Antroquinonol

ASCO GI 2024: Golden Biotech's Antroquinonol Shows Significantly Prolonged Survival in Untreated Metastatic Pancreatic Cancer Patients (Yahoo Finance) TAIPEI, Jan. 18, 2024 /PRNewswire/ -- Golden Biotechnology Corp. (TPEX 4132) ("GoldenBiotech", GBC), an advanced biopharmaceutical drug development company, had unveiled the findings of its Phase II clinical trial investigating Antroquinonol (HOCENA) in combination with the standard of care (SOC): nab-paclitaxel + gemcitabine, as first-line treatment for metastatic pancreatic cancer. The trial showed a positive median overall survival (mOS) of 14.1 months, which is a substantial increase compared to 8.5 months mOS observed in the standard of care Phase III clinical study (nab-paclitaxel + gemcitabine). Notably, when compared to current first-line treatment options for this very difficult to treat cancer, there was a highly significant survival advantage of patients treated with oral Antroquinonol in combination with SOC. Metastatic Pancreatic Cancer remains a devastating disease with very low survival rate and significant unmet medical needs in terms of treatment options. Photo of Antroquinonol.(Golden Biotechnology Corp.) The ASCO Gastrointestinal Cancers Symposium 2024 Committee has selected Golden Biotech's Phase 2 Study, titled "A Phase I/II study of Antroquinonol in combination with Nab-Paclitaxel and Gemcitabine for patients with metastatic pancreatic cancer," for poster presentation. This multinational study, registered under NIH Clinical Trial Registration Number NCT03310632, employed a single-arm, open-label design with participating sites in the United States, South Korea, and Taiwan. The study revealed clinically meaningful responses in subjects treated with Antroquinonol in combination with the standard of care. The treatment demonstrated significantly longer overall survival (median OS) and OS rates at both 6 and 12 months when compared to the standard of care Phase III study. The OS figures were 14.1, 8.5, and 6.7 months for (Antroquinonol + nab-paclitaxel + gemcitabine), (nab-paclitaxel + gemcitabine), and gemcitabine alone, respectively. The corresponding OS rates at 6 months were 85.5%, 67%, and 55%, while the rates at 12 months were 62.2%, 35%, and 22%. In addition, Antroquinonol in combination with the standard of care surpassed the efficacy of another chemotherapy regimen, FOLFIRINOX, in terms of median OS and OS rates (Antroquinonol + standard of care vs FOLFIRINOX: OS= 14.1 vs 11.1 months; OS rate at 6 months=85.5% vs 76%; OS rate at 12 months=62.2% vs 48%). The trial results also showed an mPFS of 5.3 months and a 6-month PFS rate of 41.7% for Antroquinonol in combination with the standard of care drugs. The American Society of Clinical Oncology (ASCO) Committee have defined Clinically Meaningful Goals for clinical trials in Pancreas, Breast, Lung, and Colorectal Cancers. For Pancreatic Cancer patients eligible for treatment with Gemcitabine or Gemcitabine/Nab-paclitaxel, the current baseline median overall survival is estimated to range from 8 to 9 months. It is considered "clinically meaningful" if the minimum improvement over current overall survival is between 3 to 4 months. Golden Biotech's Antroquinonol has gained recognition for its groundbreaking work in the field of cancer treatment. It has been granted Orphan Drug Designation (ODD) by the FDA for the treatment of Pancreatic Cancer, Acute Myeloid Leukemia (AML), and Hepatocellular Carcinoma (liver cancer), as well as ODD by the EMA for Pancreatic Cancer. These acknowledgments underscore the potential of Antroquinonol in addressing the high-unmet medical needs associated with these challenging diseases. When compared to gemcitabine and other existing first-line therapies for metastatic pancreatic cancer, Antroquinonol in combination with the standard of care exhibited a significant survival advantage. Additionally, hematological adverse events (AEs) induced by nab-paclitaxel and gemcitabine, such as neutropenia, thrombocytopenia, anemia, and leukopenia, were substantially improved across all grade levels. No