Biomira jetzt !!!!! - 500 Beiträge pro Seite
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ISIN: CA09161R1064 · WKN: 881836
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Bei Biomira ( BIOM ) bietet sich aktuell eine spekulative Einstiegschance. Nach dem Kursrückschlag der letzten Tage ( über 60% , siehe unten ), bietet der Wert den spekulativem Anleger eine kurzfristige 50% - Chance ! Aktuell notiert das Papier an Nasdaq bei etwa 1,82$. Bei regen Umsätzen wird Biomira auch in Deutschland gehandelt , aktuell bei etwa 1,56€ !( WKN 881836 )
EDMONTON, AB and DARMSTADT, GERMANY, Jun 17, 2003 /PRNewswire-FirstCall via COMTEX/ -- Biomira Inc. (BIOM) (CA:BRA) and Merck KGaA of Darmstadt, Germany, announced today that the results from a large pivotal Phase III trial of Theratope(R) vaccine for women with metastatic breast cancer did not meet the two pre-determined statistical endpoints of time to disease progression and overall survival. However, one pre-stratified subset of patients in the treatment group, women on hormonal treatment following chemotherapy, appeared to show a favourable trend to improvement in survival. Further analysis of this subset of patients is underway, as is additional analyses of the complete trial data.
Following this further analysis of the subset data, the Companies plan to discuss the results with regulatory agencies. Based on these conversations and a full evaluation of the data, the Companies will then determine how to proceed and the information will be communicated to stakeholders at that time.
"Metastatic breast cancer is a serious, life-threatening disease. This study has resulted in a wealth of information about metastatic breast cancer, and it is important that we conduct a complete review of the data so that we can determine our best course of action," said Alex McPherson, MD, PhD, President and CEO of Biomira. "After analysis of the subset data, we intend to discuss this information with the respective regulatory agencies in the U.S., Canada and Europe as soon as possible. We hope to have the first of these discussions within the next three to five months."
"We have additional clinical trials underway and plan to continue those Theratope trials while we fully evaluate the data from the Phase III metastatic breast cancer study and determine our next steps," said Nancy Wysenski, President of EMD Pharmaceuticals Inc., Merck KGaA`s wholly-owned U.S. subsidiary.
Dr. Will Steward, Chairman of the Data Safety Monitoring Board (DSMB) complimented the Companies saying, "This study was conducted to the highest possible standards, with no safety concerns, excellent compliance and high quality data. From the DSMB`s perspective, it is a good example of how to run a trial."
The working hypothesis for Theratope is that it stimulates an immune response to the tumour associated STn marker; this in turn may lead to a therapeutic effect. The Phase III randomized, double-blind trial was designed and powered primarily as a survival study. Enrolment in the trial totaled 1,030 women at more than 120 sites in 10 countries and, to date, is believed to be the largest trial of a therapeutic vaccine conducted in women with metastatic breast cancer. Overall, Theratope was well tolerated by patients, with the most common side effects being flu-like symptoms and local injection site reactions.
"I would like to thank the patients and clinicians who participated in this study," said David W. Miles, MD, BSc, FRCP, Senior Lecturer and Honourary Consultant in Medical Oncology at Guy`s Hospital in London, England and lead clinical investigator. "It has yielded important information that warrants further investigation."
In addition to the Phase III trial for women with metastatic breast cancer, Theratope is also being studied in a Phase II study of women with metastatic breast cancer being treated with hormone therapy and a Phase II study in men and women for the treatment of colorectal cancer. The Phase II colorectal cancer study results, presented in a poster at the American Society of Clinical Oncology Meeting in May 2003, showed that patients are capable of mounting an immune response to the investigational vaccine while receiving concurrent chemotherapy. The study also showed a current median of 8.4 months for progression of their disease.
Biomira and Merck KGaA are also collaborating on the development of BLP25 Liposomal vaccine. BLP25 is being evaluated in a 171-patient Phase IIb controlled study for non-small cell lung cancer and in a Phase II pilot study for prostate cancer patients. Results from both of these trials are expected later this year or in early 2004.
"We appreciate the continued support of our investors in our collaborative effort to develop innovative approaches for cancer control," said Alex McPherson.
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).
With more than 34,500 employees in 53 countries, the Merck Group generated sales of EUR 7.5 billion in 2002. Founded in 1668 in Darmstadt, Germany, the Company aims to be a world leader in its core businesses of pharmaceuticals and chemicals. Merck groups its operating activities under Merck KGaA, in which the Merck family holds 74 percent and the remaining 26 percent is publicly traded. The former U.S. subsidiary, Merck & Co., has been a completely independent company since 1917. Merck KGaA has built a strategic oncology portfolio by developing and in-licensing product candidates in four areas -- monoclonal antibodies, therapeutic vaccines, immunocytokines and angiogenesis inhibitors.
