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Jaguar Health to Initiate Commercial Footprint in Cancer Supportive Care at American Society of Clinical Oncology (ASCO) Annual Meeting With Exhibit Booth for FDA-Approved Gelclair Oral Mucositis Product

Jaguar Health to Initiate Commercial Footprint in Cancer Supportive Care at American Society of Clinical Oncology (ASCO) Annual Meeting With Exhibit Booth for FDA-Approved Gelclair Oral Mucositis Product

捷豹健康將在美國臨床腫瘤學會(ASCO)年會上啓動癌症支持治療的商業版圖,屆時將展出經美國食品藥品管理局批准的Gelclair口腔粘膜炎產品展位
Jaguar Health ·  05/23 12:00

Oral mucositis, also called "chemo mouth," has emerged as the most significant adverse event in oncology according to a National Comprehensive Cancer Network task force

根據國家綜合癌症網絡工作組的數據,口腔粘膜炎,也被稱爲 “口腔化療”,已成爲腫瘤學中最重要的不良事件

Top line results imminent for company's phase 3 OnTarget trial of crofelemer for preventative treatment of cancer therapy-related diarrhea

公司第三階段的業績迫在眉睫 OnTarg crofelemer 預防性治療癌症療法相關腹瀉的試驗

18 million people in U.S. are living with a cancer diagnosis and more than 2 million people in U.S. are expected to be diagnosed with cancer in 2024

美國有1800萬人被診斷出患有癌症,預計到2024年,美國將有超過200萬人被診斷出患有癌症

SAN FRANCISCO, CA / ACCESSWIRE / May 23, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that it is initiating the company's commercial footprint in its core focus area of cancer supportive care at the May 31 - June 4 American Society of Clinical Oncology (ASCO) Annual Meeting with a Napo Pharmaceuticals (Napo) exhibit booth for Gelclair, the FDA-approved oral mucositis prescription product Jaguar in-licensed last month for the U.S. market. Napo is a Jaguar family company. Jaguar plans to begin the commercial launch in Q3 2024 for Gelclair.

加利福尼亞州舊金山/ACCESSWIRE/2024 年 5 月 23 日/ 捷豹健康公司 (納斯達克股票代碼:JAGX) (“捷豹”)今天宣佈,將於5月31日至6月4日啓動公司在其癌症支持性護理核心重點領域的商業版圖 美國臨床腫瘤學會(ASCO)年會納波製藥 (Napo) Gelclair的展位,美國食品藥品管理局批准的口腔粘膜炎處方產品捷豹上個月在美國市場上市。Napo 是一家捷豹家族企業。捷豹計劃在2024年第三季度開始Gelclair的商業上市。

"Oral mucositis is among the most common, painful, and debilitating cancer treatment-related side effects. Gelclair is a protective gel with a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis. Unlike other products for oral mucositis, it is not a numbing agent and does not sting the mouth," said Lisa Conte, Jaguar's president and CEO.

“口腔粘膜炎是最常見、最痛苦和最使人衰弱的癌症治療相關副作用之一。Gelclair是一種具有機械作用的保護凝膠,用於通過粘附在口腔粘膜表面來控制疼痛和緩解疼痛,舒緩各種病因的口腔病變,包括口腔粘膜炎/口炎。與其他治療口腔粘膜炎的產品不同,它不是麻醉劑,也不會刺痛口腔。” 捷豹總裁兼首席執行官麗莎·孔戴說。

Oral mucositis, also called "chemo mouth," has emerged as the most significant adverse event in oncology according to a National Comprehensive Cancer Network (NCCN) task force.1 Up to 40% of all patients treated with chemotherapy develop oral mucositis, and this percentage rises to approximately 90% for patients with head and neck cancers treated with chemotherapy and radiotherapy. Of the latter, 19% may end up being hospitalized, experiencing a delay in antineoplastic treatment for high-grade mucositis management, resulting in a reduction of the quality of life, a worse prognosis, and an increase in patient management costs.2

根據國家綜合癌症網絡(NCCN)工作組的數據,口腔粘膜炎,也被稱爲 “口腔化療”,已成爲腫瘤學中最重要的不良事件。1 在接受化療治療的所有患者中,多達40%會出現口腔粘膜炎,對於接受化療和放射療法治療的頭頸癌患者,這一比例上升到約90%。在後者中,有19%的人可能最終住院,因爲高級粘膜炎治療的抗腫瘤治療延遲,導致生活質量降低,預後惡化,患者管理成本增加。2

Oral mucositis can negatively affect diet, nutrition, oral hygiene, as well as quality of life.3 Its adverse physical, social and psychological impacts on patients are manifest and include the need for total parenteral nutrition, higher risk of systemic infections, increased use of antifungals and opioid analgesics, increased hospitalizations with longer hospital stays, social isolation and depression due to the inability to talk and eat, subsequent dose reductions, treatment interruptions and discontinuations, and as a corollary to dose reductions and treatment interruptions/discontinuations, diminished anti-tumor responses and shorter survival.1

