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Biotech / Medical : Oncothyreon -- Ignore unavailable to you. Want to Upgrade?

To: StockMiser who wrote (739)	5/15/1999 9:08:00 AM
From: Michael Brody	Read Replies (1) \| Respond to of 2344

SM, Here's some news off the Pr wire to start the weekend off right. THERATOPE(R) VACCINE DATA PUBLISHED AT AMERICAN SOCIETY OF CLINICAL ONCOLOGY Annual Meeting Company Releases Final Bridging Trial Data ATLANTA, May 15 /PRNewswire/ -- Biomira Inc. (Nasdaq: BIOM) (TSE, ME: BRA) announced today results of the THERATOPE(R) vaccine Bridging Study published in the 1999 American Society of Clinical Oncology (ASCO) Annual Proceedings under Official Abstract 1761. Charles Vogel, MD, FACP, of the Columbia Cancer Research Network, and colleagues reported that in an interim analysis, the improved formulation of THERATOPE(R) vaccine for metastatic breast cancer resulted in an enhanced immune response against the target cancer antigen. Biomira also released today final analysis of the Bridging Study. Following several Phase II studies with THERATOPE(R) vaccine, Biomira's researchers demonstrated that the strength of immune response to the vaccine appears to be correlated with improved survival. On the heels of these studies, the Company entered into a Bridging Study with an enhanced formulation of its lead product candidate. Biomira entered into a pivotal Phase III trial in late 1998 to enroll over 900 patients at approximately 75 sites worldwide after initial results of the Bridging Study suggested that the new formulation was as safe as the earlier version of the drug. Biomira has since completed analysis of data from the Bridging Study, and today announced that the final data confirm the enhanced product is more potent than the original formulation of THERATOPE(R) vaccine used in the Phase II studies. Blood samples from breast cancer patients treated in the Bridging Study were compared with blood samples from breast cancer patients treated in the Phase II trials in a blinded immunological test. The mean and median antibody titres against the STn-bearing mucin OSM were higher in the patients treated with the new formulation. The highest anti-OSM titres were found in patients in the Bridging Study, 35% having IgG titres greater than or equal to the highest titre achieved by only a single patient in the Phase II studies. This is statistically significant (p=0.03). "In the Phase II studies improved survival was seen for those patients who achieved higher titres against OSM. This prompted the question: can we improve THERATOPE(R) vaccine to induce higher titres in a greater number of patients? The final bridging study data confirms that the new formulation induces higher titres in a greater percentage of patients. This validates our decision to use the improved formulation in the Phase III study now underway," commented Dr. Grant MacLean, Vice-President Clinical and Regulatory Affairs. Also at ASCO, an investigator from the Fred Hutchinson Cancer Research Center is presenting data suggesting that THERATOPE(R) vaccine increases survival in ovarian and breast cancer patients following high-dose chemotherapy and autologous stem cell rescue. ASCO's 1999 Annual Meeting is currently ongoing at the Georgia World Congress Center and is featuring over 150 scientific and educational presentations, as well as an exhibition with over 250 industry representatives. It is the largest professional meeting on clinical data about new cancer therapies.

To: StockMiser who wrote (739)	5/15/1999 9:12:00 AM
From: Michael Brody	Read Replies (1) \| Respond to of 2344

Sm, and here's a second piece of news. (Applies to: BIOM BIOMF) STUDY SUGGESTS VACCINE INCREASES SURVIVAL IN OVARIAN AND BREAST CANCER Patients Following High-Dose Chemotherapy and Autologous Stem Cell Transplant Fred Hutchinson Cancer Research Center Researcher Presents Results at American Society of Clinical Oncology Meeting in Atlanta ATLANTA, May 15 /PRNewswire/ -- A new study suggests that the administration of an experimental cancer vaccine following autologous stem cell transplant can increase survival and decrease relapse in ovarian and breast cancer patients when compared to the stem cell transplant procedure alone. The data was presented today at the 35th annual meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, May 15-18, 1999. The research team at the Fred Hutchinson Cancer Research Center, led by Leona Holmberg, M.D., Ph.D., and Brenda Sandmaier, M.D., treated 40 cancer patients (11 high-risk stage II/III breast, 22 stage IV breast and 7 stage III/IV ovarian) with high-dose chemotherapy followed by autologous/syngeneic stem cell transplantation. Twenty-six of the 40 patients also received five doses of THERATOPE(R) vaccine (STn-KLH), a therapeutic vaccine being developed by Biomira, Inc. of Alberta, Canada (Nasdaq: BIOM) (TSE, ME: BRA) that induces the body's immune system to mount a response against cancerous cells. All patients were treated between Sept. 1, 1995 and Nov. 18, 1997. To gain preliminary evidence of the potential efficacy of the THERATOPE(R) vaccine, the outcome of vaccinated patients was retrospectively compared to the outcome of patients not vaccinated. Investigators found that the chance of death was more than 2 times greater among patients in the control group compared to patients vaccinated with THERATOPE(R) vaccine. The chance of relapse was approximately 1.7 times greater for patients in the control group compared to those vaccinated. In addition, those vaccinated patients with the highest amount of specific killing activity against STn-bearing cancer cells appeared to remain the longest in remission. According to Dr. Holmberg, "THERATOPE(R) vaccine was well tolerated after autologous stem cell transplant and appeared to decrease the relative risk for relapse and death. These results need to be considered within the debate over hematopoietic stem cell transplant as a treatment for advanced stage IV disease." "The use of immunotherapy is more likely to be successful when there is significant reduction in tumor burden," added Dr. Sandmaier. "In advanced disease states, more aggressive therapy combined with therapy to stimulate the patient's own immune system may prove to be effective therapy." The cancer vaccine used in the study, THERATOPE(R) vaccine, is currently being evaluated in a pivotal Phase III clinical trial which will involve 900 evaluable patients with metastatic breast cancer at approximately 75 sites worldwide. ASCO's 1999 Annual Meeting is being held at the Georgia World Congress Center and features over 150 scientific and educational presentations, as well as an exhibition with over 250 industry representatives. It is the largest professional meeting on clinical data about new cancer therapies. The Fred Hutchinson Cancer Research Center is an independent, non-profit research institution dedicated to the development and advancement of biomedical technology to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone marrow transplantation, the Center has four scientific divisions collaborating to form a unique environment for conducting basic and applied science. One of 35 National Cancer Institute-designated comprehensive cancer centers in the country, it is the only one in the Northwest. More information is available on the Hutchinson Center web site at fhcrc.org .