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NervGen Pharma to Receive More Than US$3 Million From Wings for Life to Support Upcoming Clinical Study in Spinal Cord Injury

NervGen Pharma to Receive More Than US$3 Million From Wings for Life to Support Upcoming Clinical Study in Spinal Cord Injury

NervGen Pharma 將從 Wings for Life 獲得超過 300 萬美元,用於支持即將進行的脊髓損傷臨床研究
newsfile ·  2023/06/27 20:30

Vancouver, British Columbia--(Newsfile Corp. - June 27, 2023) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQX: NGENF) ("NervGen" or the "Company"), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, announced today that it has been awarded a grant of up to US$3.18 million from Wings for Life, a not-for-profit spinal cord injury research foundation, under the foundation's Accelerated Translational Program. The funding will support the upcoming Phase 1b/2a proof of concept clinical trial for the Company's proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI). Additionally, the U.S. Food and Drug Administration (FDA) has completed their review of the Company's clinical trial protocol and has determined that the study may proceed. The Company will continue to work to resolve the ongoing partial clinical hold from the FDA, but the hold does not impact the conduct of this trial.

溫哥華,不列顛哥倫比亞省-(Newsfile Corp.-2023年6月27日)-NervGen製藥公司(TSXV:NGEN)(OTCQX:NGENF)(“NervGen”或“公司”)是一家致力於開發神經系統損傷治療創新解決方案的臨床階段生物技術公司,該公司今天宣佈,根據基金會的加速翻譯計劃,它已從非營利性脊髓損傷研究基金會Wings for Life獲得高達318萬美元的贈款。這筆資金將用於該公司專利先導化合物NVG-291即將進行的1b/2a階段概念驗證臨床試驗,用於治療脊髓損傷(SCI)患者。此外,美國食品和藥物管理局(FDA)已經完成了對該公司臨床試驗方案的審查,並確定該研究可能會繼續進行。該公司將繼續努力解決FDA正在進行的部分臨床擱置,但擱置不會影響本次試驗的進行。

"We are very grateful to have the support of Wings for Life for this important clinical study of NVG-291 in individuals with spinal cord injury," stated Mike Kelly, NervGen's President & CEO. "Our goal is to begin enrolling subjects in this trial in the third quarter of this year. Wings for Life's grant support for our SCI clinical program comes at an important inflection point for NervGen as we transition from our recently completed Phase 1 study in healthy volunteers to this Phase 1b/2a proof of concept study."

NervGen首席執行官總裁兼首席執行官Mike·凱利表示:“我們非常感謝生命之翼對NVG-291在脊髓損傷患者中的這項重要臨床研究的支持。我們的目標是在今年第三季度開始招募受試者參加這項試驗。生命之翼對我們的SCI臨床專案的撥款支持對NervGen來說是一個重要的轉捩點,因為我們正在從最近完成的健康志願者第一階段研究過渡到這項1b/2a階段的概念驗證研究。“

"Wings for Life USA is thrilled to partner with NervGen, Dr. Monica Perez, and Shirley Ryan AbilityLab to translate this promising intervention from laboratory research to human clinical trial," said Andrew Wagner, CEO of Wings for Life USA. "Bridging this gap is critical to accelerating progress. We are more excited than ever about driving our mission to find a cure for spinal cord injuries, and we thank our generous donors who make it possible to fund this progress."

