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SHANGHAI, Nov. 29, 2024 /PRNewswire/ -- Minghui Pharmaceutical, a late-stage biopharmaceutical company dedicated to developing transformative medicines in immunology and oncology, today announced positive topline results from its phase Ⅲ trial of MH004 (tofacitinib etocomil) ointment 1.0%, a twice-daily pan-Jak inhibitor, in adolescents (ages 12 years and older) and adults with mild to moderate atopic dermatitis (AD). This multicenter, double-blind, randomized, vehicle-controlled phase Ⅲ clinical trial was conducted to evaluate the efficacy and safety of MH004 1.0% in adolescents and adults with mild to moderate AD. A total of 377 participants were randomized 2:1 to receive either MH004 1.0% or Vehicle BID with an 8-week treatment period, followed by 44-week open-label extension for long-term safety. The primary endpoints were the proportion of participants achieving IGA-TS (Investigator Global Assessment (IGA) of 'clear' or 'almost clear' with a 2-grade improvement) at Week 4 and the proportion achieving a 75% improvement in Eczema Area and Severity Index (EASI-75) at Week 4. Key efficacy results are as follows: IGA-TS at Week 441.0% of individuals treated with MH004 1.0% achieving IGA-TS at Week 4 compared to 10.3% treated with vehicle (P<0.0001). EASI-75 at Week 458.2% of individuals treated with MH004 1.0% achieving EASI-75 at Week 4 compared to 19.8% treated with vehicle (P<0.0001). Additionally, the key secondary endpoints, including IGA-TS and EASI-75 at week 8, as well as the proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (NRS4) score at week 8, were successfully met. MH004 1.0% demonstrated statistically significant improvements across all these parameters compared to the vehicle. MH004 1.0% was well-tolerated, with a safety profile consistent with findings from the previous Phase II study. All TRAEs were mild to moderate (grade 1 or 2) in severity. No drug-related serious adverse events (SAEs) were reported. "We are thrilled with the positive topline results from the Phase Ⅲ study. MH004 showed significant symptom improvement in patients with atopic dermatitis and was well-tolerated." said Guoqing Cao, Ph.D., Chief Executive Officer of Minghui Pharmaceutical. "The rapid onset of action observed with MH004 is particularly valuable for patients. These findings reinforce MH004's potential as a meaningful addition to current treatment options for atopic dermatitis, addressing both safety and efficacy needs. Moreover, MH004's benefits may extend to other inflammatory skin diseases as well. In our ongoing phase Ⅱ for vitiligo, we have seen convincing PoC, and the preliminary efficacy data looks highly encouraging." Dr. Cao continued, "I would like to extend my sincere gratitude to all the patients who participated in the trial, as well as to the physicians and staff for their dedicated work. Their contributions were essential to the success of this trial. We look forward to working with regulators to make this treatment available to patients as soon as possible." "Atopic dermatitis is a chronic inflammatory condition, particularly prevalent in children, underscoring the urgent need for effective, fast-acting topical therapies beyond corticosteroids." said Jianzhong Zhang, M.D., lead investigator in the Phase 3 trial and Professor of Peking University People's Hospital. "While corticosteroids are reasonably effective, their long-term use is often limited due to local side effects and safety concerns. MH004 demonstrated superior clinical efficacy in this pivotal phase Ⅲ study, achieving the co-primary endpoints of IGA-TS and EASI-75. The treatment also exhibited a favorable safety profile, and as the leading PI of this study, I am highly encouraged by these results and optimistic about MH004's potential to advance AD care." About Minghui Pharmaceutical Minghui Pharmaceutical, established in 2018, is a late-stage biopharmaceutical company committed to developing innovative therapies for unmet medical needs in oncology and autoimmune diseases. Leveraging expertise in medical science and proprietary technology platforms, the company is advancing a robust clinical-stage pipeline that features a range of first-in-class or best-in-class product candidates. For more information, please visit www.minghuipharma.com. About MH004 Ointment MH004 (tofacitinib etocomil) ointment is a topical product containing a JAK inhibitor that was designed and formulated with Minghui's proprietary technologies. MH004 is expected to have much improved skin permeability to achieve extensive target inhibition in local skin tissues without systemic toxicities that have been widely reported for oral JAK inhibitors. MH004 is intended to be used for the treatment of multiple dermatologic autoimmune diseases. Forward-Looking Statements This press release provided by Minghui Pharmaceutical Inc. (the "Company") contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "predict," "should," "will," "would" or words of similar meaning. These statements are based on the Company's current beliefs and expectations and subject to risks and uncertainties that may cause actual results to differ materially from those set forth in the statements herein. Risks and uncertainties include but not limited to: general industry conditions and competition; changes in economic and financial conditions of the Company's and the collaborators' businesses; the risk that clinical trials are discontinued or delayed for any reasons, including for efficacy, safety, enrollment, or manufacturing; the risk that success in early stage clinical trials may not be predictive of results in later stage trials or trials of other potential indications; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials; expectations for regulatory approvals; challenges to obtain, maintain and enforce patents and other intellectual property protection for the Company's product(s) and product candidate(s). These forward-looking statements speak only as of the date they are posted to this website, and the Company undertakes no obligation to update any forward-looking statements contained herein.
