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Tilray Medical Announces Positive Results from Study on Oral Cannabis Extract for Chemotherapy-Induced Emesis

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Tilray Medical has announced final results from a clinical study on oral cannabis extract for Chemotherapy-Induced Nausea and Vomiting (CINV). The randomized, placebo-controlled trial involved 147 participants from 2016 to 2022, testing capsules containing 2.5mg THC and 2.5mg CBD versus placebo. The study showed significant improvements, with complete response rates increasing from 8% (placebo) to 24% (THC:CBD). While demonstrating reduced nausea and fewer daily vomits, some side effects were observed, including sedation (18% vs 7%), dizziness (10% vs 0%), and anxiety (4% vs 1%).

Tilray Medical ha annunciato i risultati finali di uno studio clinico su un estratto di cannabis orale per la nausea e il vomito indotti da chemio (CINV). Lo studio randomizzato, controllato con placebo, ha coinvolto 147 partecipanti dal 2016 al 2022, testando capsule contenenti 2,5 mg di THC e 2,5 mg di CBD rispetto al placebo. Lo studio ha mostrato miglioramenti significativi, con tassi di risposta completa che sono aumentati dall'8% (placebo) al 24% (THC:CBD). Mentre sono stati dimostrati una riduzione della nausea e un minor numero di vomiti giornalieri, sono stati osservati alcuni effetti collaterali, tra cui sonnolenza (18% rispetto a 7%), vertigini (10% rispetto a 0%) e ansia (4% rispetto a 1%).

Tilray Medical ha anunciado los resultados finales de un estudio clínico sobre extracto de cannabis oral para la náusea y vómito inducidos por quimioterapia (CINV). El ensayo aleatorizado y controlado con placebo involucró a 147 participantes desde 2016 hasta 2022, probando cápsulas que contenían 2.5 mg de THC y 2.5 mg de CBD en comparación con el placebo. El estudio mostró mejoras significativas, con tasas de respuesta completa que aumentaron del 8% (placebo) al 24% (THC:CBD). Aunque se demostró una reducción de las náuseas y menos vómitos diarios, se observaron algunos efectos secundarios, incluidos la sedación (18% frente al 7%), mareos (10% frente al 0%) y ansiedad (4% frente al 1%).

틸레이 메디컬은 화학요법으로 인한 구역질 및 구토(CINV)에 대한 경구 대마초 추출물의 임상 연구 최종 결과를 발표했습니다. 이 무작위, 위약 대조 시험은 2016년부터 2022년까지 147명의 참가자가 참여하여 2.5mg THC와 2.5mg CBD가 포함된 캡슐을 위약과 비교하여 테스트했습니다. 연구는 유의미한 개선을 보여주었으며, 완전 반응 비율이 8%(위약)에서 24%(THC:CBD)로 증가했습니다. 구역질 감소와 일일 구토 횟수 감소가 나타났지만, 진정(18% 대 7%), 현기증(10% 대 0%), 불안(4% 대 1%) 등 일부 부작용이 관찰되었습니다.

Tilray Medical a annoncé les résultats finaux d'une étude clinique sur un extrait de cannabis oral pour des nausées et vomissements induits par la chimiothérapie (CINV). L'essai randomisé, contrôlé par placebo, a impliqué 147 participants de 2016 à 2022, testant des capsules contenant 2,5 mg de THC et 2,5 mg de CBD par rapport au placebo. L'étude a montré des améliorations significatives, avec des taux de réponse complète passant de 8% (placebo) à 24% (THC:CBD). Tout en démontrant une réduction des nausées et moins de vomissements quotidiens, certains effets secondaires ont été observés, notamment la sédation (18% contre 7%), des vertiges (10% contre 0%) et de l'anxiété (4% contre 1%).

Tilray Medical hat die endgültigen Ergebnisse einer klinischen Studie über orale Cannabisextrakte gegen durch Chemotherapie induzierte Übelkeit und Erbrechen (CINV) bekannt gegeben. Die randomisierte, placebo-kontrollierte Studie umfasste 147 Teilnehmer von 2016 bis 2022, bei der Kapseln mit 2,5 mg THC und 2,5 mg CBD gegen ein Placebo getestet wurden. Die Studie zeigte signifikante Verbesserungen, wobei die vollständigen Ansprechquoten von 8% (Placebo) auf 24% (THC:CBD) anstiegen. Während eine verringerte Übelkeit und weniger tägliche Erbrechensanfälle nachgewiesen werden konnten, wurden einige Nebenwirkungen beobachtet, darunter Sedierung (18% gegenüber 7%), Schwindel (10% gegenüber 0%) und Angst (4% gegenüber 1%).

Positive
  • Clinical trial demonstrated significant efficacy with complete response rates tripling from 8% to 24%
  • Study validates potential new revenue stream in CINV treatment market
  • Research strengthens Tilray's position in medical cannabis sector across 20+ countries
Negative
  • Notable side effects reported including sedation, dizziness, and anxiety
  • Complete response rate of 24% still leaves majority of patients without full relief

SYDNEY, Australia, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Tilray Medical, a division of Tilray Brands, Inc. ("Tilray Brands") (NASDAQ: TLRY and TSX: TLRY) and a global leader in medical cannabis empowering the therapeutic alliance between patients and healthcare practitioners to make informed individualized health decisions, is pleased to announce the final results of a new scientific study their team has supported titled, "Oral Cannabis Extract for Secondary Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)."

