المتابع اليومي
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- التسجيل
- 11 يوليو 2003
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- 216
cvm&biom ونجاح التجارب
Financial News
Press Release Source: CEL-SCI Corporati
CEL-SCI Announces New Conference Webcast
Monday December 8, 8:04 am ET
VIENNA, Va., Dec. 8 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION (Amex: CVM - News) announces the following Webcast:
What: CEL-SCI Corporation News Conference
When: December 8, 2003 @ 11:00 a.m. EST
Where: http://www.videonewswire.com/event.asp?id=19208
How: Live over the Internet -- Simply log on to the web at the
address above.
Contact: Gavin de Windt (703) 506-9460
The webcast will discuss the science behind the new discovery that Multikine cancer immunotherapy may significantly increase the kill rate of cancer cells from radiation therapy.
CEL-SCI Corporation is developing new immune system based treatments for cancer and infectious diseases. The Company has operations in Vienna, Virginia and Baltimore, Maryland.
biom
Financial News
Press Release Source: Biomira Inc.
Data from Biomira's Theratope(R) Vaccine clinical trial presented at 26th Annual San Antonio Breast Cancer Symposium
Monday December 8, 7:30 am ET
EDMONTON, AB, Dec. 8 /PRNewswire-FirstCall/ - Biomira Inc. (Nasdaq:BIOM - News; TSX:BRA - News) and Merck KGaA of Darmstadt, Germany today announced that data from the final analysis of their Theratope® Vaccine Phase III clinical trial in women with metastatic breast cancer were presented at the 26th Annual San Antonio Breast Cancer Symposium (SABCS) on December 6, 2003. David W. Miles, MD, BSc, FRCP, Senior Lecturer and Honorary Consultant in Medical Oncology at Guy's Hospital in London, England and principal clinical investigator in the trial presented the results in an oral presentation. Dr. Alex McPherson, President and CEO of Biomira Inc., and Ms. Nancy Wysenski, President of EMD Pharmaceuticals Inc., Merck KGaA's wholly owned U.S. subsidiary, will discuss this presentation and the trial results in a conference call today at 9:00 a.m. Eastern Time.
ADVERTISEMENT
Theratope is an investigational therapeutic cancer vaccine that consists of a synthetic version of the tumour-associated antigen Sialyl Tn (STn) linked to the protein carrier, keyhole limpet hemocyanin (KLH), and is designed to stimulate an immune response to STn. The Phase III trial randomized 1,028 women with metastatic breast cancer. The primary objectives of the trial were to compare time to disease progression and survival in patients receiving Theratope vaccine and those on the KLH control arm of the study. Secondary objectives were to document the product safety profile, to measure anti-STn, anti-OSM, and anti-KLH antibody titres and to evaluate the impact of Theratope vaccine therapy on patients' health-related quality of life.
Biomira and its collaborator Merck KGaA announced in June that the Phase III trial of Theratope did not meet the two pre-determined statistical endpoints of time to disease progression and overall survival. However, in one pre-stratified subset of more than 300 women who received hormonal treatment following chemotherapy, those on the Theratope arm appeared to show a favourable trend toward improvement in survival.
Exploratory analyses were conducted, that included five additional months of survival follow-up and adjustments correcting for mis-stratifications and mis-randomizations. From these analyses, results for the subgroup of patients on hormonal therapy showed a median time to disease progression of 8.3 months for patients treated with Theratope versus 5.8 months for those patients on control (Cox p(equal sign)0.220; Log Rank p(equal sign)0.207). The median survival was 38.2 months in the Theratope arm versus 30.7 months in the control arm (Cox p(equal sign)0.077; Log Rank p(equal sign)0.066), a difference of 7.5 months.
