Exemestane

Atossa Therapeutics Presents Data from 40mg Cohort of Phase 2 EVANGELINE Clinical Trial Showing 100% Disease Control Rate After 24-Weeks of Treatment with (Z)-Endoxifen

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星期二, 四月 9, 2024
Plasma, MRI, Neoplasm, Atossa, Ki-67, Associate, RECIST, Magnetic resonance imaging, Incidence, Patient, MD, Woman, AACR, Clinical trial, Therapy, Breast cancer, Safety, Division, Recurrence, Exemestane, Annual general meeting, Medical imaging

SEATTLE, April 09, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced promising safety and efficacy data from the Company’s Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) clinical trial.

Key Points: 
  • SEATTLE, April 09, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced promising safety and efficacy data from the Company’s Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) clinical trial.
  • Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.
  • The data, which is being presented at the American Association for Cancer Research (AACR) Annual Meeting, is from the 40mg pharmacokinetic (PK) run-in cohort of the study.
  • At 28 days, six of the seven had Ki-67 levels below 10% and stayed on treatment for an additional five months.

Atossa Therapeutics Announces Year-End 2023 Financial Results and Provides Corporate Update

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星期一, 四月 1, 2024
Comparison, Atossa, Patient, Mayo Clinic, Neoplasm, Ductal carcinoma, Woman, AACR, CFA, Clinical trial, Therapy, Breast cancer, Safety, DCIS, FDA, Exemestane, Breast, Annual general meeting, Pharmaceutical industry

SEATTLE, April 01, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an update on recent Company developments.

Key Points: 
  • SEATTLE, April 01, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an update on recent Company developments.
  • Full enrollment was achieved in November 2023 and data is expected in the second half of 2024.
  • Factors contributing to the increased operating expenses in the year ended December 31, 2023 are explained below.
  • The following table provides a breakdown of major categories within R&D expense for the years ended December 31, 2023 and 2022, together with the dollar change in those categories (in thousands):

Data from Atossa’s Phase 2 EVANGELINE Clinical Trial to be Presented at American Association for Cancer Research (AACR) Annual Meeting

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星期三, 三月 6, 2024
Breast cancer, Cancer, Woman, Neoadjuvant therapy, Atossa, AACR, Exemestane, Therapy, Health, Patient, Estrogen receptor

The EVANGELINE study is investigating (Z)-endoxifen as a neoadjuvant treatment for premenopausal women diagnosed with Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer.

Key Points: 
  • The EVANGELINE study is investigating (Z)-endoxifen as a neoadjuvant treatment for premenopausal women diagnosed with Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer.
  • Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology, with a focus on breast cancer.
  • “We're excited that the EVANGELINE data from the 40 mg cohort of patients was accepted for presentation at the 2024 American Association for Cancer Research Annual Meeting,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer.
  • Organized by the American Association for Cancer Research, the AACR Annual Meeting is the largest and most important cancer drug discovery event in the world.

Atossa Therapeutics Issues Letter to Shareholders

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星期二, 一月 9, 2024
Woman, Weill Cornell Medicine, Research, Breast cancer screening, Share repurchase, Exemestane, University, Neoadjuvant therapy, Prognosis, Cancer, Breast, Risk, Breast Cancer Research Foundation, Cell death, University of California, Mastectomy, Ductal carcinoma, Diagnosis, Nature Portfolio, Growth, Silicon, Quantum Leap, Therapy, Neoplasm, BCRF, Seminal vesicles, Breast cancer, Disease, Patient, Lymph, Apoptosis, Radiation, Letter, Recurrence, TNBC, Phenotype, DCIS, PKC, Partnership, Mayo Clinic, Plasma, Triple-negative breast cancer, AKT, Springer Nature, FDA, Biomarker, PCR, Phosphorylation, Medical imaging

SEATTLE, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announces the issuance of the following Letter to Shareholders from Steven Quay, M.D., Ph.D., the Company’s President and Chief Executive Officer:

Key Points: 
  • SEATTLE, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announces the issuance of the following Letter to Shareholders from Steven Quay, M.D., Ph.D., the Company’s President and Chief Executive Officer:
    2023 marked another year of significant progress for Atossa.
  • If you would like to learn more about the study, please visit www.atossatherapeutics.com to view a short video interview I conducted with Dr.
  • Adding to the issue is the fact that there are currently no approved treatments to reduce breast density.
  • On behalf of the board of directors, management, and employees of Atossa Therapeutics, we thank you for your investment and continued support of our Company.

