CF102用于肝癌的治疗：一个I / II期，开放标签，剂量递增研究

StephenW

www.natap.org
CF102 for the Treatment of Hepatocellular Carcinoma: A Phase I/II, Open-Label, Dose-Escalation Study [the oncologist]……..http://theoncologist.alphamedpress.org/content/18/1/25.full?sid=ecf72239-5cca-49b0-a8dc-97c6b6b1e8bc
Results. Eighteen patients received CF102—six at each dose level. No serious drug-related adverse events or dose-limiting toxicities were observed. CF102demonstrated good oral bioavailability and linear PK behavior. Median overall survival in the study population, 67% of whom had received prior sorafenib, was 7.8 months, and for Child Pugh B patients (28%) it was 8.1 months. Stable disease by RECIST was observed in four patients for at least 4 months. CF102 maintained liver function over a 6-month period. A correlation between receptor overexpression levels at baseline and patients' overall survival was found. One of the patients who presented with skin nodules that were biopsy-proven to be HCC metastases prior to the trial showed complete metastasis regression during three months of treatment with CF102.

U.S. Food and Drug Administration Grants Fast Track Designation to Can-Fite's CF102 in the Treatment of Liver Cancer
- Global market for liver cancer drugs is projected to exceed $2 billion in 2015PETACH TIKVA, Israel, Sept. 17, 2015 /PRNewswire/ -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, today announced the U.S. Food and Drug Administration (FDA) has granted the Company's drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer. CF102 had already received the FDA's Orphan Drug designation.
Can-Fite is currently conducting a Phase II study for this indication in the U.S., Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar® (sorafenib). Patients are treated twice daily with 25 mg of oral CF102, which has been found to be the most efficacious dose in Can-Fite's earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.
Fast Track, aimed at getting important new drugs that meet an unmet need to patients earlier, is expected to expedite the development of CF102. Drugs that receive Fast Track designation benefit from more frequent meetings and communications with the FDA to review the drug's development plan to support approval. It also allows the Company to submit parts of the New Drug Application (NDA) on a rolling basis for review as data becomes available. Since the Fast Track Program started, from March 1998 through June 30, 2015 a total of 318 Fast Track applications have been received by the FDA. The FDA has granted 202 of them, and denied 110, with 6 more pending.
"We are very pleased that the FDA recognizes the potential for CF102 to treat HCC patients who have tried, and not been responsive to Nexavar, the only FDA approved drug currently on the market for this indication," stated Can-Fite CEO Dr. Pnina Fishman. "We consider Fast Track designation to be a major catalyst for our CF102 development program and we believe it could shorten our time to market for CF102, thereby making a considerable difference for patients."
According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar® annual sales, as reported by Bayer, were €773 million in 2014.

About CF102  
CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite's pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company is preparing for a Phase III CF101 trial for rheumatoid arthritis and is preparing its protocol for its next advanced psoriasis clinical trial. Can-Fite's liver cancer drug CF102 is in Phase II trials and has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration. CF102 has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. The Company's CF602 has shown efficacy in the treatment of erectile dysfunction. Can-Fite has initiated a full pre-clinical program for CF602 in preparation for filing an IND with the U.S. FDA in this indication. These drugs have an excellent safety profile with experience in over 1,200 patients in clinical studies to date. For more information please visit: www.can-fite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about Can-Fite's expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as "believe," "expect," "intend," "plan," "may," "should" or "anticipate" or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite's authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Can-Fite's actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite's actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements, including, but not limited to, the factors summarized in Can-Fite's filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.
Contact
Can-Fite BioPharma
Motti Farbstein
[email protected]

StephenW

www.natap.org

CF102用于肝癌的治疗：一个I / II期，开放标签，剂量递增研究[中oncologist]……..http://theoncologist.alphamedpre ... 0-a8dc-97c6b6b1e8bc
结果。 18例患者接受CF102个在每个剂量水平。无严重的药物相关的不良事件或剂量限制性毒性进行观察。 CF102demonstrated良好的口服生物利用度和直线PK行为。在研究人群中位总生存期，曾收到过索拉非尼之前，67％的7.8个月，并为孩子Pugh B级患者（28％），其为8.1个月。观察到在四名患者病情稳定通过RECIST至少4个月。 CF102维持肝功能超过6个月的时间。受体表达水平在基线和患者的总生存期之间的相关性被发现。一个谁表现有皮肤结节那名患者活检证实为前审判肝癌转移期间治疗3个月CF102显示完全转移回归。
     
美国食品和药物管理局授予快速通道指定到CAN-菲特的CF102在肝癌的治疗

- 肝癌药物的全球市场预计将超过$ 2十亿在2015年

佩塔提科瓦，以色列，2015年9月17日/新华美通/ - 灿菲特生物制药有限公司（NYSE MKT：CANF）（TASE：CFBI），一家生物技术公司专有的小分子药物，解决炎症和癌症疾病管道今天宣布，美国食品和药物管理局（FDA）已经批准该公司的候选药物CF102快速轨道指定为第二线治疗肝细胞癌（HCC），肝癌的最常见形式。 CF102已经收到美国FDA的孤儿药。

