Bionor Pharma entwickelt HIV-Impfstoff - 500 Beiträge pro Seite
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Da es noch keine thread zu dieser Biotechfirma aus Norwegen gibt, stelle ich mal eine aktuelle Erfolgsmeldung dieser Firma hier ein und eröffne hiermit die Diskussion.
With Final Review of Phase IIb Viral Load Data Completed, Researchers Confirm Statistically Significant Reduction of HIV Viral Load on Vacc-4x Compared to Placebo
15 Feb 2012
Bionor's Clinical Research Program Moves Forward With Three Main Pathways to Market
OSLO, Norway I February 15, 2012 I Bionor Pharma (Oslo: BIONOR.OL - News)
Final review of phase IIb data confirms statistically significant 64% reduction of viral load "set point" (average of the last two viral load measurements before the end of the study) in patients receiving Vacc-4x compared to those given placebo, indicating a possible new option for patients and doctors.
The HIV viral load set point in patients given Vacc-4x was 60% lower than pre-ART (level before starting with standard medicine, ART). In the placebo group, no change compared to pre-ART was observed.
The conclusive data provide a basis for further HIV trials, offering Bionor three main pathways to market:
Re-vaccination to reduce the viral set point further -- aiming at a 'functional cure'
Immunization in the presence of Revlimid®, targeting patients that fail to regain immune competence (CD4 counts) while on ART
Combining Vacc-4x and Vacc-C5, which could potentially revolutionize HIV management
Bionor Pharma (Oslo: BIONOR.OL - News) announced today that researchers have completed a final review of the Company's lead therapeutic HIV vaccine, Vacc-4x, and its ability to reduce the amount of HIV circulating in patients ("viral load"). These final conclusions from the phase IIb, placebo-controlled, double-blind, international, multicenter trial, confirm initial findings of a statistically significant difference in viral load set point between Vacc-4x and placebo groups at the end of the study. The full results in addition to the final review of the immunological assessment are being prepared for publication in an international peer reviewed journal.
Vacc-4x is designed to generate immune responses to conserved domains of p24 that are common to all strains of HIV. Sustained immune responses to p24 have previously been shown to delay HIV disease progression.
Researchers from the Ragon Institute, Harvard, and MIT published in 2011 findings confirming the existence of conserved regions on p24 and emphasizing their potential as targets for an HIV vaccine. Bionor identified these domains over a decade earlier, and began developing the vaccine based on these findings. Today Bionor's Vacc-4x is the most studied immunotherapeutic product targeting p24.
About Vacc-4x phase IIb study and results
136 patients participated in the five country trial, with two-thirds (93) randomized to receive Vacc-4x together with ART, while one-third (43) received a placebo injection and ART. Patients were immunized with Vacc-4x or placebo while on ART over a period of 28 weeks. This was followed by a period without treatment, lasting up to 24 weeks (until week 52).
For patients that successfully completed the study (week 52), the placebo group (n=25) had a viral load set point of 61,900 cmL compared to the Vacc-4x group (n=56) that had a viral load set point of 22,300 cmL. This difference represents a reduction of 64% and is statistically significant (p=0.04). All values represent median.
A subgroup comparison has been performed with only those patients who had a known viral load measurement before starting ART (pre-ART). The placebo group (n=18) had no statistically significant difference between pre-ART viral load (52,731 cmL) and the viral load set point at the completion of the study (50,400 cmL, p=0.98). In contrast, the Vacc-4x group (n=45) had pre-ART viral load of 60,470 cmL, compared to 24,150 cmL at study completion, resulting in a statistically significant reduction of 60% (p=0.0001).
The previously reported findings showing an association between viral load and HIV-specific immune responses are also confirmed. Patients with immune responses to p24 at study termination had a higher viral load set point in the placebo group (61,900 cmL) compared to the Vacc-4x group (22,925 cmL). HIV-specific immune responses resulted in increased viral load in the placebo subjects, whereas the Vacc-4x group had a significantly better viral control (p=0.048).
"These final results confirm that Vacc-4x lowers viral load in patients with HIV who have remained off ART for at least 6 months," said Vidar Wendel-Hansen, MD, Chief Medical Officer, Bionor Pharma, "and suggests a correlation between this effect and the vaccine induced immune responses to p24."
Several independent further paths to market for Vacc-4x
Based on the conclusive phase IIb data, Bionor is studying several paths to guide the direction towards a Phase III pivotal trial, the final study before regulatory review and market entry:
1. Vacc-4x revaccination of patients from the phase IIb study, to further reduce the viral load set point (study planned 1H 2012). Based on the statistically significant lowering of viral load after vaccination with Vacc-4x compared to before taking ART, Bionor researchers plan to re-vaccinate Vacc-4x patients from the IIB study to see if the viral set point can be reduced even further. Such an approach may eventually form a "functional cure," meaning that HIV viral load is gradually reduced to lower levels following successive ART-free periods.
