Protein Polymer's Partner, Femcare Ltd., Receives Approval to Begin Human
Clinical Trials of Incontinence Product
SAN DIEGO, May 1 -- Protein Polymer Technologies, Inc.
(OTC Bulletin Board: PPTI) today announced that its partner, Femcare, Ltd.,
had received approval to initiate human clinical trials in the United Kingdom
of PPTI's urethral bulking agent for the treatment of female stress urinary
incontinence. The trials are projected to begin at U.K. clinical sites within
a few weeks.
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.'s Medical
Device Authority to begin human clinical testing. Femcare subsequently expects
to gain a CE mark for the product before the end of 2001, and projects limited
commercialization will begin in Europe by the 3rd quarter of 2002.
PPTI's incontinence product -- a formulation containing
one of its patented silk-elastin polymers -- 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,
PPTI's 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.
PPTI's 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 Diego-based
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.
Femcare, Ltd., St. Peters Street, Nottingham, NG7 3EN,
United Kingdom, was founded in 1982. The Filshie Clip for Female Sterilization,
Femcare's 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 company's success in gynecology to urological applications,
in particular female stress urinary incontinence. Based upon PPTI's 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. To visit the Femcare, Ltd. website, Netscape Navigator users
click here.
Microsoft Internet Explorer users click
here.
