share_log

FDA Grants Fast Track Designation to Nuvectis Pharma's NXP800 for the Treatment of Platinum-Resistant, ARID1A-Mutated Ovarian Carcinoma

FDA Grants Fast Track Designation to Nuvectis Pharma's NXP800 for the Treatment of Platinum-Resistant, ARID1A-Mutated Ovarian Carcinoma

FDA批准Nuvetis Pharma公司的NXP800用於治療對鉑耐藥、ARID1A突變的卵巢癌
GlobeNewswire ·  2022/12/01 08:06

Fort Lee, NJ, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced that the U.S. Food and Drug Administration (the "FDA") has granted Fast Track Designation to NXP800 for the treatment of platinum-resistant, ARID1A-mutated ovarian carcinoma.

新澤西州李堡,2022年12月1日(環球通訊社)紐維蒂斯製藥公司(納斯達克代碼:NVCT)(“紐維蒂斯”或“公司”)專注於開發創新的精密藥物,用於治療腫瘤學中未得到滿足的醫療需求的嚴重條件的生物製藥公司,今天宣佈,美國食品和藥物管理局(FDA)已授予NXP800快速通道稱號,用於治療鉑耐藥、ARID1A突變的卵巢癌。

"We are very pleased with the FDA's decision to grant Fast Track Designation to NXP800 for the treatment of platinum-resistant, ARID1A-mutated ovarian carcinoma, which underscores the potential of NXP800 to address this serious condition of unmet medical need," said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. Mr. Bentsur added, "We remain focused on our mission of developing novel treatments for severe oncological conditions, and we believe that with our pipeline of targeted-therapy drug candidates and experienced development team we are well positioned to achieve our goals."

Nuvetis公司董事長兼首席執行官羅恩·本特蘇爾説:“我們對FDA批准NXP800用於治療鉑耐藥、ARID1A突變的卵巢癌的決定感到非常高興,這突顯了NXP800有潛力解決這一嚴重的未得到滿足的醫療需求。”本特蘇爾補充説,“我們仍然專注於為嚴重的腫瘤疾病開發新療法的使命,我們相信,憑藉我們的靶向治療候選藥物流水線和經驗豐富的開發團隊,我們有能力實現我們的目標。”

About Fast Track Designation

關於快速通道指定

Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Clinical programs conducted under Fast Track Designation may be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

快速通道是一個旨在促進開發和加快藥物審查的過程,以治療嚴重疾病和滿足未得到滿足的醫療需求。這樣做的目的是為了讓患者更早地獲得重要的新藥。如果符合相關標準,在快速通道指定下進行的臨牀項目可能有資格申請加速批准和優先審查。

About Nuvectis Pharma, Inc.

Nuvetis製藥公司簡介

Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for serious conditions of unmet medical need in oncology. The Company is currently developing two drug candidates: NXP800, a clinical-stage HSF1 pathway inhibitor currently in a Phase 1a dose-escalation study in patients with advanced solid tumors, and NXP900, a novel SRC/YES1 kinase inhibitor currently in preclinical development with IND-enabling studies ongoing.

Nuvetis Pharma,Inc.是一家生物製藥公司,專注於為腫瘤學中未得到滿足的醫療需求的嚴重情況開發創新的精確藥物。該公司目前正在開發兩種候選藥物:NXP800和NXP900。NXP800是一種臨牀階段的HSF1途徑抑制劑,目前正處於對晚期實體腫瘤患者的1a期劑量遞增研究中;NXP900是一種新型SRC/YES1激酶抑制劑,目前正處於臨牀前開發階段,使IND成為可能的研究。

