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BG4003 Dandelion New

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by

Ning Mao

on 10 November 2013

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Transcript of BG4003 Dandelion New

Monkey Model
Swine Model
Similar artery size
Low cost
Murine Model
Angio-Dandelion™
Brings the "seeds" of cure to atherosclerosis
NEED
Introducing Angio-Dandelion™:
a shear-activated drug delivery vehicle
SOLUTION
Analogy
Uniqueness
Proposed Patent:
Hemodynamics-based drug targeting device for the treatment of atherosclerosis.

Patentable Features
FDA Regulatory Pathway
IPs
MARKET
SAFETY&EFFICACYTESTS
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
Simulated test
Heart Pump
Animal Test
Choice of species is based on which will give the best correlation to human trials.
--> Contract Research Organization
High cost

Plasma Lipids concentration

Artery size: crucial for product efficiency assessment

Atherosclerotic lesion: observed by oil red O-stainning test.
Evaluation Parameters
Clinical 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)
Main Claims:

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
Magnetism targeting
Light-activated targeting
PH / temperature-activated targeting
Materials for Drug Delivery Device
Target Market
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)
PLGA
Class II Medical device
Fluorescence-loaded particles

Two types of artificial arteries:
A: Healthy artery
B: Atherosclerotic artery

Fluorescence release patterns
- 30 pigs weighted 20-30kg
- 300 "C57BL/6" mice
endarterectomy:
- painful
stenting:
- recurrence
drugs:
- hemorrhage
minimally invasive


more effective


more specific
A Treatment to Atherosclerosis, that is...
Microaggregates
dissociated particles
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.
Full transcript