MELBOURNE, Australia, Nov. 28, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) and Grand Pharmaceutical Group Limited (00512.HK, Grand Pharma) today announce that a first patient has been dosed in the Phase III ZIRCON-CP trial of TLX250-CDx positron emission tomography (PET) imaging of clear cell renal cell carcinoma (ccRCC). The patient was successfully dosed and imaged at Beijing Cancer Hospital in Beijing, China. ZIRCON-CP is a multi-centre Phase III registration trial in China intended to bridge to Telix's global Phase III ZIRCON trial, which met all co-primary and secondary endpoints, including showing 86% sensitivity and 87% specificity, and a mean positive-predictive value (PPV) of 93% for ccRCC[1]. The trial, which will enrol up to 82 patients, is being conducted in collaboration with the Company's strategic partner for the Greater China region, Grand Pharma, to demonstrate that the diagnostic utility of TLX250-CDx is equivalent in Chinese and Western populations. The clinical data from ZIRCON-CP is intended to support future marketing authorisation applications for this breakthrough technology. Greater China represents a major market opportunity for radiopharmaceuticals, including TLX250-CDx, driven by increasing cancer incidence rates and an investment in installation of PET/CT cameras. In China alone – 73,000 people are newly diagnosed with kidney cancer each year[2]. Dr David N. Cade, Chief Medical Officer at Telix said, "Dosing and imaging a first patient in the ZIRCON-CP trial is a significant milestone for Telix and our partner Grand Pharma. We would like to thank Professor Peng Du and his team, as well as the patients who will contribute to this important trial, helping to advance TLX250-CDx towards regulatory filings in Greater China, where there is currently critical unmet medical need." About TLX250-CDx TLX250-CDx (Zircaix®[3]) is an investigational PET agent that is under development to characterise indeterminate renal masses (IRMs) as ccRCC or non-ccRCC in a non-invasive manner. Telix's pivotal Phase III ZIRCON trial (Zirconium in Renal Cancer Oncology, ClinicalTrials.gov ID: NCT03849118) evaluating TLX250-CDx in 300 patients, of which 284 were evaluable, met all primary and secondary endpoints including showing 86% sensitivity and 87% specificity and a 93% positive-predictive value for ccRCC across three independent readers. We believe this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing ccRCC. Confidence intervals exceeded expectations in all three readers, showing evidence of high accuracy and consistency of interpretation. As part of Telix's commitment to access to medicine, the Company continues to run an expanded access program (EAP) in the U.S.[4], named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia to allow continued access to TLX250-CDx outside of a clinical trial to patients for whom there are no comparable or satisfactory alternate options. Telix's Policy on Offering Compassionate Use to Investigational Medicines can be downloaded at the following link. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX). Telix's lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)[5], by the Australian Therapeutic Goods Administration (TGA)[6], and by Health Canada[7]. No other Telix product has received a marketing authorisation in any jurisdiction. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our registration statement on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Illuccix® and Zircaix®[3] names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. [1] Shuch et al. Lancet Oncol. 2024. Telix ASX disclosures 7 November 2022. [2] Globocan 2022. [3] Brand name subject to final regulatory approval. [4] ClinicalTrials.gov ID: NCT06090331. [5] Telix ASX disclosure 20 December 2021. [6] Telix ASX disclosure 2 November 2021. [7] Telix ASX disclosure 14 October 2022.
