Goserelin

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

Retrieved on: 
Tuesday, April 2, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Breast cancer, Goserelin, Patient, Lung, Social media, Immunoglobulin G, National Cancer Institute, Neoplasm, Merck & Co., TNBC, Capecitabine, DXD, BRCA, Clinical Cancer Research, Metabolism, Immunology, Biopharmaceutical, World Health Organization, Cancer, Safety, ADC, BLA, Daiichi Sankyo, Vinorelbine, IHC, Mutation, NSCLC, Disease, Merck, AKT, Death, MD, AstraZeneca, PARP, Oncotarget, PFS, FDA, OS, HER2, Eribulin, Cleavage, Progression-free survival, Triple-negative breast cancer, Female, Emerging, Olaparib, Biology, Sapporo Medical University, Medicine, Pharmaceutical industry

The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.

Key Points: 
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.
  • A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple-negative breast cancer (TNBC) and HR-positive, HER2-negative breast cancer.
  • Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer.

Goserelin Dosing Options Included in the National Comprehensive Cancer Network® (NCCN) Breast Cancer Guidelines

Retrieved on: 
Monday, February 5, 2024
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Breast cancer, Division, Goserelin, MD, NCCN, Safety, Patient, HR, Therapy, Hematology, University, Woman, Birth control

The inclusion of goserelin 10.8 mg every 12 weeks in the breast cancer guidelines as a method for ovarian function suppression is a category 2A recommendation.

Key Points: 
  • The inclusion of goserelin 10.8 mg every 12 weeks in the breast cancer guidelines as a method for ovarian function suppression is a category 2A recommendation.
  • Multiple international studies have evaluated the safety and efficacy of goserelin 10.8 mg every 12 weeks for ovarian function suppression in premenopausal patients with HR+ breast cancer.2-5
    In the United States, ZOLADEX® (goserelin implant) 3.6 mg is the only dosage form approved for use in breast cancer.
  • ZOLADEX 10.8 mg is not approved by FDA for breast cancer.
  • Additionally, ZOLADEX 10.8 mg is approved for use in breast cancer in over 60 countries, with multiple additional regulatory reviews underway.

Amide Technologies Announces Complex Peptide Manufacturing Platform, Raises $16.5M to Expedite Frontier Drug Discovery

Retrieved on: 
Thursday, December 14, 2023
Professional Services, Health, Other Professional Services, Other Health, Finance, Pharmaceutical, Biotechnology, Peptide, Dicarboxylic acid, SPPS, Acquisition, DNA, Liraglutide, Organization, Therapy, MIT, Velia, ITA Software, Dulaglutide, Flight, Leuprorelin, Protein, Multimedia, AFPS, Infection, Biology, FDA, General partnership, CIO, Drug design, Structural biology, Goserelin, Hand, Drug discovery, Ginkgo Bioworks, Doctor of Philosophy, Cancer, Diabetes, Type 2, Chemistry, Fine chemical, Amide

Amide Technologies , a biotech that synthesizes challenging peptides, announced today that it has begun commercializing its novel peptide manufacturing platform.

Key Points: 
  • Amide Technologies , a biotech that synthesizes challenging peptides, announced today that it has begun commercializing its novel peptide manufacturing platform.
  • New advances in structural biology, recombinant biologics, and AI-driven technologies have improved drug design and delivery methods, overcoming many previous pharmacokinetic behavior drawbacks of peptides .
  • “Amide delivers on complex peptide orders that other vendors refuse because peptide sourcing shouldn’t stand in the way of discovery,” said Amide CEO Mark Simon, PhD.
  • ITA Software founder and CEO Jeremy Wertheimer is an Amide co-founder and Board Member, alongside MIT Professor of Chemistry Brad Pentelute, PhD.

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

Retrieved on: 
Thursday, July 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.”

George Clinical and EPS Collaborate on Important HR+/HER2- Breast Cancer Study in Asia Pacific

Retrieved on: 
Tuesday, June 27, 2023
Multicenter trial, AMED, Partnership, User experience, International, Progression-free survival, Metastatic breast cancer, Clinical trial, Pfizer, Research, Women's Community Cancer Project Mural, Language, PFS, Goserelin, Organization, HR, Patient, Randomness, Kidney, EPS, NCCH, Medical research, United States Army Medical Research and Development Command, Safety, Breast cancer, ATLAS, Pharmaceutical industry, Birth control, Woman, Tamoxifen

In 2016, among all the Clinical Research Core Hospitals in Japan, NCCH was selected by AMED (Japan Agency for Medical Research and Development) as one of the Global Clinical Trials Core Centers, focused on the reinforcement of facilitating international clinical trials in Japan between 2016-2018. This study is their first global investigator-initiated registration-directed trial (IIRDT) -- an important step toward the pursuit of the development of treatments and new drugs for the Asian population.

Key Points: 
  • In 2019 George Clinical and EPS formed a strategic partnership to help expand their operations across the Asia-Pacific region.
  • Since September 2019, EPS and George Clinical have been involved in a major study for the National Cancer Center Hospital, Japan (NCCH) on the clinical usefulness of a combination therapy in patients of any menopausal status with advanced or metastatic HR+/HER2- breast cancer.
  • George Clinical is entirely responsible for study execution in Singapore and Taiwan with specific duties including full study conduct, regulatory, safety reporting and site monitoring.
  • George Clinical's strong expertise in regulatory, site knowledge and oncology expertise in the Asia Pacific region add value to the EPS strengths in Japan.

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

Retrieved on: 
Monday, June 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.

