SHAFAQNA-First there are reams of applications to submit to the Food and Drug Administration (FDA), years of documented research, various trial phases, and a litany of other hoops to jump through that make the process daunting, albeit ultimately worthy.
Consider this: global spending on cancer medicines topped $107 billion last year, and is expected to reach $150 billion by 2020. Over the past decade our understanding of how different cancers evade the immune system has grown exponentially. Likewise, in the past decade the number of potential cancer medicines in mid- to late-stage clinical studies has grown 63 percent to 586, involving more than 500 companies.
For those companies that choose to focus on orphan diseases — that is, those conditions deemed rare — applying and gaining an orphan drug designation could pave an easier path for gaining market approval.
For Propanc Health Group (OTCBB: PPCH), filing for orphan medicinal product designation (OMPD) in Europe for pancreatic cancer for PRP, an anti-cancer compound, means that it is one step closer to bringing a cure for certain types of cancer to patients who desperately need it, as approval requires evidence showing a significant clinical benefit over available 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,” says James Nathanielsz, Propanc’s chief executive officer. “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 is a naturally derived proenzyme formulation that seeks to halt cancer progression and spreading by eradicating cancer stem cells (CSC) while leaving normal stem cells unaffected.
Experiments were conducted using isolated CSCs from patients, comparing the behavior of the cells pre- and post-treatment with PRP by examining the genetic pathways that control the cells.
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.