Bio-Technology General Reports Interim Phase II Results of Fibrimage
Initiation of Phase III Study Planned for Third Quarter
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Wednesday June 30, 8:31 am Eastern Time
Company Press Release
Bio-Technology General Reports Interim Phase II Results of Fibrimage
Initiation of Phase III Study Planned for Third Quarter
ISELIN, N.J.--(BUSINESS WIRE)--June 30, 1999--Bio-Technology General Corp. (NASDAQ:BTGC - news) today announced that the investigators involved in the Phase II study of Fibrimage®, 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 earlier this month.
Based on the interim results, the investigators concluded that Fibrimage® is proving to be a very promising radiopharmaceutical for the detection of DVT.
Fibrimage® is the lead product among several radiopharmaceuticals under development by DRAXIMAGE Inc., the DRAXIS Health Inc. (TSE: DAX - news; NASDAQ:DRAXF - news) radiopharmaceutical subsidiary. Fibrimage® is based upon Fibrin Binding Domain (FBD), a recombinant polypeptide with high binding affinity for fibrin, which is the primary component of venous thrombus. FBD was developed by Bio-Technology General Corp. and is licensed to DRAXIMAGE on an exclusive, worldwide basis. Under the terms of the license agreement, BTG will receive a royalty on all commercial sales of Fibrimage®.
Patient qualification for the Phase II study was based on a presumptive clinical diagnosis of DVT and supported by ultrasound and a positive d-dimer test, whether the patient was on heparin anticoagulant therapy or not. All qualifying patients were then injected with Fibrimage® 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® had a positive correlation with the initial diagnosis of 72% after 30 minutes and 84% overall. These data suggest a high probability of rapid confirmation of clinical diagnosis of acute DVT with Fibrimage® within a shorter time frame than that required to reach a definitive diagnosis with the combination of ultrasound and a d-dimer test. Fibrimage® could therefore represent a novel diagnostic tool with significant potential value.
The Phase II investigation with respect to the first 18 patients was reported on by Dr. R. Taillefer 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.
DRAXIMAGE expects that the Phase II study target enrollment will be completed this quarter and plans to commence Phase III studies in Q3 1999.
DVT is a serious medical condition caused by the spontaneous formation of blood clots (i.e. thrombi) in the lower limbs. An individual with DVT is exposed to the risk that a portion of the clot can unpredictably break free and result in a blockage of blood flow to the lungs - known as pulmonary embolism. It is estimated that in the United States over 2,000,000 people are afflicted with DVT annually and that approximately 200,000 deaths per year are attributable, directly or indirectly, to pulmonary embolism, the vast majority of which arise from DVT.
FBD is covered in the United States by several composition of matter and use patents, all of which are assigned to BTG. Corresponding patents have been filed and are pending in other countries.
Bio-Technology General Corp., a leading biopharmaceutical company, develops, manufactures and markets genetically engineered and other products for human healthcare. The Company's worldwide 1998 product sales were $68.2 million.
Statements in this news release concerning the Company's business outlook or future economic performance; anticipated profitability, revenues, expenses or other financial items; and statements concerning assumptions made or expectations as to any future events, conditions performance or other matters, are ''forward-looking statements'' as that term is defined under the Federal Securities Laws. Forward-looking statements are subject to risks, uncertainties and other factors which could cause actual results to differ materially from those states in such statements. Such risks, uncertainties and factors include, but are not limited to, changes and delays in product development plans and schedules, customer acceptance of new products, changes in pricing or other actions by competitors, patents owned by the Company and its competitors, and general economic conditions, as well as other risks detailed in the Company's filings with the Securities and Exchange Commission.
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