Astrocytoma

Rhythm Pharmaceuticals Announces Clinical Development Plan of Setmelanotide for Hypothalamic Obesity in Japan

Retrieved on: 
Thursday, February 22, 2024
Incidence, EMA, MC4R, Obesity, FDA, Growth, Astrocytoma, Polyphagia, Prevalence, Hunger, PMDA, European Medicines Agency, Weight gain, Patient, Brain, Craniopharyngioma, Pharmaceutical industry

BOSTON, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today announced plans to add a cohort of patients with hypothalamic obesity in Japan to its ongoing global Phase 3 clinical trial of setmelanotide, with dosing expected to begin in the third quarter of 2024.

Key Points: 
  • “Following constructive discussions with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), we are pleased to have developed a clear and efficient plan to support the potential approval of setmelanotide for hypothalamic obesity in Japan,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm.
  • The condition most frequently follows the growth and surgical removal or other treatment of craniopharyngioma, astrocytoma, or other rare brain tumors.
  • These individuals often experience rapid weight gain, a reduction in energy expenditure, and an increase in hunger leading to severe obesity within six to 12 months following the hypothalamic lesions.
  • Rhythm also announced today that it completed enrollment in the pivotal, 120-patient cohort in its global Phase 3 trial of setmelanotide in hypothalamic obesity with patients, aged 4 years or older with hypothalamic obesity randomized 2:1 to setmelanotide therapy or placebo for a total of 60 weeks, including up to eight weeks for dose titration.

Human medicines European public assessment report (EPAR): Carmustine medac (previously Carmustine Obvius), carmustine, Date of authorisation: 18/07/2018, Revision: 10, Status: Authorised

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Friday, January 5, 2024
RNA, Medical Subject Headings, Brain, Marketing, Agency, Health, INN, Risk, Stomach, Ependymoma, ATC, Medulloblastoma, Radiation, International, Blood, Language, DNA, Literature, Hodgkin lymphoma, Chemotherapy, Cancer, Skin cancer, Glioblastoma, Astrocytoma, Haematopoiesis, European Medicines Agency, Neoplasm, Transplant, Select, Cell, Patient, Anatomy, IIA, Medical device

Human medicines European public assessment report (EPAR): Carmustine medac (previously Carmustine Obvius), carmustine, Date of authorisation: 18/07/2018, Revision: 10, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Carmustine medac (previously Carmustine Obvius), carmustine, Date of authorisation: 18/07/2018, Revision: 10, Status: Authorised

EQS-News: CureVac Announces Financial Results for the Third Quarter and First Nine Months of 2023 and Provides Business Update

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Tuesday, December 26, 2023
Survival, Research and development, BioNTech, CureVac, Workforce, Operating cost, GSK, Epitope, Webcast, Safety, Business development, RNA, CVAC, Conference, Sąd rejonowy, Astrocytoma, Neoplasm, Pfizer–BioNTech COVID-19 vaccine, Development, Vaccine, Commercial, LNP, Phase II, Acquisition, Immortalised cell line, Animal, GMP, Interim, Palatine Higher Regional Court, Patent, SARS-CoV-2, Tumor microenvironment, Toxicity, Glioblastoma, Antigen, Therapy, Research, Messenger, Mouse, COVID-19, Infection, Clinical trial, District court, Cancer, Patient, CMO, CD8

ET / 3 p.m. CET

Key Points: 
  • ET / 3 p.m. CET
    TÜBINGEN, Germany/BOSTON, USA – November 14, 2023 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced financial results for the third quarter and first nine months of 2023 and provided a business update.
  • Positive preliminary data reported in early 2023 in COVID-19 and flu provided strong validation of CureVac’s mRNA technology platform.
  • All jointly tested candidates are based on CureVac’s proprietary second-generation mRNA backbone, targeting improved intracellular mRNA translation for early and strong immune responses.
  • The first nine months of 2022 were positively impacted by €36.8 million related to the reversal of an outstanding CRO provision.

New Analyses from Pivotal Phase 3 INDIGO Study Reinforce Vorasidenib's Potential to Change the Treatment Paradigm for IDH-Mutant Diffuse Glioma

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Saturday, November 18, 2023
NDA, Glioma, Safety, TGR, Food, European Medicines Agency, Astrocytoma, Dana–Farber Cancer Institute, Progression-free survival, IDH2, Aes, Clinical trial, EMA, Data, Patient, Abstract, PFS, FDA, INDIGO, Division, Pembrolizumab, Merck, Neoplasm, IDH, IDH1, Growth, Merck & Co., Quality of life, Society, SNO, HIV disease progression rates, Medical imaging, Pharmaceutical industry, Laboratoires Servier

BOSTON, Nov. 18, 2023 /PRNewswire/ -- New data from Servier's clinical development program for vorasidenib in IDH-mutant diffuse glioma, presented at the 28th Annual Meeting of the Society for Neuro-Oncology (SNO) in Vancouver, Canada, showed that vorasidenib reduced tumor growth as measured by a blinded independent radiology committee. Additional data from the INDIGO study being presented at SNO include health-related quality of life data, indicating patients receiving vorasidenib experience preservation of quality of life, stable neurocognitive function, and seizure control, as well as translational data demonstrating vorasidenib's efficacy across IDH-mutant diffuse gliomas with various additional mutations.

