BMTI has received orphan drug designation from the FDA for its protein therapeutic, recombinant human platelet derived growth factor (rhPDGF-BB), to be used in conjunction with autograft and/or commercially available osteochondral allograft for the treatment of osteochondritis dissecans (OCD) of the knee, elbow or ankle. Orphan drug status, designated to drugs that have the potential to treat rare diseases, provides an accelerated path to FDA approval and may provide 7 years of market exclusivity.
OCD is a joint condition in which cartilage, along with a fragment of the bone beneath it (subchondral bone), becomes detached from the end of a bone due to a loss of blood supply.
- The adult form of the disease is associated with a diminished prognosis and increased necessity for surgical intervention, coupled with a predisposition to early osteoarthritis,
- The etiology of the disease is multi-factorial and may include trauma, ischemia, abnormal ossification centers, and genetic predisposition.
BMTI’s product candidates use rhPDGF-BB (recombinant human Platelet-Derived Growth Factor), one of the principal wound healing stimulators in the body, in combination with tissue specific matrices.
- rhPDGF-BB acts like a magnet to attract cells necessary for tissue healing through a process known as chemotaxis, while also stimulating an increase in the number of healing cells through a process known as mitogenesis, thereby expanding the number of cells available for the repair process.
As published in vivo and in vitro studies demonstrate that rhPDGF-BB may enhance processes important in new blood vessel formation at the wound site, a process called angiogenesis which is critical for wound healing.