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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用于治疗对铂耐药、ARID1A突变的卵巢癌
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.

新泽西州李堡,2022年12月1日(环球通讯社)纽维蒂斯制药公司(纳斯达克代码:NVCT)(“纽维蒂斯”或“公司”)专注于开发创新的精密药物,用于治疗肿瘤学中未得到满足的医疗需求的严重条件的生物制药公司,今天宣布,美国食品和药物管理局(FDA)已授予NXP800快速通道称号,用于治疗铂耐药、ARID1A突变的卵巢癌。

"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公司董事长兼首席执行官罗恩·本特苏尔说:“我们对FDA批准NXP800用于治疗铂耐药、ARID1A突变的卵巢癌的决定感到非常高兴,这突显了NXP800有潜力解决这一严重的未得到满足的医疗需求。”本特苏尔补充说,“我们仍然专注于为严重的肿瘤疾病开发新疗法的使命,我们相信,凭借我们的靶向治疗候选药物流水线和经验丰富的开发团队,我们有能力实现我们的目标。”

About Fast Track Designation

关于快速通道指定

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.

快速通道是一个旨在促进开发和加快药物审查的过程,以治疗严重疾病和满足未得到满足的医疗需求。这样做的目的是为了让患者更早地获得重要的新药。如果符合相关标准,在快速通道指定下进行的临床项目可能有资格申请加速批准和优先审查。

About Nuvectis Pharma, Inc.

Nuvetis制药公司简介

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.是一家生物制药公司,专注于为肿瘤学中未得到满足的医疗需求的严重情况开发创新的精确药物。该公司目前正在开发两种候选药物:NXP800和NXP900。NXP800是一种临床阶段的HSF1途径抑制剂,目前正处于对晚期实体肿瘤患者的1a期剂量递增研究中;NXP900是一种新型SRC/YES1激酶抑制剂,目前正处于临床前开发阶段,使IND成为可能的研究。

Forward Looking Statements

前瞻性陈述

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.

本新闻稿包含联邦证券法所指的“前瞻性陈述”,这些陈述会受到重大风险和不确定性的影响。除有关历史事实的陈述外,本新闻稿中包含的所有陈述均为前瞻性陈述。本新闻稿中包含的前瞻性陈述可通过使用“预期”、“相信”、“考虑”、“可能”、“估计”、“预期”、“打算”、“寻求”、“可能”、“可能”、“计划”、“潜在”、“预测”、“项目”、“目标”、“目标”、“应该”、“将”、“将”、“可能”、“计划”、“潜在”、“预测”、“计划”、“目标”、“目标”、“应该”、“将”、“可能”、“计划”、“潜在”、“预测”、“计划”、“目标”、“目标”、“应该”、“将”、“可能”、“可能”、“计划”、“潜在”、“预测”、“计划”、“目标”、“目标”、“应该”、“将”“或这些词语的否定或其他类似表述,尽管并非所有前瞻性陈述都包含这些词语。前瞻性陈述基于Nuvetis制药公司对未来事件和趋势的当前预期、估计和预测,我们认为这些事件和趋势可能会影响我们的业务、财务状况、经营结果、前景、业务战略和财务需求。这些前瞻性陈述包括但不限于关于指定NXP800的快速通道的任何潜在好处以及NXP800改善铂耐药、ARID1A突变的卵巢癌或任何其他形式癌症的临床结果的潜力的陈述。这些前瞻性陈述中描述的事件的结果受固有的不确定性、风险、假设、市场和其他条件以及其他难以预测的因素的影响,这些因素包括对NXP800和NXP900的临床前和临床预期,包括NXP800的1a阶段剂量递增研究的结果和完成,NXP800的1b阶段研究的预期开始,NXP900 IND支持研究的结果和完成,以及NXP900的IND或同等申请的预期提交和可能的接受。进一步, 某些前瞻性陈述是基于对未来事件的假设,而事实可能证明这些假设并不准确。这些和其他风险和不确定性受市场和其他条件的影响,在提交给美国证券交易委员会(“美国证券交易委员会”)的2021年Form 10-K中题为“风险因素”的一节中有更详细的描述。然而,这些风险并不是包罗万象的,新的风险和不确定性不时出现,我们不可能预测到所有可能对本新闻稿或其他提交给美国证券交易委员会的文件中包含的前瞻性声明产生影响的风险和不确定性。本新闻稿中包含的任何前瞻性陈述仅限于本新闻稿发布之日。我们明确表示不承担任何义务或承诺公开发布本文中包含的任何前瞻性陈述的任何更新或修订,以反映我们预期的任何变化或任何此类陈述所基于的事件、条件或情况的任何变化,除非法律可能要求,我们要求保护1995年私人证券诉讼改革法中包含的前瞻性陈述的安全港。

Company Contact:

公司联系人:

Ron Bentsur

罗恩·本苏尔

Chairman, Chief Executive Officer and President

董事长、首席执行官、总裁

rbentsur@nuvectis.com

邮箱:rbentsur@nuvetis.com

Media Relations Contact:

媒体关系联系人:

Christopher M. Calabrese

克里斯托弗·M·卡拉布雷斯

LifeSci Advisors

LifeSci顾问

Tel: 917-680-5608

电话:917-680-5608

ccalabrese@lifesciadvisors.com 

邮箱:ccalabrese@lifescivisors.com


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