{"id":392471,"date":"2020-12-03T07:03:38","date_gmt":"2020-12-03T12:03:38","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=392471"},"modified":"2020-12-03T07:03:38","modified_gmt":"2020-12-03T12:03:38","slug":"greenwich-lifesciences-announces-new-manufacturing-agreement-for-its-planned-phase-iii-clinical-trial-and-enters-into-lease-for-office-and-lab-space","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/greenwich-lifesciences-announces-new-manufacturing-agreement-for-its-planned-phase-iii-clinical-trial-and-enters-into-lease-for-office-and-lab-space\/","title":{"rendered":"Greenwich LifeSciences Announces New Manufacturing Agreement for its Planned Phase III Clinical Trial and Enters into Lease for Office and Lab Space"},"content":{"rendered":"

<\/p>\n

Greenwich LifeSciences Announces New Manufacturing Agreement for its Planned Phase III Clinical Trial and Enters into Lease for Office and Lab Space<\/b><\/p>\n

STAFFORD, Texas–(BUSINESS WIRE<\/a>)–
\nGreenwich LifeSciences, Inc. (Nasdaq: GLSI) (the \u201cCompany\u201d), 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, today announced that it has entered into a contract for the final formulation and filling of GP2 into vials, which when completed will allow for the storage and distribution of GP2 to clinical sites. The contract manufacturer plans to commence activities in 2021. In addition, the Company has leased office, laboratory, and storage space to provide research, manufacturing, and clinical trial support activities.\n<\/p>\n

\nSnehal Patel, CEO of Greenwich LifeSciences, commented, \u201cWe are pleased to have entered into these key manufacturing and facility agreements, which along with the continued recruitment of key opinion leaders and clinical sites, will be some of the major last steps before commencing the upcoming Phase III clinical trial.\u201d\n<\/p>\n

\nThe Company\u2019s new manufacturing partner specializes in the current Good Manufacturing Practice (cGMP) of formulating, filling, and labeling drug vials and follows the recent completion of the manufacturing of the GP2 active ingredient.\n<\/p>\n

\nThe Company\u2019s new facility is located in Stafford, Texas and will enable the Company to support its manufacturing activities, develop analytical methods, and process clinical trial samples. The facility may also be instrumental in supporting potential additional research and development activities into other drug products that could complement the GP2 immunotherapy platform and expand the pipeline of the Company.\n<\/p>\n

About Breast Cancer and HER2\/neu<\/i> Positivity<\/b><\/p>\n

\nOne in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2\/neu<\/i> (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.\n<\/p>\n

About Greenwich LifeSciences, Inc.<\/b><\/p>\n

\nGreenwich 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. GP2 is a 9 amino acid transmembrane peptide of the HER2\/neu<\/i> protein. In a randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial, no recurrences were observed in the HER2\/neu<\/i> 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338<\/i>). Of the 138 patients that have been treated with GP2 to date over 4 clinical trials, GP2 treatment was well tolerated and no serious adverse events were observed related to GP2 immunotherapy. 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 company\u2019s website: www.greenwichlifesciences.com<\/a><\/p>\n

Forward-Looking Statement Disclaimer<\/b><\/p>\n

\nStatements in this press release contain \u201cforward-looking statements\u201d that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccontemplate,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cseek,\u201d \u201cmay,\u201d \u201cmight,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201ctarget,\u201d \u201caim,\u201d \u201cshould,\u201d “will\u201d \u201cwould,\u201d or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.\u2019s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled \u201cRisk Factors\u201d in the final prospectus related to the public offering filed with the Securities and Exchange Commission. 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.\n<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20201203005349\/en\/<\/a><\/span><\/p>\n

Company Contact
\n<\/b>
Snehal Patel
\n
Investor Relations
\n
(832) 819-3232
\n
info@greenwichlifesciences.com<\/a><\/p>\n

Investor & Public Relations Contact for Greenwich LifeSciences
\n<\/b>
Dave Gentry
\n
RedChip Companies Inc.
\n
Office: 1-800-RED CHIP (733 2447)
\n
Cell: (407) 491-4498
\n
dave@redchip.com<\/a><\/p>\n

KEYWORDS:<\/b> United States North America Texas<\/p>\n

INDUSTRY KEYWORDS:<\/b> Oncology Health Clinical Trials Research Science Pharmaceutical Biotechnology<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
\"Logo\"<\/td>\n<\/tr>\n
<\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Greenwich LifeSciences Announces New Manufacturing Agreement for its Planned Phase III Clinical Trial and Enters into Lease for Office and Lab Space STAFFORD, Texas–(BUSINESS WIRE)– Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the \u201cCompany\u201d), 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, today announced that it has entered into a contract for the final formulation and filling of GP2 into vials, which when completed will allow for the storage and distribution of GP2 to clinical sites. The contract manufacturer plans to commence activities in 2021. In addition, the Company has leased office, laboratory, and storage space to provide research, manufacturing, and clinical trial support activities. Snehal … <\/p>\n

Continue reading “Greenwich LifeSciences Announces New Manufacturing Agreement for its Planned Phase III Clinical Trial and Enters into Lease for Office and Lab Space”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-392471","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nGreenwich LifeSciences Announces New Manufacturing Agreement for its Planned Phase III Clinical Trial and Enters into Lease for Office and Lab Space - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/greenwich-lifesciences-announces-new-manufacturing-agreement-for-its-planned-phase-iii-clinical-trial-and-enters-into-lease-for-office-and-lab-space\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Greenwich LifeSciences Announces New Manufacturing Agreement for its Planned Phase III Clinical Trial and Enters into Lease for Office and Lab Space - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Greenwich LifeSciences Announces New Manufacturing Agreement for its Planned Phase III Clinical Trial and Enters into Lease for Office and Lab Space STAFFORD, Texas–(BUSINESS WIRE)– Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the \u201cCompany\u201d), 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, today announced that it has entered into a contract for the final formulation and filling of GP2 into vials, which when completed will allow for the storage and distribution of GP2 to clinical sites. The contract manufacturer plans to commence activities in 2021. In addition, the Company has leased office, laboratory, and storage space to provide research, manufacturing, and clinical trial support activities. 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(Nasdaq: GLSI) (the \u201cCompany\u201d), 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, today announced that it has entered into a contract for the final formulation and filling of GP2 into vials, which when completed will allow for the storage and distribution of GP2 to clinical sites. The contract manufacturer plans to commence activities in 2021. In addition, the Company has leased office, laboratory, and storage space to provide research, manufacturing, and clinical trial support activities. 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