HONG KONG, Nov. 28, 2024 /PRNewswire/ -- Akeso, Inc. (9926. HK) ("Akeso" or the "Company") is pleased to announce that two of its independently developed, globally pioneering bispecific antibody drugs—cadonilimab Injection (PD-1/CTLA-4 bispecific antibody) and ivonescimab Injection (PD-1/VEGF bispecific antibody)—have both been included in the most recent National Reimbursement Drug List (NRDL) released by China's National Healthcare Security Administration. The most recent NRDL will become effective on January 1, 2025. Cadonilimab is included for the treatment of relapsed or metastatic cervical cancer (R/M CC) patients who progressed on or after platinum-based chemotherapy. Ivonescimab is included for the treatment of epidermal growth factor receptor (EGFR) mutated locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC). China's medical insurance system includes basic medical insurance, work-related injury insurance, and maternity insurance, covering over 95% of the population. The NRDL defines the medications eligible for reimbursement under the medical insurance fund. According to statistical reports, in 2023, expenditures from China's basic medical insurance, work-related injury insurance, and maternity insurance funds on drugs listed in the NRDL accounted for 90% of total hospital procurement orders. Dr. Xia Yu, the Founder, Chairwoman, President, and Chief Executive Officer of Akeso, said, " The inclusion of cadonilimab and ivonescimab in the National Reimbursement Drug List emphasizes the innovative and clinical significance of these groundbreaking biologics, both of which are developed by Akeso. The inclusion marks a significant milestone in improving patient access to innovative treatments. It will substantially reduce the financial burden on patients, allowing more individuals to benefit from globally leading therapies. This development aligns perfectly with Akeso's core philosophy of advancing public health through scientific and technological innovation." Cadonilimab: Global First Approved Cancer Immunotherapy Bispecific AntibodyCadonilimab is an innovative bispecific antibody that simultaneously targets PD-1 and CTLA-4, leveraging a synergistic antitumor effect. This unique mechanism significantly enhances therapeutic outcomes, offering superior efficacy while greatly reducing toxicity. The latest data on cadonilimab for R/M CC shows that cadonilimab benefits both PD-L1 positive and negative patient populations, especially addressing an unmet need from PD-L1 negative patients, which previously lacked effective treatment options. For R/M CC, cadonilimab demonstrated a median overall survival (mOS) of over 18 months (NR), with an objective response rate (ORR) of 31.3% and a complete response (CR) rate of 13.1% in In the PD-L1 positive subgroup, the ORR reached 43.8%, with a median progression-free survival (mPFS) of 6.34 months, and the mOS is yet to be reached. On September 2024, cadonilimab was approved by NMPA for first-line treatment of advanced gastric cancer. The sNDA for first-line treatment of advanced cervical cancer is under review. Cadonilimab has been strongly recommended in 16 clinical treatment guidelines and consensus statements, covering a variety of cancers, including gastric cancer, gynecological cancers, liver cancer, esophageal cancer, and nasopharyngeal cancer. Furthermore, cadonilimab is currently undergoing more than 23 clinical trials across 16 indications, including gastric, lung, liver, cervical, and pancreatic cancers. Among these trials, 8 are registration Phase III trials. Ivonescimab: Global First Approved PD-1/VEGF Bispecific AntibodyIvonescimab is the world's first bispecific antibody that integrates "cancer immunotherapy and anti-angiogenesis" into a synergistic mechanism. In the Phase III HARMONi-A trial, for 2L+ EGFRm NSCL, ivonescimab combination therapy reduced the risk of disease progression or death by a record 54%, with a significant trend towards long-term survival benefits. Additionally, the Phase III HARMONi-2 trial comparing ivonescimab monotherapy with pembrolizumab in first-line treatment of PD-L1-positive non-small cell lung cancer (NSCLC) showed ivonescimab's superiority. Ivonescimab is the only drug globally to have demonstrated significantly better efficacy than pembrolizumab in a Phase III head-to-head trial. The sNDA for Ivonescimab in the first-line treatment of PD-L1-positive NSCLC is currently under regulatory review, with priority review status granted. Ivonescimab has already been robustly recommended within six major clinical treatment guidelines and consensus statements. Additionally, ivonescimab has been engaged in over 25 clinical trials spanning more than 17 varieties of cancers, namely lung cancer, head and neck squamous cell carcinoma, biliary tract cancer, pancreatic cancer, breast cancer, hepatocellular carcinoma, and colorectal cancer. Nearly 10 Phase III trials of ivonescimab are progressing efficiently in China and the rest of the World, with one of them being on head and neck squamous cell carcinoma. About AkesoAkeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin, and X (formerly Twitter).
