Protein Polymer Announces the Initiation of Clinical Trials For Its Unique
Dermal Augmentation Product
SAN DIEGO, February 7 -- Protein Polymer Technologies,
Inc. (OTC Bulletin Board: PPTI), today announced FDA approval to initiate
human clinical trials of its injectable product for the correction of dermal
contour deficiencies (facial lines, wrinkles, and scars) caused by aging
and environmental exposure, disease such as acne and cancer, and surgery.
Trials are expected to begin later this month. The product formulation is
based on one of the Company's patented silk-elastin polymers. Once injected
into the skin, the solution irreversibly transforms into a pliable hydrogel
that is expected to yield a pleasing, durable cosmetic effect.
PPTI's dermal augmentation product has completed preclinical
testing and an Investigational Device Exemption (IDE) has been approved
by the FDA to begin human clinical testing. Preclinical studies in animals
have shown the product to be effective for contour correction, easy to use,
biocompatible, resistant to migration, and more durable than other products
currently being marketed. Last year, Protein Polymer initiated human clinical
trials of a similar product formulation for women suffering from stress
urinary incontinence. This injectable product is designed to eliminate or
alleviate female stress incontinence by adding bulk to muscles at the base
of the bladder to increase control over the release of urine.
"Both population demographics and increased demand for
improving one's appearance through cosmetic procedures make this an exciting,
growing market," said J. Thomas Parmeter, President and Chief Executive
Officer of Protein Polymer Technologies, Inc. "Dermatologists and cosmetic
surgeons continue to seek safe, effective, and more durable treatments for
correcting facial contour deficiencies in response to patient demand. This
unique dermal contouring product, in addition to the stress urinary incontinence
product already in clinical trials, fits our overall goal of providing new
classes of high performance biomaterials designed through genetic and protein
engineering to meet present and future needs in tissue repair and drug delivery."
Protein Polymer Technologies, Inc. (PPTI), 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. 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 in addition to its dermal contouring product include a
urethral bulking agent for the treatment of stress urinary incontinence,
tissue 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 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
1999 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.