"We continue exploratory analyses of the Phase III trial data and we are investigating possible theories to explain the findings in this study," said Alex McPherson. "In previous Phase II studies, peak immune responses were seen after 12 weeks, however, time to disease progression for most of the Phase III patients who were not on concurrent hormonal therapy was less than 12 weeks. One possible theory is that when the Phase III patients who were not on hormonal therapy progressed and were taken off Theratope, their immune systems had not had time to obtain a maximum response. This theory suggests that if patients had the opportunity to stay on Theratope longer, as was the case with the patients on concurrent hormonal therapy, this may have allowed their immune systems more time to respond.
Based on our assessment of the data to date, we are not planning to seek a registration for this product at this time," said McPherson. "We do, however, believe that there may be scientific rationale from these Phase III data to continue with the development plans for Theratope. Once our strategy has matured, we intend to discuss our plans, which may include a registration trial, with the regulatory authorities."
"We wish to thank the many women who participated in this clinical trial and the investigators from around the world who helped in completing this important research," said Nancy Wysenski.
The Companies
Biomira is a biotechnology company specializing in the development of innovative therapeutic approaches to cancer management. Biomira's commitment to the treatment of cancer currently focuses on the development of synthetic vaccines and novel strategies for cancer immunotherapy. We are The Cancer Vaccine People(TM).
Merck KGaA was founded in 1668 and has positioned itself to be on the cutting edge of cancer research with an oncology portfolio based on four technology platforms - monoclonal antibodies, vaccines, immunocytokines and angiogenesis inhibitors.
Conference Call Details
To participate in the conference call, analysts are invited to call 1-888- 295-1311 (USA/Canada), 0-800-917-4860 (United Kingdom) or 0-800-1815-287 (Germany). For the general public, the call will be Web cast and live or archived listening may be accessed through the Company's Web site at www.biomira.com.
This release may contain forward-looking statements. Various factors could cause actual results to differ materially from those projected in forward-looking statements, including those predicting the timing and results of clinical trials and additional analyses, potential meetings with regulatory authorities, availability or adequacy of financing, the sales and marketing of commercial products or the efficacy of products. Although the Company believes that the forward-looking statements contained herein are reasonable, it can give no assurance that the Company's expectations are correct. All forward- looking statements are expressly qualified in their entirety by this cautionary statement.
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Source: CEL-SCI Corporation
Financial News
Press Release Source: CEL-SCI Corporati
CEL-SCI Announces New Conference Webcast
Monday December 8, 8:04 am ET
VIENNA, Va., Dec. 8 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION (Amex: CVM - News) announces the following Webcast:
What: CEL-SCI Corporation News Conference
When: December 8, 2003 @ 11:00 a.m. EST
Where: http://www.videonewswire.com/event.asp?id=19208
How: Live over the Internet -- Simply log on to the web at the
address above.
Contact: Gavin de Windt (703) 506-9460
The webcast will discuss the science behind the new discovery that Multikine cancer immunotherapy may significantly increase the kill rate of cancer cells from radiation therapy.
CEL-SCI Corporation is developing new immune system based treatments for cancer and infectious diseases. The Company has operations in Vienna, Virginia and Baltimore, Maryland.
biom
Financial News
Press Release Source: Biomira Inc.
Data from Biomira's Theratope(R) Vaccine clinical trial presented at 26th Annual San Antonio Breast Cancer Symposium
Monday December 8, 7:30 am ET
EDMONTON, AB, Dec. 8 /PRNewswire-FirstCall/ - Biomira Inc. (Nasdaq:BIOM - News; TSX:BRA - News) and Merck KGaA of Darmstadt, Germany today announced that data from the final analysis of their Theratope® Vaccine Phase III clinical trial in women with metastatic breast cancer were presented at the 26th Annual San Antonio Breast Cancer Symposium (SABCS) on December 6, 2003. David W. Miles, MD, BSc, FRCP, Senior Lecturer and Honorary Consultant in Medical Oncology at Guy's Hospital in London, England and principal clinical investigator in the trial presented the results in an oral presentation. Dr. Alex McPherson, President and CEO of Biomira Inc., and Ms. Nancy Wysenski, President of EMD Pharmaceuticals Inc., Merck KGaA's wholly owned U.S. subsidiary, will discuss this presentation and the trial results in a conference call today at 9:00 a.m. Eastern Time.