Real-world evidence bolsters the efficacy of ORSERDU for the treatment of patients with ER+/HER2- ESR1-mut advanced or mBC. Updated results of elacestrant in combination with abemaciclib show favorable efficacy regardless of the ESR1 mutation status, with a manageable and predictable safety profile in patients with ER+/HER2- mBC. FLORENCE, Italy and NEW YORK, Nov. 26, 2024 /PRNewswire/ -- The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, will present new and expanded data on ORSERDU® (elacestrant) at the upcoming 2024 San Antonio Breast Cancer Symposium (SABCS), December 10-13, 2024. Of note, the company will bring real-world progression-free survival (rwPFS) results of ORSERDU in adult patients with ER+/HER2-, advanced or metastatic breast cancer (mBC). Additionally, the company will present updated efficacy results of elacestrant plus abemaciclib, along with a pooled safety analysis from phase 1b/2 of both the ELECTRA and ELEVATE trials. ORSERDU Real-World Progression-Free Survival Data ORSERDU is the first and only oral estrogen receptor antagonist (SERD) approved to target ESR1-mutated tumors, which occur in up to 50% of ER+, HER2- advanced or mBC tumors, as a result of prior exposure to endocrine therapy (ET) in the metastatic setting. Since its approval by the U.S. Food & Drug Administration (FDA) in January 2023, sufficient time has passed to be able to characterize the real-world use of ORSERDU in the current mBC treatment landscape. Results to be reported at SABCS 2024 show the efficacy of ORSERDU in the real-world setting in patients with ER+/HER2- advanced or mBC. The overall population analysis demonstrated median rwPFS of 6.8 months. Median rwPFS for patients with 1-2 lines of prior ET in mBC was 8 months. The rwPFS observed is consistent across the subgroups in the analysis. Updated results and additional information from other patient subgroups will be presented at the congress. The full abstract (SESS-1876) can be viewed here (page 1748). "These exciting data show clinically meaningful real-world progression-free survival with ORSERDU monotherapy," said Virginia Kaklamani, MD, DSc, breast medical oncologist and professor of medicine, UT Health San Antonio, MD Anderson Cancer Center. "As a practicing physician, these results underscore the need to test patients' tumors for the ESR1 mutation at each disease progression using liquid biopsy, so that we can appropriately tailor their treatment and optimize their care." Elacestrant Plus Abemaciclib Combination Study Both the ELEVATE and ELECTRA phase 1b/2 studies were designed with the objective to evaluate patient outcomes through combination treatment options, by overcoming a tumor's resistance to ET. Results to be reported at SABCS 2024 include updated efficacy results from the ELECTRA study which demonstrate favorable progression-free survival (PFS) data. In all efficacy-evaluable patients, median progression-free survival (mPFS) was 8.6 months. In patients with an ESR1 mutation, mPFS was 8.7 months. In patients without an ESR1 mutation, mPFS was 7.2 months. Additionally, a pooled safety analysis of patients from ELECTRA and ELEVATE show a manageable and predictable safety profile in patients with ER+/HER2- mBC that is treated with elacestrant plus abemaciclib, and who previously received one or more lines of prior therapy. Safety was evaluated in all patients who received this combination and was consistent with the known safety profiles of both compounds. The most common all-grade adverse events (AEs) (≥20%) were diarrhea, nausea, neutropenia, vomiting, fatigue, anemia and decreased appetite. No Grade 4 AEs were observed. The full abstract (SESS-1910) can be viewed here (page 3330). "These updated results on the combination of elacestrant plus abemaciclib continue to show encouraging progression-free survival data, and a favorable safety profile, without any new toxicity signals when using these agents in combination," said Hope S. Rugo, MD, Professor of Medicine and Winterhof Family Endowed Professor in Breast Cancer, Director, Breast Oncology and Clinical Trials Education, University of California San Francisco. "Elacestrant continues to show potential to become an endocrine therapy backbone for combination regimens in metastatic breast cancer, and we are excited to explore this treatment combination further as these trials move forward." "It is exciting to see these progression-free survival outcomes in a real-world setting, which shows ORSERDU brings a meaningful benefit for oncologists to offer their patients," said Elcin