美國生命之翼公司首席執行官安德魯·瓦格納說:“美國生命之翼公司很高興能與NervGen、莫妮卡·佩雷斯博士和雪莉·瑞安能力實驗室合作,將這一有希望的幹預措施從實驗室研究轉化為人類臨床試驗。彌合這一差距對加快進展至關重要。我們比以往任何時候都更興奮地推動我們的使命,尋找治療脊髓損傷的方法,我們感謝我們慷慨的捐贈者,他們使這一進展成為可能。

"One of the novel aspects of this clinical trial is the use of advanced quantitative electrophysiology to assess recovery of motor connectivity following treatment with NVG-291, in addition to clinical assessments to measure recovery of motor function," stated Monica A. Perez, PT, PhD, Scientific Chair of the Arms + Hands Lab at Shirley Ryan AbilityLab; Professor of Physical Medicine & Rehabilitation at Northwestern University; Research Scientist at the Edward Hines Jr. VA Hospital; and the principal investigator of this trial. "At Shirley Ryan AbilityLab, we have leveraged electrophysiology extensively to strengthen neuronal connectivity using non-invasive spike-timing dependent plasticity protocols, but this approach has been sparsely used in clinical trials of investigational pharmacologic therapies for individuals with spinal cord injury. We are excited that Shirley Ryan AbilityLab will be the single center working with NervGen on this important clinical trial."

雪莉·瑞安能力實驗室手臂+手實驗室科學主席、西北大學物理醫學和康復教授、小愛德華·海因斯研究科學家莫妮卡·A·佩雷斯說:“這項臨床試驗的新方面之一是使用先進的定量電生理學來評估NVG-291治療後運動連接性的恢復,以及用臨床評估來衡量運動功能的恢復。弗吉尼亞醫院;這項試驗的主要調查者。在雪莉·瑞安能力實驗室,我們廣泛利用電生理學,使用非侵入性的尖峰時序依賴可塑性協定來加強神經元的連接,但這種方法在針對脊髓損傷患者的研究性藥物治療的臨床試驗中很少使用。我們感到興奮的是,雪莉·瑞安能力實驗室將成為與NervGen合作進行這項重要臨床試驗的單一中心。“

The placebo-controlled proof of concept trial will evaluate the efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (10-49 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers, that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function. Specifically, the primary objective is to assess the change in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment, based on changes in motor evoked potential amplitudes. Secondary objectives are to evaluate changes in a number of clinical outcome assessments focusing on motor function, upper extremity dexterity and grasping and mobility, as well as changes in additional electrophysiological measurements. Each cohort will be evaluated independently as the data becomes available. The grant funding from Wings for Life, which is to be provided in several milestone-based payments, will offset a portion of the direct costs of this clinical trial.

這項安慰劑對照的概念驗證試驗將評估NVG-291在兩組不同的頸髓損傷患者中的療效:慢性(損傷後1-10年)和亞急性(損傷後10-49天),在慢性和急性脊髓損傷的臨床前模型中都證明瞭有效性。這項試驗旨在使用多種臨床結果指標以及客觀的電生理和核磁共振成像指標以及血液生物標記物來評估固定劑量NVG-291的療效,這些指標一起將提供有關功能恢復程度的全面資訊,重點是運動功能的改善。具體地說,主要目標是根據運動誘發電位幅度的變化,評估治療後確定的上肢和下肢肌群的皮質脊髓連通性的變化。次要目標是評估一些臨床結果評估的變化,重點是運動功能、上肢靈活性和抓握和活動能力,以及其他電生理測量的變化。當數據可用時,將對每個隊列進行獨立評估。Wings for Life的贈款資金將分幾次以里程碑為基礎支付,將抵消這項臨床試驗的部分直接成本。

About Wings for Life Spinal Cord Research Foundation

關於生命之翼脊髓研究基金會

Worldwide, millions of people are dependent on a wheelchair after having sustained a spinal cord injury, most often as the result of a traffic accident or a fall. Wings for Life is a not-for-profit spinal cord research foundation with the single mission to find a cure for spinal cord injury. Since 2004, Wings for Life has funded life-changing research projects and clinical trials around the globe. While a cure is still to be found, steady progress has been made. Wings for Life USA was recognized as a 501 (c)(3) non-profit foundation in 2017 to fund scientific research and clinical trials in the United States.

