Fexapotide

Fexapotide TRriflutate is a protein injectable for benign prostatic

hyperplasia (prostate enlargement, "BPH") and for low grade localized

prostate cancer. It has been designed to be administered in the urologist's

office in a simple injection that takes a few minutes. FT is a new molecular

entity which safely targets prostate glandular cells that have proliferated in

BPH. FT works by a mechanism of inducing apoptosis (programmed cell death)

which selectively removes cells in the enlarged BPH prostate gland, and that

also is useful in removing low grade localized early stage prostate cancers.

In research studies, FT is associated with increased expression of

important apoptosis markers, and all of the cellular signs of the hallmarks of

apoptotic cell loss. FT has remarkable selectivity for the overgrowth of the

prostate gland cells in BPH and in low grade localized prostate cancer. Studies

of FT's cellular effects, metabolism and kinetics have shown that FT does not

have any effects on nearby structures or on important distant organs. Repeated

injections of FT do not induce any discernible immune reaction in patients,

which is another important reason for FT's excellent safety results. In

large clinical trials involving over 1700 men there have been minimal side

effects from FT.

Long-term studies of FT involving 997 enrolled patients followed for up to

7 years showed statistically significant lasting improvement in BPH symptom

scores compared to placebo controls. The symptom scores reflect improvements in

urgency, frequency, nocturia, poor urinary flow, stopping and starting,

incomplete emptying, and straining. Long-term studies also showed that patients

who received 1 or 2 injections of FT had significantly less need for invasive

BPH surgical interventions than control patients who did not receive FT. The

clinical trials also demonstrated improvements in sexual function in patients

given FT. FT treatment led to lower incidence of the need for bladder

catheterization, and none of the typical side effects associated with current

drug treatments.

FT works by a mechanism of inducing apoptosis (programmed cell death) which

selectively removes cells in the enlarged BPH prostate gland, and that also is

useful in removing low grade localized early stage prostate cancers. In

research studies, FT is associated with increased expression of important

apoptosis markers, and all of the cellular signs of the hallmarks of apoptotic

cell loss. In large clinical trials involving over 1700 men there have been

minimal side effects from FT, which is based on FT's remarkable selectivity for

the overgrowth of the prostate gland cells in BPH and in low grade localized

prostate cancer. Studies of FT's cellular effects, metabolism and kinetics have

shown that FT does not have any effects on nearby structures or on important

distant organs. Repeated injections of FT do not induce any discernible immune

reaction in patients which is another important reason for FT's excellent

safety results.