FDA Grants Protein Polymer Technologies Permission to Begin Testing Its
Incontinence Product in Humans
SAN DIEGO, May 20 -- 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.
