Cancer nanomedicines: so many papers and so few drugs!
Cancer nanomedicines: so many papers and so few drugs!
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DOI：
10.1016/j.addr.2012.09.038
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发表时间：
2013-01
影响因子：
16.1
通讯作者：
Szoka, Francis C., Jr.
中科院分区：
文献类型：
--
作者：
Venditto, Vincent J.;Szoka, Francis C., Jr.
这篇评论确定了一个时间轴，纳米抗癌药物批准使用的商业模式的发明者，创新者和模仿者。通过评估纳米医学癌症治疗的出版记录，我们发现在FDA批准之前很少有出版物的趋势。我们首先列举了涉及聚合物、脂质体或单克隆抗体的癌症相关出版物，并确定了每篇出版物的引用数量以及出版物中已发表的临床试验数量。将这些数据与特定纳米医学的发展相结合，我们能够确定一个发明阶段，该阶段由特定纳米医学发展所需的基础科学中的开创性论文组成。创新阶段包括第一份报告，开发和涉及纳米医学的临床试验。最后，模仿阶段在批准后开始，当其他人通过使用相同的新药配方或使用相同的药物来验证其他纳米药物而获得成功时。然后，我们将我们的分析集中在含有喜树碱衍生物的纳米药物上，这些药物尚未获得批准，包括两种被认为是创新的聚合物和一种处于模仿阶段的脂质体制剂。从喜树碱的分析中可以得出的结论是，在聚合物和脂质体癌症纳米药物中重新配制的批准药物在批准过程中比母体分子更难导航。这可能是由于对于大多数目前批准的药物，在纳米载体中重新配制它们提供了性能的小幅提高，大型制药公司认为不值得开发时间，精力和费用。药物载体似乎也比单克隆抗体更难通过临床。纳米载体增加的复杂性也阻碍了它们用于递送新的分子实体。因此，可能通过纳米载体中的药物递送得到最大改善的新候选药物不是以这种方式配制的。
This review identifies a timeline to nanomedicine anticancer drug approval using the business model of inventors, innovators and imitators. By evaluating the publication record of nanomedicine cancer therapeutics we identified a trend of very few publications prior to FDA approval. We first enumerated the publications related to cancer involving polymers, liposomes or monoclonal antibodies and determined the number of citations per publication as well as the number of published clinical trials amongst the publications. Combining these data with the development of specific nanomedicines, we are able to identify an invention phase consisting of seminal papers in basic science necessary for the development of a specific nanomedicine. The innovation phase includes the first report, the development and the clinical trials involving that nanomedicine. Finally, the imitation phase begins after approval when others ride the wave of success by using the same formulation for new drugs or using the same drug to validate other nanomedicines. We then focused our analysis on nanomedicines containing camptothecin derivatives, which are not yet approved including two polymers considered innovations and one liposomal formulation in the imitation phase. The conclusion that may be drawn from the analysis of the camptothecins is that approved drugs reformulated in polymeric and liposomal cancer nanomedicines have a more difficult time navigating through the approval process than the parent molecule. This is probably due to the fact that for most currently approved drugs, reformulating them in a nanocarrier provides a small increase in performance that large pharmaceutical companies do not consider being worth the time, effort and expense of development. It also appears that drug carriers have a more difficult path through the clinic than monoclonal antibodies. The added complexity of nanocarriers also deters their use to deliver new molecular entities. Thus, the new drug candidates that might be most improved by drug delivery in nanocarriers are not formulated in this fashion.
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影响因子：
4.7
作者：
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通讯作者：
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