Associated tags: Phase, MD Anderson Cancer Center, Immunotherapy, Patient, Cancer, Breast, Breast cancer, Health, Biotechnology, Pharmaceutical, Pharmaceutical industry, Woman, Recurrence, DTH, Trastuzumab, Clinical Trials, HER2/neu, Survivor, HLA, Oncology
Locations: US, EUROPE, TEXAS, UNITED STATES, NORTH AMERICA, STAFFORD, TX, GREENWICH
Retrieved on:
Wednesday, March 13, 2024
STAFFORD, Texas, March 13, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that its Board of Directors has extended the lock-up of the shares owned by the Company's directors, officers, and existing pre-IPO investors to June 30, 2025 which is approximately 57 months from date of the Company's IPO.
Key Points:
- STAFFORD, Texas, March 13, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that its Board of Directors has extended the lock-up of the shares owned by the Company's directors, officers, and existing pre-IPO investors to June 30, 2025 which is approximately 57 months from date of the Company's IPO.
- During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company's common stock unless otherwise modified by the Board of Directors.
Principal,
GP2,
Faculty,
Breast cancer,
Gregorio,
Immunotherapy,
Disease,
Patient,
Knowledge,
GM-CSF,
Research,
Hospital,
Observation,
Pi,
Cancer,
Death,
Teaching hospital,
Baylor College of Medicine,
ECIS,
Complutense University of Madrid,
Woman,
Prognosis,
Book,
Vaccine,
Map The Company has partnered with GEICAM, the largest academic breast cancer research network in Spain, where 38 hospitals have agreed to participate in FLAMINGO-01.
Key Points:
- The Company has partnered with GEICAM, the largest academic breast cancer research network in Spain, where 38 hospitals have agreed to participate in FLAMINGO-01.
- These sites were recently approved by Spanish authorities, which led to site initiation visits and training of the first sites this past week.
- Founded in 1995, GEICAM is a not-for-profit organization leading academic breast cancer research in Spain.
- Breast cancer is the leading cause of death in women between the ages 35-45 in Spain with 6,836 deaths in 2022.
Retrieved on:
Tuesday, February 27, 2024
The Company's application to expand Flamingo-01 into Europe has been formally approved by Spain, France, Germany, Italy, and Poland.
Key Points:
- The Company's application to expand Flamingo-01 into Europe has been formally approved by Spain, France, Germany, Italy, and Poland.
- The academic networks participating in each country are Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and a network of Polish sites.
- We look forward to working very closely with our European colleagues and will start by training site staff, pharmacists, and nurses.
- We hope to open sites as quickly as possible, while applying to open additional sites in the approved countries and potentially adding additional countries in Europe."
Retrieved on:
Thursday, February 22, 2024
The Company's application to expand Flamingo-01 into Europe has been reviewed by European Medicines Agency (EMA) through EMA's Clinical Trials Information System (CTIS).
Key Points:
- The Company's application to expand Flamingo-01 into Europe has been reviewed by European Medicines Agency (EMA) through EMA's Clinical Trials Information System (CTIS).
- The Company was informed that the manufacturing, non-clinical, clinical, statistical, and regulatory sections of its application are acceptable and the regulators' requests for information have been addressed.
- The regulators have thus approved the clinical trial, marking a major milestone for the Company.
- Once an individual site has been activated patients can be screened and enrolled.
Retrieved on:
Wednesday, February 14, 2024
Using the early Phase III trial data to reaffirm the size of the arms of the Phase III trial may be the best information we could use to reduce risk and improve the chances of success of Flamingo-01."
Key Points:
- Using the early Phase III trial data to reaffirm the size of the arms of the Phase III trial may be the best information we could use to reduce risk and improve the chances of success of Flamingo-01."
- Phase II Clinical Trial Study Report: The Company is preparing a comprehensive study report of the Phase II trial for the FDA prior to the filing of a BLA.
- These findings have not materially affected the power of the Phase III study as the assumptions for that design were selected conservatively."
- Patients who are interested in participating in the Flamingo-01 Phase III clinical trial can learn more about the study at www.clinicaltrials.gov/study/NCT05232916 .
Retrieved on:
Tuesday, November 21, 2023
STAFFORD, Texas, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced that its Board of Directors has extended the lock-up of the shares owned by the Company’s directors, officers, and existing pre-IPO investors to December 31, 2024 which is approximately 51 months from date of the Company’s IPO.
Key Points:
- STAFFORD, Texas, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced that its Board of Directors has extended the lock-up of the shares owned by the Company’s directors, officers, and existing pre-IPO investors to December 31, 2024 which is approximately 51 months from date of the Company’s IPO.
- During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company's common stock unless otherwise modified by the Board of Directors.
Retrieved on:
Thursday, December 29, 2022
Oncology,
Health,
Clinical Trials,
Research,
Science,
Pharmaceutical,
Biotechnology,
Cancer,
David Geffen School of Medicine at UCLA,
Baylor College of Medicine,
Baylor University Medical Center,
Texas Oncology,
Department of Medicine – University of Pamplona,
Grey Literature International Steering Committee,
Dan,
Woman,
Immunotherapy,
Patient,
Northwestern University,
Baylor University,
Committee,
Santa Claus,
UCLA,
HER2,
Feinberg School of Medicine,
Hematology,
GP2,
Management,
Medical imaging,
Pharmaceutical industry,
McKesson Corporation,
Medicine,
Breast cancer Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today provided the following year end update.
Key Points:
- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today provided the following year end update.
- We believe that GP2 carries great potential to improve outcomes for patients with HER2 positive breast cancer.
- The Company has added a new page to its website to provide updates to Flamingo-01 which includes a map of participating clinical sites in the US (view here ).
- The current listing of US sites from www.clinicaltrials.gov with email contact information for some sites is also shown below and will be continually updated during the trial:
Retrieved on:
Thursday, December 1, 2022
Research,
Clinical Trials,
Other Health,
Biotechnology,
General Health,
Pharmaceutical,
Health,
Science,
Oncology,
Other Science,
Recurrence,
Breast,
HER2/neu,
GM-CSF,
DTH,
HLA,
Cancer,
Patient,
Phase,
IPO,
Survivor,
Trastuzumab,
Security (finance),
Baylor College of Medicine,
MD Anderson Cancer Center,
Breast cancer,
Woman,
Immunotherapy,
Safety,
Pharmaceutical industry,
GP2 During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company's common stock unless otherwise modified by the Board of Directors.
Key Points:
- During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company's common stock unless otherwise modified by the Board of Directors.
- Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial.
- For more information on Greenwich LifeSciences, please visit the Companys website at www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS .
- Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Retrieved on:
Thursday, August 11, 2022
Research,
Pharmaceutical,
Oncology,
Other Education,
Other Manufacturing,
Education,
Packaging,
Clinical Trials,
Science,
Surgery,
Manufacturing,
Health,
Woman,
Baylor College of Medicine,
U.S. Securities and Exchange Commission,
Phase,
Survival,
Forward-looking statement,
Recurrence,
MD Anderson Cancer Center,
Population,
Security (finance),
Cancer,
HLA,
Patient,
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Twitter,
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Breast cancer,
Trastuzumab,
Safety,
Reproduction,
Breast,
Survivor,
Immunotherapy,
HER2/neu,
Nasdaq,
DTH,
Pharmaceutical industry,
Vaccine,
GP2 The trial will be led by Baylor College of Medicine and will include US and international clinical sites from university-based hospitals and cooperative networks.
Key Points:
- The trial will be led by Baylor College of Medicine and will include US and international clinical sites from university-based hospitals and cooperative networks.
- The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required.
- Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial.
- For more information on GP2 immune response and clinical data, please visit the Companys clinical trial tab at https://greenwichlifesciences.com/clinical-trials/ .
Retrieved on:
Wednesday, August 3, 2022
Biotechnology,
Health,
Pharmaceutical,
Clinical Trials,
Oncology,
Twitter,
Budget,
U.S. Securities and Exchange Commission,
MD Anderson Cancer Center,
Phase,
HER2/neu,
Recurrence,
Nasdaq,
Clinical trial,
Safety,
Cancer,
Baylor College of Medicine,
Security (finance),
Patient,
Woman,
Population,
Breast cancer,
Forward-looking statement,
Arm,
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ATM,
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Pharmaceutical industry,
Medicine,
Generic drug,
GP2 Clinical site initiation visits to train clinicians, nurses, coordinators, and pharmacists are underway, after which sites will be activated and the Flamingo-01 Phase III clinical trial will commence.
Key Points:
- Clinical site initiation visits to train clinicians, nurses, coordinators, and pharmacists are underway, after which sites will be activated and the Flamingo-01 Phase III clinical trial will commence.
- Mr. Patel further added, We look forward to commencing Flamingo-01, to sharing more information about the clinical sites, key opinion leaders, clinical networks, and countries participating in the Phase III trial, and to publishing the open label Phase III data during the trial.
- We anticipate dovetailing our use of the ATM with these major milestones and validating events as we compare the Phase III trial progress to our Phase IIb trial results.
- Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial.
