Biomira 2004
25.03.04 18:51
#26
catweazle
good news, good Kurs in USA
American Society of Clinical Oncology (ASCO) Accepts Biomira`s BLP25 Liposomal Vaccine Phase IIB Non-Small Cell Lung Cancer Trial Results for Poster Presentation at 2004 Meeting
Thursday March 25, 9:00 am ET
ASCO Also Accepts Two Additional Abstracts for Poster Presentation
EDMONTON, March 25 /PRNewswire-FirstCall/ - Biomira Inc. (Nasdaq:BIOM - News; TSX:BRA - News) announced today that data from the Company`s Phase IIb BLP25 Liposomal vaccine (L-BLP25) trial in non-small cell lung cancer has been accepted as the subject of a poster presentation at the 2004 Annual Meeting of ASCO. The meeting will take place in New Orleans, Louisiana, June 5-8. The lead investigator for the Phase IIb trial and scheduled ASCO presenter is Dr. Charles Butts, Medical Oncologist, the Cross Cancer Institute, Edmonton, Alberta.
The trial is being conducted at 17 sites across Canada and the United Kingdom. This controlled, randomized trial involves 171 men and women whose disease was stable or who had responded to treatment following completion of their first line standard chemotherapy. The study is designed to document the safety profile of the vaccine and to evaluate efficacy by comparing survival in the two arms. Patients were randomized to either L-BLP25 plus best standard of care or to best standard of care alone. Best standard of care included palliative radiotherapy and/or second line chemotherapy according to standard clinical practice. Biomira and its collaborator Merck KGaA of Darmstadt, Germany are currently preparing for the clinical analysis of the results from this trial, with an announcement of the results expected in the next few weeks.
" ASCO receives thousands of abstracts each year for review by the Scientific Program Committee, and we are very pleased that Dr. Butts` abstract was accepted," said Alex McPherson, MD, PhD, President and CEO of Biomira. " This presentation at ASCO will be our first opportunity to discuss our clinical results at a scientific forum, and we look forward to it."
L-BLP25 Phase II Prostate Poster Presentation
Biomira has also been notified that clinical data will be presented at the Annual Meeting of ASCO on the L-BLP25 Phase II study in prostate cancer. This is also scheduled to be a poster presentation.
In June 2003 Biomira announced results from its Phase II study of L-BLP25 in a small group of patients with rising prostate specific antigen (PSA) post radical prostatectomy. The trial was conducted to determine whether the vaccine could reduce or stabilize PSA levels. L-BLP25 showed a good safety profile and the dose and schedule were also well accepted by the patients. Preliminary results in this small patient population did not conclusively show a reduction or stabilization of serum PSA levels. However, there appears to be a prolongation of PSA doubling time (PSADT) in approximately 40 per cent of the patients. While there has been no commitment to conduct further trials at this time in this indication, the patients continue to be followed for PSA levels for a period of 12 months following their last vaccination. The lead investigator on this trial is Dr. Scott North, Medical Oncologist, the Cross Cancer Institute, Edmonton, Alberta.
Theratope® Vaccine Phase III Data Poster Presentation
The third abstract accepted for poster presentation at ASCO involves the Theratope Phase III study. The poster will focus on immune response of the women involved in this randomized, controlled, double blind, multi-centre study.
The Companies reported in June 2003 that the Phase III results showed that Theratope did not show a statistical difference in the two pre-determined endpoints of time to disease progression and overall survival. However, one large pre-stratified subset of more than 300 women, those on hormonal treatment following chemotherapy, appeared to show a favourable trend to improvement in survival, although not statistically significant. The Companies are conducting further analysis of this subset of patients to potentially determine a mechanism of action that could help explain the perceived benefit to this group of women.
ASCO
The ASCO Annual Meeting is the premier educational and scientific event for oncology professionals. The 2004 meeting is expected to attract more than 26,000 attendees from all over the world.
