FDA Grants Protein Polymer Technologies Permissionto Begin Testing Its Incontinence Product in Humans
SAN DIEGO, May 20 - Protein Polymer Technologies, Inc. (Nasdaq: PPTI), today announced that it has received permission from the U.S. Food and Drug Administration (FDA) to begin human clinical testing of its urethral bulking agent for treatment of female stress urinary incontinence. Contingent upon the availability of working capital, the Company plans to begin enrolling patients in the 3rd quarter of 1999.
"The FDA's clearance for us to proceed with the clinical testing of our incontinence product is a major milestone for the Company" said PPTI's President and Chief Executive Officer, J. Thomas Parmeter. "The biomaterial and underlying technology on which the product is based had previously never been reviewed by the FDA, and so a significant educational effort was required. We are extremely pleased with the FDA's review and response. The FDA has determined that the demonstrated safety of the product in preclinical studies satisfy the regulatory requirements for initiating human testing."
PPTI's urethral bulking agent has been specifically designed to address the shortcomings in biocompatibility, ease of use, and durability associated with both existing treatments and those known to be under development. The Company's product is based on a patented new biomaterial having unique properties created by combining specific features of natural silk and elastin proteins. The material has been designed to be far less susceptible to absorption by the body compared to collagen or other materials that are derived from natural tissues.
According to the U.S. Department of Health and Human Services Agency for Health Care Policy and Research (1996), urinary incontinence, the involuntary loss of urine, affects approximately 13 million Americans, mostly women. It is generally recognized as one of the major causes of institutionalization of the elderly. The direct cost of caring for people with incontinence has been estimated to be over $16 billion per year.
Stress urinary incontinence (SUI) is the most common type of incontinence and is caused by failure of the urethral sphincter to prevent urine flow, particularly associated with physical activity. Treatments range from non-invasive behavioral training to abdominal surgery.
There is one urethral bulking agent currently approved by the FDA for treatment of a subclass of SUI in which the urethral sphincter is unable to close. The product, a suspension of cross-linked bovine collagen particles, is injected into the urethral tissues at the base of the bladder to increase the physical bulk of the sphincter, thus sealing the urethra to prevent involuntary urine leakage. However, the effectiveness of the treatment decreases with time and multiple injection procedures are required to maintain patient benefits. Additionally, about 3% of the patient population have allergic reactions to the product.
PPTI's urethral bulking agent will be tested in women suffering from all types of SUI. It has been developed to be an alternative to surgery that can be administered in an office-based procedure under local anesthesia. The product is unique in that it is injected as a fluid which quickly transforms to a gel within the urethral tissues. The Company believes this feature will offer significant advantages over preformed products that are difficult to inject or implant, and over particle-based products where the injected volume decreases over time as the carrier liquid dissipates and/or as particle migration may occur.
Protein Polymer Technologies, Inc., 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 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 include urethral bulking agents for the treatment of stress urinary incontinence, dermal augmentation products for cosmetic and reconstructive surgery, surgical 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 raising adequate capital to continue operations, compliance with Nasdaq listing requirements, 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 1998 Annual Report Form 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. |