Menarini Group Presents New Progression-Free Survival Data from EMERALD Clinical Study of ORSERDU® (Elacestrant) in Clinically Relevant Subgroups of Patients with ER+, HER2- Metastatic Breast Cancer (mBC) with ESR1 Mutations at SABCS 2023

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星期五, 十二月 8, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Medicine, DSM-IV codes, Vomiting, Woman, Safety, CDK, Potassium, Therapy, Letrozole, Progression-free survival, Back pain, Fulvestrant, Abdominal pain, Doctor of Science, Headache, Risk, Liver, Disease, Cholesterol, PIK3CA, Constipation, Fatigue, Indigestion, Anastrozole, Patient, Multimedia, PFS, Metastasis, MD Anderson Cancer Center, ESR1, FDA, MBC, Neoplasm, Creatinine, Standard of care, Diarrhea, MD, Nausea, Cancer, Trial of the century, Death, Exemestane, Menarini, Anemia, SOC, TP53, Knowledge, Arthralgia, HIV disease progression rates, Triglyceride, Medical imaging, Pharmaceutical industry

This data is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.

Key Points: 
  • This data is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
  • ESR1 mutations are present in up to 40% of ER+, HER2- advanced or mBC.
  • “At Menarini Stemline our goal is to provide transformational treatments to help extend and improve the lives of people living with cancer.
  • See here for details of the Menarini Group/Stemline Therapeutics' full range of presentations at SABCS 2023.

Atossa Therapeutics Receives Approval from Health Canada to Conduct Phase 2 EVANGELINE Clinical Trial in Canada

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星期四, 七月 20, 2023
Exemestane, Ki-67, Goserelin, Woman, Atossa, SERM, Clinical trial, Patient, ESD, Therapy, Health Canada, Breast cancer, Pharmaceutical industry

SEATTLE, July 20, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announced that Health Canada has issued a “No Objection Letter” following the Company’s Clinical Trial Application for its Phase 2 EVANGELINE study.

Key Points: 
  • SEATTLE, July 20, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announced that Health Canada has issued a “No Objection Letter” following the Company’s Clinical Trial Application for its Phase 2 EVANGELINE study.
  • This means Atossa can open sites and enroll patients in their Phase 2 EVANGELINE study throughout Canada.
  • The study is expected to enroll approximately 175 patients at sites across the United States and Canada.
  • Once the dose is confirmed, we expect the pace of enrollment to increase as we activate additional sites in the United Sates and Canada.”

Atossa Completes Enrollment of Pharmacokinetic Run-In Cohort in Phase 2 EVANGELINE Clinical Trial Evaluating (Z)-Endoxifen as a Neoadjuvant Treatment for ER+ / HER2- Breast Cancer

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星期一, 六月 12, 2023
PK, Exemestane, Goserelin, Woman, Plasma, SERM, Patient, Therapy, Breast cancer

The PK run-in cohort consists of six patients, all of whom will be treated with (Z)-endoxifen at 40mg/day for four weeks.

Key Points: 
  • The PK run-in cohort consists of six patients, all of whom will be treated with (Z)-endoxifen at 40mg/day for four weeks.
  • Once the optimal dose of (Z)-endoxifen is determined, the Treatment Cohort will commence.
  • Participants in the treatment cohort will receive neoadjuvant treatment for up to six months, followed by surgery.
  • The study is expected to enroll approximately 175 patients at up to 25 sites across the United States.

