NK012 is a 'nanodevice' formulation of
SN-38
SN-38 is an antineoplastic drug. It is the active metabolite of irinotecan (an analog of camptothecin - a topoisomerase I inhibitor) but has 1000 times more activity than irinotecan itself. In vitro cytotoxicity assays show that the potency of SN ...
(an
irinotecan
Irinotecan, sold under the brand name Camptosar among others, is a medication used to treat colon cancer, and small cell lung cancer. For colon cancer it is used either alone or with fluorouracil. For small cell lung cancer it is used with cispl ...
metabolite). NK012 is an SN-38-releasing
polymeric micelle constructed by covalently attaching SN-38 to the
block copolymer
In polymer chemistry, a copolymer is a polymer derived from more than one species of monomer. The polymerization of monomers into copolymers is called copolymerization. Copolymers obtained from the copolymerization of two monomer species are some ...
PEG-PGlu, followed by self-assembly of
amphiphilic
An amphiphile (from the Greek αμφις amphis, both, and φιλíα philia, love, friendship), or amphipath, is a chemical compound possessing both hydrophilic (''water-loving'', polar) and lipophilic (''fat-loving'') properties. Such a compoun ...
block copolymers in aqueous media.
It has completed phase II clinical trials for
triple-negative breast cancer
Triple-negative breast cancer (TNBC) is any breast cancer that lacks or show low levels of estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) overexpression and/or gene amplification (i.e. the tum ...
and relapsed
small cell lung cancer
Small-cell carcinoma is a type of highly malignant cancer that most commonly arises within the lung, although it can occasionally arise in other body sites, such as the cervix, prostate, and gastrointestinal tract. Compared to non-small cell car ...
. In 2016,
Nippon Kayaku
(Japan Pharmaceuticals) is a Japanese company that was founded in 1916 as the first industrial explosives manufacturer in Japan under the company name Nippon Kayaku Seizo Co., Ltd.. Its main business areas are functional chemicals, pharmaceutical ...
received
orphan drug
An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases.
The assignment of ...
designation for NK012 from the
US FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
.
[Nippon Kayaku Announces FDA Orphan Drug Designation to New Polymeric micelle Anti-Cancer Drug NK012 for Small Cell Lung Cancer. (2016). Evaluategroup.com. Retrieved 24 November 2017, from http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=644017] This means that if it is approved in the United States, Nippon Kayaku will be entitled to 7 years of market exclusivity. This is intended to incentivize future development, but does not mean the drug has been approved.
See also
*
Nanomedicine
Nanomedicine is the medical application of nanotechnology. Nanomedicine ranges from the medical applications of nanomaterials and BioBrick, biological devices, to Nanoelectronics, nanoelectronic biosensors, and even possible future applicatio ...
*
Targeted drug delivery Targeted drug delivery, sometimes called smart drug delivery, is a method of delivering medication to a patient in a manner that increases the concentration of the medication in some parts of the body relative to others. This means of delivery is la ...
References
Experimental cancer drugs
{{antineoplastic-drug-stub