口腔粘膜炎會對飲食、營養、口腔衛生和生活質量產生負面影響。3 它對患者的不利身體、社會和心理影響顯而易見,包括需要全身營養、增加全身感染風險、增加抗真菌和阿片類鎮痛藥的使用、住院時間延長而住院人數增加、由於無法說話和進食而導致的社交隔離和抑鬱、隨後的劑量減少、治療中斷和中斷,以及減少劑量和中斷/停止治療的必然結果,抗腫瘤反應減弱,存活時間縮短。1

"A key attribute in the management of head and neck cancer patients with Gelclair is, in my experience, to delay the onset which may decrease the severity of oral mucositis, allowing the patients to continue meeting their nutritional needs without having to go on a feeding tube, supporting their ability to withstand their 6 weeks of radiation therapy without having to go to lower doses or treatment interruptions, and to avoid the need for heavy prescription meds for oral mucositis-related pain," said Maged Ghaly, MD, a radiation oncologist at Northwell Health Cancer Institute, Monter Cancer Center.

“根據我的經驗,使用Gelclair管理頭頸部癌症患者的一個關鍵特性是延緩發作,這可能會降低口腔粘膜炎的嚴重程度,使患者無需使用餵食管即可繼續滿足其營養需求,支持他們在不必降低劑量或中斷治療的情況下承受6周放射治療的能力,並避免需要大量處方藥來購買口服粘膜藥物與炎症相關的疼痛,” Northwell Health的放射腫瘤學家Maged Ghaly醫學博士說癌症研究所,蒙特癌症中心。

The economic consequences are far from trivial, with the incremental cost of oral mucositis exceeding $17,000 for patients with head and neck cancer.4

經濟後果遠非微不足道,頭頸部癌患者口腔粘膜炎的增量成本超過17,000美元。4

Gelclair is a clinically proven, convenient, and easy to use gel that provides rapid and long-lasting pain relief and improves the ability of oral mucositis patients to eat, drink, swallow, speak and sleep. Gelclair also reduces the need to use parenteral feeding or opiate analgesics.

Gelclair是一種經臨床證明、方便且易於使用的凝膠,可快速持久地緩解疼痛,並提高口腔粘膜炎患者進食、飲水、吞嚥、說話和睡覺的能力。Gelclair還減少了使用腸外餵養或阿片類鎮痛藥的需求。

"We look forward to driving awareness among oncologists at the ASCO Annual Meeting about Gelclair and Jaguar's expanding focus on cancer supportive care," said Conte. "The depth of our commitment to people living with a cancer diagnosis is further exemplified by the 5-year commitment we've made to clinically study prophylaxis of cancer therapy-related diarrhea with our phase 3 OnTarget trial - specifically focusing on the more than 24 targeted cancer agents that have an incidence of greater than 50% diarrhea. Top line results from this pivotal study are imminent."

孔戴說:“我們期待在ASCO年會上提高腫瘤學家對Gelclair和Jaguar越來越關注癌症支持服務的認識。”“我們承諾在三期臨床研究癌症療法相關腹瀉的預防方法,這進一步體現了我們對癌症診斷患者的承諾之深。 OnTarg 試驗-特別關注超過24種腹瀉發病率超過50%的靶向癌症藥物。這項關鍵研究的關鍵結果迫在眉睫。”

About the Pivotal Phase 3 OnTarget Trial

關於關鍵性三期OnTarget試驗

OnTarget is a first-of-its-kind, 24-week (two 12-week stages) clinical trial with a primary endpoint based on patient-reported outcomes that address the highly neglected and unmet burden of cancer therapy-related diarrhea, an indication Jaguar also refers to as preventive treatment of chemotherapy-induced overactive bowel (CIOB) - which includes symptoms such as chronic and/or episodic debilitating diarrhea (loose and/or watery stools), urgency, bowel incontinence and abdominal pain and discomfort.

