DRAXIS Reports Presentation of Interim Phase II Results of Fibrimage at Society of Nuclear Medicine Meeting.
DRAXIS Health Inc. (NASDAQ:DRAXF) (TSE:DAX.) announced today that the investigators involved in the Phase II study of Fibrimage(R), a novel Technetium-99m radiopharmaceutical for the imaging of active thrombus in Deep Vein Thrombosis (DVT), presented their interim results at the Society of Nuclear Medicine Meeting held in Los Angeles last week.
Based on the interim results, the investigators concluded that Fibrimage(R) is a new and very promising radiopharmaceutical for the detection of DVT.
Fibrimage(R) is the lead product among several radiopharmaceuticals under development by DRAXIMAGE Inc., the DRAXIS radiopharmaceutical subsidiary.
Patient qualification for the Phase II study was based on a presumptive diagnosis of DVT supported by an ultrasound and a positive d-dimer test, whether the patient was on heparin or not. All qualifying patients were then injected with Fibrimage(R) and subjected to imaging 30 minutes, 2 hours and 4-6 hours following injection.
Interpretations of the images were carried out by three separate blinded experienced observers who made their interpretation without reference to any other clinical information.
For the first 18 patients in the Phase II study, the imaging procedure utilizing Fibrimage(R) had a positive correlation with the initial diagnosis of 72 percent after 30 minutes and 84 percent overall.
The investigation was reported on by Dr. R. Taillefer, MD, FRCP, ABNM, of the Centre Universitaire de Montreal Campus Hotel Dieu, Montreal, Canada reporting on behalf of himself and his co-investigators Drs. R. Lambert, L. Boucher, P. Wells, A. Driedger, and M. Kovacs.
The Company expects that the Phase II study target enrollment will be completed this quarter and to commence Phase III studies in the third quarter of 1999.
DRAXIS Health Inc. is a diversified and fully integrated pharmaceutical company operating in three niche markets: Companion Animal Health (through its global alliance with Pfizer Inc.) Radiopharmaceuticals (DRAXIMAGE) and Canadian sales and marketing (DRAXIS Pharmaceutica). DRAXIS supports its own as well as third party manufacturing requirements through its subsidiary, DRAXIS Pharma, located in Kirkland, Quebec.
Except for historical information, this news release contains certain forward-looking statements that involve risk and uncertainties, which may cause actual results to differ materially from the statements made. Such factors include, but are not limited to, changing market conditions, clinical trial results, the establishment of new corporate alliances, the impact of competitive products and pricing, the timely development, regulatory approval and market acceptance of the Company's products, and other risks detailed from time-to-time in the Company's filings with the U.S. Securities and Exchange Commission and Canadian securities authorities.
|Printer friendly Cite/link Email Feedback|
|Date:||Jun 17, 1999|
|Previous Article:||Onsale and Intuit Launch Live Auction Feed to Quicken.com; Wholesale Computer Equipment and Other Products Available To Small Businesses Online.|
|Next Article:||Flushing Financial Corporation Announces Sixth Stock Repurchase Program.|