Key Points: 
  • We are honored and excited at the prospect of ushering in a new era of targeted treatment options for patients living with this devastating disease."
  • The safety lead-in was conducted to determine the recommended combination dose for the recently initiated perioperative phase of the study.
  • In this phase, approximately 60 patients will be randomized to the combination treatment, vorasidenib 40 mg once-daily alone, or no treatment prior to surgery.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Kintara Therapeutics Presents Case Studies of Glioblastoma Patients Treated with VAL-083 at 2023 European Association for Neuro-Oncology Annual Meeting

Retrieved on: 
Monday, September 25, 2023
Astrocytoma, Poster, European Association for the Study of the Liver, Radiation, RT, Therapy, GBM, SAN, Neuro-Oncology (journal), Safety, Annual general meeting, Pharmaceutical industry

SAN DIEGO, Sept. 25, 2023 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor therapies, today announced the presentation of compelling patient case studies in a poster at the 2023 European Association for Neuro-Oncology (EANO) Annual Meeting in Rotterdam.

Key Points: 
  • SAN DIEGO, Sept. 25, 2023 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor therapies, today announced the presentation of compelling patient case studies in a poster at the 2023 European Association for Neuro-Oncology (EANO) Annual Meeting in Rotterdam.
  • In the first case, a 32-year-old woman with grade four GBM (MGMT-unmethylated) received conventional radiotherapy with concurrent chemotherapy with VAL-083 followed by adjuvant VAL-083 for a total of 13 cycles of VAL-083.
  • The patient was tumor-free and has survived more than four years as of the last follow-up in March 2023.
  • The patient was re-treated with VAL-083 and was stable as of the last follow-up in March 2023.

Rhythm Pharmaceuticals Receives Orphan Drug Designation from European Medicines Agency for Setmelanotide for Treatment of Acquired Hypothalamic Obesity

Retrieved on: 
Tuesday, September 19, 2023
Polyphagia, Brain, Obesity, International, European Medicines Agency, Rhythm, Weight gain, Astrocytoma, EMA, Patient, Medicine, European, MC4R, Diagnosis, Growth, United, Hunger, Craniopharyngioma, Disease, Pharmaceutical industry

“Acquired hypothalamic obesity is a serious disease with severe implications for patients and families and no effective treatment options,” said Yann Mazabraud, Executive Vice President and Head of International at Rhythm.

Key Points: 
  • “Acquired hypothalamic obesity is a serious disease with severe implications for patients and families and no effective treatment options,” said Yann Mazabraud, Executive Vice President and Head of International at Rhythm.
  • Rhythm is evaluating setmelanotide in a global Phase 3 clinical trial in acquired hypothalamic obesity and expects to complete patient enrollment in the fourth quarter of 2023.
  • Acquired hypothalamic obesity is a rare form of extreme obesity that occurs following damage to the hypothalamic region of the brain, which includes the MC4R pathway and is responsible for controlling physiological functions such as hunger and weight regulation.
  • Rhythm estimates there are approximately 3,500 to 10,000 patients living with acquired hypothalamic obesity in the European countries of Germany, France, Spain, Italy, The Netherlands, and the United Kingdom.1

EQS-News: CureVac Announces Financial Results for the Second Quarter and First Half of 2023 and Provides Business Update

Retrieved on: 
Tuesday, August 22, 2023
Vaccine, BioNTech, GMP, Operating cost, GSK, Intellectual property, Workforce, Omicron, Palatine Higher Regional Court, Vaccination, COVID-19, Infection, Clinical trial, CureVac, Cancer, Pfizer–BioNTech COVID-19 vaccine, CMO, Part, Astrocytoma, Messenger, Sale, Research and development, Development, Radiation, HIV disease progression rates, Patent, Patient, Hearing, Sąd rejonowy, Epitope, Research, CVAC, Safety, Virus, Pfizer, Cryptocurrency, Fine chemical, Pharmaceutical industry, Glioblastoma

“During the first six months of 2023, we continued building on the momentum from the strong start to the year.