2. Vacc-4x in combination with Revlimid® (Lenalidomide), for patients with unmet medical needs (study planned 1H 2012). Based on the confirmed ability for Vacc-4x to lower viral load in HIV patients, Bionor will study the effect of combining Vacc-4x with Revlimid, for patients who are well controlled on ART but fail to regain immune competence (CD4 T-cell counts). By combining Vacc-4x with Revlimid, an immunomodulatory drug, Bionor's researchers will determine whether patients experience improvement.
3. Vacc-4x in combination with Vacc-C5, to reduce viral load and the spread of infection. Vacc-C5 is designed to induce antibodies to HIV that can reduce HIV associated immune hyperactivation which leads to AIDS. Preclinical studies have shown that Vacc-C5 successfully induced antibodies against HIV in animal models such as rabbits and sheep. Bionor intends to conduct the first clinical study of Vacc-C5 in man in 2Q 2012. Subsequent to the Vacc-C5 phase I/II trial, Bionor intends to combine Vacc-4x with Vacc-C5, a treatment that can potentially revolutionize the management of HIV infections and could form the basis for both a therapeutic and a preventative vaccine.
Bionor is furthermore investigating different options for administration of its vaccines. An ongoing trial at Oslo University Hospital aims to reveal whether Vacc-4x given by nasal administration can provide equivalent effect compared to delivery by needle injection. Such administration will be important for cost and availability in both Western and especially developing countries. All patients have been successfully included in the trial and the results are expected in first half of 2012.
Partnering process
The successful outcome of the phase IIb clinical trial, together with the Company's further preclinical and clinical program, makes a partnering process a natural next step for Bionor Pharma.
About Bionor Pharma ASA
Bionor Pharma is a biopharmaceutical, listed company based in Oslo, Norway.
The Company's lead investigational product, the HIV therapeutic vaccine Vacc-4x, has completed a phase IIb multinational, placebo controlled double-blind trial, which found a statistically significant reduction in viral load in treated subjects.
A second HIV therapeutic vaccine, Vacc-C5 is developed to induce antibodies to HIV that can reduce immune hyperactivation associated with HIV infection, which leads to AIDS. The first clinical trial for Vacc-C5 is planned 2Q 2012. Because researchers have already found that patients with antibodies to the C5 region on HIV have little virus in their blood and slow disease progression, Bionor anticipates that Vacc-C5 will offer an important weapon towards finding a functional cure for HIV. Vacc-4x in combination with Vacc-C5 can potentially revolutionize the management of HIV infection and could form the basis for a preventative HIV vaccine.
The Company's innovative technology platform is also well suited to the development of vaccines for a wide range of other viral diseases, such as Influenza, HCV (Hepatitis C) and HPV (Human Papilloma Virus). Preclinical studies with Vacc-Flu (Universal Influenza vaccine) and Vacc-HCV (Hepatitis C vaccine) are planned to be finalized in second half 2012, preparing for the clinical stage of development and partnering.
Bionor's vaccines are based on the proprietary technology platform developed following several years of research on peptides. The vaccines are designed to safely activate each person's immune system to combat viral disease.
Bionor seeks to create positive cash flow at an early stage of development by signing partnering deals with biotechnology and pharmaceutical companies. This includes short-term out-licensing of products with royalty payments or direct funding of clinical trials, such as Bionor's agreement signed in August 2011 with one of the world's largest Biotech companies. The collaboration includes a clinical trial on patients/subjects with HIV using a combination of Vacc-4x, and the cancer drug Revlimid.
More information about Bionor Pharma, its research and products, is available at www.bionorpharma.com
SOURCE: Bionor
With Final Review of Phase IIb Viral Load Data Completed, Researchers Confirm Statistically Significant Reduction of HIV Viral Load on Vacc-4x Compared to Placebo
15 Feb 2012
Bionor's Clinical Research Program Moves Forward With Three Main Pathways to Market
OSLO, Norway I February 15, 2012 I Bionor Pharma (Oslo: BIONOR.OL - News)
Final review of phase IIb data confirms statistically significant 64% reduction of viral load "set point" (average of the last two viral load measurements before the end of the study) in patients receiving Vacc-4x compared to those given placebo, indicating a possible new option for patients and doctors.
The HIV viral load set point in patients given Vacc-4x was 60% lower than pre-ART (level before starting with standard medicine, ART). In the placebo group, no change compared to pre-ART was observed.