EMD Pharmaceuticals Inc., the U.S. affiliate of Merck KGaA, is a new, fully integrated pharmaceutical company with an initial emphasis on launching new products in oncology. Located in Durham, N.C., EMD focuses on meeting patient and physician needs with pioneering pharmaceutical products and services.
As information becomes available relevant to patients, it will be conveyed to the applicable clinical investigator. Therefore, patients with questions currently involved in trials involving Theratope should contact their physicians. For all other persons desiring additional information about clinical trials involving Theratope, please call the following numbers for assistance: Residents of North America should call the Theratope Hotline toll-free at 866-518-8811. Residents outside of the United States and Canada should call 919-768-9741. In addition, information about clinical trials can be found on the companies` Web sites: http://www.biomira.com and http://www.emdpharmaceuticals.com.
Conference Call Details:
Today at 08:45 a.m. EDT, Biomira Inc. and Merck KGaA will webcast an analyst conference call co-hosted by Alex McPherson, MD, PhD, President and CEO of Biomira, and Nancy J. Wysenski, President of EMD Pharmaceuticals Inc. Investors and the general public are invited to listen to the live conference call on the Web, by accessing the following site: www.viavid.com/detailpage.asp?sid(equal sign)2053 or the archive following the call at www.biomira.com. The archive of the analyst conference call will be available on the Biomira Web site for approximately 30 days following the live call. Analysts may participate in the conference call at 1-888-295-1311 (North America toll-free), 0-800-91-748-60 (United Kingdom), 0-800-181-5287 (Germany), approximately 10 minutes before the start of the call.
Except for historical information contained herein, this release contains forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those risks and uncertainties surrounding the efficacy of Theratope(R) vaccine to treat women with metastatic breast cancer, risks and uncertainties surrounding the presentation of data to the regulatory authorities and approval of marketing applications by the regulatory authorities and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such a difference include risks related to the fact that our analyses of the clinical results from our Phase III clinical trial involving Theratope vaccine to treat women with metastatic breast cancer is ongoing, the risk that the regulatory authorities may not be satisfied with our analyses of such data, the risk that further analyses of the data from our clinical trials may not support the results observed to date or a marketing application, the risk that additional trials may not demonstrate the safety and efficacy required to satisfy the regulatory authorities, the risk that the Company may lack the financial resources and access to capital to fund the required clinical trials, or that it will elect to conduct such additional trials, and other matters required to bring products to market, the uncertainties as to when, if at all, the regulatory authorities will agree to discuss the trial results with the Company, the need to establish and scale-up manufacturing processes, dependence on the efforts of third parties, including suppliers and collaborators, dependence on intellectual property rights and the effectiveness thereof, difficulties or delays in manufacturing products, and regulatory developments involving products and manufacturing facilities. For more detailed information on the risks and uncertainties associated with the Company`s product candidates and other activities see the Company`s periodic reports filed with the applicable securities regulatory authorities in Canada and the United States Securities and Exchange Commission. The Company assumes no obligation to update any forward-looking statements.
SOURCE Biomira Inc.
EDMONTON, AB and DARMSTADT, GERMANY, Jun 17, 2003 /PRNewswire-FirstCall via COMTEX/ -- Biomira Inc. (BIOM) (CA:BRA) and Merck KGaA of Darmstadt, Germany, announced today that the results from a large pivotal Phase III trial of Theratope(R) vaccine for women with metastatic breast cancer did not meet the two pre-determined statistical endpoints of time to disease progression and overall survival. However, one pre-stratified subset of patients in the treatment group, women on hormonal treatment following chemotherapy, appeared to show a favourable trend to improvement in survival. Further analysis of this subset of patients is underway, as is additional analyses of the complete trial data.
Following this further analysis of the subset data, the Companies plan to discuss the results with regulatory agencies. Based on these conversations and a full evaluation of the data, the Companies will then determine how to proceed and the information will be communicated to stakeholders at that time.
"Metastatic breast cancer is a serious, life-threatening disease. This study has resulted in a wealth of information about metastatic breast cancer, and it is important that we conduct a complete review of the data so that we can determine our best course of action," said Alex McPherson, MD, PhD, President and CEO of Biomira. "After analysis of the subset data, we intend to discuss this information with the respective regulatory agencies in the U.S., Canada and Europe as soon as possible. We hope to have the first of these discussions within the next three to five months."
"We have additional clinical trials underway and plan to continue those Theratope trials while we fully evaluate the data from the Phase III metastatic breast cancer study and determine our next steps," said Nancy Wysenski, President of EMD Pharmaceuticals Inc., Merck KGaA`s wholly-owned U.S. subsidiary.
Dr. Will Steward, Chairman of the Data Safety Monitoring Board (DSMB) complimented the Companies saying, "This study was conducted to the highest possible standards, with no safety concerns, excellent compliance and high quality data. From the DSMB`s perspective, it is a good example of how to run a trial."
