Protein Polymer Technologies Begins Human Clinical Testing Of Its Product
for Female Urinary Incontinence
SAN DIEGO, Dec. 17 -- Protein Polymer Technologies,
Inc. (OTC Bulletin Board: PPTI), today announced that it has initiated human
clinical testing of its urethral bulking agent for treatment of female stress
urinary incontinence. Urinary incontinence is a common problem experienced
by many women over the age of forty that tends to become progressively worse
over time.
PPTI's urethral bulking agent has been specifically designed
to address the shortcomings in biocompatibility, ease of use, and durability
associated with both existing treatments and those known to be under development.
The Company's product is based on a patented new biomaterial having unique
properties created by combining specific features of natural silk and human
elastin into a new rDNA protein formulation. The material has been
designed to be far less susceptible to absorption by the body compared to
collagen or other materials that are derived from natural tissues, and because
once injected it forms a solid implant, PPTI's product is expected to enable
patients to remain "dry" longer than patients treated with other product
formulations.
According to the U.S. Department of Health and Human
Services Agency for Health Care Policy and Research (1996), urinary incontinence,
the involuntary loss of urine, affects approximately 13 million Americans,
mostly women. It is generally recognized as one of the major causes
of institutionalization of the elderly. The direct cost of caring
for people with incontinence has been estimated to be over $16 billion per
year.
Stress urinary incontinence (SUI) is the most common
type of incontinence and is caused by failure of the urethral sphincter
to prevent urine flow, particularly associated with physical activity.
Treatments range from non-invasive behavioral training to abdominal surgery.
Urethral bulking agents currently approved by the FDA
are only for treatment of a subclass of SUI in which the urethral sphincter
is unable to close (approximately 15% of the potential patient population).
These products, formulations of solid particles suspended in a liquid or
gel carrier, are injected into the urethral tissues at the base of the bladder
to increase the physical bulk of the sphincter, thus sealing the urethra
to prevent involuntary urine leakage. However, the effectiveness of
these treatments decrease with time and multiple injection procedures are
required to maintain patient benefits.
PPTI's urethral bulking agent will be tested in women
suffering from all types of SUI. It has been developed to be an alternative
to surgery that can be administered in an office-based procedure under local
anesthesia. The product is unique in that it is injected as a fluid
which quickly transforms to a solid gel within the urethral tissues.
The Company believes this feature will offer significant advantages over
preformed products that are difficult to inject or implant, and over particle-based
products where the injected volume decreases over time as the carrier liquid
dissipates and/or as particle migration may occur.
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 design and
synthesis, developing an extensive portfolio of proprietary biomaterials.
These genetically engineered biomaterials are high molecular weight proteins,
processed into products with physical and biological characteristics tailored
to specific clinical performance requirements. Targeted products include
urethral bulking agents for the treatment of stress urinary incontinence,
dermal augmentation products for cosmetic and reconstructive surgery, surgical
adhesives and sealants, scaffolds for wound healing and tissue engineering,
and depots for local drug delivery.