Barker Ergun, CEO of the Menarini Group. "We are committed to advancing our robust clinical research program on elacestrant and unlocking its full potential, both in monotherapy and combination treatment settings, with the goal of bringing ORSERDU to new patient populations which may benefit." Menarini Stemline will also share results of other relevant data from the Phase 3 EMERALD trial, as well as several trials in progress. Complete List of Menarini Stemline Abstracts: Title: Elacestrant real-world progression-free survival (rwPFS) of adult patients with ER+/HER2-, advanced breast cancer: a retrospective analysis using insurance claims in the United StatesPoster Number: P3-10-08Date & Time: Thursday, December 12, 12-2 PM CSTLocation: TBCPresenting Author: Elyse Swallow Title: Elacestrant plus abemaciclib (abema) combination in patients (pts) with estrogen receptor-positive (ER+), HER2-negative (HER2-) advanced or metastatic breast cancer (mBC)Poster Number: PS7-07Date & Time: Thursday, December 12, 7-8:30 AM CSTLocation: TBCPresenting Author: Hope Rugo Title: Elacestrant combination in patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC): Update from ELEVATE, a phase 1b/2, open-label, umbrella studyPoster Number: PS7-06Date & Time: Thursday, December 12, 7-8:30 AM CSTLocation: TBCPresenting Author: Hope Rugo Title: Elacestrant vs SOC in ER+, HER2- advanced or metastatic breast cancer (mBC) with ESR1-mutated tumors: ESR1 allelic frequencies and clinical activity from the phase 3 EMERALD trialPoster Number: P1-01-25Date & Time: Wednesday, December 11, 12-2 PM CSTLocation: TBCPresenting Author: Aditya Bardia Title: ELEGANT: Elacestrant versus standard endocrine therapy in women and men with node-positive, estrogen receptor-positive, HER2-negative, early breast cancer with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 studyPoster Number: P2-08-21Date & Time: Wednesday, December 11, 5:30-7:30 PM CSTLocation: TBCPresenting Author: Aditya Bardia Title: ADELA: A randomized, phase 3, double-blind, placebo-controlled trial of elacestrant plus everolimus versus elacestrant in ER+/HER2-advanced breast cancer (aBC) patients with ESR1-mutated tumors progressing on endocrine therapy (ET) plus CDK4/6iPoster Number: P2-10-21Date & Time: Wednesday, December 11, 5:30-7:30 PM CSTLocation: TBCPresenting Author: Antonio Llombart-Cussac Title: ELCIN: Elacestrant in women and men with CDK4/6 inhibitor (CDK4/6i)-naïve estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (mBC): An open-label multicenter phase 2 studyPoster Number: P2-08-20Date & Time: Wednesday, December 11, 5:30-7:30 PM CSTLocation: TBCPresenting Author: Virginia Kaklamani About The Elacestrant Clinical Development Program Elacestrant is also being investigated in several company-sponsored clinical trials in metastatic breast cancer, alone or in combination with other therapies. EMERALD (NCT03778931) is a randomized Phase 3 trial, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+, HER2- advanced/metastatic breast cancer patients. ELEVATE (NCT05563220) is a phase 1b/2 clinical trial evaluating the safety and efficacy of elacestrant combined with alpelisib, everolimus, capivasertib, palbociclib, ribociclib or abemaciclib. ELECTRA (NCT05386108) is an open-label phase 1b/2, multicenter study evaluating elacestrant in combination with abemaciclib in patients with ER+, HER2- breast cancer. The phase 2 portion evaluates this treatment regimen in patients with brain metastases. ELCIN (NCT05596409) is a phase 2 trial evaluating the efficacy of elacestrant in patients with ER+, HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6 inhibitors in the metastatic setting. ADELA (NCT06382948) is a phase 3 randomized, double-blinded trial evaluating elacestrant in combination with everolimus in patients with ER+, HER2- mBC with ESR1-mut tumors. ELEGANT (NCT06492616) is a phase 3 study evaluating elacestrant versus standard endocrine therapy in women and men with node-positive, estrogen receptor-positive, HER2-negative, early breast cancer with high risk of recurrence. Elacestrant is also being evaluated in additional investigator-led trials, in trials conducted in collaboration with other companies, in metastatic breast cancer as well as in early disease. About ORSERDU (elacestrant) U.S. Indication: ORSERDU (elacestrant), 345 mg tablets, is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Full prescribing information for the U.S. can be found at www.orserdu.com. Important Safety Information Warning and Precautions Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid profile prior to starting and periodically while taking ORSERDU. Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the final dose. Adverse Reactions Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).The most common adverse reactions (≥10%), including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite(15%), diarrhea(13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%). Drug interactions Concomitant use with CYP3A4 Inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU. Use in specific populations Lactation: Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose. Hepatic Impairment: Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B). The safety and effectiveness of ORSERDU in pediatric patients have not been established. To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $4.7 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit www.menarini.com. About Stemline Therapeutics Inc. Stemline Therapeutics, Inc. ("Stemline") a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics. Stemline commercializes ORSERDU® (elacestrant) in the U.S. and Europe, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline also commercializes ELZONRIS® (tagraxofusp-erzs), a novel targeted treatment directed to CD123 for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment for BPDCN in the U.S. and E.U. to date. Stemline also commercializes NEXPOVIO® (selinexor) in Europe, an XPO1 inhibitor for multiple myeloma. Stemline also has an extensive clinical pipeline of small molecules and biologics in various stages of development for a host of solid and hematologic cancers.
YONGIN, South Korea, Nov. 26, 2024 /PRNewswire/ -- GC Biopharma and Novel Pharma today announced that the first patient in the US has been dosed in multinational clinical trial with 'GC1130A', an innovative new drug for Sanfillippo syndrome type A (MPS IIIA). GC Biopharma and Novel Pharma have received IND clearance for Phase I clinical trial of 'GC1130A' in the US, Korea, and Japan and are currently conducting multi-national clinical trial. Through this Phase I clinical trial, they plan to evaluate the safety, tolerability, and efficacy of 'GC1130A' over a two-year period for children aged between two and six diagnosed with Sanfillippo syndrome type A (MPS IIIA). This Phase I clinical trial will be conducted at two to three institutions in the US including University of California San Francisco (UCSF) Benioff Children's Hospitals, Samsung Medical Center and Ajou University Hospital in Korea, and one institution in Japan. Patients who meet eligibility criteria after screening will undergo surgery to implant an intracerebroventricular (ICV) access device and will receive 'GC1130A' once every two weeks. Sanfillippo syndrome type A (MPS IIIA) is an autosomal recessive genetic disorder that damages the central nervous system due to the accumulation of heparan sulfate. The main clinical manifestation is brain deficit, and it is a devastating disease where patients die around the age of 15. As no treatment option currently exists, there is a huge unmet medical need. 'GC1130A' is a first-in-class treatment that uses GC Biopharma's proprietary platform to produce concentrated, high quality recombinant protein which is administered via ICV injection to bypass the blood brain barrier. GC Biopharma developed the first ICV administered enzyme replacement therapy (ERT) for patients with Hunter syndrome and marketed in Japan under the brand name Hunterase ICV. In a non-clinical study, GC Biopharma has proven that ICV injection is up to 47 times more effective than that of intrathecal (IT). SooKyung Shin, Head of Medical Division at GC Biopharma commented, "The initiation of patient dosing in the US is a significant milestone for 'GC1130A' global clinical trials and we will do our best to expedite the clinical development process." About GC Biopharma Corp. GC Biopharma Corp. (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma Corp. is one of the leading plasma protein and vaccine product manufacturers globally and has been dedicated to quality healthcare solutions for more than half a century. About Novel Pharma Inc. Novel Pharma is an emerging biotechnology company that focuses on developing first-in-class treatments for rare pediatric diseases (MPS/LSD) utilizing ICV (intracerebral ventricular) administration. Headquartered in Seoul, South Korea, it is currently engaged in the development of (i) MPSIIIA, (ii) GM1, (iii) MPSIVB and (iv) Krabbe disease. This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule.
