Curative Biotechnology Announces Completion of IND Enabling Reformulated Metformin HCL Eye Drop Study
Curative Biotechnology Announces Completion of IND Enabling Reformulated Metformin HCL Eye Drop Study
Boca Raton, FL, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Curative Biotechnology Inc. (OTC: CUBT) ("Curative Biotech" or the "Company"), a development-stage biomedical company focused on novel treatments for rare diseases and conditions, announced today that it has successfully completed its Investigational New Drug (IND) enabling Tolerance and Toxicology Study of Metformin HCL Solution by Topical Instillation (eye drops) in Rabbits.
佛羅里達州博卡拉頓，2023 年 1 月 05 日（GLOBE NEWSWIRE）-治療生物科技股份有限公司（OTC：CUBT）（「治療生物技術」或「公司」），專注於罕見疾病和病症的發展階段生物醫學公司，今天宣布，已成功完成其新藥研究（IND）啟用 HSTITMIN 解決方案的藥物容忍和毒理學研究。眼藥水）在兔子。
Paul Michaels, Chairman and President of Curative Biotechnology, said, "We are pleased to announce the successful completion of these important studies, outlined in our Pre IND meeting with the FDA. We are now able to move on to preparing the Company's first IND application to move our Metformin reformulation into a clinical trial to treat Intermediate Dry Age-Related Macular Degeneration (AMD) and Geographical Atrophy (GA) resulting from AMD."
治療生物技術主席兼總裁保羅·邁克爾斯（Paul Michaels）表示：「我們很高興地宣布成功完成這些重要研究，這些重要研究在我們與 FDA 的 IND 預會議中概述。我們現在能夠繼續準備該公司的第一個 IND 應用程序，將我們的二甲雙胍重新配方轉化為臨床試驗，以治療 AMD 引起的中間性乾燥年齡相關性黃斑變性（AMD）和地理萎縮（GA）。」
Michaels continued, "Both Dry AMD and GA are currently unmet medical needs with no FDA approved efficacious treatment options. As previously announced, we will be conducting the first in human study under a CRADA (Cooperative Research and Development Agreement) with the National Eye Institute of the National Institutes of Health, in Bethesda Maryland."
邁克爾斯繼續說道：「Dry AMD 和 GA 目前尚未滿足醫療需求，沒有經 FDA 批准的有效治療選擇。正如之前宣布的那樣，我們將根據 CRADA（合作研究與發展協議）與美國馬里蘭州貝塞斯達國家衛生研究院國家眼科研究所進行的首次人類研究。」
About Macular Degeneration (AMD)
關於黃斑變性 (AMD)
Macular Degeneration is a common eye disorder among people over 50 causing blurred or reduced central vision due from the deterioration of the inner layers of the macula. The macula is the part of the retina that gives the eye clear vision in the direct line of sight. Dry AMD accounts for 80-90% of all age-related macular degeneration (AMD cases), while wet AMD represents 10-20% of patient cases. Currently there are no approved drug treatments for Dry AMD or Geographic Atrophy (late-stage dry AMD).
黃斑變性是 50 歲以上人士中常見的眼睛疾病，由於黃斑內層惡化，導致中央視力模糊或減弱。黃斑是視網膜的一部分，可在直接視線中使眼睛清晰視力。乾燥的 AMD 佔所有與年齡相關的黃斑變性（AMD 病例）的 80-90％，而濕的 AMD 佔患者病例的 10-20％。目前沒有經過批准的藥物治療方法用於乾燥 AMD 或地理萎縮（晚期乾燥 AMD）。
About Curative Biotechnology, Inc.
關於療癒生物科技股份有限公司
Curative Biotechnology, Inc. (Curative Biotech) is a development stage biomedical company focused on novel therapies for rare diseases. The Company is focused on identifying, acquiring and developing disease modifying therapeutic drug candidates with a concentration on rare disease indications. Curative Biotech has ongoing programs in three different therapeutic areas: infectious disease, neuro oncology and degenerative eye disease. The Company's pipeline includes IMT504, CURB906 and Metformin Reformulation. IMT504 is a novel immune therapy to treat rabies and an adjuvant for vaccines. CURB906 is a fully humanized CD56 monoclonal antibody carrying a cytotoxic drug conjugate directly to the tumor cancer site to kill the tumor by inhibiting tumor growth and migration of the tumor. Metformin Reformulation is targeting the treatment of intermediate and late-stage Age-Related Macular Degeneration (AMD) disease.
治療生物科技股份有限公司（Curative Biotech）是一家發展階段的生物醫學公司，專注於治療罕見疾病的新型療法。該公司專注於識別，獲取和開發修改治療性候選藥物的疾病，並專注於罕見疾病適應症。治療生物技術在三個不同的治療領域持續進行計劃：傳染病，神經腫瘤學和退行性眼病。該公司的產品線包括 IMT504、CURB906 和二甲雙胍重新配方。IMT504 是一種新穎的免疫療法，用於治療狂犬病和疫苗的輔助劑。CURB906 是一種完全人性化的 CD56 單克隆抗體，攜帶細胞毒性藥物直接與腫瘤癌部位共軛，通過抑制腫瘤的生長和遷移來殺死腫瘤。二甲雙胍重新配方的目標是治療中期和晚期年齡相關性黃斑變性（AMD）疾病。
Forward-Looking Statements
前瞻性陳述
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. CUBT is not yet generating revenues. Although forward-looking statements in this release reflect the good faith judgment of management, forward-looking statements are inherently subjected to known, unknown risks and uncertainties that may cause actual results to be materially different from those discussed in these forward-looking statements, including but not limited our ability to generate sufficient market acceptance for our products and services, our ability to generate sufficient operating cash flow, and general economic conditions. Readers are urged to carefully review and consider the various disclosures made by us in our reports filed with OTC Markets from time to time which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. We assume no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.
本新聞稿包含經修訂的《1933 年證券法》第 27A 條所指的「前瞻性陳述」及《1934 年證券交易法》第 21E 條。CUBT 尚未創造收入。儘管此版本中的前瞻性陳述反映了管理層的善意判斷，但前瞻性陳述本質上會受到已知、未知的風險和不確定性，這些可能導致實際結果與這些前瞻性陳述中討論的結果有很大不同，包括但不限於我們能夠為我們的產品和服務產生足夠市場接受度的能力，產生足夠的營運現金流，以及一般經濟條件。我們呼籲讀者不時審閱和考慮我們在向場外市場提交的報告中作出的各項披露，以試圖向有關方面提供可能影響我們業務、財務狀況、營運結果和現金流的風險和因素向有關人士提供意見。如果這些風險或不確定性中的一個或多個實現，或者如果相關假設證明不正確，我們的實際結果可能與預期或預期的結果有很大差異。敦促讀者不要對這些前瞻性陳述作出不當的依賴，這些陳述僅在本發布日期發表之日起發言。我們假設沒有義務更新任何前瞻性陳述，以反映在此發布日期之後可能出現的任何事件或情況。
Contact:
聯繫方式：
Steve Chizzik
Investor Relations
Curative Biotech (CUBT)
201-454-5845
ir@curativebiotech.com
史蒂夫·齊茲克
投資者關係
治療性生物科技
201-454-5845
ir@curativebiotech.com
譯文內容由第三人軟體翻譯。