MIV Therapeutics Reports Successful Progress of Animal Studies on Proprietary Hydroxyapatite Coatings for Coronary Stents
Friday April 15, 5:21 pm ET Positive Results Open Door for Next Phase Studies in Path towards Commercialization of Passive and Drug-Eluting Coatings
VANCOUVER, British Columbia--(BUSINESS WIRE)--April 15, 2005-- MIV Therapeutics, Inc. (OTCBB: MIVT - News) a developer of next-generation biocompatible stent coatings and drug delivery technologies, has reported positive results from several scientific animal studies of the Company's proprietary ultra-thin Hydroxyapatite coating for cardiovascular stents and other implantable medical devices. These highly encouraging results open the door for the next phase of testing, that are required on the path toward product commercialization of both the Company's advanced passive and drug-eluting coating technologies based on Hydroxyapatite (HAp).
"We are extremely pleased with preliminary results from these animal trials," said Alan Lindsay, President and CEO of MIVT. "At this stage of preparations for clinical trials we are particularly interested in confirmation of consistent and problem-free performance of stents with our proprietary HAp coating. Positive outcome from animal trials provided us with significant additional assurances regarding the expected safety and biocompatibility of our coating technologies."
The tests confirmed excellent performance in both MIVT's passive HAp-based coatings as well as its active, drug-eluting coatings. The passive coatings are designed to improve the body's response to implanted vascular stents or other medical devices. The active drug-eluting coatings provide advanced therapeutic capabilities, enabling medicines to be impregnated into MIVT proprietary coating formulae and then released once implanted in a time- and dosage-controlled manner directly in the implantation point, where the drugs can have the optimal therapeutic effect.
"The preliminary evaluation of MIVT's prototype drug-eluting systems, based on our proprietary drug eluting formulae, also delivered extremely encouraging results," added Mr. Lindsay.
Here is a summary of the results of the animal studies on MIVT's HAp coatings.
September 2004 - in vivo safety study performed on rabbits at the University of Cape Town, South Africa, prove MIVT coating does not cause any adverse arterial responses and demonstrates safety.
October 2004 - preliminary in-vivo Pilot Coronary Arteries Implantation Study conducted at The Methodist DeBakey Heart Centre in Houston, Texas, suggests favorable healing, with complete endothelialization and stable neointima.
December 2004 - Pathology study of four different proprietary coating technologies concluded at the Cardiovascular Pathology Laboratory of Texas Heart Institute, Houston, Texas. HAp coated stents demonstrated exceptional biocompatibility and safety -- a positive attribute rarely encountered in polymer coatings.
December 2004 - Preclinical long-term evaluation of "passive" HAp coating commenced at the Cardiovascular Pathology Laboratory of Texas Heart Institute, Houston, Texas. The study, titled "Preclinical Evaluation of Hydroxyapatite Stent Coating in Porcine Vasculature; A Safety and Biocompatibility Study of the Stent Coating Formulation D4080 in Porcine Coronary Arteries," evaluated the safety of stents coated with ultra-thin hydroxyapatite coating in 24 Yucatan pigs which also carry bare metal stents as comparative controls. The study has follow-up planned at 4 weeks, 12 weeks and 26 weeks after implanting, and is performed in full compliance with GLP and regulatory requirements. The 4-week and 12-week arms of the study were already completed successfully and are awaiting formal reports. At the time of writing of this report there was no loss of animal life during this study, and all implanted animals were in good health. December 2004 - January 2005 - MIVT performed preliminary short-term animal study of MIVT's proprietary drug-eluting formulae. The study was conducted to provide an early indication of performance of cardiovascular stents coated with novel drug eluting composite in back-to-back comparisons of the performance of equivalent bare metal stents. The scope of the study includes angiography, intravascular ultrasound and histology as well as operational characteristics, safety and biocompatibility of coated stents. This study was completed successfully and is awaiting a final report.
"We are progressing systematically through comprehensive range of in-vitro and in-vivo evaluations which must be completed ahead of clinical trials," said Arc Rajtar, VP Operations, who coordinates MIVT's R&D program. "We have a dedicated R&D team that drives our innovations and helps maintain our program on budget and on time. These successful evaluations of our drug-eluting prototypes have opened an avenue for potential use of our proprietary technologies to a broad range of drug delivery systems that extend beyond cardiovascular applications. We intend to focus on exciting opportunities in this area in the near future."
About MIV Therapeutics
MIV Therapeutics is developing a next generation line of advanced biocompatible coatings for passive and drug-eluting application on cardiovascular stents and other implantable medical devices. MIVT's ultra-thin coating formulation is designed primarily to protect surrounding tissue from the chemical interaction of metal stents. MIVT's ultra-thin coating has been derived from a unique biocompatible material called hydroxyapatite (HAp) that demonstrated during in-vivo animal trials excellent safety and superior healing properties pursued by the medical science in the field of advanced implantable drug delivery systems. Hydroxyapatite is a bioactive porous material that makes up the bone mineral and matrix of teeth. It is widely used as a bone substitute material and for coating implantable fixation devices in orthopedic, dental and other applications. MIVT reached a Collaborative Research Agreement (CRA) with the University of British Columbia and received a research and development grant from the Natural Sciences and Engineering Research Council of Canada (NSERC) in 2002 for the development of hydroxyapatite as a drug eluting coating. In December 2004 MIVT received a Government grant for the research program titled "Development of Novel Drug Eluting Composite Coatings for Cardiovascular Stents" under the National Research Council - Industrial Research Assistance Program (NRC-IRAP). Under this sponsorship the Company will progress to the development stage, which is expected to finalize the drug-eluting research and development program.
Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements. Such statements are indicated by words or phrases such as "believe", "will", "breakthrough", "significant", "indicated", "feel", "revolutionary", "should", "ideal", "extremely" and "excited". These statements are made under "Safe Harbor" provisions of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those described in forward-looking statements and are subject to risks and uncertainties. See the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's recent Form 10-K and Form 10-Qs, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
-------------------------------------------------------------------------------- Contact: MIV Therapeutics Inc. Investors: Dan Savino, 800-221-5108 ext.16 Fax: 604-301-9546 dsavino@mivi.ca or Trilogy Capital Partners Investors: Paul Karon, 800-342-1467 paul@trilogy-capital.com or Product inquiries and business opportunities: Arc Rajtar, 604-301-9545 ext.22 arajtar@mivi.ca
-------------------------------------------------------------------------------- Source: MIV Therapeutics Inc.
Posts: 433 | Registered: Jun 2004
| IP: Logged |
UBBFriend: Email this page to someone!
Printer-friendly view of this topic
