The first targeted nanopreparation performed well in a clinical study
Scientists from the Brigham Women's Clinic, the Dana-Farber Cancer Institute, Harvard University and a number of other research institutions in the United States have received promising results during the first clinical trial of the BIND-014 targeted nanopreparation intended for the treatment of solid tumors.
According to one of the leaders of the study, Professor Robert Langer from the Massachusetts Institute of Technology, earlier attempts to create such nanoparticles did not reach the stage of clinical research due to the complexity of creating and large-scale production of nanoparticles that can simultaneously have a directed effect, circulate in the bloodstream for a long time (to avoid the development of an immune reaction) and release the drug in the required mode.
The new drug BIND-014 is a polymer nanoparticles loaded with the chemotherapy drug docetaxel, used for the treatment of solid tumors. These nanoparticles selectively interact with the membrane prostate-specific antigen, which is a clinically confirmed marker of prostate cancer cells; in addition, PSA express solid tumor cells of a number of other organs.
When conducting preliminary studies on several animal models of tumors (mice, rats and monkeys), scientists have demonstrated that the amount of docetaxel enclosed in nanoparticles corresponds to a 100 times higher (compared to taking a conventional drug) concentration in plasma and 10 times – inside the tumor with minimal accumulation in liver tissue. This pharmacodynamics persisted for more than 24 hours. At the same time, compared with the use of conventional docetaxel, a longer and more pronounced suppression of tumor growth was observed.
Moreover, the primary clinical data obtained during a study involving 17 patients with progressive or metastatic tumors of solid organs who had previously undergone intensive antitumor therapy not only confirm the adequacy of preclinical data, but indicate that the clinical effects of BIND-014 are manifested when a dose corresponding to only 20% of the traditional therapeutic dose is administered. dosages of docetaxel. At the same time, the drug affects even tumors that do not respond well to docetaxel therapy, such as cervical cancer.
According to the researchers, BIND-014 has so far been used in doses up to 75 mg per square meter of the patient's body surface. Taking all tested doses was well tolerated by patients and did not cause previously unknown side effects. Currently, the experimental dosage is being increased in order to select the optimal therapeutic doses.
Article by Jeffrey Hrkach et al. Preclinical Development and Clinical Translation of a PSMA-Targeted Docetaxel Nanoparticle with a Differentiated Pharmacological Profile is published in the preliminary on-line version of the journal Science Translational Medicine.
Evgeniya Ryabtseva
Portal "Eternal youth" http://vechnayamolodost.ru Based on ScienceDaily: First Targeted Nanomedicine to Enter Human Clinical Studies.
10.04.2012