlands (Abstract #12497). VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2 The study of more than 450 women considered unsuitable for hormone therapy met all primary and secondary endpoints at 24 weeks. For the primary endpoint of mean change from baseline in the frequency of moderate to severe VMS, fezolinetant 45 mg demonstrated a statistically significant reduction of -1.93 (p<0.001) compared to placebo. For the key secondary endpoint of mean change from baseline in the severity of moderate to severe VMS, fezolinetant 45 mg demonstrated a statistically significant reduction of -0.39 (p<0.001) compared to placebo. For the secondary endpoint of mean change from baseline in patient-reported sleep disturbance, fezolinetant 45 mg demonstrated a statistically significant reduction of -2.5 (p<0.001) compared to placebo. Treatment-emergent adverse events (TEAEs) were reported by 65% of patients in the fezolinetant group compared to 61% in the placebo group. The most common TEAEs were COVID-19 (13.3% for fezolinetant vs. 12.8% for placebo), headache (8.8% for fezolinetant vs. 9.3% for placebo) and fatigue (5.8% for fezolinetant vs. 0.4% for placebo). Serious TEAEs occurred in 4.4% of patients in the fezolinetant group and 3.5% of patients in the placebo group. Prof. Rossella Nappi, Full Professor of Obstetrics and Gynecology, Chief of the Research Center for Reproductive Medicine and Director of the Gynecological Endocrinology & Menopause Unit, IRCCS San Matteo Foundation, University of Pavia "I know many women want options for managing hot flashes based on their medical history and personal choices, which is why these DAYLIGHT results are encouraging. The statistically significant reductions observed over the 24-week period demonstrate the potential fezolinetant has to help women who are experiencing VMS due to menopause yet cannot or choose not to take hormone therapy." Marci English, Vice President, Head of BioPharma Development, Astellas "DAYLIGHT is the first 24-week placebo-controlled efficacy study for fezolinetant. Astellas is committed to advancing innovative science, and these data provide further affirmation to healthcare providers of the positive impact fezolinetant can have on reducing the frequency and severity of VMS, as well as sleep disturbances over a longer period of time." About DAYLIGHT DAYLIGHT (NCT05033886) is a Phase 3b, randomized, double-blind, placebo-controlled, 24-week study to assess the efficacy and safety of fezolinetant 45 mg in menopausal women aged 40-65 suffering from moderate to severe VMS and considered unsuitable for hormone therapy (HT): contraindicated, averse (made informed choice not to take HT), stoppers (previously discontinued HT) and caution (based on prior medical history). The primary endpoint was mean change in the frequency of moderate to severe VMS from baseline to week 24. Secondary endpoints were mean change in severity of moderate to severe VMS from baseline to week 24 and mean change in patient-reported sleep disturbance on the Patient-Reported Outcomes Measurement Information System Sleep Disturbance (PROMIS SD) – Short Form 8b from baseline to week 24. A total of 453 women were enrolled at 69 sites in Canada, Europe and Turkey. Topline results of the DAYLIGHT study were announced in June 2023. About Fezolinetant Fezolinetant is an investigational oral, nonhormonal medicine in clinical development for the treatment of moderate to severe VMS associated with menopause. VMS are also known as hot flashes or night sweats. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron, helping restore the balance in the brain's temperature control center (the hypothalamus) to reduce the number and intensity of hot flashes and night sweats.3,4,5 There is no guarantee the agent will receive regulatory approval in Europe or become commercially available for the uses being investigated. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at . Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. References 1 Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005;3:47. 2 Jones RE, Lopez KH, eds. Human Reproductive Biology. 4th ed. Waltham, MA: Elsevier, 2014:120. 3 Depypere H, Timmerman D, Donders G, et al. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. J Clin Endocrinol Metab. 2019;104:5893-5905. 4 Fraser GL, Lederman S, Waldbaum A, et al. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Menopause. 2020;27:382-392. 5 Fraser GL, Hoveyda HR, Clarke IJ, et al. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. Endocrinology. 2015;156:4214-4225. SOURCE Astellas Pharma Inc.