The working hypothesis for Theratope is that it stimulates an immune response to the tumour associated STn marker; this in turn may lead to a therapeutic effect. The Phase III randomized, double-blind trial was designed and powered primarily as a survival study. Enrolment in the trial totaled 1,030 women at more than 120 sites in 10 countries and, to date, is believed to be the largest trial of a therapeutic vaccine conducted in women with metastatic breast cancer. Overall, Theratope was well tolerated by patients, with the most common side effects being flu-like symptoms and local injection site reactions.
"I would like to thank the patients and clinicians who participated in this study," said David W. Miles, MD, BSc, FRCP, Senior Lecturer and Honourary Consultant in Medical Oncology at Guy`s Hospital in London, England and lead clinical investigator. "It has yielded important information that warrants further investigation."
In addition to the Phase III trial for women with metastatic breast cancer, Theratope is also being studied in a Phase II study of women with metastatic breast cancer being treated with hormone therapy and a Phase II study in men and women for the treatment of colorectal cancer. The Phase II colorectal cancer study results, presented in a poster at the American Society of Clinical Oncology Meeting in May 2003, showed that patients are capable of mounting an immune response to the investigational vaccine while receiving concurrent chemotherapy. The study also showed a current median of 8.4 months for progression of their disease.
Biomira and Merck KGaA are also collaborating on the development of BLP25 Liposomal vaccine. BLP25 is being evaluated in a 171-patient Phase IIb controlled study for non-small cell lung cancer and in a Phase II pilot study for prostate cancer patients. Results from both of these trials are expected later this year or in early 2004.
"We appreciate the continued support of our investors in our collaborative effort to develop innovative approaches for cancer control," said Alex McPherson.
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).
With more than 34,500 employees in 53 countries, the Merck Group generated sales of EUR 7.5 billion in 2002. Founded in 1668 in Darmstadt, Germany, the Company aims to be a world leader in its core businesses of pharmaceuticals and chemicals. Merck groups its operating activities under Merck KGaA, in which the Merck family holds 74 percent and the remaining 26 percent is publicly traded. The former U.S. subsidiary, Merck & Co., has been a completely independent company since 1917. Merck KGaA has built a strategic oncology portfolio by developing and in-licensing product candidates in four areas -- monoclonal antibodies, therapeutic vaccines, immunocytokines and angiogenesis inhibitors.
EMD Pharmaceuticals Inc., the U.S. affiliate of Merck KGaA, is a new, fully integrated pharmaceutical company with an initial emphasis on launching new products in oncology. Located in Durham, N.C., EMD focuses on meeting patient and physician needs with pioneering pharmaceutical products and services.
As information becomes available relevant to patients, it will be conveyed to the applicable clinical investigator. Therefore, patients with questions currently involved in trials involving Theratope should contact their physicians. For all other persons desiring additional information about clinical trials involving Theratope, please call the following numbers for assistance: Residents of North America should call the Theratope Hotline toll-free at 866-518-8811. Residents outside of the United States and Canada should call 919-768-9741. In addition, information about clinical trials can be found on the companies` Web sites: http://www.biomira.com and http://www.emdpharmaceuticals.com.
Conference Call Details:
Today at 08:45 a.m. EDT, Biomira Inc. and Merck KGaA will webcast an analyst conference call co-hosted by Alex McPherson, MD, PhD, President and CEO of Biomira, and Nancy J. Wysenski, President of EMD Pharmaceuticals Inc. Investors and the general public are invited to listen to the live conference call on the Web, by accessing the following site: www.viavid.com/detailpage.asp?sid(equal sign)2053 or the archive following the call at www.biomira.com. The archive of the analyst conference call will be available on the Biomira Web site for approximately 30 days following the live call. Analysts may participate in the conference call at 1-888-295-1311 (North America toll-free), 0-800-91-748-60 (United Kingdom), 0-800-181-5287 (Germany), approximately 10 minutes before the start of the call.
Except for historical information contained herein, this release contains forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those risks and uncertainties surrounding the efficacy of Theratope(R) vaccine to treat women with metastatic breast cancer, risks and uncertainties surrounding the presentation of data to the regulatory authorities and approval of marketing applications by the regulatory authorities and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such a difference include risks related to the fact that our analyses of the clinical results from our Phase III clinical trial involving Theratope vaccine to treat women with metastatic breast cancer is ongoing, the risk that the regulatory authorities may not be satisfied with our analyses of such data, the risk that further analyses of the data from our clinical trials may not support the results observed to date or a marketing application, the risk that additional trials may not demonstrate the safety and efficacy required to satisfy the regulatory authorities, the risk that the Company may lack the financial resources and access to capital to fund the required clinical trials, or that it will elect to conduct such additional trials, and other matters required to bring products to market, the uncertainties as to when, if at all, the regulatory authorities will agree to discuss the trial results with the Company, the need to establish and scale-up manufacturing processes, dependence on the efforts of third parties, including suppliers and collaborators, dependence on intellectual property rights and the effectiveness thereof, difficulties or delays in manufacturing products, and regulatory developments involving products and manufacturing facilities. For more detailed information on the risks and uncertainties associated with the Company`s product candidates and other activities see the Company`s periodic reports filed with the applicable securities regulatory authorities in Canada and the United States Securities and Exchange Commission. The Company assumes no obligation to update any forward-looking statements.
