SAN DIEGO, Sept. 18 /PRNewswire/ -- 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 PPTI's 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.'s Medical Device Authority
to begin human clinical testing. Femcare subsequently expects to gain a CE
mark for the product next year.
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. More about Protein Polymer can be found on its web
site, http://www.ppti.com.
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. More about Femcare can be found on its web site,
http://www.femcare.co.uk.
This press release contains forward-looking statements that are based on
management's views and expectations. Actual results could differ materially
from those expressed here; further, the Company is not obligated to comment
specifically on those differences. Risks associated with the Company's
activities include scientific and product development uncertainties,
competitive products and approaches, continuing collaborative partnership
interest and funding, regulatory testing and approvals, and manufacturing
scale-up. The reader is encouraged to refer to the Company's 2000 Annual
Report and 10-KSB, and recent filings with the Securities and Exchange
Commission, copies of which are available from the Company, to further
ascertain the risks associated with the above statements.
SOURCE Protein Polymer Technologies, Inc.
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Related links:
http://www.ppti.com
Company News On-Call:
http://www.prnewswire.com/comp/721876.html
CONTACT:
John E. Flowers, Vice President of Protein
Polymer Technologies, Inc., +1-858-558-6064, fax +1-858-558-6477,
info@ppti.com; or Michael Degun, Urology Manager, Femcare, Ltd.,
44-115-978-6322, fax 44-115-942-0234, marketing@femcare.co.uk
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