The Companies
Our key collaboration in developing therapeutic cancer vaccines is with Merck KGaA. With more than 34,200 employees in 53 countries, the Merck Group generated sales of EUR 7.2 billion in 2003. 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.
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).
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, 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: Biomira Inc.
Thursday March 25, 9:00 am ET
ASCO Also Accepts Two Additional Abstracts for Poster Presentation
EDMONTON, March 25 /PRNewswire-FirstCall/ - Biomira Inc. (Nasdaq:BIOM - News; TSX:BRA - News) announced today that data from the Company`s Phase IIb BLP25 Liposomal vaccine (L-BLP25) trial in non-small cell lung cancer has been accepted as the subject of a poster presentation at the 2004 Annual Meeting of ASCO. The meeting will take place in New Orleans, Louisiana, June 5-8. The lead investigator for the Phase IIb trial and scheduled ASCO presenter is Dr. Charles Butts, Medical Oncologist, the Cross Cancer Institute, Edmonton, Alberta.
The trial is being conducted at 17 sites across Canada and the United Kingdom. This controlled, randomized trial involves 171 men and women whose disease was stable or who had responded to treatment following completion of their first line standard chemotherapy. The study is designed to document the safety profile of the vaccine and to evaluate efficacy by comparing survival in the two arms. Patients were randomized to either L-BLP25 plus best standard of care or to best standard of care alone. Best standard of care included palliative radiotherapy and/or second line chemotherapy according to standard clinical practice. Biomira and its collaborator Merck KGaA of Darmstadt, Germany are currently preparing for the clinical analysis of the results from this trial, with an announcement of the results expected in the next few weeks.
" ASCO receives thousands of abstracts each year for review by the Scientific Program Committee, and we are very pleased that Dr. Butts` abstract was accepted," said Alex McPherson, MD, PhD, President and CEO of Biomira. " This presentation at ASCO will be our first opportunity to discuss our clinical results at a scientific forum, and we look forward to it."
L-BLP25 Phase II Prostate Poster Presentation
Biomira has also been notified that clinical data will be presented at the Annual Meeting of ASCO on the L-BLP25 Phase II study in prostate cancer. This is also scheduled to be a poster presentation.
In June 2003 Biomira announced results from its Phase II study of L-BLP25 in a small group of patients with rising prostate specific antigen (PSA) post radical prostatectomy. The trial was conducted to determine whether the vaccine could reduce or stabilize PSA levels. L-BLP25 showed a good safety profile and the dose and schedule were also well accepted by the patients. Preliminary results in this small patient population did not conclusively show a reduction or stabilization of serum PSA levels. However, there appears to be a prolongation of PSA doubling time (PSADT) in approximately 40 per cent of the patients. While there has been no commitment to conduct further trials at this time in this indication, the patients continue to be followed for PSA levels for a period of 12 months following their last vaccination. The lead investigator on this trial is Dr. Scott North, Medical Oncologist, the Cross Cancer Institute, Edmonton, Alberta.
Theratope® Vaccine Phase III Data Poster Presentation
The third abstract accepted for poster presentation at ASCO involves the Theratope Phase III study. The poster will focus on immune response of the women involved in this randomized, controlled, double blind, multi-centre study.
The Companies reported in June 2003 that the Phase III results showed that Theratope did not show a statistical difference in the two pre-determined endpoints of time to disease progression and overall survival. However, one large pre-stratified subset of more than 300 women, those on hormonal treatment following chemotherapy, appeared to show a favourable trend to improvement in survival, although not statistically significant. The Companies are conducting further analysis of this subset of patients to potentially determine a mechanism of action that could help explain the perceived benefit to this group of women.
ASCO
The ASCO Annual Meeting is the premier educational and scientific event for oncology professionals. The 2004 meeting is expected to attract more than 26,000 attendees from all over the world.
The Companies
Our key collaboration in developing therapeutic cancer vaccines is with Merck KGaA. With more than 34,200 employees in 53 countries, the Merck Group generated sales of EUR 7.2 billion in 2003. 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.
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).