Clinical ResultPhase 2Phase 3

03 Apr 2023

·www.sciencedaily.com

Early menopause, later start to hormone therapy may increase risk of Alzheimer's disease

Women are more likely than men to develop Alzheimer's disease (AD), with women making up two-thirds of the population living with AD. A new study sheds light on the relationship between the risk of Alzheimer's disease and age of menopause and use of hormone therapy (HT). Women are more likely than men to develop Alzheimer's disease (AD), with women making up two-thirds of the population living with AD. A new study, led by Mass General Brigham researchers, sheds light on the relationship between the risk of Alzheimer's disease and age of menopause and use of hormone therapy (HT). The results, published in JAMA Neurology, indicate that early age at menopause may be a risk factor for AD dementia, but that women who were prescribed HT around the age of menopause onset did not show increased risk. "HT is the most reliable way to ameliorate severe menopause symptoms, but over the last few decades, there has been a lack of clarity on how HT affects the brain," said corresponding author Rachel Buckley, PhD, of the Department of Neurology at Massachusetts General Hospital (MGH), a founding member of the Mass General Brigham healthcare system. "We found that the highest levels of tau, a protein involved in Alzheimer's disease, were only observed in hormone therapy users who reported a long delay between age at menopause onset and their initiation of hormone therapy. The idea that tau deposition may underlie the association between late hormone therapy intervention and Alzheimer's disease dementia was a huge finding, something that hadn't been seen before." Premature menopause, defined as menopause that occurs spontaneously before the age of 40 or due to surgical intervention before the age of 45, has been associated with increased risk of AD dementia. HT improves many severe symptoms related to menopause and has been hypothesized to also prevent cognitive impairment. However, two decades ago, the seminal Women's Health Initiative (WHI) study found that HT use was associated with a nearly two-fold higher incidence of dementia compared to a placebo among women aged 65 years and older, possibly due to the initiation of HT many years after menopause onset. To better understand these findings, Buckley and colleagues used positron emission tomography (PET) neuroimaging to study how the presence of two proteins involved in AD dementia, ?-amyloid and tau, related to age at menopause and HT use. While previous studies examined symptoms of cognitive decline in menopausal women, few investigations analyzed the biological factors underlying these changes, which may be at play in determining risk of Alzheimer's disease. "When it comes to hormone therapy, timing is everything," said co-author JoAnn Manson, MD, MPH, DrPH, one of the lead investigators of the WHI and chief of the Division of Preventive Medicine at Brigham and Women's Hospital, a founding member of the Mass General Brigham healthcare system. "Our previous findings from the WHI suggested that starting HT early in menopause, rather than late initiation, provides better outcomes for heart disease, cognitive function, and all-cause mortality -- and this study suggests that the same is true for tau deposition." The researchers used data from the Wisconsin Registry for Alzheimer's Prevention (WRAP), one of the few longitudinal studies on AD dementia that includes detailed information on menopause and HT use as well as PET neuroimaging. They analyzed PET scans from 292 cognitively unimpaired adults to determine levels of amyloid and tau in seven regions of the brain. Tau, which is known to be present in greater quantities in women compared to men in these brain regions, was the primary focus of the investigation, as its presence may offer insight into the sex-specific aspects of AD dementia and the risks that post-menopausal women may experience, even before they begin to display symptoms of cognitive decline. As expected, women had greater levels of tau compared to men of the same age, especially in cases where they also had elevated ?-amyloid. But the researchers also found that the association between abnormal levels of ?-amyloid and tau was much stronger in women who had earlier menopause onset, even after adjusting for known causes of premature menopause, such as smoking and oophorectomy, and even genetic risk factors for AD dementia. Notably, tau levels were high in the entorhinal and inferior temporal regions, which are located close to the memory-center of the brain and are known to be involved in the progression of AD dementia. Given that many women who undergo premature menopause use HT, the researchers examined whether HT use was associated with ?-amyloid and tau. While they did confirm this association, they observed that late initiation of HT -- five years or more after menopause -- drove this relationship. Many women in the late-HT-initiation group began HT close to a decade after menopause. Going forward, the researchers are continuing to study sex-specific risk factors for AD dementia by analyzing biological signatures, including sex hormones, in blood plasma and on the X-chromosome. They are also continuing to engage in efforts to understand the unique role that tau plays in women compared to men, its impact on the brain, and why earlier menopause and late HT initiation may be associated with increased tau, even in cognitively unimpaired women. "Up to 10 percent of women experience premature or early menopause, and our findings suggest that earlier age at menopause may be a risk factor for AD dementia," said first author Gillian Coughlan, PhD, of the MGH Department of Neurology. "Hormone therapy can have negative effects on cognition, but only if initiated several years after age at menopause. These observational findings support clinical guidelines that state hormone therapy should be administered close to menopause onset, but not several years after."