SOURCE Biomira Inc.
die sind doch heute schon gut gelaufen. +11%
+2,8% an Nasdaq. Spead 1,82$ zu 1,56€.
2,50 - 3,00$ sollten rasch wieder drin sein.
2,50 - 3,00$ sollten rasch wieder drin sein.
aktuell Biomira bei 1,56€. Vor 3 Tagen wurden dafür fast 4€ bezahlt !
sorry, aber diesen Tipp gab ich schon heute Vormittag!!
trptzdem ist da noch mehr zu holen
trptzdem ist da noch mehr zu holen
Trading Spotlight
Frage wieso glaubt ihr das Biomira unterbewertet ist bzw. eine Erholung einsetzten muss wenn das Hauptprodukt in manchen Unternehmen nennt man auch das Kerngeschäft nicht
mehr trag_fähig ist???
mehr trag_fähig ist???
#6
daher nannte ich auch Biomira als " spekulatives " Insvest ! Nach 70% Kursrückgang an nur einem Tag, ist natürlich immer die Hoffnung auf " Besserung ", oder dem Kursverfall konträrer News impliziet.
Wie war das doch gleich ; 80% der Börse ist Physchologie
Dafür könnte ich aus jüngster Vergangenheit mehrere Beispiele nennen. Die Börse hat halt immer recht.
Siehe IIJI ! 150% in wenigen Wochen . Einfach nur Markt !
daher nannte ich auch Biomira als " spekulatives " Insvest ! Nach 70% Kursrückgang an nur einem Tag, ist natürlich immer die Hoffnung auf " Besserung ", oder dem Kursverfall konträrer News impliziet.
Wie war das doch gleich ; 80% der Börse ist Physchologie
Dafür könnte ich aus jüngster Vergangenheit mehrere Beispiele nennen. Die Börse hat halt immer recht.
Siehe IIJI ! 150% in wenigen Wochen . Einfach nur Markt !
daher nannte ich auch Biomira als " spekulatives " Insvest ! Nach 70% Kursrückgang an nur einem Tag, ist natürlich immer die Hoffnung auf " Besserung ", oder dem Kursverfall konträrer News impliziet.
Wie war das doch gleich ; 80% der Börse ist Physchologie
Dafür könnte ich aus jüngster Vergangenheit mehrere Beispiele nennen. Die Börse hat halt immer recht.
Siehe IIJI ! 150% in wenigen Wochen . Einfach nur Markt !
=Börsenweisheit
Schönes Argument um die Aktie zu kaufen!
Die -70% sehe ich zurecht da hier ein Anstieg mit der Hoffnung der FDA Zulassung folgte,daher sind Kurse bis zur 1Euro genauso vorhersehbar!
Hier überliegt das Risiko weit mehr .....!
Trotzdem allen viel Glück!
Wie war das doch gleich ; 80% der Börse ist Physchologie
Dafür könnte ich aus jüngster Vergangenheit mehrere Beispiele nennen. Die Börse hat halt immer recht.
Siehe IIJI ! 150% in wenigen Wochen . Einfach nur Markt !
=Börsenweisheit
Schönes Argument um die Aktie zu kaufen!
Die -70% sehe ich zurecht da hier ein Anstieg mit der Hoffnung der FDA Zulassung folgte,daher sind Kurse bis zur 1Euro genauso vorhersehbar!
Hier überliegt das Risiko weit mehr .....!
Trotzdem allen viel Glück!
Danke !
#8
Schließlich zwinge ich ja niemand den Wert zu kaufen !
Möchte nur auf die Chance einer " technischen Erholung " aufmerksam machen. Grundsätzlich bleiben dabei fundamentale Aspekte meist außen vor.
Lass uns in 14 Tagen mal drüber reden...
Schließlich zwinge ich ja niemand den Wert zu kaufen !
Möchte nur auf die Chance einer " technischen Erholung " aufmerksam machen. Grundsätzlich bleiben dabei fundamentale Aspekte meist außen vor.
Lass uns in 14 Tagen mal drüber reden...
@robby13
So argumentiert man
gruss
WL
Theratope wirkt bis jetzt nur bei 32% der Testpersonen!
Man beachte nebenbei das es hier keine Alternative auf den Markt gibt um die Lebenserhaltung zu verlängern!
Biomira had cut its workforce to pare costs and also slowed development of other drugs to focus on Theratope.
While this data is being reviewed, Biomira said it plans to continue its two other Theratope trials, which includes one on colorectal cancer.
Theratope is intended to stimulate an immune response to tumours. The current trial with Merck included 1,030 women at 120 sites in 10 countries.
But Biomira focused on a spark of hope from one group of patients — women who used Theratope while on hormonal treatment following chemotherapy — that had improved survival rates. Biomira said it will further analyze the data of that group and the trial over-all, then discuss the results with regulatory agencies before deciding on its next steps.
"Results showed that Theratope appeared to increase the median survival in a subset of patients," McPherson said, adding that this is preliminary information and hasn`t yet been fully analyzed.
"So I cannot say that this subset of patients has hit a level of statistical significance at this point," he said. "We are hopeful that our further analysis will confirm that Theratope will be a treatment for women in this subset of the metastatic breast cancer patient population."
The survival rate of those in this select group, which represented about 32 per cent of the patients enrolled in the trial, was a difference of months, McPherson said.
Käufe setzten in Frankfurt ein!
Musik wird aber bei den Amis gespielt
1 Tr.Ziel 2,00 Dollar
Stop bei 1,60 Dollar
.
So argumentiert man
gruss
WL
Theratope wirkt bis jetzt nur bei 32% der Testpersonen!
Man beachte nebenbei das es hier keine Alternative auf den Markt gibt um die Lebenserhaltung zu verlängern!
Biomira had cut its workforce to pare costs and also slowed development of other drugs to focus on Theratope.
While this data is being reviewed, Biomira said it plans to continue its two other Theratope trials, which includes one on colorectal cancer.
Theratope is intended to stimulate an immune response to tumours. The current trial with Merck included 1,030 women at 120 sites in 10 countries.
But Biomira focused on a spark of hope from one group of patients — women who used Theratope while on hormonal treatment following chemotherapy — that had improved survival rates. Biomira said it will further analyze the data of that group and the trial over-all, then discuss the results with regulatory agencies before deciding on its next steps.
"Results showed that Theratope appeared to increase the median survival in a subset of patients," McPherson said, adding that this is preliminary information and hasn`t yet been fully analyzed.
"So I cannot say that this subset of patients has hit a level of statistical significance at this point," he said. "We are hopeful that our further analysis will confirm that Theratope will be a treatment for women in this subset of the metastatic breast cancer patient population."
The survival rate of those in this select group, which represented about 32 per cent of the patients enrolled in the trial, was a difference of months, McPherson said.
Käufe setzten in Frankfurt ein!
Musik wird aber bei den Amis gespielt
1 Tr.Ziel 2,00 Dollar
Stop bei 1,60 Dollar
.
Genauso kann man auch DELTAGEN INC. an der (Nasdaq)und (Frankfurt)Kaufen WKN 938999
KK Schnitt 1,38
Mal sehen ob der morgige Tag mehr Klarheit bringt!
Biomira Inc. - Annual General Meeting Webcast - June 26, 2003
Tuesday June 24, 8:00 am ET
EDMONTON, June 24 /CNW/ - Notification of Annual General Meeting Webcast:
Biomira Inc. (TSX: BRA - News; NASDAQ: BIOM - News)
Annual General Meeting Webcast
June 26, 2003, 3:30 PM ET
To listen to this event, please enter http://webevents.broadcast.com/cnw/biomira20030626 in your web browser.
For a complete listing of upcoming and archived webcasts available through Canada NewsWire, please visit our events calendar at http://www.newswire.ca/webcast." target="_blank" rel="nofollow ugc noopener">http://www.newswire.ca/webcast. CNW`s webcast of earnings calls is consistent with Market Regulation Services Inc. (RS) initiatives to broaden investor access through the use of new technology.
For further information
Jane Tulloch, Director, Investor Relations, (780) 490-2812
BIOMIRA INC., Tel: (780) 450-3761, Fax: (780) 463-0871, http://www.biomira.com_;_ To request a free copy of this organization`s annual report, please go to http://www.newswire.ca and click on reports@cnw.
Mal sehen ob der morgige Tag mehr Klarheit bringt!
Biomira Inc. - Annual General Meeting Webcast - June 26, 2003
Tuesday June 24, 8:00 am ET
EDMONTON, June 24 /CNW/ - Notification of Annual General Meeting Webcast:
Biomira Inc. (TSX: BRA - News; NASDAQ: BIOM - News)
Annual General Meeting Webcast
June 26, 2003, 3:30 PM ET
To listen to this event, please enter http://webevents.broadcast.com/cnw/biomira20030626 in your web browser.
For a complete listing of upcoming and archived webcasts available through Canada NewsWire, please visit our events calendar at http://www.newswire.ca/webcast." target="_blank" rel="nofollow ugc noopener">http://www.newswire.ca/webcast. CNW`s webcast of earnings calls is consistent with Market Regulation Services Inc. (RS) initiatives to broaden investor access through the use of new technology.
For further information
Jane Tulloch, Director, Investor Relations, (780) 490-2812
BIOMIRA INC., Tel: (780) 450-3761, Fax: (780) 463-0871, http://www.biomira.com_;_ To request a free copy of this organization`s annual report, please go to http://www.newswire.ca and click on reports@cnw.
Heute morgen schon mal empfohlen
Gestern zugeschlagen KK Schnitt 1,38
Mit spekulation auf den 26.06.03,das hier nicht alles um sonst war
Biomira Inc. - Annual General Meeting Webcast - June 26, 2003
Tuesday June 24, 8:00 am ET
EDMONTON, June 24 /CNW/ - Notification of Annual General Meeting Webcast:
Biomira Inc. (TSX: BRA - News; NASDAQ: BIOM - News)
Annual General Meeting Webcast
June 26, 2003, 3:30 PM ET
To listen to this event, please enter http://webevents.broadcast.com/cnw/biomira20030626 in your web browser.
For a complete listing of upcoming and archived webcasts available through Canada NewsWire, please visit our events calendar at http://www.newswire.ca/webcast." target="_blank" rel="nofollow ugc noopener">http://www.newswire.ca/webcast. CNW`s webcast of earnings calls is consistent with Market Regulation Services Inc. (RS) initiatives to broaden investor access through the use of new technology.
For further information
Jane Tulloch, Director, Investor Relations, (780) 490-2812
BIOMIRA INC., Tel: (780) 450-3761, Fax: (780) 463-0871, http://www.biomira.com_;_ To request a free copy of this organization`s annual report, please go to http://www.newswire.ca and click on reports@cnw.
Umsätze von Gestern jetzt schon überschritten
Tageshöchstkurs 1,82
.
Theratope wirkt bis jetzt nur bei 32% der Testpersonen!
Man beachte nebenbei das es hier keine Alternative auf den Markt gibt um die Lebenserhaltung zu verlängern!
Biomira had cut its workforce to pare costs and also slowed development of other drugs to focus on Theratope.
While this data is being reviewed, Biomira said it plans to continue its two other Theratope trials, which includes one on colorectal cancer.
Theratope is intended to stimulate an immune response to tumours. The current trial with Merck included 1,030 women at 120 sites in 10 countries.
But Biomira focused on a spark of hope from one group of patients — women who used Theratope while on hormonal treatment following chemotherapy — that had improved survival rates. Biomira said it will further analyze the data of that group and the trial over-all, then discuss the results with regulatory agencies before deciding on its next steps.
"Results showed that Theratope appeared to increase the median survival in a subset of patients," McPherson said, adding that this is preliminary information and hasn`t yet been fully analyzed.
"So I cannot say that this subset of patients has hit a level of statistical significance at this point," he said. "We are hopeful that our further analysis will confirm that Theratope will be a treatment for women in this subset of the metastatic breast cancer patient population."
The survival rate of those in this select group, which represented about 32 per cent of the patients enrolled in the trial, was a difference of months, McPherson said.
Gestern zugeschlagen KK Schnitt 1,38
Mit spekulation auf den 26.06.03,das hier nicht alles um sonst war
Biomira Inc. - Annual General Meeting Webcast - June 26, 2003
Tuesday June 24, 8:00 am ET
EDMONTON, June 24 /CNW/ - Notification of Annual General Meeting Webcast:
Biomira Inc. (TSX: BRA - News; NASDAQ: BIOM - News)
Annual General Meeting Webcast
June 26, 2003, 3:30 PM ET
To listen to this event, please enter http://webevents.broadcast.com/cnw/biomira20030626 in your web browser.
For a complete listing of upcoming and archived webcasts available through Canada NewsWire, please visit our events calendar at http://www.newswire.ca/webcast." target="_blank" rel="nofollow ugc noopener">http://www.newswire.ca/webcast. CNW`s webcast of earnings calls is consistent with Market Regulation Services Inc. (RS) initiatives to broaden investor access through the use of new technology.
For further information
Jane Tulloch, Director, Investor Relations, (780) 490-2812
BIOMIRA INC., Tel: (780) 450-3761, Fax: (780) 463-0871, http://www.biomira.com_;_ To request a free copy of this organization`s annual report, please go to http://www.newswire.ca and click on reports@cnw.
Umsätze von Gestern jetzt schon überschritten
Tageshöchstkurs 1,82
.
Theratope wirkt bis jetzt nur bei 32% der Testpersonen!
Man beachte nebenbei das es hier keine Alternative auf den Markt gibt um die Lebenserhaltung zu verlängern!
Biomira had cut its workforce to pare costs and also slowed development of other drugs to focus on Theratope.
While this data is being reviewed, Biomira said it plans to continue its two other Theratope trials, which includes one on colorectal cancer.
Theratope is intended to stimulate an immune response to tumours. The current trial with Merck included 1,030 women at 120 sites in 10 countries.
But Biomira focused on a spark of hope from one group of patients — women who used Theratope while on hormonal treatment following chemotherapy — that had improved survival rates. Biomira said it will further analyze the data of that group and the trial over-all, then discuss the results with regulatory agencies before deciding on its next steps.
"Results showed that Theratope appeared to increase the median survival in a subset of patients," McPherson said, adding that this is preliminary information and hasn`t yet been fully analyzed.