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, 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: Biomira Inc.
10.05.05 13:42
#27
salto1
Biomira heut schon ca. 10% im Plus!
Hallo Leute!
Biomira hab ich schon seit längerer Zeit im Depot liegen. Die Aktien beweisen eine erstaunliche Standfestigkeit und haben die Verluste der letzten Wochen immer heil überstanden.
Heute sind sie stark gestiegen - weiß jemand warum?
Liebe Grüße
tom
Biomira hab ich schon seit längerer Zeit im Depot liegen. Die Aktien beweisen eine erstaunliche Standfestigkeit und haben die Verluste der letzten Wochen immer heil überstanden.
Heute sind sie stark gestiegen - weiß jemand warum?
Liebe Grüße
tom
12.05.05 21:25
#28
salto1
Heut wieder 7 % im Plus! Wohin geht Biomira?
Biomira kommt nicht zur Ruhe - im positiven Sinn. In den letzten Tagen bewegt sich die Aktie.
Catweazle - bist noch drin?
Tom
Catweazle - bist noch drin?
Tom
26.01.06 14:39
#29
Steff23
Biomira
26.01.2006 14:08
Biomira Inc. announces amendment to licensing agreement for BLP25 Liposome Vaccine
EDMONTON, Jan. 26 /PRNewswire-FirstCall/ -- Biomira Inc. (Nachrichten) (TSX: BRA) today announced the signing of a letter of intent to amend the licensing agreement between Biomira B.V. and Merck KGaA of Darmstadt, Germany for BLP25 Liposome Vaccine (L-BLP25), currently in development for the treatment of non-small cell lung cancer (NSCLC).
Under the letter of intent, approved by the Boards of both Companies, Merck KGaA will take over administrative and financial responsibility for the development and commercialization of L-BLP25, including the planned phase 3 trial in NSCLC, which remains on schedule with the enrolment of the first patient expected in mid 2006. Merck also plans to investigate the use of L-BLP25 to treat other types of cancer. All future development, regulatory, commercialization and marketing costs for L-BLP25 (including the planned phase 3 trial, but excluding the Canadian territory) will be borne exclusively by Merck KGaA effective March 1, 2006.
In return, Biomira's co-promotion interest in U.S. sales will be converted to a specified royalty rate, which will be higher than what Merck has agreed to pay on its sales of L-BLP25 in all markets outside of North America or the Rest of World (ROW). The royalty and other arrangements with respect to the ROW will remain generally unchanged (Merck KGaA to assume a specified third party royalty obligation on behalf of Biomira). Similarly, the milestone payments to be made by Merck KGaA pursuant to the collaboration will remain essentially the same. The agreed upon royalty rate for the U.S. territory reflects the stage and promise of L-BLP25.
Biomira will retain responsibility for manufacturing L-BLP25, both for clinical trials and following any marketing approval. The existing arrangements for Canada remain in place with Biomira responsible for the Canadian territory.
Dr. Alex McPherson, President and CEO of Biomira Inc., commented, "This is an excellent agreement and will ensure the fastest possible initiation of the phase 3 program in NSCLC as well as the possibility of exploring L-BLP25's potential in other forms of cancer. We are delighted by the strong and continued commitment that Merck has shown to this innovative and promising product. Merck's decision to take over the full cost of the trials will enable Biomira to focus our efforts and resources on our follow-on cancer vaccine, BGLP40, and on building our pipeline by acquiring new products."
"Merck is pleased that it has the opportunity to develop what appears to be a very promising treatment for NSCLC, which is one of the most prevalent and deadly of all cancers," said Elmar Schnee, Merck Deputy Executive Board Member with responsibility for Pharmaceuticals. "We believe this new agreement is not only beneficial for both companies but also for patients."