13 Oct 2022

·medcitynews.com

Evernow CEO and founder shares why she started a healthcare startup focused on women over 40

This article is part of a series sponsored by HLTH highlighting topics that will be discussed at the HLTH conference November 13-16 in Las Vegas. Alicia Jackson of Evernow will take part in the panel discussion Women are Healthcare, Gallery stage, Monday, Nov. 14, 11:50-12:20 pm. Alicia Jackson is the CEO and founder of Evernow, a healthcare company designed to help women over 40 years old navigate their shifting healthcare needs. In response to emailed questions, she talked about why she started the company and how it is responding to shifting legal landscape for women’s health following the overturning of Roe v. Wade by the U.S. Supreme Court. What attracted you to healthcare? What did you do before you began working for this company? I’ve been a scientist for most of my life because I’m drawn to solving big problems. I have a PhD from MIT, and I also spent much of my career working with the sciences in Washington—ultimately as the Deputy Director of DARPA’s Biological Technologies Office managing their 300 million dollar portfolio. During my time at DARPA, I became intrigued by what I saw being accomplished by bringing the best of biotech into the startup space, and I eventually moved to San Francisco to co-found Drawbridge Health with GE. This experience, in turn, started to pave the way toward what I do today. I had been thinking a lot about the impact of hormone changes on fertility, and that quickly brought me to what happens in menopause and what a critical moment that is for women. Hormonal shifts have a massive impact on both short-term and long-term health, and can represent a true crossroad in a woman’s healthcare journey. In light of this, it was clear that there was a need for more research—and for more actions on that research. If you’re looking for big problems, half the population is a pretty compelling place to double down. Alicia Jackson What does your company do? What services do you provide? Evernow is a healthcare company for women in their second half lives—this typically means women over 40 who are experiencing the hormone shifts associated with perimenopause and menopause. We’ve offered hormone therapy (HT) plans since day one, and as a team of scientists and technologists we take a great deal of pride in our ability to really follow and evolve with the latest research. Whether or not a woman opts into HT, we offer 24/7 virtual care from our expert medical team on all aspects of hormone health. Our members never have to wait more than 24 hours for an answer, and we think this is important because the symptoms women experience at this time of life can be extremely surprising and even scary. Recently, we’ve also launched symptom-based programs for all of our members, as well as an app to really help members take control of their health. In addition to how we work with members day-to-day, we’re also committed to moving science forward through research. Our ongoing menopause study includes well over 100,000 women and at this fall’s North American Menopause Society meeting we presented a poster on a subset of this data focused on how the symptoms of menopause are affected by race. That poster represents the largest body of research of its kind, and we believe it can play a role in creating better, more inclusive care delivery. We’re truly energized by the telemedicine’s potential to not just deliver but also actually improve care. What unmet need or inadequately met need does your company seek to provide? Imagine if there was one key factor that would greatly affect your lifespan and yet you had no way to learn about it and few options for addressing it. That’s been the status quo for generations of women facing menopause. It’s a crucial period for so very many aspects of health—from metabolic health to brain health to cardiovascular health. Yet until recently there just wasn’t much out there for women because the problem was complex and we’ve had a centuries-long precedent of sweeping it under the rug. We’re here to not only address that need through technology, but also use science innovate on what can be done. What niche do you seek to fill? What sets you apart from other companies already in or moving into this space? For too long, menopause has been under-researched, under-invested, and under-served, failing women during what can be an incredibly challenging time. Evernow is built with the ability to meet our members’ evolving needs—providing a core backbone of expert clinical support, informed and guided by deep patient data, to deliver the right personalized care at the right time for years to come. We see ourselves as part of our members’ long-term health team and also their scientific team, using our research to continuously help improve women’s healthcare for the second half of their lives. Who are your target customers? We primarily serve women over 40 who are experiencing the symptoms of perimenopause and menopause. To give a sense of scale, more than two million women enter the menopause transition each year, and it’s a journey that can last ten-to-twenty years. Despite this, 75 percent of those who seek treatment don’t receive it. We’re here to meet their needs with both the care we deliver today and the ways we can move science forward for tomorrow. Are there any challenges that the overturning of Roe v Wade and the abortion restrictions imposed by states present to women’s health that you are addressing with your business? Women over 40 can and do get pregnant—and something that we don’t talk about nearly enough is that they can even get pregnant while they’re on hormone therapy. Midlife pregnancies tend to be more likely to end in miscarriage, and they’re also more likely to be ectopic. Right now there’s a lot of confusion around when and how doctors can treat these patients. We really see ourselves as a source of information for women around this period of changing hormones, and now this feels more crucial than ever. What’s on your to-do list for 2022-2023? What milestones are you seeking to meet in the next 18 months? Our vision for the next 18 months is all about serving more women, for more of their needs. We’ll continue to extend the capabilities of our app and of our new flexible care platform that sets us up as a longitudinal care partner that can meet women’s needs wherever they are on their journey. As we do this, we’re also looking to expand our treatments (Rx, OTC, and digital programs) to address a wider array of menopause-related symptoms. Lastly, we’re diving even deeper with our research in order to deliver even greater insights on menopause and women’s health to help create better and more inclusive solutions for women everywhere.