ADVERTISEMENT
Theratope is an investigational therapeutic cancer vaccine that consists of a synthetic version of the tumour-associated antigen Sialyl Tn (STn) linked to the protein carrier, keyhole limpet hemocyanin (KLH), and is designed to stimulate an immune response to STn. The Phase III trial randomized 1,028 women with metastatic breast cancer. The primary objectives of the trial were to compare time to disease progression and survival in patients receiving Theratope vaccine and those on the KLH control arm of the study. Secondary objectives were to document the product safety profile, to measure anti-STn, anti-OSM, and anti-KLH antibody titres and to evaluate the impact of Theratope vaccine therapy on patients' health-related quality of life.
Biomira and its collaborator Merck KGaA announced in June that the Phase III trial of Theratope did not meet the two pre-determined statistical endpoints of time to disease progression and overall survival. However, in one pre-stratified subset of more than 300 women who received hormonal treatment following chemotherapy, those on the Theratope arm appeared to show a favourable trend toward improvement in survival.
Exploratory analyses were conducted, that included five additional months of survival follow-up and adjustments correcting for mis-stratifications and mis-randomizations. From these analyses, results for the subgroup of patients on hormonal therapy showed a median time to disease progression of 8.3 months for patients treated with Theratope versus 5.8 months for those patients on control (Cox p(equal sign)0.220; Log Rank p(equal sign)0.207). The median survival was 38.2 months in the Theratope arm versus 30.7 months in the control arm (Cox p(equal sign)0.077; Log Rank p(equal sign)0.066), a difference of 7.5 months.
"We continue exploratory analyses of the Phase III trial data and we are investigating possible theories to explain the findings in this study," said Alex McPherson. "In previous Phase II studies, peak immune responses were seen after 12 weeks, however, time to disease progression for most of the Phase III patients who were not on concurrent hormonal therapy was less than 12 weeks. One possible theory is that when the Phase III patients who were not on hormonal therapy progressed and were taken off Theratope, their immune systems had not had time to obtain a maximum response. This theory suggests that if patients had the opportunity to stay on Theratope longer, as was the case with the patients on concurrent hormonal therapy, this may have allowed their immune systems more time to respond.
Based on our assessment of the data to date, we are not planning to seek a registration for this product at this time," said McPherson. "We do, however, believe that there may be scientific rationale from these Phase III data to continue with the development plans for Theratope. Once our strategy has matured, we intend to discuss our plans, which may include a registration trial, with the regulatory authorities."
"We wish to thank the many women who participated in this clinical trial and the investigators from around the world who helped in completing this important research," said Nancy Wysenski.
The Companies
Biomira is a biotechnology company specializing in the development of innovative therapeutic approaches to cancer management. Biomira's commitment to the treatment of cancer currently focuses on the development of synthetic vaccines and novel strategies for cancer immunotherapy. We are The Cancer Vaccine People(TM).
Merck KGaA was founded in 1668 and has positioned itself to be on the cutting edge of cancer research with an oncology portfolio based on four technology platforms - monoclonal antibodies, vaccines, immunocytokines and angiogenesis inhibitors.
Conference Call Details
To participate in the conference call, analysts are invited to call 1-888- 295-1311 (USA/Canada), 0-800-917-4860 (United Kingdom) or 0-800-1815-287 (Germany). For the general public, the call will be Web cast and live or archived listening may be accessed through the Company's Web site at www.biomira.com.
This release may contain forward-looking statements. Various factors could cause actual results to differ materially from those projected in forward-looking statements, including those predicting the timing and results of clinical trials and additional analyses, potential meetings with regulatory authorities, availability or adequacy of financing, the sales and marketing of commercial products or the efficacy of products. Although the Company believes that the forward-looking statements contained herein are reasonable, it can give no assurance that the Company's expectations are correct. All forward- looking statements are expressly qualified in their entirety by this cautionary statement.
--------------------------------------------------------------------------------
Source: CEL-SCI Corporation