SAN DIEGO, Oct. 18 /PRNewswire/ -- Protein Polymer Technologies, Inc.
(OTC Bulletin Board: PPTI.OB), 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 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 1997 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.
SOURCE Protein Polymer Technologies, Inc.
 back to top
Company News On-Call:
http://www.prnewswire.com/comp/721876.html or fax,
800-758-5804, ext. 721876
CONTACT:
J. Thomas Parmeter, President, or Laura
Sarno, Vice President, Clinical Affairs, both of Protein Polymer
Technologies, Inc., 858-558-6064, info@ppti.com
|
