Can-Fite：显示用 Namodenoson 治疗的患者癌症完全清除的结果将

StephenW

Can-Fite：显示用 Namodenoson 治疗的患者癌症完全清除的结果将在 AASLD 肝脏会议® 上发表

Namodenoson 现在正处于晚期肝癌的全球关键 III 期研究中

PETACH TIKVA，以色列，2022 年 10 月 25 日--(BUSINESS WIRE)--(美国商业资讯)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI)，一家生物技术公司，推进一系列专有小分子药物治疗炎症，癌症和肝脏疾病，今天宣布将在美国肝病研究协会 (AASLD) 上展示题为“A3 腺苷受体激动剂 Namodenoson 在晚期肝细胞癌患者中诱导的完全反应”的海报。 Liver Meeting® 于 2022 年 11 月 7 日星期一下午 1:00 在华盛顿特区举行。研究结果发表在 2022 年 10 月的 HEPATOLOGY 增刊上，摘要 4413，这是肝病领域的主要同行评审期刊，代表发表的 AASLD。

摘要摘要：
该患者是一名 61 岁的女性，患有肝细胞癌 (HCC)，这是最常见的肝癌形式，并伴有中度肝功能障碍 Child-Pugh B (CPB7)，参与了 Can-Fite 之前的 II 期研究。该患者在 II 期研究的 Namodenoson 组中，并在开放标签扩展计划下继续使用 Namodenoson 治疗 5 年。根据 2022 年 8 月在罗马尼亚建立的同情使用计划，治疗正在进行中。

强调：

    在基线时，计算机断层扫描 (CT) 扫描显示在基线时存在多灶性疾病背景下的大 HCC 肿瘤。两个治疗周期后（例如，大约 7 周后）CT 显示肿瘤块缩小，这与部分反应一致。

    在治疗 4 年内，观察到肿瘤块、腹水和腹膜癌病的消失，这与 RECIST 1.1 和 mRECIST 的完全反应一致。

    患者的丙氨酸转氨酶 (ALT) 和天冬氨酸转氨酶 (AST) 水平在基线时升高（分别为 68 U/L 和 44 U/L），并在 1 个治疗周期后恢复正常。正常的 ALT 和 AST 水平维持了 5 年。

    基线时血清甲胎蛋白水平为 47 ng/ml，治疗 5 个周期后降至正常水平，完全缓解时达到 1.3 ng/mL。

    没有报告治疗中出现的不良事件。

    在报告此病例时（治疗开始后 5 年），如肝功能评估和影像学研究所示，反应仍在进行中。

结论：
该病例报告表明，使用 Namodenoson 治疗可导致 HCC 和 CPB7 患者完全和持久的反应。

“晚期 HCC 的完全反应是罕见的，我们很高兴地报告，在 Namodenoson 的治疗下，该患者现在已经存活了五年以上，随着腹水和腹膜癌病的消失，肝功能恢复正常，” Can-Fite 首席执行官菲什曼博士说。 “我们期待在肝脏会议上与肝病学家社区分享我们对这个病例的发现，以推进科学知识，并将安全有效的肝癌治疗方法推向市场。”

Can-Fite 对晚期肝癌患者的关键 III 期研究对患者开放招募，并将在以色列、美国和欧洲五个国家招募患者。如果该研究达到终点，公司将能够提交 Namodenoson 以供美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）批准。 Namodenoson 具有 FDA 和 EMA 的孤儿药状态以及 FDA 的快速通道状态。注册计划已提交给 FDA 并被 FDA 接受。

肝脏会议于 2022 年 11 月 4 日至 8 日在华盛顿特区举行，汇集了来自世界各地的临床医生、同事和科学家，就最新研究交流信息，讨论肝脏治疗和移植的新进展，并建立网络与肝病学领域的领先专家。