The conclusive data provide a basis for further HIV trials, offering Bionor three main pathways to market:
Re-vaccination to reduce the viral set point further -- aiming at a 'functional cure'
Immunization in the presence of Revlimid®, targeting patients that fail to regain immune competence (CD4 counts) while on ART
Combining Vacc-4x and Vacc-C5, which could potentially revolutionize HIV management
Bionor Pharma (Oslo: BIONOR.OL - News) announced today that researchers have completed a final review of the Company's lead therapeutic HIV vaccine, Vacc-4x, and its ability to reduce the amount of HIV circulating in patients ("viral load"). These final conclusions from the phase IIb, placebo-controlled, double-blind, international, multicenter trial, confirm initial findings of a statistically significant difference in viral load set point between Vacc-4x and placebo groups at the end of the study. The full results in addition to the final review of the immunological assessment are being prepared for publication in an international peer reviewed journal.
Vacc-4x is designed to generate immune responses to conserved domains of p24 that are common to all strains of HIV. Sustained immune responses to p24 have previously been shown to delay HIV disease progression.
Researchers from the Ragon Institute, Harvard, and MIT published in 2011 findings confirming the existence of conserved regions on p24 and emphasizing their potential as targets for an HIV vaccine. Bionor identified these domains over a decade earlier, and began developing the vaccine based on these findings. Today Bionor's Vacc-4x is the most studied immunotherapeutic product targeting p24.
About Vacc-4x phase IIb study and results
136 patients participated in the five country trial, with two-thirds (93) randomized to receive Vacc-4x together with ART, while one-third (43) received a placebo injection and ART. Patients were immunized with Vacc-4x or placebo while on ART over a period of 28 weeks. This was followed by a period without treatment, lasting up to 24 weeks (until week 52).
For patients that successfully completed the study (week 52), the placebo group (n=25) had a viral load set point of 61,900 cmL compared to the Vacc-4x group (n=56) that had a viral load set point of 22,300 cmL. This difference represents a reduction of 64% and is statistically significant (p=0.04). All values represent median.
A subgroup comparison has been performed with only those patients who had a known viral load measurement before starting ART (pre-ART). The placebo group (n=18) had no statistically significant difference between pre-ART viral load (52,731 cmL) and the viral load set point at the completion of the study (50,400 cmL, p=0.98). In contrast, the Vacc-4x group (n=45) had pre-ART viral load of 60,470 cmL, compared to 24,150 cmL at study completion, resulting in a statistically significant reduction of 60% (p=0.0001).
The previously reported findings showing an association between viral load and HIV-specific immune responses are also confirmed. Patients with immune responses to p24 at study termination had a higher viral load set point in the placebo group (61,900 cmL) compared to the Vacc-4x group (22,925 cmL). HIV-specific immune responses resulted in increased viral load in the placebo subjects, whereas the Vacc-4x group had a significantly better viral control (p=0.048).
"These final results confirm that Vacc-4x lowers viral load in patients with HIV who have remained off ART for at least 6 months," said Vidar Wendel-Hansen, MD, Chief Medical Officer, Bionor Pharma, "and suggests a correlation between this effect and the vaccine induced immune responses to p24."
Several independent further paths to market for Vacc-4x
Based on the conclusive phase IIb data, Bionor is studying several paths to guide the direction towards a Phase III pivotal trial, the final study before regulatory review and market entry:
1. Vacc-4x revaccination of patients from the phase IIb study, to further reduce the viral load set point (study planned 1H 2012). Based on the statistically significant lowering of viral load after vaccination with Vacc-4x compared to before taking ART, Bionor researchers plan to re-vaccinate Vacc-4x patients from the IIB study to see if the viral set point can be reduced even further. Such an approach may eventually form a "functional cure," meaning that HIV viral load is gradually reduced to lower levels following successive ART-free periods.
2. Vacc-4x in combination with Revlimid® (Lenalidomide), for patients with unmet medical needs (study planned 1H 2012). Based on the confirmed ability for Vacc-4x to lower viral load in HIV patients, Bionor will study the effect of combining Vacc-4x with Revlimid, for patients who are well controlled on ART but fail to regain immune competence (CD4 T-cell counts). By combining Vacc-4x with Revlimid, an immunomodulatory drug, Bionor's researchers will determine whether patients experience improvement.
3. Vacc-4x in combination with Vacc-C5, to reduce viral load and the spread of infection. Vacc-C5 is designed to induce antibodies to HIV that can reduce HIV associated immune hyperactivation which leads to AIDS. Preclinical studies have shown that Vacc-C5 successfully induced antibodies against HIV in animal models such as rabbits and sheep. Bionor intends to conduct the first clinical study of Vacc-C5 in man in 2Q 2012. Subsequent to the Vacc-C5 phase I/II trial, Bionor intends to combine Vacc-4x with Vacc-C5, a treatment that can potentially revolutionize the management of HIV infections and could form the basis for both a therapeutic and a preventative vaccine.
