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Avicanna Announces Completion of Topical Gel Observational Real-World Evidence Study

Avicanna Announces Completion of Topical Gel Observational Real-World Evidence Study

Avicanna宣佈完成外用凝膠觀察性真實世界證據研究
GlobeNewswire ·  04/10 08:37

The study results revealed improvements in symptoms and quality of life in patients with musculoskeletal pain and inflammation

研究結果顯示,肌肉骨骼疼痛和炎症患者的症狀和生活質量有所改善

TORONTO, April  10, 2024  (GLOBE NEWSWIRE) -- Avicanna Inc. ("Avicanna" or the "Company") (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce the completion of its observational real-world evidence ("RWE") study using RHO Phyto branded cannabigerol ("CBG") transdermal gel on patients with musculoskeletal pain and inflammation.

多倫多,2024年4月10日(GLOBE NEWSWIRE)——專注於植物衍生大麻素產品開發、製造和商業化的生物製藥公司Avicanna Inc.(“Avicanna” 或 “公司”)(OTCQX:AVCNF)(FSE:0NN)很高興地宣佈其觀察性現實世界證據已完成(“RWE”)使用RHO Phyto品牌的大麻比格羅(“CBG”)透皮凝膠對肌肉骨骼疼痛和炎症患者進行了研究。

The RWE study evaluated patient-reported efficacy of the RHO Phyto CBG Transdermal Gel containing 2% cannabidiol ("CBD") and 1% CBG on a range of clinical conditions including arthritis, osteoarthritis, rheumatoid arthritis, fibromyalgia, muscle and joint pain, localized pain, muscular and structural injuries, and post-surgical pain. Seventy-one participants completed baseline testing and a follow up at one month including demographic, medical history, medication use and two standardized symptom questionnaires.

萊茵集團的研究評估了患者報告的含有 2% 大麻二酚(“CBD”)和 1% CBG 的 RHO Phyto CBG 透皮凝膠對一系列臨床疾病的療效,包括關節炎、骨關節炎、類風溼關節炎、纖維肌痛、肌肉和關節痛、局部疼痛、肌肉和結構損傷以及術後疼痛。71名參與者在一個月內完成了基線測試和隨訪,包括人口統計、病史、藥物使用和兩份標準化症狀問卷。

The RWE study revealed a meaningful improvement in overall Musculoskeletal Health Questionnaire scores (p<0.001) as compared from baseline to one month. Specifically, there was a reported 35.4% improvement in health-related domains including symptoms, physical functioning, daily activities and work, physical well-being, and confidence to manage symptoms. In addition, evaluation of the Edmonton Symptom Assessment System questionnaire also revealed an improvement in pain, sleep, anxiety, and well-being symptoms from baseline to one month (p<0.001).

萊茵集團的研究顯示,與基線到一個月相比,肌肉骨骼健康問卷的總體分數(p

"The preliminary result of this study is in line with the reported results of our products with Canadian patients providing valuable insight for our next stages of clinical development. In parallel, this will propel our efforts under medical cannabis or cosmetic legislation internationally," stated Dr. Karolina Urban, Executive Vice President Medical Affairs.

“這項研究的初步結果與我們報告的產品結果一致,加拿大患者爲我們下一階段的臨床開發提供了寶貴的見解。同時,這將推動我們在國際上根據醫用大麻或化妝品立法所做的努力。” 醫學事務執行副總裁卡羅琳娜·厄本博士說。

The RWE study participants with an average age of 58 ± 15 (64% women) all presented with symptoms of chronic pain. According to ICD-10 diagnosis classification, 21.1% of participants had a diagnosis related to arthritis (polyarthritis, osteoarthritis, etc.), 17.5% of participants with a diagnosis of dorsalgia, 12.3% with fibromyalgia, and 8% with chronic intractable pain. Prior to initiation of the study, study participants reported they were taking an average of ten medications including NSAIDs, opioids, antidepressants, or skeletal muscle relaxants. Each RWE study participant was assigned a common treatment plan of a combination of a CBD oil (83.3%) or balance oil (16.7%) with the RHO Phyto CBG Transdermal Gel.

