Protein Polymer's Partner, Femcare Ltd., Enrolling Patients for Human
Clinical Trials of Incontinence Product
SAN DIEGO, September 18 -- Protein Polymer Technologies,
Inc. (OTC Bulletin Board: PPTI),today announced that its partner, Femcare,
Ltd., has begun enrolling patients for human clinical trials in the United
Kingdom of PPTIÕs urethral bulking agent for the treatment of female stress
urinary incontinence. Based on an agreement executed last year, Femcare
will conduct clinical studies and commercialize the incontinence product
in Europe and Australia. Femcare recently received the approval of the U.K.Õs
Medical Device Authority to begin human clinical testing. Femcare subsequently
expects to gain a CE mark for the product next year. 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. PPTI believes this
property will translate into increased efficacy. PPTIÕs UBA product has
received an Investigational Device Exemption (IDE) from the FDA and human
testing is in progress in the United States. Preclinical animal studies
have shown the product to be easy to use, biocompatible, resistant to migration,
and more durable than collagen-based products. The product is projected
to enter the U.S. market in late 2004. 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 20 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, www.ppti.com . Femcare, Ltd., St. Peters Street, Nottingham,
NG7 3EN, United Kingdom, was founded in 1982. The Filshie Clip for Female
Sterilization, FemcareÕs lead product, is the female sterilization market
leader in the Western world. During the past 18 years Femcare has expanded
its product line and geographical business base and now markets its products
in countries worldwide. In addition to the Filshie Clip, Femcare has developed
products for male sterilization and urology. A Urology division has been
established to extend the companyÕs success in gynecology to urological
applications, in particular female stress urinary incontinence. Based upon
PPTIÕs urethral bulking agent, Femcare will utilize its existing customer
base and its extensive distribution network as the basis for introducing
the product into Europe and Australia. More about Femcare can be found on
its web site, www.femcare.co.uk.