在世界範圍內,數以百萬計的人在遭受脊髓損傷後依賴輪椅,最常見的原因是交通事故或摔倒。生命之翼是一個非營利性的脊髓研究基金會,唯一的使命是找到治療脊髓損傷的方法。自2004年以來,Wings for Life在全球範圍內資助了改變生活的研究項目和臨床試驗。雖然仍未找到治癒方法,但已經取得了穩步進展。2017年,美國生命之翼被認定為501(C)(3)非營利性基金會,為美國的科學研究和臨床試驗提供資金。

About Wings for Life Accelerated Translational Program

關於生命之翼加速翻譯計劃

Even with very promising discoveries, the translation from scientific discovery to applied therapeutics is a long and difficult road due to regulatory burdens, complexities of clinical trial design, patient recruitment and retention barriers, and the high cost of cutting-edge research. The Wings for Life Accelerated Translational Program (ATP) has been specifically designed to be able to accommodate obstacles to efficient clinical translation.

即使有非常有希望的發現,由於監管負擔、臨床試驗設計的複雜性、患者招募和保留障礙以及尖端研究的高昂成本,從科學發現到應用療法的轉換是一條漫長而艱難的道路。生命之翼加速翻譯計劃(ATP)是專門為適應高效臨床翻譯的障礙而設計的。

The ATP strives to assist applicants to find the best way forward in clinical translation of high caliber, promising therapies. The ATP is supported by a network of clinicians, scientists, and other professionals with expertise in all aspects of clinical trials. Select members of the ATP Support Network will be called upon, as required, to assist in ensuring that treatments with auspicious potential are translated in the most scientifically rigorous and efficient way possible.

ATP努力幫助申請者在高水平、有前途的療法的臨床翻譯中找到最佳的前進方向。ATP由臨床醫生、科學家和其他在臨床試驗各個方面具有專業知識的專業人員組成的網路提供支持。根據需要,將要求ATP支持網路的特定成員協助確保以最科學、最嚴格和最有效的方式翻譯具有良好潛力的治療方法。

About Shirley Ryan AbilityLab

關於雪莉·瑞安能力實驗室

Shirley Ryan AbilityLab, formerly the Rehabilitation Institute of Chicago (RIC), is the global leader in physical medicine and rehabilitation for adults and children with the most severe, complex conditions - from traumatic brain and spinal cord injury to stroke, amputation and cancer-related impairment. The organization expands and accelerates leadership in the field that began at RIC in 1953. The quality of its care has led to the designation of "No. 1 Rehabilitation Hospital in America" by U.S. News & World Report every year since 1991. Upon opening in 2017, the $550 million, 1.2-million-square-foot Shirley Ryan AbilityLab became the first-ever "translational" research hospital in which clinicians, scientists, innovators and technologists work together in the same space, surrounding patients, discovering new approaches and applying (or "translating") research real time. This unique model enables patients to have 24/7 access to the brightest minds, the latest research and the best opportunity for recovery. Shirley Ryan AbilityLab is a 501 (c)(3) non-profit organization. For more information, go to .

Shirley Ryan AbilityLab,前身為芝加哥康復研究所(RIC),是為患有從創傷性腦和脊髓損傷到中風、截肢和癌症相關損害等最嚴重、最複雜疾病的成人和兒童提供物理醫學和康復方面的全球領導者。該組織擴大並加速了在該領域的領導地位,該領域始於1953年的RIC。自1991年以來,其護理質量每年都被《美國新聞與世界報道》評為美國第一康復醫院。2017年開業後,佔地120萬平方米英尺的雪莉·瑞安能力實驗室(Shirley Ryan AbilityLab)耗資5.5億美元,成為有史以來第一家臨床醫生、科學家、創新者和技術專家在同一空間共同工作的研究醫院,圍繞患者,發現新的方法,並即時應用(或“翻譯”)研究。這種獨特的模式使患者能夠全天候接觸到最聰明的頭腦、最新的研究和最好的康復機會。雪莉·瑞安能力實驗室是一個501(C)(3)非營利性組織。有關更多資訊,請訪問。

About NVG-291

關於NVG-291

NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic peptide targeting mechanisms that interfere with nervous system repair. NVG-291 is derived from the intracellular domain of the receptor type protein tyrosine phosphatase sigma (PTPσ). NVG-291-R, a rodent analog of NVG-291, has been shown to promote nervous system repair and functional recovery in animal models of spinal cord injury (acute and chronc intervention), peripheral nerve injury, multiple sclerosis and stroke, through enhanced plasticity, axonal regeneration, and remyelination.