RWE的研究參與者平均年齡爲58±15(64%爲女性)均出現慢性疼痛症狀。根據 ICD-10 診斷分類,21.1% 的參與者的診斷與關節炎(多關節炎、骨關節炎等)有關,17.5% 的參與者被診斷爲背痛,12.3% 的參與者被診斷爲纖維肌痛,8% 的參與者患有慢性難治性疼痛。在研究開始之前,研究參與者報告說,他們平均服用十種藥物,包括非甾體抗炎藥、阿片類藥物、抗抑鬱藥或骨骼肌鬆弛劑。每位萊茵集團研究參與者都被分配了將CBD油(83.3%)或平衡油(16.7%)與RHO Phyto CBG透皮凝膠混合的通用治療計劃。

About the RHO Phyto Transdermal CBG Gel

關於 RHO Phyto 透皮 CBG 凝膠

The CBG Transdermal Gel is a part of Avicanna's RHO Phyto formulary of medical products which includes proprietary oral, sublingual, and topical products containing a range of cannabinoids. The gel includes a combination of CBG and CBD in a fast-absorbing, water-based gel intended for application locally to area of focus. The gel utilizes Avicanna's deep tissue emulsion technology and combines cannabinoids with synergistic natural ingredients and terpenes including menthol, eugenol and beta-caryophyllene.

CBG 透皮凝膠是 Avicanna 的 RHO Phyto 醫療產品配方的一部分,其中包括含有一系列大麻素的專有口服、舌下和外用產品。該凝膠在快速吸收的水基凝膠中混合了CBG和CBD,旨在局部塗抹於重點區域。該凝膠利用Avicanna的深層組織乳液技術,將大麻素與協同天然成分和萜烯結合在一起,包括薄荷醇、丁香酚和β-石竹烯。

About Avicanna Inc.

關於 Avicanna Inc.

Avicanna is a commercial-stage international biopharmaceutical company focused on the advancement and commercialization of cannabinoid-based products and formulations for the global medical and pharmaceutical market segments. Avicanna has an established scientific platform including R&D and clinical development leading to the commercialization of more than thirty proprietary, evidence-based finished products and supporting four commercial-stage business pillars.

Avicanna是一家處於商業階段的國際生物製藥公司,專注於全球醫療和製藥細分市場中基於大麻素的產品和配方的發展和商業化。Avicanna擁有成熟的科學平台,包括研發和臨床開發,從而實現了三十多種基於證據的專有成品的商業化,並支持了四個商業階段的業務支柱。

  • Medical Cannabis formulary (RHO Phyto): The formulary offers a diverse range of proprietary products including oral, sublingual, topical, and transdermal deliveries with varying ratios of cannabinoids, supported by ongoing patient, and medical community education. RHO Phyto is an established leading medical brand in Canada currently available nationwide to patients across several medical channels and continues to expand into new international markets.

  • 醫用大麻處方集(RHO Phyto):該處方集提供各種專有產品,包括口服、舌下、局部和透皮給藥,採用不同比例的大麻素,並由持續的患者和醫學界教育提供支持。RHO Phyto是加拿大知名的領先醫療品牌,目前通過多種醫療渠道在全國範圍內爲患者提供服務,並將繼續向新的國際市場擴張。

  • Medical cannabis care platform (MyMedi.ca): MyMedi.ca is a medical cannabis care platform formed with the aim to better serve medical cannabis patients' needs and enhance the patient journey. MyMedi.ca is operated by Northern Green Canada Inc. and features a diverse portfolio of products and bilingual pharmacist-led patient support programs. MyMedi.ca also provides specialty services to distinct patient groups such as veterans and collaborates with public and private payers for adjudication and reimbursement. MyMedi.ca provides educational resources to the medical community to facilitate the incorporation of medical cannabis into health care regimens.

  • 醫用大麻護理平台(myMedi.ca):mymedi.ca是一個醫用大麻護理平台,旨在更好地滿足醫用大麻患者的需求並改善患者旅程。Mymedi.ca 由加拿大北方綠色公司運營,提供多樣化的產品組合和由藥劑師主導的雙語患者支持計劃。Mymedi.ca 還爲退伍軍人等不同患者群體提供專業服務,並與公共和私人付款人合作進行裁決和報銷。Mymedi.ca 向醫學界提供教育資源,以促進將醫用大麻納入醫療保健方案。

  • Pharmaceutical products (Trunerox) and pipeline: Leveraging Avicanna's scientific platform, vertical integration, and real-world evidence, Avicanna has developed a pipeline of proprietary, indication-specific pharmaceutical products that are in various stages of clinical development and commercialization. These cannabinoid-based drug candidates aim to address unmet medical needs in the areas of dermatology, chronic pain, and various neurological disorders. Avicanna's first indication-specific pharmaceutical drug, Trunerox, was approved Q1 2024 by the Health Authority of Colombia INVIMA as an adjuvant treatment for seizures associated with Lennox-Gastaut Syndrome and Dravet Syndrome.

