GP2

Greenwich LifeSciences Announces Activation of Clinical Sites and Commencement of Phase III Clinical Trial

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, Company, Twitter, Acquisition, 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/ .

Greenwich LifeSciences Provides Updates on Flamingo-01 Phase III Clinical Trial

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, Immunotherapy, ATM, Breast, Trastuzumab, Company, DTH, Pharmacist, Nursing, Survivor, HLA, GM-CSF, 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.

Greenwich LifeSciences Provides Financing Strategy & Corporate Update

Retrieved on: 
Thursday, July 28, 2022
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Sale, Time, DTH, ATM, Trastuzumab, U.S. Securities and Exchange Commission, Twitter, Woman, Forward-looking statement, Survivor, Research, Safety, HER2/neu, Baylor College of Medicine, MD Anderson Cancer Center, Recurrence, Burn, Immunotherapy, Technology, Company, HLA, Breast, Cancer, Patient, Security (finance), Nasdaq, Breast cancer, Phase, Public expenditure, Population, Pharmaceutical industry, Bank, GP2

There can be no assurance that the Company will sell any shares under or fully utilize this source of financing.

Key Points: 
  • There can be no assurance that the Company will sell any shares under or fully utilize this source of financing.
  • 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.

Greenwich LifeSciences Announces Removal of Clinical Hold Permitting Phase III Clinical Trial to Proceed

Retrieved on: 
Tuesday, July 12, 2022
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, FDA, Clinical Trials, Food, FDA, Company, GP2, Food and Drug Administration, Nasdaq, Phase, Pharmaceutical industry

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the Company), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, announced that the Food and Drug Administration (FDA) has removed the clinical hold permitting the Flamingo-01 Phase III clinical trial to proceed.

Key Points: 
  • Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the Company), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, announced that the Food and Drug Administration (FDA) has removed the clinical hold permitting the Flamingo-01 Phase III clinical trial to proceed.
  • As previously announced, the Phase III clinical trial was placed on clinical hold by the FDA related to manufacturing and the pharmacy process.
  • The Company through discussions with the FDA and testing of GP2 in the pharmacy process has satisfactorily addressed the clinical hold issues.
  • On July 11, 2022, the FDA formally removed the clinical hold and thus the Flamingo-01 Phase III clinical trial may proceed as planned.

Greenwich LifeSciences Provides Updates on Upcoming Phase III Clinical Trial & ASCO Meeting

Retrieved on: 
Monday, May 23, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Committee, U.S. Securities and Exchange Commission, Review, Twitter, Cancer, Breast, Physician, Immunotherapy, HER2, Woman, DSMB, Phase, Nursing, Clinical trial, Oncology, Observation, Chemistry, Company, Breast cancer, 2021 Essex County Council election, Health, Survivor, Â, HLA, FDA, Recurrence, Time, ASCO, Pharmacist, Security (finance), Letter, IIB, MD Anderson Cancer Center, Population, Nasdaq, Patient, Trastuzumab, Injection, DTH, Industry, CRO, Forward-looking statement, HER2/neu, Safety, GM-CSF, Baylor College of Medicine, Pharmaceutical industry, Medicine, Vaccine, GP2

Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, We continue to make progress towards opening up our first sites.

Key Points: 
  • Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, We continue to make progress towards opening up our first sites.
  • Three abstracts and two posters were accepted for presentation at the upcoming AACR Annual Meeting 2022.
  • 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/ .

Greenwich LifeSciences to Resume Stock Repurchase Program

Retrieved on: 
Monday, May 23, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, Cancer, Company, MD Anderson Cancer Center, Immunotherapy, U.S. Securities and Exchange Commission, Nasdaq, Breast cancer, Director, Patient, Phase, Time, Forward-looking statement, Board, Program, Twitter, Breast, Security (finance), Share repurchase, Fine chemical, GP2

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the Company), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, announced today it would resume its existing Stock Repurchase Program.

Key Points: 
  • Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the Company), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, announced today it would resume its existing Stock Repurchase Program.
  • Under the repurchase program previously authorized by the board of directors, Greenwich LifeSciences may repurchase its outstanding shares of common stock from time to time in open market or privately-negotiated transactions, including accelerated share repurchase transactions, block trades, or pursuant to 10b5-1 trading plans.
  • The stock repurchase program may be modified, suspended or terminated by the Board of Directors at any time.
  • 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 .

Greenwich LifeSciences to Participate in Upcoming Jefferies, Wainwright, ASCO and BIO International Conferences

Retrieved on: 
Wednesday, April 20, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, DTH, Woman, Annual general meeting, U.S. Securities and Exchange Commission, Population, Security (finance), Patient, Breast cancer, Forward-looking statement, 2021 Essex County Council election, Hope, HLA, ASCO, Society, Conference, Survivor, Company, Disease, CEO, Twitter, Phase, Trastuzumab, III, Jefferies, Nasdaq, Safety, Industry, Cancer, MD Anderson Cancer Center, Biotechnology, Recurrence, Clinical trial, HER2/neu, Immunotherapy, American Society of Clinical Oncology, Baylor College of Medicine, Breast, Health, Physician, Pharmaceutical industry, GP2

Founded in 1964, ASCO is the world's leading professional organization for physicians and oncology professionals caring for people with cancer.