About L-BLP25
L-BLP25 is a synthetic MUC1 peptide vaccine and is a biological response modifier with a chemically synthesized peptide of a cancer-associated protein antigen widely expressed on common cancers. It is designed to induce an immune response to both the synthetic antigen and the natural corresponding antigen as expressed on the cancer. In October 2005 Biomira announced that median survival for patients with Stage IIIB locoregional NSCLC who received L-BLP25 in a phase 2b study had been determined. These results demonstrated an average survival of 30.6 months in the vaccinated group compared with 13.3 months for the unvaccinated group. A more comprehensive analysis of these data is expected in the first quarter of this year. In November 2005 Biomira announced the interim results of a phase 2 NSCLC single-arm, multi-centre, open label study of L-BLP25. The results showed that the new formulation of the vaccine to be used in the phase 3 clinical trial program is not different from the previous formulation from a safety perspective.
The reformulated vaccine incorporated manufacturing changes intended to secure the future commercial supply of the vaccine. Thus far, ongoing testing has demonstrated that the steps taken to address the manufacturing issue discovered in late 2005 have been successful. Pending completion of this testing, it is expected that manufacturing for the phase 3 trial will resume in the first quarter of this year.
Analyst Conference Call Details:
Today at 10:00 a.m. EST, Biomira Inc. will Web cast an analyst conference call hosted by Alex McPherson, M.D., Ph.D., President and CEO of Biomira. Analysts may participate in the conference call by dialing 1-210-234-0075 (Pass code: BIOM) approximately 10 minutes before the start of the call.
Investors and the general public are invited to listen to the live conference call on the Web, by accessing the following site: https://e-meetings.mci.com/ and entering the conference number: PA1499468 and the participant pass code: BIOM. The archive of the analyst conference call will be available for approximately 30 days following the live call.
About Lung Cancer
In 2005, approximately 172,000 new cases of lung cancer were diagnosed in the U.S. Approximately 163,000 people are estimated to have died of this disease in the U.S. alone in 2005. NSCLC accounts for approximately 75 to 80 per cent of all primary lung cancers. At the time of diagnosis, only 25 per cent of patients are potentially curable by surgery.
About Biomira Inc.
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.
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, duration and results of clinical trials, particularly the phase 3 clinical trial of L-BLP25 and the possible additional phase 2 trials for its use in other indications, trial reviews and analyses and regulatory reviews, the safety and efficacy of the product, the ability to secure and manufacture vaccine supplies and the resolution of a recent manufacturing problem by an outside vendor of the vaccine, and the ability of Biomira to acquire new pipeline product candidates. 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 or that the Company will have sufficient resources to fund clinical trials and in-license new product candidates. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Biomira Inc. announces amendment to licensing agreement for BLP25 Liposome Vaccine
EDMONTON, Jan. 26 /PRNewswire-FirstCall/ -- Biomira Inc. (Nachrichten) (TSX: BRA) today announced the signing of a letter of intent to amend the licensing agreement between Biomira B.V. and Merck KGaA of Darmstadt, Germany for BLP25 Liposome Vaccine (L-BLP25), currently in development for the treatment of non-small cell lung cancer (NSCLC).
Under the letter of intent, approved by the Boards of both Companies, Merck KGaA will take over administrative and financial responsibility for the development and commercialization of L-BLP25, including the planned phase 3 trial in NSCLC, which remains on schedule with the enrolment of the first patient expected in mid 2006. Merck also plans to investigate the use of L-BLP25 to treat other types of cancer. All future development, regulatory, commercialization and marketing costs for L-BLP25 (including the planned phase 3 trial, but excluding the Canadian territory) will be borne exclusively by Merck KGaA effective March 1, 2006.
In return, Biomira's co-promotion interest in U.S. sales will be converted to a specified royalty rate, which will be higher than what Merck has agreed to pay on its sales of L-BLP25 in all markets outside of North America or the Rest of World (ROW). The royalty and other arrangements with respect to the ROW will remain generally unchanged (Merck KGaA to assume a specified third party royalty obligation on behalf of Biomira). Similarly, the milestone payments to be made by Merck KGaA pursuant to the collaboration will remain essentially the same. The agreed upon royalty rate for the U.S. territory reflects the stage and promise of L-BLP25.