Twenty studies validate AI performance across diverse populations and clinical settings, including award-winning research in emergency radiology SEOUL, South Korea, Nov. 25, 2024 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced its participation in the Radiological Society of North America (RSNA) 2024 Annual Meeting, presenting a record-breaking 20 abstracts. As RSNA 2024 highlights the transformative role of AI in radiology, Lunit's groundbreaking research and solutions emphasize how AI can address critical challenges in healthcare, from improving diagnostic accuracy to enhancing clinician efficiency. Among Lunit's studies, two groundbreaking research presentations stand out: 1. Enhancing Breast Cancer Detection Across Diverse Populations Presented by Dr. Hari Trivedi from Emory University, the study focuses on Lunit INSIGHT DBT, an AI-powered solution for breast cancer detection using digital breast tomosynthesis (DBT) images. Conducted on a large, racially heterogeneous screening population from Emory University (137,460 cases from 2013-2020), the research demonstrated Lunit AI's consistent performance across various subgroups, including race, ethnicity, age, and breast density. Key findings include: Robust overall AUC of 0.920 High sensitivity (84.5%) and specificity (83.8%) Consistent performance across lesion types, from calcifications to architectural distortions Demonstrated the reliability and potential of Lunit INSIGHT DBT to address disparities in breast cancer detection, underscoring its capability to serve as a robust tool for diverse patient populations globally 2. Empowering Clinicians Through AI-Assisted Chest X-Ray Interpretation Presented by Dr. Ruchir Shah from Oxford University Hospitals and awarded the Trainee Research Prize - Resident, this study evaluated the impact of Lunit INSIGHT CXR, an AI-powered solution for chest X-ray interpretation, on clinician performance in emergency and inpatient care settings. The study involved 30 clinicians from various specialties and experience levels, who interpreted 500 chest X-rays with and without AI assistance on the RAIQC platform. Notable results include: AI demonstrated superior standalone performance with AUCs of 0.83-0.99 across 10 pathologies, with exceptional accuracy (AUC>0.9) in 8 pathologies Significant improvement in clinicians' accuracy in 8 out of 10 pathologies with AI assistance, including pulmonary nodules, pleural effusion, and fibrosis Marked greatest improvement in fibrosis detection with a delta AUC of 0.193 Underscored Lunit INSIGHT CXR's potential to empower clinicians in making accurate and timely decisions, improving both efficiency and patient outcomes in high-pressure clinical environments, addressing growing diagnostic demands in hospitals worldwide "RSNA 2024's focus on AI in radiology aligns seamlessly with Lunit's mission to conquer cancer through AI," said Brandon Suh, CEO of Lunit. "The studies we're presenting this year exemplify how our AI solutions address real-world challenges—ensuring diagnostic equity in breast cancer detection and empowering clinicians with improved accuracy for critical chest X-ray findings. These innovations are about reshaping the standard of care for diverse patient populations globally. We are honored to contribute to this year's discussion on AI's role in radiology and look forward to sharing how Lunit is driving meaningful impact in the field." The RSNA 2024 Annual Meeting will take place in Chicago, Illinois, from December 1-6, 2024. For more information, visit Lunit's booth #4929 in the AI Showcase. Presentations at RSNA 2024 featuring the Lunit INSIGHT suite include: Lunit INSIGHT MMG, "AI Software Performance in Unliteral Mammography: Simulating Total Mastectomy Scenarios" | S3A-SPBR-6 Lunit INSIGHT MMG, "Real-World