Key Points: 
  • Founded in 1964, ASCO is the world's leading professional organization for physicians and oncology professionals caring for people with cancer.
  • BIO International Convention June 13-16, 2022
    The Company will be participating in the BIO International Convention in San Diego, CA with an in-person presentation and one-on-one partnering meetings.
  • 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 .

Greenwich LifeSciences Presents Phase IIb Data, Published at AACR 2022, Further Supporting the Role of GP2 in Preventing Metastatic Breast Cancer

Retrieved on: 
Tuesday, April 19, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, Patient, PIS, DTH, GM-CSF, Recurrence, Woman, Association, Trastuzumab, Immunotherapy, HER2, Probability, GM, Kaplan–Meier estimator, Injection, DFS, Nasdaq, Company, Breast cancer, American Association for Cancer Research, Neoplasm, Clinical trial, 2021 Essex County Council election, American Association, AACR, IIB, Pharmaceutical industry, Vaccine, GP2

In addition, a GP2 immune response prior to any GP2 treatment may help in predicting the probability and timing of breast cancer recurrence.

Key Points: 
  • In addition, a GP2 immune response prior to any GP2 treatment may help in predicting the probability and timing of breast cancer recurrence.
  • One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021.
  • Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery.
  • Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial.

GoPro's New HERO10 Black Bones Is the Ultimate No-Compromises FPV Camera

Retrieved on: 
Tuesday, April 12, 2022
CEO, Technology, Aircraft, TikTok, Quik, Current, GoPro, Twitter, NASDAQ, YouTube, FPV, Crash, LinkedIn, First-person view (radio control), HERO, Bone, Just, Instagram, GP2, Tesla, Multimedia, GPRO, Television, Public relations, Medical imaging, Camera, Facebook

SAN MATEO, Calif., April 12, 2022 /PRNewswire/ -- GoPro, Inc. (NASDAQ: GPRO) today announced the lightest GoPro ever, HERO10 Black Bones, which is purpose-built to be the ultimate FPV (First Person View) drone camera. Featuring GoPro's flagship imaging pipeline – including the high-performance GP2 processor and Emmy® Award-Winning HyperSmooth 4.0 – the camera delivers the same breakthrough image quality and blistering video frame rates as HERO10 Black, packaged in a minimalistic, lightweight enclosure designed specifically for FPV use.

Key Points: 
  • Weighing in at only 54 grams, HERO10 Black Bones is uniquely suited to FPV capture as the lightest GoPro ever providing only the essentials for FPV enthusiasts.
  • "With HERO10 Black Bones, the FPV community now has the lightest GoPro ever an easy to set up, no-compromise, custom-designed camera for the FPV use-case.
  • We're excited to see how far the community can push the limits of FPV content creation with HERO10 Black Bones."
  • HERO10 Black Bones is launching just two weeks after GoPro's innovative new camera designed specifically for vloggers and content creators, HERO10 Black Creator Edition .

Greenwich LifeSciences Provides Updates on Upcoming Phase III Clinical Trial, Patent Filings, & AACR Meeting

Retrieved on: 
Thursday, March 3, 2022
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Breast, Trastuzumab, Recurrence, Patient, Immunotherapy, Research, Phase, Greenwich, Woman, Population, Forward-looking statement, Strathcona County, Twitter, Breast cancer, MD Anderson Cancer Center, HLA, AACR, HER2/neu, Company, DTH, SEC, Cancer, Patent, Medicine, 2021 Essex County Council election, Nasdaq, Survivor, Prospectus, Pharmaceutical industry, GP2, the AACR Annual Meeting 2022, FLAMINGO-01 and GLSI-100, Breast Cancer and HER2/neu Positivity, Greenwich LifeSciences, Inc., GP2 Immunotherapy Immune Response, THE AACR ANNUAL MEETING 2022, FLAMINGO-01 AND GLSI-100, BREAST CANCER AND HER2/NEU POSITIVITY, GREENWICH LIFESCIENCES, INC., GP2 IMMUNOTHERAPY IMMUNE RESPONSE

Three abstracts/posters were accepted for presentation at the upcoming AACR Annual Meeting 2022.

Key Points: 
  • Three abstracts/posters were accepted for presentation at the upcoming AACR Annual Meeting 2022.
  • If these patent claims are issued, they have the potential to extend the patent life of GP2 beyond 2040.
  • The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100.
  • Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial.