BIOSYNTECH Announces Successful Results of Preclinical Safety Evaluation of BST-GEL.Business Editors LAVAL, Quebec--(BUSINESS WIRE)--Sept. 25, 2000 BIOSYNTECH Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : BSYI) today announced it has successfully completed pre-clinical safety and evaluation studies of one of its lead products, BST-GEL(TM), an injectable, thermo-sensitive hydrogel hy·dro·gel n. A colloidal gel in which the particles are dispersed in water. hydrogel a gel that contains water. hydrogel Wound care A polymer absorptive wound dressing. See Dressing. for therapeutics delivery. The studies showed BST-GEL(TM) to have no systemic toxic effects at dose levels up to 100 times greater than would be used in clinical therapy. The pre-clinical acute and sub-chronic repeat-dose subcutaneous animal toxicology trials were performed at ITR See Internet Talk Radio. Laboratories Canada Inc., in full compliance with the Good Laboratory Practice (GLP See gateway location protocol. ) Regulations of the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. . "The successful completion of these pre-clinical studies is very encouraging," said Dr. Ajay Gupta, Vice-President of Business and Product Development. "BST-GEL(TM) is at the core of the development of a wide array of innovative biomedical products in many different therapeutic areas." The BST-GEL(TM) was also found to localize as a deposit at the site of administration by injection, without causing any inflammatory response or other obvious indications of systemic effects, such as overt clinical signs, mortality, and loss of appetite loss of appetite Medtalk Anorexia, see there or of body weight. The terminal investigations in the sub-chronic studies showed no significant changes in the organ weights and gross pathology findings were limited to localized deposits of BST-GEL(TM) at injection sites without evidence of encapsulation or other adverse biological response. "We are very pleased with the safety profile emerging from these pre-clinical evaluations of BST-GEL(TM)," commented Marie-Claire Pilon, recently appointed CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of BIOSYNTECH. "With these results, we will be moving forward aggressively, as planned, to the next phase of clinical assessment." BIOSYNTECH is an advanced biomaterials company specializing in tissue engineering, the delivery of advanced injectable biomaterials and biotherapeutic agents. This press release contains certain "forward-looking" statements, as defined in the united states private securities litigation reform act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management's current expectations. such factors are detailed from time to time in the company's filings with the regulatory authorities having jurisdiction. no regulatory authority has approved or disapproved the content of this release. |
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