Impact of AI CAD in Population-Based Breast Cancer Screening - Comparing Screening Metrics Before and After the ScreentrustCAD Trial" | S5-SSBR02-3 Lunit INSIGHT MMG, "Early Alerts - an Analysis of Temporal Changes in Three Mammography-Based Artificial Intelligence Algorithm Scores Over the Course of a Patient's Screening Timeline" | S5-SSBR02-5 Lunit INSIGHT MMG, "Enhancing Mammography Screening: a Comparative Analysis of AI Ensemble Strategies" | M1-SSBR04-4 Lunit INSIGHT MMG, "Artificial Intelligence (AI)-Based Mammography Scores for Predicting Lymph Node Metastasis in Early-Stage Breast Cancer" | M5A-SPBR-6 Lunit INSIGHT MMG, "Feature Analysis of Screening Detected Cancer and Missed Cancer of Artificial Intelligence-Based Computer-Assisted Diagnosis (AI-CAD) on AI-Stream Study" | M5A-SPBR-7 Lunit INSIGHT MMG, "External Multi-Center Multi-Manufacturer Validation of a Mammography-Based AI Score to Select Patients for Supplemental Breast Cancer Screening" | M5A-SPBR-8 Lunit INSIGHT MMG, "Comparison of the Risk Score for Cancer Detection on Screening Mammograms Given by an AI Algorithm and the Radiologists" | M5A-SPBR-10 Lunit INSIGHT MMG, "Using Artificial Intelligence (AI) Scores for Mammography Interpretation in Predicting Recurrence After DCIS Treatment" | R1-SSBR10-1 Lunit INSIGHT MMG, "AI Score on Screening Mammograms by Time" | T7-SSBR07-2 Lunit INSIGHT MMG, "Artificial Intelligence Mammography Interpretation Systems are More Affected by Mammographic Image Quality Issues than Radiologists" | T7-SSBR07-3 Lunit INSIGHT MMG, "Post-Market Surveillance of AI in a Breast Cancer Screening Setting" | M2-SPBR-9 Lunit INSIGHT MMG, "Combining Two or Three AI CAD Systems to Replace Radiologist Double-Read and Consensus Discussion in Breast Cancer Screening - A Retrospective Evaluation" | S2-SSBR01-3 Lunit INSIGHT MMG, "Comparing Different Scenarios for the Combined Use of Two Commercial AI Algorithms to Improve Mammography Interpretation and Decrease Radiologist Workload" | T7-SSBR07-5 Lunit INSIGHT DBT, "Use of Artificial Intelligence to Reduce the Interval Cancer Rate of Screening Digital Breast Tomosynthesis" | S5-SSBR02-2 Lunit INSIGHT DBT, "Performance of a Commercial Digital Breast Tomosynthesis Cancer Detection Model in a Large, Racially Diverse US Screening Population" | M1-SSBR04-5 Lunit INSIGHT CXR, "Real-World, Post-Market Surveillance Study of a Chest X-ray AI Model in a Multicenter Study" | T6-SSCH06-1 Lunit INSIGHT CXR, "Optimizing Chest Radiograph Workflow: Efficiency Gains of AI-Assisted Reporting in a Multi-Ethnic Cohort" | T6-SSCH06-4 Lunit INSIGHT CXR, "Does AI Assistance Improve Clinician Interpretation of Inpatient and Emergency Department Chest X-rays?" | W3-SSER02-6 Lunit INSIGHT CXR, "Role of AI for Chest X-ray Interpretation: is It a Valid Support?" | R5B-SPCH-4 About Lunit Founded in 2013, Lunit (KRX:328130.KQ) is a medical AI company on a mission to conquer cancer. We harness AI-powered medical image analytics and AI biomarkers to ensure accurate diagnosis and optimal treatment for each cancer patient. The FDA-cleared Lunit INSIGHT suite for cancer screening serves over 4,500 hospitals and medical institutions across 55+ countries. Lunit clinical studies have been published in top journals, including the Journal of Clinical Oncology and the Lancet Digital Health, and presented at global conferences such as ASCO and RSNA. In 2024, Lunit acquired Volpara Health Technologies, setting the stage for unparalleled synergy and accuracy, particularly in breast health and screening technologies. Headquartered in Seoul, South Korea, with a network of offices worldwide, Lunit leads the global fight against cancer. Discover more at lunit.io.
Clinical Trials/Medical Discoveries
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