Protein Polymer Expands Clinical Testing of Female Stress Urinary Incontinence
Product
SAN DIEGO, February 20-- Protein Polymer Technologies,
Inc. (OTC Bulletin Board: PPTI) announced that it has added an additional
clinical center to accelerate human clinical testing of its urethral bulking
agent for the treatment of female stress urinary incontinence, a progressively
worsening condition commonly experienced by women older than 40 years of
age.
Patient enrollment will begin next week at Urology Northwest,
P.S., a part of the Northwest Outpatient Medical Center, located in Seattle,
Washington. The principal investigator is Dr. Karny Jacoby, a Board Certified
Urologist, who in addition to her group practice in female urology, serves
as Chief of Surgery at SeattleÕs Northwest Hospital. Clinical testing of
PPTIÕs incontinence product initiated last year at the Cleveland Clinic
Florida located in Weston, Florida, is continuing.
PPTIÕs incontinence product Š a formulation containing
one of its patented silk-elastin polymers Š is designed for use as an injectable
urethral bulking agent (UBA). By injecting the product into the tissues
surrounding the sphincter at the base of the bladder, the lumen of the urethra
is narrowed to prevent the leakage of urine. Unlike other UBA products,
PPTIÕs product does not lose bulk immediately following injection since
the material irreversibly transforms from a polymer solution to a firm yet
pliable hydrogel. In addition to its ease of use, PPTI believes these properties
will translate into increased effectiveness.
PPTIÕs UBA product has received an Investigational Device
Exemption (IDE) from the FDA. Preclinical animal studies have shown the
product to be easy to use, biocompatible, resistant to migration, and more
durable than collagen-based products. PPTI is conducting clinical testing
of the UBA product in the United States, and its partner, Femcare Ltd.,
is concurrently conducting clinical testing in the United Kingdom. The product
is projected to enter the U.S. market in 2005.
In the United States, urinary incontinence (the unintentional
loss of urine) is estimated to affect approximately 13 million people, 85%
of them women. Although caused by a variety of factors, women are most likely
to develop incontinence either during or following pregnancy or childbirth,
or after the hormonal changes of menopause, which cause weakened pelvic
muscles. Urinary incontinence can lead to lifestyle restrictions, depression,
and may also lead to complications such as urinary tract infections and
skin rashes. It is estimated that over $3 billion is spent in the U.S. every
year on incontinence-related care.
Protein Polymer Technologies, Inc., is a San DiegoŠbased
company focused on developing products to improve medical and surgical outcomes.
From its inception in 1988, PPTI has been a pioneer in protein polymer design
and synthesis, developing an extensive portfolio of proprietary biomaterials.
Protein polymers are synthetic proteins created "from scratch" through chemical
DNA (gene) synthesis, and produced in quantity by traditional large-scale
fermentation methods. PPTI now holds 21 U.S. patents on the design, composition
of matter, and production of protein polymers, with corresponding international
applications in major markets. In addition to its urethral bulking agent
for the treatment of stress urinary incontinence, targeted products include,
a dermal contouring agent for use in cosmetic surgery and dermatology, tissue
adhesive and sealants with emphasis on Spinal disc repair, scaffolds for
wound healing and tissue engineering, and depots for local drug delivery.
More about Protein Polymer can be found on its web site, http://www.ppti.com.