Menarini Group Shares New Analysis from EMERALD Clinical Study of ORSERDU® (Elacestrant) in Metastatic Breast Cancer at ASCO 2023

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星期四, 五月 25, 2023
Biotechnology, Health, Oncology, Arm, ESR1, University of Texas Health Science Center at San Antonio, Neoplasm, Sinus bradycardia, Aes, MBC, Fulvestrant, Trae tha Truth, Anastrozole, Woman, Mutation, UT Health San Antonio Cancer Center, Multimedia, SOC, Medicine, PFS, Trial of the century, ASCO, Doctor of Science, Exemestane, American Society of Clinical Oncology, HIV disease progression rates, MD, Patient, Standard of care, Risk, Annual general meeting, Nausea, FDA, Death, Society, MD Anderson Cancer Center, Letrozole, ER, Disease, Medical imaging, Pharmaceutical industry

Results from this new post-hoc subgroup analysis will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

Key Points: 
  • Results from this new post-hoc subgroup analysis will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
  • In this new analysis to be presented at ASCO 2023, researchers evaluated treatment with elacestrant in a subgroup of patients with Non-Detected ESR1-mut enrolled in the EMERALD study with rapidly progressing disease.
  • “Endocrine therapy given in combination with a CDK4/6 inhibitor is a mainstay in ER+/HER2- metastatic breast cancer for first-line treatment.
  • “At Menarini Group, we are focused on developing innovative solutions that address the greatest unmet needs in cancer treatments,” said Elcin Barker Ergun, CEO of the Menarini Group.

Menarini Group Shares New Analysis from EMERALD Clinical Study of ORSERDU® (Elacestrant) in Metastatic Breast Cancer at ASCO 2023

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星期五, 五月 26, 2023
Disease, Arm, HER2, ESR1, University of Texas Health Science Center at San Antonio, Neoplasm, Sinus bradycardia, Aes, MBC, Fulvestrant, Trae tha Truth, Anastrozole, Woman, Mutation, UT Health San Antonio Cancer Center, Medicine, SOC, PFS, Trial of the century, ASCO, Doctor of Science, Exemestane, American Society of Clinical Oncology, HIV disease progression rates, Patient, Standard of care, Risk, Annual general meeting, Nausea, Menarini, FDA, Death, Society, MD Anderson Cancer Center, Letrozole, ER, Breast cancer, Pharmaceutical industry, Medical imaging, MD

This new post-hoc subgroup analysis expands our understanding of a potential role for elacestrant in patients with ER+/HER2- breast cancer with Non-Detected ESR1-mut.

Key Points: 
  • This new post-hoc subgroup analysis expands our understanding of a potential role for elacestrant in patients with ER+/HER2- breast cancer with Non-Detected ESR1-mut.
  • These data, while exploratory, further build upon our understanding of elacestrant as an oral endocrine therapy in the second-line metastatic breast cancer setting.
  • Results from this new post-hoc subgroup analysis will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
  • "Endocrine therapy given in combination with a CDK4/6 inhibitor is a mainstay in ER+/HER2- metastatic breast cancer for first-line treatment.

Menarini Group Shares New Analysis from EMERALD Clinical Study of ORSERDU® (Elacestrant) in Metastatic Breast Cancer at ASCO 2023

Retrieved on: 
星期五, 五月 26, 2023
Disease, Arm, HER2, ESR1, University of Texas Health Science Center at San Antonio, Neoplasm, Sinus bradycardia, Aes, MBC, Fulvestrant, Trae tha Truth, Anastrozole, Woman, Mutation, UT Health San Antonio Cancer Center, Medicine, SOC, PFS, Trial of the century, ASCO, Doctor of Science, Exemestane, American Society of Clinical Oncology, HIV disease progression rates, Patient, Standard of care, Risk, Annual general meeting, Nausea, Menarini, FDA, Death, Society, MD Anderson Cancer Center, Letrozole, ER, Breast cancer, Pharmaceutical industry, Medical imaging, MD

This new post-hoc subgroup analysis expands our understanding of a potential role for elacestrant in patients with ER+/HER2- breast cancer with Non-Detected ESR1-mut.

Key Points: 
  • This new post-hoc subgroup analysis expands our understanding of a potential role for elacestrant in patients with ER+/HER2- breast cancer with Non-Detected ESR1-mut.
  • These data, while exploratory, further build upon our understanding of elacestrant as an oral endocrine therapy in the second-line metastatic breast cancer setting.
  • Results from this new post-hoc subgroup analysis will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
  • "Endocrine therapy given in combination with a CDK4/6 inhibitor is a mainstay in ER+/HER2- metastatic breast cancer for first-line treatment.