OnTarget是首個爲期24周(兩個12周階段)的臨床試驗,其主要終點是基於患者報告的結局,旨在解決嚴重忽視和未得到滿足的癌症治療相關腹瀉負擔,捷豹也將該適應症稱爲化療誘發的腸道過度活躍(CIOB)的預防性治療,包括慢性和/或偶發性衰弱性腹瀉(稀鬆和/或水樣大便)、尿急等症狀,腸失禁和腹痛和不適。

Diarrhea is a common side effect of targeted therapies and new treatments are needed. Up to 95% of patients on tyrosine kinase inhibitors (TKIs) suffer from diarrhea, depending on the TKI used.5 The OnTarget study is testing whether the company's plant-based prescription drug crofelemer (versus placebo) can prevent (or substantially reduce) diarrhea and other symptoms of CIOB when any one of the selected 24 different targeted therapies (that are associated with diarrhea in at least 50% of patients) is initiated. More than 2 million people are expected to be diagnosed with cancer in 2024 in the U.S., according to the American Cancer Society.6 Cancer patients with diarrhea have been shown to be 40% more likely to discontinue their targeted therapy.7

腹瀉是靶向療法的常見副作用,需要新的治療方法。服用酪氨酸激酶抑制劑(TKI)的患者中,多達95%患有腹瀉,具體取決於所使用的TKI。5 OnTarget研究正在測試當選定的24種不同的靶向療法(與至少50%的患者腹瀉有關)中的任何一種啓動時,該公司的植物性處方藥crofelemer(與安慰劑相比)能否預防(或顯著減輕)腹瀉和其他CIOB症狀。根據美國癌症協會的數據,預計到2024年,美國將有超過200萬人被診斷出患有癌症。6 事實證明,腹瀉癌患者停止靶向治療的可能性要高40%。7

About ASCO

關於 ASCO

Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO) is committed to the principle that knowledge conquers cancer. Together with the Association for Clinical Oncology, ASCO represents nearly 50,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of high quality, equitable patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. Conquer Cancer, the ASCO Foundation, supports ASCO by funding groundbreaking research and education across cancer's full continuum. Learn more at www.asco.org.

美國臨床腫瘤學會(ASCO)成立於1964年)致力於知識戰勝癌症的原則。ASCO與臨床腫瘤學協會一起,代表了近50,000名爲癌症患者提供護理的腫瘤學專業人員。通過研究、教育和促進高質量、公平的患者護理,ASCO致力於戰勝癌症,創造一個癌症可以預防或治癒、每個倖存者都健康的世界。ASCO基金會 “征服癌症” 通過資助癌症的整個生命週期的開創性研究和教育來支持ASCO。要了解更多,請訪問 www.asco.org

About Gelclair

關於 Gelclair

INDICATIONS

適應症

GELCLAIR has a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also, indicated for diffuse aphthous ulcers.

GELCLAIR 具有機械作用,可通過粘附在口腔粘膜表面來控制疼痛和緩解疼痛,舒緩各種病因的口腔損傷,包括口腔粘膜炎/口炎(可能由化療或放射療引起)、口腔手術引起的刺激、由牙套或不合身的假牙引起的創傷性潰瘍或疾病。此外,適用於瀰漫性口瘡性潰瘍。

IMPORTANT SAFETY INFORMATION

重要的安全信息

Do not use GELCLAIR if there is a known or suspected hypersensitivity to any of its ingredients.

如果已知或疑似對GELCLAIR的任何成分過敏,請勿使用GELCLAIR。

No adverse effects have been reported in clinical trials, although postmarketing reports have included infrequent complaints of burning sensation in the mouth.

儘管上市後報告不經常出現口腔燒灼感,但臨床試驗中沒有報告任何不良反應。

If GELCLAIR is swallowed accidentally, no adverse effects are anticipated.

如果意外吞下GELCLAIR,預計不會產生任何不良影響。

If no improvement is seen within 7 days, a physician should be consulted.

如果在 7 天內未見改善,應諮詢醫生。

You are encouraged to report negative side effects of prescription medical products to the FDA.

我們鼓勵您向 FDA 報告處方醫療產品的負面副作用。

Visit www.fda.gov/safety/medwatch, call 1-855-273-0468 or fill-in the form at this link.

參觀 www.fda.gov/safety/medwatch,致電 1-855-273-0468 或在此處填寫表格 鏈接

Please see full Prescribing Information at:

請在以下網址查看完整的處方信息:

About the Jaguar Health Family of Companies

關於 Jaguar Health 旗下公司

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo Pharmaceuticals' crofelemer drug product candidate is the subject of the OnTarget study, a pivotal Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

Jaguar Health, Inc.(Jaguar)是一家商業階段的製藥公司,專注於開發可持續地從雨林地區植物中提取的新型專有處方藥,用於患有胃腸道不適的人和動物,特別與腸道過度活躍有關,包括慢性衰弱性腹瀉、尿急、腸失禁和抽筋痛等症狀。捷豹家族企業Napo Pharmaceuticals專注於開發和商業化人類處方藥,用於在多種複雜疾病狀態下提供基本支持性護理和管理被忽視的胃腸道症狀。Napo Pharmaceuticals的crofelemer候選藥物產品是該研究的主題 OnTarg 該研究是一項關鍵的3期臨床試驗,用於對接受靶向治療的成年癌症患者化療誘發的腸道過度活躍(CIOB)進行預防性治療。捷豹家族企業Napo Therapeutics是一家意大利公司,捷豹於2021年在意大利米蘭成立,專注於擴大crofelemer在歐洲的使用範圍,特別是孤兒和/或罕見疾病。捷豹動物健康是捷豹的商品名。瑪格達萊納生物科學,由捷豹和Filament Health Corp. 組建的合資企業,從捷豹旗下崛起 Entheogen療法倡議 (ETI)專注於開發源自植物的新型處方藥,用於心理健康適應症。