Key Points: 
  • “During the first six months of 2023, we continued building on the momentum from the strong start to the year.
  • “Our unwavering commitment to innovation has enabled us to further expand our intellectual property portfolio, strengthening our mRNA technology ownership.
  • All jointly tested candidates are based on CureVac’s proprietary second-generation mRNA backbone, targeting improved intracellular mRNA translation for early and strong immune responses.
  • The first six months of 2022 were positively impacted by €21.3 million related to the reversal of an outstanding CRO provision.

Rhythm Pharmaceuticals Announces Pre-Marketing Early Access Authorization for Setmelanotide for Use in Patients with Hypothalamic Obesity in France

Retrieved on: 
Monday, August 7, 2023
Polyphagia, Brain, Obesity, International, Setmelanotide, Prevalence, National Agency for Food and Drug Administration and Control, Weight loss, Rhythm, Bardet–Biedl syndrome, Medication, Palestinian National Authority, Appetite, Weight gain, Teaching hospital, Astrocytoma, BBS, Incidence, HAS, Patient, ANSM, Growth, Body mass index, AP1, Hunger, Safety, Craniopharyngioma, Pharmaceutical industry, Nutrition, MC4R, BMI

BOSTON, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases, today announced that the French National Agency for Medicines and Health Products Safety (ANSM) and French National Authority for Health (HAS) have granted pre-marketing early access authorization AP1 (Autorisation d’Accès Précoce), for IMCIVREE® (setmelanotide), an MC4R agonist, for patients with lesional hypothalamic obesity.

Key Points: 
  • Setmelanotide has been available through a similar program for patients in France with Bardet-Biedl syndrome (BBS) since July 2022.
  • Rhythm estimates there are approximately 500-2,000 patients living with hypothalamic obesity in France, with approximately 50 to 200 new cases each year.
  • In the United States, the Company estimates the prevalence in hypothalamic obesity to be approximately 5,000-10,000 patients with an annual incidence of approximately 500 new patients.
  • “This AP1 addresses a significant unmet need for patients with severe obesity and hyperphagia, two hallmark symptoms of hypothalamic obesity, for the first time.”

In-Depth Analysis of the Astrocytoma Market 2023-2032: Unveiling Future Challenges and Opportunities - ResearchAndMarkets.com

Retrieved on: 
Wednesday, July 26, 2023
Health, Pharmaceutical, PESTLE, Prevalence, Intelligence, SWOT, Porter's five forces analysis, Diagnosis, Epidemiology, Risk management, Tourism, Medical device, Pharmaceutical industry, Astrocytoma

This in-depth analysis aims to empower businesses and stakeholders with crucial insights into the evolving Astrocytoma market landscape.

Key Points: 
  • This in-depth analysis aims to empower businesses and stakeholders with crucial insights into the evolving Astrocytoma market landscape.
  • The market outlook segment projects the future trends of the Astrocytoma market, considering factors such as current therapies' impact, unmet medical needs, market drivers, and barriers.
  • Employing various competitive intelligence tools, including SWOT analysis, PESTLE analysis, and Porter's five forces, enables businesses to identify strengths, weaknesses, and opportunities in the Astrocytoma market.
  • With a focus on emerging trends, potential therapies, and market dynamics, this report empowers stakeholders to make informed decisions and tap into the vast opportunities within the evolving Astrocytoma market.

NeOnc Technologies Holdings Receives FDA Authorization to Proceed with Phase 1/2 Trials of NEO212 for Primary Brain Tumors and for Brain Metastasis in Combination with Standard of Care Therapy

Retrieved on: 
Tuesday, June 27, 2023
University of Southern California, Brain, University, Food, Biotechnology, Clinical trial, Esophagus, Head, Research, USC, Neck, Glioblastoma, Lung, Colon, Astrocytoma, U.S. FDA, Brain tumor, MD, Patient, Cancer, Kidney, LOS, FDA, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NEO, Skin, Safety, Pharmaceutical industry, Medical imaging

Clinical trials to evaluate NEO212 as a single agent for patients with primary brain tumors or uncontrolled brain metastasis.

Key Points: 
  • Clinical trials to evaluate NEO212 as a single agent for patients with primary brain tumors or uncontrolled brain metastasis.
  • NEO212 is designed to more efficiently deliver a DNA alkylating agent to the brain for treatment of primary brain tumors and for brain metastases that arise from other cancers.
  • Metastases to the brain are the most common brain tumors in adults and this develops in nearly 30% of patients with solid tumors.
  • We look forward to further advancing our NeOnc platform, which we believe could potentially impact the standard of care for primary brain tumors and other cancers that can spread to the brain.”