Biomira will retain responsibility for manufacturing L-BLP25, both for clinical trials and following any marketing approval. The existing arrangements for Canada remain in place with Biomira responsible for the Canadian territory.
Dr. Alex McPherson, President and CEO of Biomira Inc., commented, "This is an excellent agreement and will ensure the fastest possible initiation of the phase 3 program in NSCLC as well as the possibility of exploring L-BLP25's potential in other forms of cancer. We are delighted by the strong and continued commitment that Merck has shown to this innovative and promising product. Merck's decision to take over the full cost of the trials will enable Biomira to focus our efforts and resources on our follow-on cancer vaccine, BGLP40, and on building our pipeline by acquiring new products."
"Merck is pleased that it has the opportunity to develop what appears to be a very promising treatment for NSCLC, which is one of the most prevalent and deadly of all cancers," said Elmar Schnee, Merck Deputy Executive Board Member with responsibility for Pharmaceuticals. "We believe this new agreement is not only beneficial for both companies but also for patients."
About L-BLP25
L-BLP25 is a synthetic MUC1 peptide vaccine and is a biological response modifier with a chemically synthesized peptide of a cancer-associated protein antigen widely expressed on common cancers. It is designed to induce an immune response to both the synthetic antigen and the natural corresponding antigen as expressed on the cancer. In October 2005 Biomira announced that median survival for patients with Stage IIIB locoregional NSCLC who received L-BLP25 in a phase 2b study had been determined. These results demonstrated an average survival of 30.6 months in the vaccinated group compared with 13.3 months for the unvaccinated group. A more comprehensive analysis of these data is expected in the first quarter of this year. In November 2005 Biomira announced the interim results of a phase 2 NSCLC single-arm, multi-centre, open label study of L-BLP25. The results showed that the new formulation of the vaccine to be used in the phase 3 clinical trial program is not different from the previous formulation from a safety perspective.
The reformulated vaccine incorporated manufacturing changes intended to secure the future commercial supply of the vaccine. Thus far, ongoing testing has demonstrated that the steps taken to address the manufacturing issue discovered in late 2005 have been successful. Pending completion of this testing, it is expected that manufacturing for the phase 3 trial will resume in the first quarter of this year.
Analyst Conference Call Details:
Today at 10:00 a.m. EST, Biomira Inc. will Web cast an analyst conference call hosted by Alex McPherson, M.D., Ph.D., President and CEO of Biomira. Analysts may participate in the conference call by dialing 1-210-234-0075 (Pass code: BIOM) approximately 10 minutes before the start of the call.
Investors and the general public are invited to listen to the live conference call on the Web, by accessing the following site: https://e-meetings.mci.com/ and entering the conference number: PA1499468 and the participant pass code: BIOM. The archive of the analyst conference call will be available for approximately 30 days following the live call.
About Lung Cancer
In 2005, approximately 172,000 new cases of lung cancer were diagnosed in the U.S. Approximately 163,000 people are estimated to have died of this disease in the U.S. alone in 2005. NSCLC accounts for approximately 75 to 80 per cent of all primary lung cancers. At the time of diagnosis, only 25 per cent of patients are potentially curable by surgery.
About Biomira Inc.
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.
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, duration and results of clinical trials, particularly the phase 3 clinical trial of L-BLP25 and the possible additional phase 2 trials for its use in other indications, trial reviews and analyses and regulatory reviews, the safety and efficacy of the product, the ability to secure and manufacture vaccine supplies and the resolution of a recent manufacturing problem by an outside vendor of the vaccine, and the ability of Biomira to acquire new pipeline product candidates. 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 or that the Company will have sufficient resources to fund clinical trials and in-license new product candidates. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
26.01.06 21:44
#30
Steff23
Sieht explosiv aus! o. T.
Angehängte Grafik:
Biomira.JPG (verkleinert auf 45%)
Biomira.JPG (verkleinert auf 45%)
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