It takes a lot of work to bring a drug to market.
First, there are numerous applications to be submitted to FDA, years of documented research, different trial phases, and many other hurdles to overcome that can make this process difficult, but ultimately rewarding.
Take this as an example: The global expenditure on cancer drugs topped $107 Billion last year and is projected to rise to $150 Billion by 2020. The understanding of how different cancers can evade the immune systems has increased exponentially in the last decade. The number of potential treatments for cancer in clinical trials in the mid- and late stages of development has risen 63 percent to 586 over the past decade, which includes more than 500 companies.
Companies that focus on rare diseases, such as orphans, may be able to apply for and gain an orphan drug designation. This could make it easier to get market approval.
For Propanc Health Group(OTCBB, PPCH), a European filing for an orphan medicinal products designation (OMPD), in Europe for pancreatic carcinoma for PRP, an anticancer compound means it is one step closer towards bringing a cure to certain types of cancer patients who need it. To be approved, it must show a significant clinical advantage over other therapies.
“This is an important step for Propanc and supports our plans for developing PRP as a treatment solution for aggressive, fast-spreading solid tumors,”Propanc’s chief executive Officer James Nathanielsz “Pancreatic cancer is an area where there is an urgent need for viable solutions and we remain determined to bring to market what could become a target and safer treatment approach, which we hope will meaningfully extend patient lives.”
The European Union grants OMPD status to products which treat rare diseases, providing a range of incentives to sponsors developing drugs or biologics such as fee waivers and a 10-year market exclusivity period (post-authorization).
PRP, a naturally derived proenzyme formulation, aims to stop the spread of cancer by eradicating cancer-stem cells (CSC). It leaves normal stem cells unaffected.
Experiments were performed using CSCs taken from patients. The experiments compared the behavior of cells pre-and post-treatment with PRP. Genetic pathways controlling the cells were also examined.
In short, the data indicates that the dramatic reduction of cellular markers associated with the process of epithelial-mesenchymal transition as a consequence of PRP treatment could not only reverse the EMT process with the implication to stop tumor growth and metastasis, but also potentially suppress the development of CSCs.
Visit www.propanc.comFind out more about the company’s work.