"So I cannot say that this subset of patients has hit a level of statistical significance at this point," he said. "We are hopeful that our further analysis will confirm that Theratope will be a treatment for women in this subset of the metastatic breast cancer patient population."
The survival rate of those in this select group, which represented about 32 per cent of the patients enrolled in the trial, was a difference of months, McPherson said.
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Es klingt mir noch in den Ohren!
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Biomira und Merck KGaA: Klinische Phase III-Studie mit Krebsimpfstoff Theratope verfehlt primäre Endpunkte
Trend zu erhöhter Überlebensrate bei einer Untergruppe von Patientinnen beobachtet
18.06.2003 - Das kanadische Biotech-Unternehmen Biomira Inc. und die Merck KGaA haben bekannt gegeben, dass in einer groß angelegten, zulassungsrelevanten Phase III-Studie mit dem Impfstoff Theratope bei Frauen mit metastasierendem Brustkrebs beide vordefinierten Endpunkte (Gesamtüberlebensdauer und Zeitdauer bis zum Wiedereinsetzen der Erkrankung) nicht erreicht wurden.
Nach den vorliegenden Ergebnissen scheint jedoch eine vordefinierte Teilgruppe der Studie (Patientinnen unter Hormonbehandlung im Anschluss an eine Chemotherapie) eine positive Tendenz hin zu einer verbesserten Überlebensrate zu zeigen. Diese Gruppe wird derzeit weiter ausgewertet. Ebenso laufen zusätzliche Analysen zu den Gesamtdaten der Studie.
Im Anschluss an die weiterführende Auswertung der Teilgruppe planen die Unternehmen, die Ergebnisse mit den Zulassungsbehörden zu diskutieren. Danach soll auf Basis dieser Gespräche sowie der vollständigen Datenlage über das weitere Vorgehen entschieden werden. Zu diesem Zeitpunkt wird auch eine entsprechende Information von Aktionären und Öffentlichkeit erfolgen.
"Metastasierender Brustkrebs ist eine schwere, lebensbedrohliche Erkrankung, zu der die Studie eine Fülle von Informationen zusammengetragen hat. Es ist jetzt wichtig, dass wir die Daten in ihrer Gesamtheit prüfen, um so über den bestmöglichen Fortgang entscheiden zu können," kommentierte Dr. Alex McPherson, der CEO von Biomira. "Nach Auswertung der Daten für die Untergruppe von Patientinnen werden wir die Ergebnisse so bald wie möglich mit den Zulassungsbehörden in den USA, in Kanada sowie in Europa besprechen. Wir hoffen, die ersten Gespräche in etwa drei bis fünf Monaten aufnehmen zu können."
"Bis zur endgültigen Auswertung der Daten wollen wir die laufenden klinischen Studien mit Theratope fortsetzen, ehe wir über weitere Schritte entscheiden," sagte Nancy Wysenski, die Vorstandsvorsitzende von EMD Pharmaceuticals, Inc., der US-Pharma-Tochtergesellschaft der Merck KGaA.
Dr. Will Stewart, der Vorsitzende des unabhängigen Data Safety Monitoring Board (DSMB), sprach den Unternehmen sein Kompliment aus: "Diese Studie wurde nach höchstmöglichen Standards und bei hervorragender Beteiligung der Patientinnen durchgeführt. Aus Sicht des DSMB ist diese Studie ein gutes Bespiel für die richtige Durchführung einer klinischen Prüfung."
Die randomisierte, doppelblinde Phase III-Studie war primär als Survival-Studie ausgelegt. Insgesamt wurden 1030 Frauen in über 120 Studienzentren in 10 Ländern in die Studie aufgenommen. Diese Studie gilt aktuell als die umfassendste klinische Prüfung, die je mit einem therapeutischen Impfstoff an Frauen mit metastasierendem Brustkrebs durchgeführt wurde. Theratope wurde von den Patientinnen generell gut vertragen. Die am häufigsten berichteten Nebenwirkungen waren grippeähnliche Symptome und lokale Reaktionen an der Injektionsstelle.
"Ich möchte den an der Studie beteiligten Patientinnen und Ärzten danken," sagte Dr. David W. Miles vom Guy`s Hospital in London, der Leitende Prüfarzt der Studie. "Die Studie lieferte wichtige Informationen, die weiterführende Untersuchungen rechtfertigt."
Neben der Phase III-Studie an Frauen mit metastasierendem Brustkrebs wird Theratope derzeit in einer Phase II-Studie an Frauen unter Hormontherapie und in einer weiteren Phase II-Studie an Patienten und Patientinnen mit Darmkrebs untersucht. Die Ergebnisse dieser Studie wurden im Rahmen der ASCO-Jahrestagung in Chicago vorgestellt. Danach sind Patienten bei laufender Chemotherapie in der Lage, eine Immunantwort auf den Impfstoff zu entwickeln. Darüber hinaus wurde ein mittleres progressionsfreies Intervall von 8,4 Monaten nachgewiesen.