100 Deals associated with Harringtonine

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Indication	Country/Location	Organization	Date
Acute Myeloid Leukemia	CN	Hainan Hotmed Tianya Pharmaceutical Co Ltd	-
Myelodysplastic Syndromes	CN	Hainan Hotmed Tianya Pharmaceutical Co Ltd	-
Philadelphia chromosome positive chronic myelogenous leukemia	CN	Hainan Hotmed Tianya Pharmaceutical Co Ltd	-
Polycythemia Vera	CN	Hainan Hotmed Tianya Pharmaceutical Co Ltd	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2020	Not Applicable	Prostatic Cancer	18	Combination AA+HT+RT	(baptpvwhry) = opnxiwjprd ndlvzbozuq (mianibnjkl ) View more	Positive	25 May 2020
				HT+RT	(baptpvwhry) = upxtmozcee ndlvzbozuq (mianibnjkl ) View more
ASCO_GU2020	Not Applicable	Prostatic Cancer	13	Abiraterone acetate/EnzalutamideAbiraterone acetate/Enzalutamide+RT	(vvilcsamlw) = dgconvkeer bizesxzbhz (szzlilhxab )	Positive	19 Feb 2020
				HT+RT	(vvilcsamlw) = wttnjngoxx bizesxzbhz (szzlilhxab )
ASCO2015	Not Applicable	Metastatic breast cancer	63	Everolimus and HT	(gxdfykhsqb) = bsdpbbgbgf aoinoshxzr (cmkbvfdlug )	-	20 May 2015

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