For more information about:

有關以下內容的更多信息:

Jaguar Health, visit https://jaguar.health

捷豹健康,訪問 https://jaguar.health

Napo Pharmaceuticals, visit www.napopharma.com

納波製藥,參觀 www.napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Napo Therapeutics,請訪問 napotherapeutics.com

Magdalena Biosciences, visit magdalenabiosciences.com

瑪格達萊納生物科學,訪問 magdalenabiosciences.com

在 LinkedIn 上訪問捷豹: https://www.linkedin.com/company/jaguar-health/

在 X 上訪問捷豹: https://twitter.com/Jaguar_Health

在 Instagram 上訪問捷豹: https://www.instagram.com/jaguarhealthcommunity/

Forward-Looking Statements

前瞻性陳述

Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that Napo will exhibit at the 2024 ASCO Annual Meeting, and Jaguar's expectation that the top line results from the OnTarget trial are imminent. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

本新聞稿中的某些陳述構成 “前瞻性陳述”。其中包括有關Napo預計將在2024年ASCO年會上參展的聲明,以及捷豹對OnTarget試驗的最終結果迫在眉睫的預期。在某些情況下,您可以使用 “可能”、“將”、“應該”、“預期”、“計劃”、“目標”、“預期”、“可能”、“打算”、“目標”、“項目”、“考慮”、“相信”、“估計”、“預測”、“潛在” 或 “繼續” 等術語來識別前瞻性陳述,或者這些術語或其他類似表述的否定詞。本新聞稿中的前瞻性陳述只是預測。捷豹的這些前瞻性陳述主要基於其當前對未來事件的預期和預測。這些前瞻性陳述僅代表截至本新聞稿發佈之日,受許多風險、不確定性和假設的影響,其中一些是無法預測或量化的,還有一些是捷豹無法控制的。除非適用法律要求,否則捷豹不計劃公開更新或修改此處包含的任何前瞻性陳述,無論是由於任何新信息、未來事件、情況變化還是其他原因。

1 Oronsky B, et al. Transl Oncol. 2018;11(3):771-778.

1 Oronsky B 等人Transl Oncol. 2018; 11 (3): 771-778。

2 Pulito C, Cristaudo A, Porta C, Zapperi S, Blandino G, Morrone A, Strano S. Oral mucositis: the hidden side of cancer therapy. J Exp Clin Cancer Res. 2020 Oct 7;39(1):210. doi: 10.1186/s13046-020-01715-7. PMID: 33028357; PMCID: PMC7542970.

2 Pulito C、Cristaudo A、Porta C、Zapperi S、Blandino G、Morrone A、Strano S. 口腔粘膜炎:癌症治療的隱藏面。J Exp Clin Cancer Res. 2020 年 10 月 7 日;39 (1): 210. doi:10.1186/s13046-020-01715-7。PMID:33028357;PMCID:PMC7542970。

3 Jensen SB, Peterson DE. J Oral Pathol Med. 2014;43(2):81-90.

3 Jensen SB,Peterson DE。口腔病理學雜誌,2014;43 (2):81-90。

4 Nonzee NJ, et al. Cancer. 2008;113(6):1446-1452.

4 Nonzee NJ 等人癌症。2008; 113 (6): 1446-1452。

5 Moschen AR, Sammy Y, Marjenberg Z, Heptinstall AB, Pooley N, Marczewska AM. The Underestimated and Overlooked Burden of Diarrhea and Constipation in Cancer Patients. Curr Oncol Rep. 2022;24(7):861-874. doi:10.1007/s11912-022-01267-3

5 Moschen AR、Sammy Y、Marjenberg Z、Heptinstall AB、Pooley N、Marczewska AM。癌症患者腹瀉和便秘的負擔被低估和被忽視。Curr Oncol Rep. 2022;24 (7): 861-874. doi: 10.1007/s11912-022-022-01267-3

6 https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pdf

6 https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pdf

7 Pablo C. Okhuysen, M.D., The impact of cancer-related diarrhea on changes in cancer therapy patterns: Real world evidence

7 Pablo C. Okhuysen,醫學博士,《癌症相關腹瀉對癌症治療模式變化的影響:真實世界的證據》

Contact:

聯繫人:

[email protected]
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

來源:捷豹健康公司

Topic:
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Company Update
公司更新

譯文內容由第三人軟體翻譯。


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