SAN DIEGO, May 20 /PRNewswire/ -- Protein Polymer Technologies, Inc.
(Nasdaq: PPTI), today announced that it has received permission from the U.S.
Food and Drug Administration (FDA) to begin human clinical testing of its
urethral bulking agent for treatment of female stress urinary incontinence.
Contingent upon the availability of working capital, the Company plans to
begin enrolling patients in the 3rd quarter of 1999.
"The FDA's clearance for us to proceed with the clinical testing of our
incontinence product is a major milestone for the Company" said PPTI's
President and Chief Executive Officer, J. Thomas Parmeter. "The biomaterial
and underlying technology on which the product is based had previously never
been reviewed by the FDA, and so a significant educational effort was
required. We are extremely pleased with the FDA's review and response. The
FDA has determined that the demonstrated safety of the product in preclinical
studies satisfy the regulatory requirements for initiating human testing."
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 elastin
proteins. 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.
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.
There is one urethral bulking agent currently approved by the FDA for
treatment of a subclass of SUI in which the urethral sphincter is unable to
close. The product, a suspension of cross-linked bovine collagen particles,
is 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 the treatment
decreases with time and multiple injection procedures are required to maintain
patient benefits. Additionally, about 3% of the patient population have
allergic reactions to the product.
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 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, compliance
with Nasdaq listing requirements, 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 Lisa Swann,
Director, Investor Relations, 619-558-6064, info@ppti.com, both
of Protein Polymer Technologies, Inc.
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