An enhanced Saw Palmetto botanical drug for treating benign prostatic hyperplasia and male pattern baldness

Benign Prostatic Hyperplasia – A Common Male Problem

Benign prostatic hyperplasia (BPH) is a non-malignant prostate enlargement that is common in older men. 5-alpha reductase is responsible for causing BPH and male pattern baldness (alopecia) in men as well as hirsutism (male-pattern body hair) in women. An estimated 50% of men above age 50 in the United States have BPH, which causes urinary hesitation, frequent urination and nighttime visits to the bathroom.

The incidence of BPH increases to 60% for men over the age of 60, 70% for men above age 70 and 80% for men above age 80, following an Arrhenius-type plot.

The BPH/Prostate Cancer Link

BPH has been linked to the incidence of prostate cancer, which is the most prevalent cancer among men and the second-leading cause of cancer death among men in the United States.

More than 500,000 prostate cancer cases are diagnosed each year in the US. One in six American men will develop prostate cancer and 300,000 dies of prostate cancer each year.

Current BPH Treatments

Currently, there are three drugs approved by the FDA to treat the symptoms of BPH – Proscar®, Hytrin®, and Cardura®, with estimated combined sales of over $1.5 billion.

These conventional drugs for BPH cause diminished libido and sexual dysfunction in some patients and about 3-4% of patients experience impotence.

A Natural Solution – Saw Palmetto

Saw palmetto, derived from the Native American palm tree Serenoa repens, has been clinically proven to be as effective as conventional medications in providing symptomatic relief for BPH. It is a natural alternative to these drugs and one with fewer side effects.

Sperol™ – A Saw Palmetto Botanical Drug in Development

By utilizing its patented SuperFluids™ CXF and CXP technologies, Aphios has developed an enhanced and standardized therapeutic composition of saw palmetto, called Sperol™, to inhibit the 5-alpha reductase enzyme [U.S. Patent].

Sperol™ is standardized by 5-alpha reductase inhibition, the same mechanism as the active pharmaceutical ingredient, finasteride, of Merck’s Proscar® for BPH and Propecia® for male pattern baldness.

Potential Applications of Sperol™

In addition to being a treatment for BPH, other potential applications of Sperol™ include:

• Male Pattern Baldness: Androgenetic alopecia can occur in both males and females. In men, hair loss generally occurs in the frontal, vertex and upper occipital regions of the scalp while sparing the posterior and lateral margins. The process may begin at any age after puberty, with temporal hair recession usually noted first. There is no actual loss of hair, but rather a conversion of thick thermal hairs to fine, unpigmented hairs. In women, the pattern of hair loss is generally more diffuse with thinning throughout the scalp. Women with elevated androgen levels, as occur in masculinizing disorders, have a balding pattern similar to that of men. Treatment generally focuses on blocking 5-α reductase, the enzyme responsible for converting testosterone to dihydrotestosterone.
• Hirsutism: The presence of excess hair in women is called hirsutism. This phenomenon is usually an androgen-dependent process. Approximately 25-35% of young women have terminal hair over the lower abdomen, around the nipples or over the upper lip. Most women gradually develop more androgen-dependent body hair with age. Nevertheless, normal patterns of female hair growth are unacceptable to many women. At the other extreme, severe hirsutism may rarely be the earliest sign of masculinizing diseases. More often, however, severe hirsutism reflects only increased androgen production in women with a non-serious underlying disorder.
• Acne and Seborrhea: These are other diseases associated with 5-α reductase activity. The key to treating these diseases is the modulation of 5-α reductase activity.