In conjunction with grants from the National Institutes of Health and Department of Defense, MicroCures is pursuing therapeutic applications of siFi2 for cavernous nerve regeneration.
Preclinical research suggests that siFi2 has potential therapeutic application for recovery after damage to peripheral nerves. Specifically, using siFi2 to silence of FL2 activity has demonstrated the potential to regenerate neural tissue after injury in preclinical models, resulting in significant functional recovery as compared with controls. MicroCures is advancing a preclinical stage program evaluating the therapeutic potential of siFi2 for cavernous nerve repair.
The company’s initial research in this area has focused on evaluating siFi2 in a rat model of crushed cavernous nerve. Results from this study demonstrated that four weeks of treatment with siFi2 led to robust erectile response in rats when the subjects received increasing levels of cavernous nerve stimulation. Conversely, rats in the study’s control group displayed little to no erectile response at any level of cavernous nerve stimulation after four weeks.
In a second study, researchers surgically removed a portion of the cavernous nerve of rats and then treated the proximal portion of the severed nerve with siFi2 or control:
3-to-4 millimeters of the cavernous nerve was surgically removed from adult male rats. The proximal portion of the severed nerve was then treated with siControl or siFi2.
Within two weeks, animals treated with siFi2 displayed visible regeneration of the transected cavernous nerve, while no regeneration was apparent in controls.
Additionally, stimulation of the cavernous nerve above the point of transection induced a significant erectile response, even at low levels of stimulation, in siFi2-treated animals. There was not a similar erectile response in control-treated animals.
Erectile dysfunction after radical prostatectomy
The cavernous nerve innervates penile erection, and damage to this nerve results in erectile dysfunction. Following radical prostatectomy, which is the most common treatment for localized prostate cancer, virtually all men experience erectile dysfunction – accompanied by a reduction in penile circumference and length. While some patients recover erectile function eventually, many do not. Preclinical studies applying siFi2 topically immediately after surgery suggest significant potential for full and rapid recovery of cavernous nerve function after injury.