Biomira Presents Ovarian Data from Tru-Scint (R) AD (TM) Phase 11 Clinical Trial.EDMONTON, Alberta--(BUSINESS WIRE)--May 28, 1996-- Biomira Inc. today announced that Graeme Boniface Boniface (bŏn`əfās), d. 432, Roman general. He defended (413) Marseilles against the Visigoths under Ataulf. Having supported Galla Placidia in her struggle with her brother, Emperor Honorius, Boniface fled to Africa in 422. , Ph.D., Biomira's director of clinical affairs, presented data from the Company's Phase II clinical trials of its Tru-Scint (R) AD (TM) imaging agent for detection of ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast , at the 13th Hammersmith Conference "Advances in the Application of Monoclonal Antibodies in Clinical Oncology" in Crete, Greece. Dr. Boniface reported that in 49 women over the age of 40 suspected of having ovarian cancer, the Tru-Scint (R) AD (TM) imaging agent detected ovarian cancer with an accuracy of 92 per cent. The Tru-Scint (R) AD (TM) kit incorporates a monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing which reacts with most adenocarcinomas and is an effective vehicle to target cancer cells. This antibody is labelled with 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, a safe low cost radioisotope radioisotope: see radioactive isotope. Radioisotope (biology) A radioactive isotope used in studying living systems, such as in the investigation of metabolic processes. . 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. The Tru-Scint (R) AD (TM) imaging agent is currently in Phase II/III clinical trials in the United States for the detection of recurrent breast cancer. At its Annual Meeting on May 23, the Company announced that it has proceeded with a Canadian New Drug Submission for its Tru-Scint (R) AD(TM) imaging agent for the detection of primary, residual or recurrent ovarian cancer, as well as recurrent breast cancer, based on the results of its Phase II clinical trials. 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 has granted the product priority evaluation status since it is a first entry new active substance which may provide more effective diagnosis of serious and life threatening diseases. Dr. Boniface reported that in a study of 77 patients, the Tru-Scint (R) AD (TM) kit detected primary ovarian cancers, residual ovarian cancer following surgery, and recurrences in patients previously diagnosed with ovarian cancer, with a sensitivity of 89 per cent, specificity of 81 per cent and accuracy of 86 per cent. These evaluators measure the precision of the test. In the 49 women over the age of 40 who were suspected of having ovarian cancer, the Tru-Scint (R) AD (TM) imaging kit showed a sensitivity, specificity and accuracy of 92 per cent, for all three indicators. The product candidate showed a high safety profile in clinical trials. "The Tru-Scint (R) AD (TM) kit is currently in U.S. Phase II/III clinical trials for the detection of recurrent breast cancer. The compelling data reported today by Dr. Boniface has led to the corporate decision to pursue Phase III clinical trials for the detection of ovarian cancer in Europe and the U.S. to support marketing applications in those two jurisdictions. The Tru-Scint (R) AD (TM) kits could be a valuable tool in the evaluation and management of women suspected of having ovarian cancer," said Biomira's Vice President of Clinical and Regulatory Affairs, Dr. Grant MacLean. 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, a test to evaluate patients' immune status, and non-toxic therapeutic vaccines and cellular therapies for the treatment of cancer. CONTACT: Biomira Inc. Jane Jack, Investor Relations Investor relations The process by which the corporation communicates with its investors. Co-ordinator, 403/490-2812 |
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