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Trial Looks at Smallpox Vaccine for Liver Cancer
Clinical Trial Evaluates Engineered Smallpox Vaccine as Potential Liver Cancer Killer
LA JOLLA, Calif., April 9 -- The University of California at San Diego issued the following news release:
As part of a multicenter clinical trial, researchers at University of California, San Diego School of Medicine are evaluating Pexa-Vec (JX-594) to slow the progression of hepatocellular carcinoma (HCC) or liver cancer. Pexa-Vec is a genetically engineered virus that is used in the smallpox vaccine.
"This clinical trial is evaluating a drug already known to be safe as a vaccine. We are applying it as a potential destructive agent for liver cancer," said Tony Reid, MD, PhD, professor of medicine, UC San Diego School of Medicine and medical oncologist at UC San Diego Moores Cancer Center. "The goal of the trial is to evaluate if Pexa-Vec can extend patients' survival through its ability to selectively target and kill cancer cells, cut off the tumor's blood supply, and activate the body's own immune system to fight the cancer."
Patients who are eligible for this Phase 2b randomized clinical trial have a diagnosis of HCC and have been found to be unresponsive to sorafenib, the only systemic therapy currently approved by the FDA.
The clinical trial is designed to compare overall survival for patients receiving the drug combined with palliative care (such as hydration, nutrition and pain management) to patients who receive palliation alone with no additional drug treatment.
While Pexa-Vec is derived from vaccinia virus and is similar to smallpox, it doesn't contain smallpox and cannot cause the disease. The virus was chosen for study because it shows an ability to target cancerous tissues relative to normal tissues.
During the 18-week trial, Pexa-Vec is given both intravenously and injected directly into the tumor. Common side effects include flu-like symptoms including fevers, chills and fatigue that generally last less than 24 hours.
Hepatocellular carcinoma is estimated to be the third most common cause of cancer-related deaths world-wide, and the 5th most common cancer diagnosis. It is estimated that 22,000 people were diagnosed in the U.S. last year, and 16,000 people died from the illness.
The Pexa-Vec clinical trial, known as TRAVERSE, is sponsored by Jennerex Biotherapeutics, Inc. of San Francisco, California.
Patients seeking more information about this clinical trial at UC San Diego Moores Cancer may call 858-822-5354 or go to http://traversetrial.com
TNS MT93 130410-4288400 61MarlizTagarum
天花疫苗临床试验评估工程对肝脏的潜在癌症杀手
赏心乐事，加利福尼亚州，4月9日 - 美国加州大学圣迭戈分校发表了如下新闻稿：
作为一个多中心临床试验的一部分，在美国加州大学圣地亚哥分校医学院的研究人员正在评估Pexa-VEC（JX-594），以延缓肝细胞肝癌（HCC）或肝癌。 pexa-VEC是遗传工程的病毒，天花疫苗中使用的。
“这项临床试验是评价药物已经作为疫苗是安全的。说：”我们把它当成一个潜在的破坏性代理肝癌，托尼·里德，医学博士，哲学博士，医学教授，加州大学圣地亚哥分校医学院和在加州大学圣迭戈穆尔斯癌症中心的医疗肿瘤学家。 “该试验的目标是，以评估如果Pexa-VEC可以延长患者的生存期，通过选择性地靶向杀死肿瘤细胞，切断肿瘤的血液供应，激活人体的自身免疫系统对抗癌症的能力。”
有资格2b期随机临床试验的患者诊断为肝癌，并已发现索拉非尼治疗反应迟钝，唯一的全身治疗，目前FDA批准的。
临床试验的目的是比较总生存期为患者接受药物与姑息治疗（如保湿，营养和疼痛管理）的病人获得缓解孤独，没有额外的药物治疗相结合。
，虽然Pexa-VEC来自牛痘病毒和类似天花，它不包含天花，不能引起疾病。该病毒被选定为研究对象是因为它显示了一个能力为目标，癌组织与正常组织。
在18周的试验中，Pexa VEC是静脉直接注射到肿瘤。常见的副作用包括类似流感的症状，包括发烧，发冷和疲劳，一般持续的时间不到24小时。
据估计，世界各地的癌症相关死亡的第三个最常见的原因，和第五的最常见的癌症诊断肝癌。据估计，在美国，22,000人被诊断去年，16000人死亡的疾病。
是由加利福尼亚州的旧金山，Jennerex生物治疗，Pexa-VEC临床试验，被称为TRAVERSE，。
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发表于 2013-3-20 21:20