根据 DelveInsight 的数据，到 2027 年，G8 国家的 HCC 药物市场预计将达到 38 亿美元。

关于 Namodenoson
Namodenoson 是一种小型口服生物可利用药物，以高亲和力和选择性与 A3 腺苷受体 (A3AR) 结合。 Namodenoson 正在评估两个适应症，在一项关键的 III 期研究中作为肝细胞癌的二线治疗，以及在 IIb 期研究中作为非酒精性脂肪性肝炎（ NASH ）的治疗。 A3AR 在患病细胞中高表达，而在正常细胞中低表达。这种差异效应说明了该药物具有出色的安全性。

StephenW

Can-Fite: Findings Showing the Complete Clearance of Cancer in Patient Treated With Namodenoson Will Be Presented at the AASLD Liver Meeting®

Namodenoson is now in a global pivotal Phase III study for advanced liver cancer

PETACH TIKVA, Israel, October 25, 2022--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today that a poster entitled "Complete Response Induced by Namodenoson, an A3 Adenosine Receptor Agonist, in a Patient with Advanced Hepatocellular Carcinoma" will be presented at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® at 1:00 pm on Monday, November 7, 2022 in Washington, D.C. The findings are published, Abstract 4413, in the October 2022 supplement of HEPATOLOGY, a premier peer-reviewed journal in the field of liver disease published on behalf of the AASLD.

Summary of Abstract:
The patient, a 61-year-old woman with hepatocellular carcinoma (HCC), the most common form of liver cancer, and moderate hepatic dysfunction Child-Pugh B (CPB7), participated in Can-Fite’s prior Phase II study. The patient was in the Namodenoson arm of the Phase II study and continued treatment with Namodenoson for 5 years under an Open Label Extension Program. Treatment is ongoing under a Compassionate Use Program established in Romania in August of 2022.

Highlights:

    At baseline, computed tomography (CT) scans demonstrated a large HCC tumor in the context of multifocal disease at baseline. Two treatment cycles later (e.g., after approximately 7 weeks) CT demonstrated shrinkage of the tumor mass that was consistent with a partial response.

    Within 4 years of treatment, disappearance of the tumor mass, ascites and peritoneal carcinomatosis was observed consistent with a complete response by RECIST 1.1 and mRECIST.

    The patient’s alanine transaminase (ALT) and aspartate aminotransferase (AST) levels were elevated at baseline (68 U/L and 44 U/L, respectively), and normalized after 1 treatment cycle. Normal ALT and AST levels were maintained for 5 years.

    Serum α-fetoprotein level was 47 ng/ml at baseline, declined to normal levels after 5 cycles of treatment, and reached 1.3 ng/mL at the time of complete response.

    No treatment-emergent adverse events were reported.

    At the time of reporting this case (5 years from treatment initiation), the response is ongoing as indicated by evaluation of liver functions and imaging studies.

Conclusion:
This case report demonstrates that treatment with Namodenoson can lead to a complete and durable response in patients with HCC and CPB7.

"A Complete Response of HCC in an advanced stage is rare, and we are pleased to report that under treatment with Namodenoson, this patient has now survived more the five years, returning to normal liver function with the disappearance of ascites and peritoneal carcinomatosis," stated Can-Fite CEO Dr. Fishman. "We look forward to sharing our findings on this case with the community of hepatologists at The Liver Meeting in order to advance scientific knowledge and bring to market safe and effective treatments for liver cancer."

Can-Fite’s pivotal Phase III study in patients with advanced liver cancer is open for patient enrolment and will recruit patients in Israel, the U.S., and five countries in Europe. If the study achieves its endpoint, the Company will be in a position to submit Namodenoson for approval with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Namodenoson has Orphan Drug Status with both the FDA and EMA and Fast Track Status with the FDA. A registration plan has been submitted to and accepted by the FDA.

The Liver Meeting, which takes place in Washington, D.C. from November 4 – 8, 2022, brings together clinicians, associates, and scientists from around the world to exchange information on the latest research, discuss new developments in liver treatment and transplantation, and network with leading experts in the field of hepatology.

The HCC drug market is expected to reach $3.8 billion in 2027 in the G8 countries according to DelveInsight.

About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated for two indications, as a second line treatment for hepatocellular carcinoma in a pivotal Phase III study, and as a treatment for non-alcoholic steatohepatitis (NASH) in a Phase IIb study. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.