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Protein Polymer Technologies Requests FDA Approval To Initiate Human Clinical Trials
SAN DIEGO, Dec. 31 /PRNewswire/ -- Protein Polymer Technologies, Inc. (Nasdaq: PPTI - news), announced that the Company has requested authorization from the U.S. Food and Drug Administration to begin human clinical testing of its urethral bulking agent for treatment of female stress urinary incontinence. Pending FDA approval of the Company's application (formally termed an ''Investigational Device Exemption'' or IDE), the Company plans to initiate clinical trials in the second quarter of 1999.
Protein Polymer Technologies, Inc., is a San Diego-based company focused on developing products to improve medical and surgical outcomes. In addition to its urethral bulking agent for the treatment of stress urinary incontinence, other targeted products include dermal augmentation agents for cosmetic, plastic and reconstructive surgery, 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
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