  • 製藥產品(Trunerox)和產品線:利用Avicanna的科學平台、縱向整合和真實證據,Avicanna開發了一系列處於臨床開發和商業化不同階段的專有適應症特異性藥物產品。這些基於大麻素的候選藥物旨在解決皮膚病學、慢性疼痛和各種神經系統疾病領域未得到滿足的醫療需求。Avicanna的首種適應症特異性藥物Trunerox於2024年第一季度獲得哥倫比亞衛生局INVIMA的批准,作爲與倫諾克斯-加斯托特綜合徵和德拉維特綜合徵相關的癲癇發作的輔助治療藥物。

  • Active pharmaceutical ingredients (Aureus Santa Marta): Active pharmaceutical ingredients ("API") supplied by the Company's majority owned subsidiary Santa Marta Golden Hemp SAS ("SMGH") is a commercial-stage business dedicated to providing a various forms high-quality CBD, THC and CBG to the Company's international partners for use in the development and production of food, cosmetics, medical, and pharmaceutical products. The business unit also forms part of the Company's supply chain and is a source of reliable input products for its consumer retail, medical cannabis, and pharmaceutical products for globally.

  • 活性藥物成分(Aureus Santa Marta):由公司控股子公司Santa Marta Golden Hemp SAS(“SMGH”)提供的活性藥物成分(“API”)是一家商業階段的企業,致力於向公司的國際合作夥伴提供各種形式的高質量CBD、四氫大麻酚和CBG,用於食品、化妝品、醫療和藥品的開發和生產。該業務部門也是公司供應鏈的一部分,是其全球消費零售、醫用大麻和藥品的可靠投入產品的來源。

SOURCE Avicanna Inc.

來源 Avicanna Inc.

Stay Connected

保持聯繫

For more information about Avicanna, visit our website, contact Ivana Maric by email at info@avicanna.com or follow us on social media on LinkedIn, Twitter, Facebook, or Instagram.

有關Avicanna的更多信息,請訪問我們的網站,發送電子郵件至 info@avicanna.com 聯繫伊萬娜·馬里奇,或在領英、推特、臉書或Instagram上的社交媒體上關注我們。

The Company posts updates through videos from the Company YouTube channel.

該公司通過公司YouTube頻道的視頻發佈最新消息。

Cautionary Note Regarding Forward-Looking Information and Statements

關於前瞻性信息和陳述的警示說明

This news release contains "forward-looking information" within the meaning of applicable securities laws. Forward-looking information contained in this news release may be identified using words such as, "may", "would", "could", "will", "likely", "expect", "anticipate", "believe", "intend", "plan", "forecast", "project", "estimate", "outlook" and other similar expressions. Although the Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include but are not limited to current and future market conditions, including the market price of the common shares of the Company, and the risk factors set out in the Company's annual information form dated April 1, 2024 filed with the Canadian securities regulators and available under the Company's profile on SEDAR at . The statements in this news release are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

本新聞稿包含適用證券法所指的 “前瞻性信息”。本新聞稿中包含的前瞻性信息可以使用 “可能”、“可能”、“將”、“可能”、“可能”、“期望”、“預期”、“相信”、“打算”、“計劃”、“預測”、“項目”、“估計”、“展望” 等詞語和其他類似表述來識別。儘管公司認爲此類前瞻性信息所依據的預期和假設是合理的,但不應過分依賴前瞻性信息,因爲公司無法保證這些信息將被證明是正確的。實際結果和發展可能與這些聲明所設想的結果和事態發展存在重大差異。前瞻性信息受各種風險和不確定性的影響,這些風險和不確定性可能導致實際事件或結果與前瞻性信息中的預測存在重大差異。此類風險和不確定性包括但不限於當前和未來的市場狀況,包括公司普通股的市場價格,以及公司於2024年4月1日向加拿大證券監管機構提交的年度信息表中列出的風險因素,可在SEDAR的公司簡介中查閱。本新聞稿中的聲明是截至本新聞稿發佈之日發表的。除非適用的證券法要求,否則公司不承擔任何更新任何前瞻性信息的意圖或義務,無論這些信息是由於新信息、未來事件或業績還是其他原因造成的。

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
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