Medgenics 公司研制出（生物）泵

yuji8

Medgenics gets (bio)pumping

By Katrina Megget
Katrina Megget 著

04/12/2007 - Medgenics' Biopump could be the solution to the issues surrounding protein therapy and is set to take on the $51bn US biopharmaceutical market after raising ?.28m ($6.76m) in funding in its Initial Public Offering.
2007年12月4日：Medgenics公司的生物泵是一种解决蛋白治疗方案中所出现问题的方法，在该公司的首次发行股票资金上涨到676万美元之后，它将开始投入到$51bn的美国生物药品市场。

The US biopharmaceutical company, with key operations based in Israel, plans to be moving into Phase I/II clinical trials with its Biopump platform technology in the second quarter of next year.
Medgenics公司是一家美国生物制药公司，它的核心业务在以色列开展，该公司计划在明年的第二季度，运用其生物泵平台技术开展第一/二期临床试验。

The technology is a protein biofactory whereby a toothpick-sized skin biopsy is taken from a patient and a particular gene is inserted into the cells and then re-implanted into the patient.
此项技术是一种蛋白质生物反应器，它是凭借从患者身体上取得的一根牙签大小的皮肤组织以及被植入细胞中的一种特定基因（来实现蛋白质的生物合成），然后再将其重新植入患者体内。

The cell uses its own machinery to produce the therapeutic protein in question.
细胞按照自身的机制来实现治疗蛋白的合成。

\"The Biopump aims to solve all the problems [associated with conventional forms of protein therapy],\" Medgenics chief executive and president Dr Andrew Pearlman told in-PharmaTechnologist.com.
Medgenics公司的首席执行官兼总裁Andrew Pearlman 表示，生物泵的目标是解决与常规蛋白治疗方法的所有问题。

While most conventional methods of protein therapy involve injecting the therapeutic protein into the patient, the Biopump is designed to enable patients to produce the protein in their own bodies on a long-term basis.
虽然大多数常规蛋白治疗方法是将治疗用的蛋白质注射入患者体内，但是生物泵的设计可以实现在患者自己的体内长期的制造蛋白质。

The issues of protein half-life, administration via injection, dosing levels and cost, were just some advantages of the system, Pearlman said.
Pearlman博士表示，生物泵系统在蛋白质的半衰期、注射给药方式、剂量以及治疗费用方面都具有一些优势。

A big advantage would be the elimination of the need for costly manufacturing facilities to produce therapeutic proteins, he said.
他还说，最大的优势在于不必再使用昂贵的制备治疗用蛋白质的生产设备。

The system works by taking a very small toothpick-sized dermal skin sample, usually from the abdominal area.
生物泵系统的运行通过从患者身体上，通常是腹部取得的一片非常小的类似一根牙签尺寸的真皮皮肤样本。
Using a gutless adenovector - a virus with no genes - a gene is introduced into the tissue's cells, specifically fibroblasts.
使用“gutless adenovector”（一种没有基因的病毒）及被引入组织细胞特别是成纤维细胞中的一种基因。

The gene is not incorporated into the cell's chromosome but rather resides in the nucleus and uses the cell's machinery to produce therapeutic proteins.
基因并没有混入细胞的染色体中，而是位于细胞核中并利用细胞的机制来制造治疗用蛋白质。

According to Pearlman, the cells should be able to produce therapeutic proteins for at least six months, by which time, because the gene is not passed on during cell division, the fibroblasts die off and a new implant would be required.
Pearlman博士介绍，细胞可以在至少六个月的时间内持续制造蛋白质，六个月之后，由于在细胞分裂过程中，基因没有被遗传，在成纤维细胞死亡后，需要植入一个新的生物泵系统。

In studies using baboons, the implant was shown to be effective for two years, Pearlman said.
Pearlman博士介绍，在使用狒狒进行的相关实验中，植入剂的有效期限为两年。

The number of Biopumps implanted under the patient's skin would depend on the rate of protein production and the patient's individual requirement.
在患者皮肤下植入的生物泵数量由蛋白制造的速度及患者个人病情需要来决定。

The company is currently looking at the production of erythropoietin (EPO) using the Biopump as a treatment for anaemia and aims to commence Phase I/II clinical trials in the second quarter of next year with initial safety and proof of efficacy results expected three to five months later.
目前该公司正在使用生物泵试产用于治疗贫血的促红细胞生成素（EPO），并准备用于明年第二季度的第一/二期临床试验，预期在三至五个月后得到最初的安全性及功效试验结果

The company is also looking at a treatment for hepatitis C with the protein interferon-alpha (IFN-a), but in the future Biopump could be used to treat multiple sclerosis, growth hormone and insulin deficiencies as well as genetic diseases, Pearlman said.
Pearlman博士表示，该公司还在关注使用α-干扰素(IFN-a) 治疗丙型肝炎的有关试验，将来生物泵将用于治疗多发性硬化症、生长激素及胰岛素缺乏，也包括遗传性疾病。

The system could also be used to incorporate more than one gene in the virus vector for production and in the future the system could use more sophisticated technology to turn specific genes on and off, he said.
他还表示，此系统也可以在病毒载体中混合一种以上的基因用于制造蛋白，将来此系统可以采用更多精密的技术来实现特定基因的开启和关闭。

The company is working on a method for widespread use so that procedures would not be limited to just one location.
该公司正在研制能够使生物泵广泛使用的方法，这样操作过程就不用仅限于一个部位了。

Due to the drug device being designated as a tissue implant, approval would fall under the medical devices category.
由于此药物被设计成一个组织植入剂，将按照医疗用具类别进行审批。