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BG4003 Dandelion New
Transcript of BG4003 Dandelion New
Similar artery size
Brings the "seeds" of cure to atherosclerosis
a shear-activated drug delivery vehicle
Hemodynamics-based drug targeting device for the treatment of atherosclerosis.
FDA Regulatory Pathway
He Shuai, Liu Yuxin, Mao Ning, Wei Shuya, Xu Tong, Zheng Xi
Non-clinical test - device feasibility
Pre-clinical test -safety and efficacy in animal model
Clinical test - safety and efficacy in patients, side effects, improvements
A physical simulation model- assess the feasibility of drug release
Choice of species is based on which will give the best correlation to human trials.
--> Contract Research Organization
Plasma Lipids concentration
Artery size: crucial for product efficiency assessment
Atherosclerotic lesion: observed by oil red O-stainning test.
Collaborate with NUH and TTS Hospital
Phase I: on patients with 90% lumen occlusion
Phase II: randomized, double-blind tests on 200 patients
Phase III: randomized, monitor side effects, on 1000 patients (possibly involve US hospitals)
Shortest regulatory pathway
De Novo 510(k)
1. A drug delivering vehicle which can specifically target an atherosclerosis plaque through automatic disassembly upon experiencing the physical forces exerted by the turbulent blood flow at a suddenly narrowed artery site.
2. Combination of blood-clot dissolving agents, lipid digesting agents and anti-inflammatory agents used for treatment of atherosclerosis carried by the drug delivery vehicle said in Claim 1.
Physical Drug Delivery Systems
PH / temperature-activated targeting
Materials for Drug Delivery Device
PLGA nanoparticle loaded with antimicrobial agent
Positive surface charged PLGA nanoparticle with ammonium cationic surfactants (QACS) and bioactive agents
PLGA nanoparticle with polyphenol conjugates as RGD-binding compounds
PLGA nanoparticle comprising hydrophobic photosensitizers and stabilizing agents
Patients diagnosed with atherosclerosis (medium to serious vessel occlusion): >10% of population above 50
Freedom to Operate
No substantially equivalent predicate
= Class III device
Novel but Low Risk
PLGA is Biocompatible & Biodegradable
PLGA is FDA approved therapeutic devices
Short direct contact time (<30 Days)
No primary characteristics of Class III device (e.g sustain life and implantable)
Class II Medical device
Two types of artificial arteries:
A: Healthy artery
B: Atherosclerotic artery
Fluorescence release patterns
- 30 pigs weighted 20-30kg
- 300 "C57BL/6" mice
A Treatment to Atherosclerosis, that is...
Product Design Specifications
Safe: bio-compatible, bio-degradable material
Specific: most effective physical property to target
Patentable: no similar patents or products
Adapted from Holme, et al. 2012, Shear-stress sensitive lenticular vesicles for targeted drug delivery. Nature Nanotechnology, 7(8), 536-543.