NervGen擁有NVG-291的全球獨家權利,NVG-291是一種幹擾神經系統修復的一流治療多肽靶向機制。NVG-291來源於受體類型蛋白酪氨酸磷酸酵素Sigma(PtPσ)的胞內結構域。NVG-291-R是NVG-291的齧齒動物類似物,已被證明通過增強可塑性、軸突再生和髓鞘再生,促進脊髓損傷(急性和慢性幹預)、周圍神經損傷、多發性硬化症和中風動物模型的神經系統修復和功能恢復。

About NervGen

關於NervGen

NervGen (TSXV: NGEN) (OTCQX: NGENF) is a clinical stage biotech company dedicated to developing innovative treatments that enable the nervous system to repair itself following damage, whether due to injury or disease. NervGen's lead drug candidate, NVG-291, is currently planned to be evaluated in a Phase 1b/2a clinical trial. The Company's initial target indication is spinal cord injury. For more information, go to .

NervGen(多倫多證券交易所股票代碼:NGENF)是一家臨床階段的生物技術公司,致力於開發創新的治療方法,使神經系統在受損後能夠自我修復,無論是由於受傷還是疾病。NervGen的主要候選藥物NVG-291目前計劃在1b/2a期臨床試驗中進行評估。該公司最初的目標適應症是脊髓損傷。有關更多資訊,請訪問。

For further information, please contact:

如需更多資訊,請聯繫:

Huitt Tracey, Corporate Communications
htracey@nervgen.com
604.537.2094

Huitt Tracey,企業傳播部
郵箱:htrey@nerggen.com
604.537.2094

Nancy Thompson, Vorticom Public Relations
nancyt@vorticom.com
212.532.2208

南希·湯普森,Vorticom公共關係部
郵箱:nancyt@vorticom.com
212.532.2208

Follow NervGen on Twitter, LinkedIn, and Facebook for the latest news on the Company.

沿著NervGen行駛推特LinkedIn,以及Facebook獲取有關該公司的最新消息。

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

多倫多證券交易所創業板交易所及其監管服務提供商(該術語在多倫多證券交易所的政策中定義)均不對本新聞稿的充分性或準確性承擔責任。

Cautionary Note Regarding Forward-Looking Statements

有關前瞻性陳述的注意事項

This news release may contain "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian and United States securities legislation. Such forward-looking statements and information herein include, but are not limited to, the Company's current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or any other future events or developments constitute forward-looking statements, and the words "may", "will", "would", "should", "could", "expect", "plan", "intend", "trend", "indication", "anticipate", "believe", "estimate", "predict", "likely" or "potential", or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements include, without limitation, statements relating to: the objectives, timing and study design of the clinical development of NVG-291 including the planned single site Phase 1b/2a clinical trial in SCI with Shirley Ryan AbilityLab; the Phase 1 results reported to date; the receipt of the milestone-based grant payments; the importance of the translation from laboratory research to human clinical trial in accelerating progress; the belief that NervGen is at an important inflection point; the Company's plans to continue to work to resolve the ongoing partial clinical hold; the belief that targeting mechanisms that interfere with nervous system repair is a promising target for reducing the clinical effects of nervous system damage through multiple mechanisms; and the creation of innovative treatments of nervous system damage due to trauma or disease.

