Protein Polymer Announces the Initiation
of Clinical Trials For Its Unique Dermal Augmentation Product
SAN DIEGO, March
29 -- Protein Polymer Technologies, Inc. (OTC Bulletin Board: PPTI), today
announced that it has begun recruiting patients for a pilot clinical study
of the safety and effectiveness of PPTI's 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. The product formulation is based on one of the Company's patented
silk-elastin polymers. Once injected into the skin, and following physician
manipulation for cosmetic effect, the solution irreversibly transforms into
a pliable hydrogel that is expected to yield a pleasing, durable cosmetic
effect.
PPTI's preclinical studies that supported the approval
of an Investigational Device Exemption (IDE) to begin the pilot clinical
study have shown the product to be effective for contour correction, easy
to use, biocompatible, and resistant to migration. Preclinical studies also
demonstrated that PPTI's product was significantly more durable than the
leading collagen-based product marketed for dermal augmentation.
"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
product is an ideal fit with our 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 regeneration."
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 adhesive bulking agent for the treatment of stress
urinary incontinence, tissue adhesive and sealant formulations for the repair
of Spinal discs, 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 2000 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.