The European Commission has certified orphan designation for cabiralizumab. The investigational antibody from Five Prime Therapeutics Inc (NASDAQ:FPRX), which inhibits the CSF-1 receptor, will now be trialed in the treatment of tenosynovial giant cell tumor, both localized and diffuse types. The endorsement comes at a time when the demand for advanced drugs is increasing by the day. The giant cell tumor is also referred to as Pigmented Villonodular Synovitis (PVNS).
The designation is dispensed to a medicine aimed at being used against the rare condition, a locally destructive tumor of the synovium. Vice president of clinical development, Five Prime, Helen Collins writes, “PVNS is a rare neoplastic joint disease that is driven by CSF1R signaling and can be associated with significant pain and debilitation.
PVNS currently lacks approved medical treatments
PVNS is heavily characterized by local overexpression of CSF-1. Over time, it recruits macrophages into the joints, which eventually forms the benign tumor mass. Currently, the condition, which is more often than not associated with high morbidity, has neither reliable treatment nor approved therapies. However, Collins outlines the investigational antibody is likely to be a potential treatment for PVNS. Meanwhile, Five Prime is in the process of carrying out a Phase 2 clinical trial studying cabiralizumab (FPA008). It is being developed under an exclusive collaboration agreement with Bristol-Myers Squibb (BMS), which was entered in October 2015.
The medicine is expected to adhere to certain criteria for designation as an orphan medicine. This is the only way it stands to gain from incentives the likes of protection from competition the moment it is embraced in the market.
Let’s explore Five Prime
The company is well known for its discovery and development of innovative therapeutics that are significant in enhancing the lives of those with serious diseases. To date, it has obtained calculated partnerships with leading global pharmaceutical companies, which will help in the delivery of its growing focus. It is at the point of exploring pathways in cancer, inflammation and their intersection in immuno-oncology.
In the meantime, Five Prime’s stock was trading at $43.88 an increase of $0.23 or 0.53%.