"Wir schätzen die fortlaufende Unterstützung unserer Investoren in die gemeinsamen Bemühungen, innovative Therapieansätze zur Krebsbekämpfung zu entwickeln," sagte Alex McPherson
Trend zu erhöhter Überlebensrate bei einer Untergruppe von Patientinnen beobachtet
18.06.2003 - Das kanadische Biotech-Unternehmen Biomira Inc. und die Merck KGaA haben bekannt gegeben, dass in einer groß angelegten, zulassungsrelevanten Phase III-Studie mit dem Impfstoff Theratope bei Frauen mit metastasierendem Brustkrebs beide vordefinierten Endpunkte (Gesamtüberlebensdauer und Zeitdauer bis zum Wiedereinsetzen der Erkrankung) nicht erreicht wurden.
Nach den vorliegenden Ergebnissen scheint jedoch eine vordefinierte Teilgruppe der Studie (Patientinnen unter Hormonbehandlung im Anschluss an eine Chemotherapie) eine positive Tendenz hin zu einer verbesserten Überlebensrate zu zeigen. Diese Gruppe wird derzeit weiter ausgewertet. Ebenso laufen zusätzliche Analysen zu den Gesamtdaten der Studie.
Im Anschluss an die weiterführende Auswertung der Teilgruppe planen die Unternehmen, die Ergebnisse mit den Zulassungsbehörden zu diskutieren. Danach soll auf Basis dieser Gespräche sowie der vollständigen Datenlage über das weitere Vorgehen entschieden werden. Zu diesem Zeitpunkt wird auch eine entsprechende Information von Aktionären und Öffentlichkeit erfolgen.
"Metastasierender Brustkrebs ist eine schwere, lebensbedrohliche Erkrankung, zu der die Studie eine Fülle von Informationen zusammengetragen hat. Es ist jetzt wichtig, dass wir die Daten in ihrer Gesamtheit prüfen, um so über den bestmöglichen Fortgang entscheiden zu können," kommentierte Dr. Alex McPherson, der CEO von Biomira. "Nach Auswertung der Daten für die Untergruppe von Patientinnen werden wir die Ergebnisse so bald wie möglich mit den Zulassungsbehörden in den USA, in Kanada sowie in Europa besprechen. Wir hoffen, die ersten Gespräche in etwa drei bis fünf Monaten aufnehmen zu können."
"Bis zur endgültigen Auswertung der Daten wollen wir die laufenden klinischen Studien mit Theratope fortsetzen, ehe wir über weitere Schritte entscheiden," sagte Nancy Wysenski, die Vorstandsvorsitzende von EMD Pharmaceuticals, Inc., der US-Pharma-Tochtergesellschaft der Merck KGaA.
Dr. Will Stewart, der Vorsitzende des unabhängigen Data Safety Monitoring Board (DSMB), sprach den Unternehmen sein Kompliment aus: "Diese Studie wurde nach höchstmöglichen Standards und bei hervorragender Beteiligung der Patientinnen durchgeführt. Aus Sicht des DSMB ist diese Studie ein gutes Bespiel für die richtige Durchführung einer klinischen Prüfung."
Die randomisierte, doppelblinde Phase III-Studie war primär als Survival-Studie ausgelegt. Insgesamt wurden 1030 Frauen in über 120 Studienzentren in 10 Ländern in die Studie aufgenommen. Diese Studie gilt aktuell als die umfassendste klinische Prüfung, die je mit einem therapeutischen Impfstoff an Frauen mit metastasierendem Brustkrebs durchgeführt wurde. Theratope wurde von den Patientinnen generell gut vertragen. Die am häufigsten berichteten Nebenwirkungen waren grippeähnliche Symptome und lokale Reaktionen an der Injektionsstelle.
"Ich möchte den an der Studie beteiligten Patientinnen und Ärzten danken," sagte Dr. David W. Miles vom Guy`s Hospital in London, der Leitende Prüfarzt der Studie. "Die Studie lieferte wichtige Informationen, die weiterführende Untersuchungen rechtfertigt."
Neben der Phase III-Studie an Frauen mit metastasierendem Brustkrebs wird Theratope derzeit in einer Phase II-Studie an Frauen unter Hormontherapie und in einer weiteren Phase II-Studie an Patienten und Patientinnen mit Darmkrebs untersucht. Die Ergebnisse dieser Studie wurden im Rahmen der ASCO-Jahrestagung in Chicago vorgestellt. Danach sind Patienten bei laufender Chemotherapie in der Lage, eine Immunantwort auf den Impfstoff zu entwickeln. Darüber hinaus wurde ein mittleres progressionsfreies Intervall von 8,4 Monaten nachgewiesen.
"Wir schätzen die fortlaufende Unterstützung unserer Investoren in die gemeinsamen Bemühungen, innovative Therapieansätze zur Krebsbekämpfung zu entwickeln," sagte Alex McPherson
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