灿菲特目前正在进行II期研究这个指示，在美国，欧洲和以色列。在随机，双盲，安慰剂对照研究，预计第一2016年上半年末的78例Child-Pugh分级B级肝硬化谁没有唯一获得FDA批准的药物在市场上，多吉美（索拉非尼）完成注册。患者的治疗，每天两次用口服CF102，25毫克已被发现是最有效的剂量在Can-菲特的较早阶段I / II期研究中得到的最长的总体生存时间，具有优异的安全性的效果。

快速通道，其目的是获得能够满足未满足的需要给患者早期重要的新的药物，预计加速CF102的发展。接收快车道指定受益于更频繁的会晤和沟通与FDA药品审查药品的开发计划，以支持批准。这也使得该公司能够为数据可用提交以滚动方式的新药申请（NDA）的部分进行审查。由于快车道计划开始，从1998年3月至2015年6月30日，共有318快车道申请已收到由FDA。美国食品药物管理局已批准其中的202，并否认110有6个待定。

“我们非常高兴的是，FDA认可为CF102治疗谁也试了，没有得到回应多吉美肝癌患者的潜力，唯一获得FDA批准的药物目前市场上的这个指示，并表示，”灿菲特CEO Pnina博士菲什曼。 “我们认为快速通道指定要为我们的CF102发展计划的主要催化剂，我们相信它可以缩短我们的上市时间CF102，从而使患者相当大的差异。”

据全球工业分析，肝癌药物的全球市场预计将超过$ 2十亿在2015年多吉美的年销售额，所报告的拜耳公司，在2014年分别为7.73亿€。
                     

关于CF102

CF102是一个小的口服生物可利用药物以高亲和力和选择性的A 3腺苷受体（A 3 AR）结合。 A 3 AR高度表达在肿瘤细胞中，而低表达在正常细胞中发现。此差是影响占药物的优良的安全性。在Can-菲特的临床前和临床研究中，CF102已经证明经由Wnt信号传导途径的失调强大的抗肿瘤作用，导致肝癌细胞的细胞凋亡。

关于灿菲特生物制药有限公司

灿菲特生物制药有限公司（NYSE MKT：CANF）（TASE：CFBI）是一种先进的临床阶段药物开发公司的平台技术，旨在解决数十亿美元的市场在癌症，炎症性疾病和性功能障碍的治疗。本公司正在准备第三阶段CF101试验为风湿性关节炎，并准备了协议下届先进的牛皮癣临床试验。灿菲特的肝癌药物CF102处于II期临床试验，并已获得孤儿药和快速通道的指定由美国食品和药物管理局。 CF102还表明概念验证潜在治疗其它癌症，包括结肠癌，前列腺癌和黑色素瘤。该公司的CF602显示功效，在治疗勃起功能障碍。可以-菲特已备案与美国FDA的IND在此指示，准备发起一个完整的临床前计划CF602。这些药物在临床研究迄今超过1200名患者体验出色的安全性。欲了解更多信息，请访问：www.can-fite.com。

前瞻性陈述

本新闻稿可能包含前瞻性陈述，涉及约灿菲特的预期，信心和意图，除其他外，其产品开发力度，业务，财务状况，运营的，战略或前景的结果。此外，不时，灿菲特或其代表作出或可能作出前瞻性陈述，口头或书面形式。前瞻性陈述可通过使用前瞻性的词语，如“相信”，“期望”，“打算”，“计划”，“可能”，“应该”或“预期”或他们的底片或其它变化来确定这些词或其他类似的词或由这些语句不严格涉及到历史或当前问题的事实。这些前瞻性声明可能包括在，但不限于，由灿菲特向美国证券交易委员会的各种申请，新闻稿或或具有灿菲特授权的高管之一的审批作了口头发言官员。前瞻性声明涉及预期或预期的事件，活动，趋势或结果，因为他们所做的日期。由于前瞻性陈述涉及尚未发生的事情，这些陈述本质上受风险和不确定性，可能导致灿菲特的实际结果与明示或前瞻性陈述中所暗示的任何未来结果存在重大差异。许多因素可能导致灿菲特的实际活动或结果与这些前瞻性陈述，其中包括预期的活动和结果产生重大差异，但不限于，总结在Can-菲特公司提交给美国证券交易委员会的因素，并在其定期报备与TASE。此外，灿菲特操作在工业部门，其中证券的值是高挥发性的，并且可以通过其无法控制的经济和其它因素的影响。可以-菲特不承担任何义务公开更新这些前瞻性陈述，无论是由于新信息，未来事件或其他原因。

联系

灿菲特生物制药

Motti Farbstein

[email protected]

MP4

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