additional safety concerns were observed during the study. By combining nab-paclitaxel and gemcitabine with Antroquinonol, the incidence of hematological side effects also decreased across all grades. The results of this clinical trial may be a potential game changer for metastatic pancreatic cancer. Antroquinonol in combination with the standard of care may provide patients with significantly improved median overall survival and reduced hematological side-effects. Providing new hope for patients everywhere, for this very difficult to treat cancer. Media Contact: pr@goldenbiotech.com FORWARD-LOOKING STATEMENTS: The statements contained herein may contain certain forward-looking statements relating to Golden Biotechnology Corporation (the “Company”) that are based on the current beliefs and expectations of the Company’s management as well as assumptions made by and information currently available to the Company’s management. These forward-looking statements include, but are not limited to, statements relating to the Company’s business prospects, future developments, trends and conditions in the industry and geographical markets in which the Company operates; the Company’s inventions, patents, patent applications, strategies, plans, objectives and goals; the Company’s ability to control costs; and statements relating to prices, volumes, operations, margins, overall market trends, risk management and exchange rates. These statements can be identified by the use of words such as “anticipate,” “estimate,” “believe,” “continue,” “could,” “intend,” “may,” “plan,” “potential,” “predict,” “should,” “seek,” “will,” “expect,” “objective,” “projection,” “forecast,” “goal,” “guidance,” “outlook,” “effort,” “target” or the negative of these terms or other comparable terms. However, the absence of these words does not mean that the statements are not forward-looking. These forward-looking statements are, by their nature, subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. These forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to update or reflect subsequent events or circumstances, changes in expectations or the occurrence of unanticipated events. All forward-looking statements herein are qualified by these cautionary statements and there can be no assurance that the actual results or anticipated developments will be realized or, even if substantially realized, that they will have the expected consequence to or effects on the Company’s business or operations. https://finance.yahoo.com/news/asco-gi-2024-golden-biotechs-101500456.html

▎药明康德内容团队编辑今日，国鼎生技（Golden Biotechnology）于美国临床肿瘤学会（ASCO）胃肠道肿瘤研讨会中公布其药品Hocena（antroquinonol）用于一线治疗转移性胰腺癌的2期临床试验积极结果。分析显示，当antroquinonol联合标准治疗方案时，患者的中位总生存期（OS）达14.1个月，显著高于标准疗法在过去3期试验中所达到的8.5个月。该研究显示，接受antroquinonol联合标准治疗的受试者出现具有临床意义的缓解。与标准治疗（白蛋白结合型紫杉醇+吉西他滨）3期试验结果相比，该治疗在6个月和12个月时均展现显著更长的总生存期和总生存率。接受antroquinonol联合标准方案、标准方案、吉西他滨单药患者的总生存期分别为14.1、8.5和6.7个月。6个月时相应的总生存率分别为85.5%、67%和55%，而12个月时的总生存率则分别为62.2%、35%和22%。此外，接受antroquinonol联合标准方案患者的总生存期亦显著高于接受另一种化疗方案FOLFIRINOX的患者。Antroquinonol联合疗法组患者的总生存期、6个月与12个月的总生存率分别为14.1个月、85.5%与62.2%。FOLFIRINOX组患者则为11.1个月、76%与48%。此外，antroquinonol联合标准治疗药物的中位无进展生存期（PFS）为5.3个月，6个月的无进展生存率为41.7%。值得一提的是，美国临床肿瘤学会委员会为胰腺癌、乳腺癌、肺癌和结直肠癌的临床试验定义了具有临床意义的目标。对于适合接受吉西他滨或吉西他滨/白蛋白结合型紫杉醇治疗的胰腺癌患者，当前基线中位总生存期估计范围为8-9个月。如果与当前总生存期相比的最小改善在3-4个月之间，则被认为“具有临床意义”。Antroquinonol是一种具有多种功能的新化学实体（NCE），通过抑制蛋白质异戊烯基转移酶活性，抑制RAS及其相关的GTP结合蛋白激活，从而激活癌细胞中的自噬作用与相关的细胞死亡。超过30%的所有人类癌症，包括95%的胰腺癌，是由RAS家族突变所驱动。Antroquinonol还作用于PI3K/AKt/mTOR通路，影响癌细胞的自噬和凋亡。它具有在不损害正常细胞的情况下靶向癌细胞的能力，因此可能改善药物的耐受性，并同时提高安全性。此外，它可以口服，为患者提供方便的治疗选择。美国FDA已授予其治疗胰腺癌、急性髓系白血病（AML）和肝细胞癌的孤儿药资格（ODD），欧洲药品管理局（EMA）也授予其治疗胰腺癌的ODD。大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料：[1] ASCO GI 2024: Golden Biotech's Antroquinonol Shows Significantly Prolonged Survival in Untreated Metastatic Pancreatic Cancer Patients. Retrieved January 18, 2024 from https://www.prnewswire.com/news-releases/asco-gi-2024-golden-biotechs-antroquinonol-shows-significantly-prolonged-survival-in-untreated-metastatic-pancreatic-cancer-patients-302038201.html免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新