本新聞稿可能包含適用於加拿大和美國證券法的“前瞻性資訊”和“前瞻性陳述”。本文中的前瞻性陳述和資訊包括但不限於,公司當前和未來的計劃、預期和意圖、結果、活動水準、業績、目標或成就,或任何其他未來事件或發展構成前瞻性陳述,“可能”、“將”、“將”、“應該”、“可能”、“預期”、“計劃”、“打算”、“趨勢”、“指示”、“預期”、“相信”、“估計”、“預測”等辭彙構成前瞻性陳述。“可能”或“潛在”,或這些詞語或其他類似詞語或短語的否定或其他變體,旨在識別前瞻性陳述。前瞻性陳述包括但不限於以下陳述:NVG-291臨床開發的目標、時間和研究設計,包括與Shirley Ryan AbilityLab在脊髓損傷中計劃的1b/2a期臨床試驗;迄今報告的第一階段結果;基於里程碑的撥款支付的收到;從實驗室研究轉換為人類臨床試驗對加快進展的重要性;NervGen正處於重要轉捩點的信念;該公司計劃繼續努力解決正在進行的部分臨床擱置;認為幹擾神經系統修復的靶向機制是通過多種機制減少神經系統損傷的臨床影響的有前途的目標;以及創造因創傷或疾病而造成的神經系統損傷的創新治療。

Forward-looking statements are based on estimates and assumptions made by the Company in light of management's experience and perception of historical trends, current conditions and expected future developments, as well as other factors that we believe are appropriate and reasonable in the circumstances. In making forward-looking statements, the Company has relied on various assumptions, including, but not limited to: the Company's ability to manage the effects of the COVID-19 pandemic; the accuracy of the Company's financial projections; the Company obtaining positive results in its clinical and other trials; the Company obtaining necessary regulatory approvals; and general business, market and economic conditions.

前瞻性陳述基於本公司根據管理層的經驗和對歷史趨勢、當前狀況和預期未來發展的看法以及我們認為在當時情況下適當和合理的其他因素而作出的估計和假設。在做出前瞻性陳述時,公司依賴於各種假設,包括但不限於:公司管理新冠肺炎疫情影響的能力;公司財務預測的準確性;公司在臨床和其他試驗中取得積極結果;公司獲得必要的監管批准;以及一般商業、市場和經濟狀況。

Many factors could cause our actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements, including without limitation, a lack of revenue, insufficient funding, the impact of the COVID-19 pandemic, reliance upon key personnel, the uncertainty of the clinical development process, competition, and other factors set forth in the "Risk Factors" section of the Company's Annual Information Form, Short Form Base Shelf Prospectus, financial statements and Management Discussion and Analysis which can be found on SEDAR.com. All clinical development plans are subject to additional funding.

許多因素可能會導致我們的實際結果、活動水準、業績或成就或未來的事件或發展與前瞻性陳述中明示或暗示的內容大不相同,包括但不限於收入缺乏、資金不足、新冠肺炎疫情的影響、對關鍵人員的依賴、臨床開發過程的不確定性、競爭以及公司年度資訊表格、簡短基礎架子簡介、財務報表以及管理討論與分析中“風險因素”部分闡述的其他因素。這些因素可在SEDAR.com上找到。所有臨床開發計劃都需要額外的資金。

Readers should not place undue reliance on forward-looking statements made in this news release. Furthermore, unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and we have no intention and undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

讀者不應過分依賴本新聞稿中的前瞻性陳述。此外,除非另有說明,本新聞稿中包含的前瞻性陳述都是截至本新聞稿發佈之日作出的,我們無意也沒有義務更新或修改任何前瞻性陳述,無論是由於新資訊、未來事件還是其他原因,除非適用法律要求。本新聞稿中包含的前瞻性陳述明確地受到本警示性聲明的限制。

To view the source version of this press release, please visit

要查看本新聞稿的源版本,請訪問

譯文內容由第三人軟體翻譯。


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