Protein Polymer Requests FDA Approval to Initiate Human Clinical Trials
of Dermal Augmentation Product
SAN DIEGO, October 18 -- Protein Polymer Technologies,
Inc. (OTC Bulletin Board: PPTI), announced that the Company is requesting
authorization from the U.S. Food and Drug Administration to begin human
clinical testing of its injectable dermal filler device for the correction
of dermal "contour deficiencies" (frown lines, worry lines, wrinkles, crow's
feet, facial scars, marionette lines, etc.). Pending FDA approval of the
Company's application (formally termed an "Investigational Device Exemption"
or IDE), the Company plans to initiate clinical trials later this year.
In 1998, there were 2.8 million cosmetic facial procedures
performed in the U.S. according to the American Academy of Cosmetic Surgery.
The principal reason people, both male and female, have such procedures
done is to improve their self-image. One popular procedure in the last decade
has been the injection of bovine collagen particles to correct dermal "contour
deficiencies." The procedure is appealling because it provides a noticeable
benefit with little recovery time and minimal risk of adverse effects. All
that is required is a quick visit to the physician's office, with resumption
of normal activities shortly thereafter. However, acceptance of the products
currently available has been less than expected, due primarily to the short
term durability of the cosmetic effect.
PPTI's injectable dermal filler device -- based on one
of its patented silk-elastin polymers -- is designed for use by dermatologists
and cosmetic surgeons for the treatment of contour deficiencies caused by
aging and environmental exposure, disease such as acne and cancer, and surgery.
Once injected into the skin, the material irreversibly transforms from a
polymer solution to a firm yet pliable hydrogel that can then be further
shaped and molded by the physician to create the desired appearance. Prior
feasibility studies in animals have shown the product to be effective for
contour correction, easy to use, biocompatible, non-immunogenic, resistant
to migration, and more durable than collagen-based products.
Currently, PPTI also is conducting human clinical testing
of a urethral bulking agent for the treatment of female stress urinary incontinence
based on the same underlying technology.
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 urethral bulking agent for the treatment
of stress urinary incontinence and its dermal filler device for correction
of dermal contour deficiencies include tissue adhesives and sealants, scaffolds
for wound healing and tissue engineering, and depots for local drug delivery.
This press release may contain forward-looking statements that are based on
management's 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