Atossa Therapeutics Announces Year-End 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, March 22, 2023
Patent, FNIH, Initiation, Comparison, Exemestane, Intellectual property, Goserelin, MBD, Cancer, Breast, Clinical trial, Woman, G&A, DCT, Bangladesh Technical Education Board, Stomach, Biomarker, Incidence, United States Patent and Trademark Office, Ongo, Patient, Cost, Risk, Administration, Research and development, R, Research, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Food, ER, Breast cancer, Pharmaceutical industry, Cryptocurrency, Atossa

Several FDA-approved neoadjuvant therapies exist for ER- breast cancers, but few exist for ER+ patients, which account for approximately 78% of breast cancers.

Key Points: 
  • Several FDA-approved neoadjuvant therapies exist for ER- breast cancers, but few exist for ER+ patients, which account for approximately 78% of breast cancers.
  • We expect to enroll approximately 175 patients at up to 25 sites across the United States.
  • Continued Enrollment in Phase 2 Karisma-Endoxifen Study – The Karisma-Endoxifen study is our randomized, double-blind, placebo-controlled trial of healthy, pre-menopausal women with increased breast density.
  • Our investment totaled $4.7 million and resulted in Atossa owning approximately 19% of the outstanding capital stock of DCT.

Atossa Therapeutics and Quantum Leap Healthcare Announce New Study Arm to Evaluate (Z)-Endoxifen in the Ongoing I-SPY 2 Clinical Trial

Retrieved on: 
Tuesday, March 21, 2023
Selective estrogen receptor modulator, FNIH, University, Axis, Exemestane, Ki-67, Neoplasm, University of California, San Francisco, Clinical trial, Goserelin, MBD, Cancer, Woman, Hypothalamic–pituitary–gonadal axis, EOP, Bangladesh Technical Education Board, Atossa, Biomarker, Incidence, SERM, Quantum Leap, Patient, Risk, SAN, Enzyme inhibitor, Disease, Growth, Mortality, ESD, Therapy, Recurrence, Regulation of tobacco by the U.S. Food and Drug Administration, Tamoxifen, Food, ER, Breast cancer, Pharmaceutical industry, Birth control

"Data from this trial will supplement data generated through our ongoing Phase 2 EVANGELINE trial, which is investigating (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with ER+ / HER2- breast cancer.

Key Points: 
  • "Data from this trial will supplement data generated through our ongoing Phase 2 EVANGELINE trial, which is investigating (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with ER+ / HER2- breast cancer.
  • The Karisma-Endoxifen trial is a randomized, double-blind, placebo-controlled efficacy study of oral (Z)–endoxifen in premenopausal women with measurable breast density.
  • Atossa will supply (Z)-endoxifen and provide financial support to Quantum Leap for this study.
  • Quantum Leap, as sponsor, will provide the clinical sites and clinical expertise.

Atossa Therapeutics and Quantum Leap Healthcare Announce New Study Arm to Evaluate (Z)-Endoxifen in the Ongoing I-SPY 2 Clinical Trial

Retrieved on: 
Tuesday, March 21, 2023
FNIH, University, Axis, Exemestane, Ki-67, Neoplasm, University of California, San Francisco, Clinical trial, Goserelin, MBD, Cancer, Woman, Hypothalamic–pituitary–gonadal axis, EOP, Bangladesh Technical Education Board, Atossa, Biomarker, Incidence, SERM, Quantum Leap, Patient, Risk, SAN, Enzyme inhibitor, Disease, Growth, Mortality, ESD, Therapy, Recurrence, Regulation of tobacco by the U.S. Food and Drug Administration, Tamoxifen, Food, ER, Breast cancer, Pharmaceutical industry, Birth control

“Data from this trial will supplement data generated through our ongoing Phase 2 EVANGELINE trial, which is investigating (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with ER+ / HER2- breast cancer.

Key Points: 
  • “Data from this trial will supplement data generated through our ongoing Phase 2 EVANGELINE trial, which is investigating (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with ER+ / HER2- breast cancer.
  • The Karisma-Endoxifen trial is a randomized, double-blind, placebo-controlled efficacy study of oral (Z)-endoxifen in premenopausal women with measurable breast density.
  • Atossa will supply (Z)-endoxifen and provide financial support to Quantum Leap for this study.
  • Quantum Leap, as sponsor, will provide the clinical sites and clinical expertise.

Atossa Doses First Patient in Phase 2 Neoadjuvant Clinical Study of (Z)-Endoxifen in Premenopausal Women with ER+/HER2- Breast Cancer

Retrieved on: 
Thursday, February 23, 2023
MBD, Breast cancer, Therapy, Goserelin, Cancer, Disease, Mortality, ESD, Risk, Ki-67, Exemestane, Patient, OFS, Growth, Breast, ER, Tamoxifen, Era, Cell proliferation, SERM, Woman, Incidence, Pharmaceutical industry, Birth control, Atossa

The study is expected to enroll approximately 175 patients at up to 25 sites across the United States.

Key Points: 
  • The study is expected to enroll approximately 175 patients at up to 25 sites across the United States.
  • (Z)-endoxifen administered as monotherapy may also obviate the need for OFS in premenopausal women and potentially reduce breast cancer cell proliferation.
  • The Company has an ongoing Phase 2 trial focused on reducing mammographic breast density (MBD) in healthy, premenopausal women.
  • Studies have also shown that women with MBD have an increased risk of developing breast cancer and that the higher the MBD, the higher the incidence of breast cancer.