Abstract
The translation of biomedical discoveries into treatments for inflammatory diseases, cancer, neurodegenerative diseases or heart diseases for the benefits of improving our lives is now considered a potential solution to the disparity between basic research and its benefits to the society. In 2005, when a herbal antagonist of TNF-α, called H-179, was first identified by means of proprietary drug discovery and screening technology – HerboChip® in an enriched fraction of Andrographis paniculata (Acanthaceae), the author of this dissertation intended to adopt the then-frontier translation approach to conduct a research and development of this herbal extract with the ultimate goal of commercializing it into a pragmatic medical treatment for rheumatoid arthritis (RA), which is one of the most commonly seen inflammatory diseases affliciting the global aging populations. In order to achieve this goal, a novel conceptual framework of rapid commercialization for technological innovations is introduced and applied to the development of this active pharmaceutical ingredient (API) H-179 into a transdermal patch in form of cataplasm in the most cost-effective manner possible and has eventually accomplished a marketable cataplasm for the relief of RA symptom. It is estimated that this cataplasm H-179 will have a potential market value reaching RMB 1 billion dollar in 5 years after the market launch.Based on previous preclinical studies using in vitro as well as well-accepted in vivo animal model, it has been demonstrated that the API developed – H-179 – for the treatment of RA is not only safe but also effective in relieving pain and inflammation. A preliminary clinical study investigating the potential benefits of H-179 for the treatment of RA patients was then undertaken at the medical school of Zhongshan University and the results confirmed the safety and efficacy of this API.
In present study, further development was carried out in transdermal drug delivery system and succeeded in developing an effective and easy-to-use dosage form – a cataplasm for H-179. Firstly, manufacturing process of H-179 cataplasm was studied. Extraction of H-179 from dried Andrographis paniculata (Acanthaceae) was optimized. Eight formulation of H-179 cataplasm were tested and compared. One was selected for manufacturing. A preliminary clinical study was then carried out to investigate the clinical effectiveness of H-179 cataplasm for the relief of signs and symptoms associated with arthritis. A group of 80 patients with RA or other arthritis conditions were recruited and were divided into 2 groups, treatment group receiving H-179 cataplasm and control group receiving known transdermal patch from market. The results showed that there was statistically significant improvement in the signs and symptoms and the degree of pain reduction after treatment.
The ultimate goal of this study is to effectively translate the development of a novel herbal transdermal patch into a pragmatic therapeutic product for the treatment of RA. In order to attain this goal, besides the technology itself, there are 2 moderating factors to be considered: one is to comply with the Chinese government on regulatory, safety and environmental issues and the other is to collaborate with local universities with grants to further develop the applied research into a commercial therapy. After consideration of a number of other issues: partner match/relationship, prototype development, product champion, cultural aspects, pioneers users, financial collaboration, strategic alliance, market alliance, time frame, pricing strategy, product compatibility and product strategy, Yunnan Baiyao (YNBY) was selected as collaborator and strategic partner in the commercialization of this H-179 cataplasm in order to ensure the future marketing of this therapeutic though its nationwide network of distribution channels. Along with YNBY, the H-179 cataplasm was patented in China. This study successfully demonstrated the feasibility of a translational research project between the academia and the pharmaceutical industry.
| Date of Award | 30 Aug 2012 |
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| Original language | English |
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| Supervisor | Shuk Han CHENG (Supervisor) |