SAN DIEGO, Feb. 20 /PRNewswire-FirstCall/ -- Protein Polymer Technologies,
Inc. (OTC Bulletin Board: PPTI) today 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 Seattle's Northwest Hospital. Clinical testing of PPTI's
incontinence product initiated last year at the Cleveland Clinic Florida
located in Weston, Florida, is continuing.
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. In addition to its ease of use, PPTI believes these properties will
translate into increased effectiveness.
PPTI's 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 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 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 .
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:
J. Thomas Parmeter, President, or John E.
Flowers, Vice President, Operations, both of Protein Polymer
Technologies, Inc., +1-858-558-6064
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