Biomira presents cancer therapeutic vaccine data.EDMONTON, ALBERTA--(BUSINESS WIRE)--Feb. 14, 1995--Biomira's Director of Immunology, Mark Reddish, today presented interim data from ongoing Phase II clinical trials of THERATOPE (R) therapeutic vaccine therapeutic vaccine Immunology A vaccine–eg, Salk's Remune™ intended to treat a viral infection by stimulating the immune system. See Vaccine therapy. . The presentation, entitled Active Specific Immunotherapy of Adenocarcinomas Using Cancer-Associated Antigens was made at the Second Annual New Advances in Vaccine Technologies & Applications conference in Bethesda, Md. As noted in the presentation, more than 50 percent of the patients studied are still alive in both the breast and ovarian groups, thus median survival time, in these late stage patients, is not yet available. The current breast and ovarian survival data, although preliminary, when tracked against a variety of chemotherapy historical comparators, reveals THERATOPE (R) therapeutic vaccine to be as good as or possibly better than chemotherapy, without the toxicity associated with chemotherapeutic agents This is a list of specific pharmacologic agents that are known to be of use in the treatment of cancer, otherwise known as chemotherapeutic agents. This list is organized by "type" of agent, though the subsections are not necessarily definitive and are subject to revision. . In the colorectal clinical trials using THERATOPE (R) therapeutic vaccine, where mature data on 40 patients exists, the median survival is 14.4 months, which parallels historical data obtained from several previous chemotherapy trials for this type of tumour. "In the colorectal studies, a high titer titer /ti·ter/ (ti´ter) the quantity of a substance required to react with or to correspond to a given amount of another substance. of IgM antibody reactive with the target STn epitope epitope: see immunity. of the vaccine appeared to be associated with a longer survival time as compared to those patients who did not develop a high titer of IgM antibody. In the breast studies prolonged survival appeared to correlate with certain peripheral blood peripheral blood Cardiology Blood circulating in the system/body lymphocyte lymphocyte: see blood; immunity. lymphocyte Type of leukocyte fundamental to the immune system, regulating and participating in acquired immunity. Each has receptor molecules on its surface that bind to a specific antigen. populations that might reflect their activation to the vaccine," said Reddish. "To date the Phase II studies with THERATOPE (R) therapeutic vaccine have generated clinical and immunological information that is important for the design and assessment of future clinical trials with the vaccine. "These trials have also been designed to answer questions about the optimal formulation and dose for the vaccine and will help us identify where THERATOPE (R) therapeutic vaccine and our follow-on therapeutic vaccines will provide benefit in the clinical setting. While the reported survival trends are comparable to historical chemotherapy data for breast, ovarian and colorectal cancers, prospective, controlled, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. studies would be required to confirm these results," said Dennis Schneck, M.D., Ph.D., vice president of clinical and regulatory affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: Experimental animal data was also presented, showing enhanced immune responses to Biomira's THERATOPE (R) therapeutic vaccine when a newly reformulated adjuvant adjuvant /ad·ju·vant/ (aj?dbobr-vant) (a-joo´vant) 1. assisting or aiding. 2. a substance that aids another, such as an auxiliary remedy. 3. , DETOX(TM)-B-SE was used for emulsion. This adjuvant formulation has Food and Drug Administration approval for use in clinical testing and is now being used in Biomira's THERATOPE (R) therapeutic vaccine clinical trials at the University of Nebraska Medical Center In 1991, a technology transfer office was created known as UNeMed. In 1997, the UNMC hospital merged with the nearby hospital operated by Clarkson College to become what was later renamed The Nebraska Medical Center. and The University of Texas M.D. Anderson Cancer Center. The M.D. Anderson breast cancer study is the first clinical trial looking at THERATOPE (R) therapeutic vaccine in combination treatment with interferon. "Information from the new U.S. clinical trials will help us determine whether to pursue THERATOPE (R) therapeutic vaccine as a single agent treatment or whether the combination approach to treatment might show tumour responses as well as increased survival, in which case less extensive Phase III clinical trials would be required to confirm the data," added Schneck. Also announced in Bethesda was the start of a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I testing BP1-7 (MUC-1 Peptide), Biomira's second therapeutic vaccine. The first breast cancer clinical trial will be conducted in Canada and patient entry is expected to be completed this year. Biomira is a biotechnology company developing an integrated line of products for disease management of cancer. Its diagnostic products are TRUQUANT (R) radioimmunoassays, which are designed to assist in early diagnosis, and TRU-SCINT (R) radioimmunoimaging compounds, which identify locoregional disease. Therapeutic product candidates range from OVAREX (TM) therapeutic antibody kits, being investigated for use in treatment 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 , through to therapeutic vaccines. THERATOPE (R) therapeutic vaccine is being investigated for use in the treatment of breast, ovarian and colorectal cancers and BP1-7 (MUC-1 peptide) therapeutic vaccine is being investigated for treatment in breast cancer. CONTACT: Biomira Inc. Jane Jack, 403/490-2812 fax: 403/450-4772 or 301/657-1234 (Bethesda, Wednesday Only, Feb. 15, 1995) |
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