Forward Looking Statements

前瞻性陳述

This press release contains "forward-looking statements" within the meaning of the federal securities laws, which statements 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 "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," 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 Nuvectis Pharma, Inc.'s current expectations, estimates, and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy, and financial needs. These forward-looking statements include, but are not limited to, statements regarding any potential benefits of the Fast Track Designation for NXP800 and NXP800's potential to improve clinical outcomes in platinum-resistant, ARID1A-mutated Ovarian Carcinoma or any other form of cancer. The outcome of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict and include expectations regarding the the preclinical and clinical expectations for NXP800 and NXP900, including the results and completion of the Phase 1a dose-escalation study of NXP800 and the expected commencement of the Phase 1b study for NXP800, as well as the results and completion of the NXP900 IND-enabling studies and the expected submission and potential acceptance of an IND, or an equivalent application, for NXP900.  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 subject to market and other conditions and described more fully in the section titled "Risk Factors" in the 2021 Form 10-K filed with the Securities and Exchange Commission ("SEC"). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

本新聞稿包含聯邦證券法所指的“前瞻性陳述”,這些陳述會受到重大風險和不確定性的影響。除有關歷史事實的陳述外,本新聞稿中包含的所有陳述均為前瞻性陳述。本新聞稿中包含的前瞻性陳述可通過使用“預期”、“相信”、“考慮”、“可能”、“估計”、“預期”、“打算”、“尋求”、“可能”、“可能”、“計劃”、“潛在”、“預測”、“項目”、“目標”、“目標”、“應該”、“將”、“將”、“可能”、“計劃”、“潛在”、“預測”、“計劃”、“目標”、“目標”、“應該”、“將”、“可能”、“計劃”、“潛在”、“預測”、“計劃”、“目標”、“目標”、“應該”、“將”、“可能”、“可能”、“計劃”、“潛在”、“預測”、“計劃”、“目標”、“目標”、“應該”、“將”“或這些詞語的否定或其他類似表述,儘管並非所有前瞻性陳述都包含這些詞語。前瞻性陳述基於Nuvetis製藥公司對未來事件和趨勢的當前預期、估計和預測,我們認為這些事件和趨勢可能會影響我們的業務、財務狀況、經營結果、前景、業務戰略和財務需求。這些前瞻性陳述包括但不限於關於指定NXP800的快速通道的任何潛在好處以及NXP800改善鉑耐藥、ARID1A突變的卵巢癌或任何其他形式癌症的臨牀結果的潛力的陳述。這些前瞻性陳述中描述的事件的結果受固有的不確定性、風險、假設、市場和其他條件以及其他難以預測的因素的影響,這些因素包括對NXP800和NXP900的臨牀前和臨牀預期,包括NXP800的1a階段劑量遞增研究的結果和完成,NXP800的1b階段研究的預期開始,NXP900 IND支持研究的結果和完成,以及NXP900的IND或同等申請的預期提交和可能的接受。進一步, 某些前瞻性陳述是基於對未來事件的假設,而事實可能證明這些假設並不準確。這些和其他風險和不確定性受市場和其他條件的影響,在提交給美國證券交易委員會(“美國證券交易委員會”)的2021年Form 10-K中題為“風險因素”的一節中有更詳細的描述。然而,這些風險並不是包羅萬象的,新的風險和不確定性不時出現,我們不可能預測到所有可能對本新聞稿或其他提交給美國證券交易委員會的文件中包含的前瞻性聲明產生影響的風險和不確定性。本新聞稿中包含的任何前瞻性陳述僅限於本新聞稿發佈之日。我們明確表示不承擔任何義務或承諾公開發布本文中包含的任何前瞻性陳述的任何更新或修訂,以反映我們預期的任何變化或任何此類陳述所基於的事件、條件或情況的任何變化,除非法律可能要求,我們要求保護1995年私人證券訴訟改革法中包含的前瞻性陳述的安全港。

Company Contact:

公司聯繫人:

Ron Bentsur

羅恩·本蘇爾

Chairman, Chief Executive Officer and President

董事長、首席執行官、總裁

rbentsur@nuvectis.com

郵箱:rbentsur@nuvetis.com

Media Relations Contact:

媒體關係聯繫人:

Christopher M. Calabrese

克里斯托弗·M·卡拉布雷斯

LifeSci Advisors

LifeSci顧問

Tel: 917-680-5608

電話:917-680-5608

ccalabrese@lifesciadvisors.com 

郵箱:ccalabrese@lifescivisors.com


声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
    搶先評論