This randomized, placebo-controlled trial aimed to test the effectiveness of an oral cannabis extract in adults suffering from CINV despite standard anti-nausea treatments. Participants received capsules containing 2.5 mg of THC and 2.5 mg of CBD or a placebo, taken three times daily for six days.

From 2016 to 2022, 147 participants were recruited. The study found that the cannabis extract significantly improved the rate of complete response—meaning no vomiting or use of additional medications—from 8% with placebo to 24% with THC: CBD. Other benefits included reduced nausea and fewer daily vomits. However, some side effects were noted, such as sedation (18% vs. 7%), dizziness (10% vs. 0%), and transient anxiety (4% vs. 1%).

Denise Faltischek, Chief Strategy Officer, and Head of International at Tilray Brands, said, “These findings are encouraging for cancer patients undergoing chemotherapy. This study is a crucial step in improving patient care and quality of life.” She continued, "Our involvement in this study underscores our commitment to advancing medical research. The positive outcomes highlight the potential of cannabinoids for managing CINV."

Tilray Medical continues to transform lives by providing access to medical cannabis. Tilray is a leading provider of EU-GMP-certified medical cannabis products in over 20 countries. The company has supported medical trials globally, studying cannabis for various conditions, including pediatric epilepsy, cancer-induced nausea, and PTSD.

About Tilray Medical 
Tilray Medical is dedicated to transforming lives and fostering dignity for patients in need through safe and reliable access to a global portfolio of medical cannabis brands, including Tilray, Aphria, Broken Coast, Symbios and Navcora. Tilray grew from being one of the first companies to become an approved licensed producer of medical cannabis in Canada to building the first GMP-certified cannabis production facilities in Europe, first in Portugal and later in Germany. Today, Tilray Medical is one of the largest suppliers of medical cannabis to patients, physicians, hospitals, pharmacies, researchers, and governments, in 20 countries and across five continents.

For more information on Tilray Medical, visit Tilray Medical EuropeTilray Medical Canada, and Tilray Medical Australia-New Zealand

About Tilray Brands
Tilray Brands, Inc. (“Tilray”) (Nasdaq: TLRY; TSX: TLRY), is a leading global lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, and Latin America that is leading as a transformative force at the nexus of cannabis, beverage, wellness, and entertainment, elevating lives through moments of connection. Tilray’s mission is to be a leading premium lifestyle company with a house of brands and innovative products that inspire joy and create memorable experiences. Tilray’s unprecedented platform supports over 40 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and craft beverages.

For more information on how we are elevating lives through moments of connection, visit Tilray.com and follow @Tilray on all social platforms.

Forward-Looking Statements
Certain statements in this communication that are not historical facts constitute forward-looking information or forward-looking statements (together, “forward-looking statements”) under Canadian securities laws and within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be subject to the “safe harbor” created by those sections and other applicable laws. Forward-looking statements can be identified by words such as “forecast,” “future,” “should,” “could,” “enable,” “potential,” “contemplate,” “believe,” “anticipate,” “estimate,” “plan,” “expect,” “intend,” “may,” “project,” “will,” “would” and the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Certain material factors, estimates, goals, projections, or assumptions were used in drawing the conclusions contained in the forward-looking statements throughout this communication. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things: expectations regarding the performance and scale of the Company, including Tilray Medical; and the Company’s ability to expand its offering to patients worldwide, including via Tilray Medical. Many factors could cause actual results, performance, or achievement to be materially different from any forward-looking statements, and other risks and uncertainties not presently known to the Company or that the Company deems immaterial could also cause actual results or events to differ materially from those expressed in the forward-looking statements contained herein. For a more detailed discussion of these risks and other factors, see the most recently filed annual information form of Tilray and the Annual Report on Form 10-K (and other periodic reports filed with the SEC) of Tilray made with the SEC and available on EDGAR. The forward-looking statements included in this communication are made as of the date of this communication and the Company does not undertake any obligation to publicly update such forward-looking statements to reflect new information, subsequent events, or otherwise unless required by applicable securities laws.

For further information:
Tilray Brands: news@tilray.com
Investors: investors@tilray.com


FAQ

What were the results of Tilray's (TLRY) cannabis study for chemotherapy-induced nausea?

The study showed that THC:CBD cannabis extract improved complete response rates from 8% to 24%, with reduced nausea and vomiting, though some side effects were reported.

What dosage was used in Tilray's (TLRY) CINV clinical trial?

The trial used capsules containing 2.5mg THC and 2.5mg CBD, administered three times daily for six days.

How many participants were in Tilray's (TLRY) 2016-2022 CINV study?

The study included 147 participants over the period from 2016 to 2022.

What side effects were reported in Tilray's (TLRY) cannabis extract study?

The reported side effects included sedation (18% vs 7%), dizziness (10% vs 0%), and transient anxiety (4% vs 1%).

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