SAN DIEGO, Dec. 17 /PRNewswire/ -- 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.
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 raising adequate capital to continue operations 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 1998 Annual Report Form 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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Company News On-Call:
http://www.prnewswire.com/comp/721876.html or fax,
800-758-5804, ext. 721876
CONTACT:
J. Thomas Parmeter, President, or Laura
Sarno, Director, Tissue Augmentation Products, of Protein Polymer
Technologies, Inc., 858-558-6064, info@ppti.com
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