Biomira announces Canadian New Drug Submission for Tru-Scint (R) AD (TM) Imaging Kits.EDMONTON, Alberta--(BUSINESS WIRE)--May 23, 1996--At its Annual Meeting today, Biomira's (TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). , ME SYMBOL:BRA)(NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on SYMBOL:BIOMF) President and 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. , Alex McPherson, announced that the Company has proceeded with a Canadian New Drug Submission for its Tru-Scint (R) AD (TM) imaging agent for the detection of recurrent breast cancer and of primary, residual or recurrent ovarian cancer, based on its Phase II clinical trials. Tru-Scint (R) AD (TM) is a diagnostic imaging agent which is currently in Phase II/III clinical trials in the United States. The NDS See eDirectory. NDS - Netware Directory Services in Canada is the equivalent of the Product License Application (PLA (Programmable Logic Array) A type of programmable logic chip (PLD) that contained arrays of programmable AND and OR gates. PLAs are no longer used. See PLD. (language, music) Pla - A high-level music programming language, written in SAIL. ) which would be filed for marketing such a biological product in the United States. "The Canadian Health Protection Branch (HPB) has indicated that the product qualifies for priority evaluation status or "fast-tracking" as it is a first entry new active substance which may provide more effective diagnosis of serious and life-threatening diseases. Under priority evaluation status, approval could be granted for Tru-Scint (R) AD (TM) imaging kits within a year. A Canadian approval would allow us to move this product candidate forward in a number of jurisdictions in the rest of the world while we continue with the US regulatory process for this product," said Alex McPherson. In Phase II clinical trials of Tru-Scint (R) AD (TM) kit, the antibody demonstrated its ability to identify sites of recurrent breast cancer in women with a suspicion of recurrent disease and in detecting both primary and recurrent ovarian cancer. In both indications the accuracy of detection was greater than 85 percent. The Tru-Scint (R) AD (TM) kit is a Technetium technetium (tĕknē`shēəm) [Gr. technetos=artificial], artificially produced radioactive chemical element; symbol Tc; at. no. 43; mass no. of most stable isotope 98; m.p. 2,200°C;; b.p. 4,877°C;; sp. gr. 11. 99m labelled monoclonal antibody which reacts with most adenocarcinomas and is an effective vehicle to target cancer cells. The patient is scanned using nuclear medicine imaging nuclear medicine imaging, n the diagnostic imaging field that evaluates organ function by injecting isotopes into a structure and documenting the amount of radiation emanating from the tissues. techniques and detection of radiotracer radiotracer /ra·dio·tra·cer/ (-tra´ser) radioactive tracer. ra·di·o·trac·er n. A radioactive isotope used as tracer. radiotracer a radioactive tracer. accumulation indicates the sites of cancer. Dr. McPherson also announced that the Company is planning to proceed with plans for an additional Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the to detect primary ovarian cancer, which is expected to start in early 1997. Data from the ovarian Phase II clinical trial will be presented on May 27, 1996, in Greece at the 13th International Hammersmith Conference "Advances in the Applications of Monoclonal Antibodies in Clinical Oncology". In March of this year Biomira announced the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval of TRUQUANT (R) BR (TM), its blood test kit for the detection of recurrent breast cancer. "Breast cancer has been an important focus for Biomira. Our approach to the management of cancer involves testing, imaging and therapy. Our development plan for commercialization of products for cancer management is now being realized. The approval of TRUQUANT (R) BR (TM) was the first phase of that plan. The next step is to move the imaging and therapeutic products to commercialization. Today's announcement of the filing of the NDS for Tru-Scint (R) AD (TM) moves us closer to the goal of providing a complete line of products for cancer management." Biomira is a biotechnology company specializing in developing novel diagnostic and therapeutic approaches for CANCER MANAGEMENT...from discovery to recovery (TM). This commitment to the diagnosis and treatment of cancer involves the development of blood tests and imaging agents for the detection of cancer recurrence, a test to evaluate patients' immune status, and non-toxic therapeutic vaccines and cellular therapies for the treatment of cancer. CONTACT: Biomira Inc., Edmonton Jane Jack, 403/490-2812 416/368-2511 - May 23-28, 1996 at the Royal York Hotel |
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