Bionor is furthermore investigating different options for administration of its vaccines. An ongoing trial at Oslo University Hospital aims to reveal whether Vacc-4x given by nasal administration can provide equivalent effect compared to delivery by needle injection. Such administration will be important for cost and availability in both Western and especially developing countries. All patients have been successfully included in the trial and the results are expected in first half of 2012.
Partnering process
The successful outcome of the phase IIb clinical trial, together with the Company's further preclinical and clinical program, makes a partnering process a natural next step for Bionor Pharma.
About Bionor Pharma ASA
Bionor Pharma is a biopharmaceutical, listed company based in Oslo, Norway.
The Company's lead investigational product, the HIV therapeutic vaccine Vacc-4x, has completed a phase IIb multinational, placebo controlled double-blind trial, which found a statistically significant reduction in viral load in treated subjects.
A second HIV therapeutic vaccine, Vacc-C5 is developed to induce antibodies to HIV that can reduce immune hyperactivation associated with HIV infection, which leads to AIDS. The first clinical trial for Vacc-C5 is planned 2Q 2012. Because researchers have already found that patients with antibodies to the C5 region on HIV have little virus in their blood and slow disease progression, Bionor anticipates that Vacc-C5 will offer an important weapon towards finding a functional cure for HIV. Vacc-4x in combination with Vacc-C5 can potentially revolutionize the management of HIV infection and could form the basis for a preventative HIV vaccine.
The Company's innovative technology platform is also well suited to the development of vaccines for a wide range of other viral diseases, such as Influenza, HCV (Hepatitis C) and HPV (Human Papilloma Virus). Preclinical studies with Vacc-Flu (Universal Influenza vaccine) and Vacc-HCV (Hepatitis C vaccine) are planned to be finalized in second half 2012, preparing for the clinical stage of development and partnering.
Bionor's vaccines are based on the proprietary technology platform developed following several years of research on peptides. The vaccines are designed to safely activate each person's immune system to combat viral disease.
Bionor seeks to create positive cash flow at an early stage of development by signing partnering deals with biotechnology and pharmaceutical companies. This includes short-term out-licensing of products with royalty payments or direct funding of clinical trials, such as Bionor's agreement signed in August 2011 with one of the world's largest Biotech companies. The collaboration includes a clinical trial on patients/subjects with HIV using a combination of Vacc-4x, and the cancer drug Revlimid.
More information about Bionor Pharma, its research and products, is available at www.bionorpharma.com
SOURCE: Bionor
Bionor Rises Most in 15 Months on AIDS Drug Study: Oslo Mover
http://www.bloomberg.com/news/2012-02-15/bionor-rises-most-i…
http://www.bloomberg.com/news/2012-02-15/bionor-rises-most-i…
Das ist eher ein Wirkstoff gegen HIV, nicht ein Impfstoff. Die Frage ist, welche wirtschaftliche Relevanz das haette. Die Medikamente wuerden ja in erster Linie von Hilfsorganisationen gekauft, die sie in Afrika verteilen.
...man wird hierzulande langsam aufmerksam...
http://www.aktiencheck.de/analysen/Artikel-BIONOR_PHARMA_Dat…
http://www.aktiencheck.de/analysen/Artikel-BIONOR_PHARMA_Dat…
Antwort auf Beitrag Nr.: 42.816.260 von COLTOROC am 28.02.12 09:16:52Ob die hier mitgelesen haben?
Mandatory notification of trade
Oslo, 29.02.212 - CEO of Bionor Pharma ASA, Steen Krøyer, has today purchased 50,000 Bionor shares at an average of NOK 2.75 per share.
The shares are held through a nominee account in Nordea Luxembourg.
Steen Krøyer's holding after the purchase is 150,000 Bionor shares.
Oslo, 29.02.212 - CEO of Bionor Pharma ASA, Steen Krøyer, has today purchased 50,000 Bionor shares at an average of NOK 2.75 per share.
The shares are held through a nominee account in Nordea Luxembourg.
Steen Krøyer's holding after the purchase is 150,000 Bionor shares.
Mandatory notification of trade
Oslo 06.03.2012 - Consultant for Bionor Pharma ASA, David Sheon, has yesterday purchased 7,500 Bionor shares at an average of NOK 2.93 per share.
David Sheon's holding after the purchase is 7,500 Bionor shares.
Oslo 06.03.2012 - Consultant for Bionor Pharma ASA, David Sheon, has yesterday purchased 7,500 Bionor shares at an average of NOK 2.93 per share.
David Sheon's holding after the purchase is 7,500 Bionor shares.
...und sie klettert leise weiter und weiter...
http://www.bionorpharma.com/en/Investors/Share_information/
http://www.bionorpharma.com/en/Investors/Share_information/
Results from Nasal Administration Study of HIV Vaccine Vacc-4x and Endocine Expected First Half of May
Oslo 10.04.2012 - Bionor Pharma ASA (OSE: BIONOR) today announces that the placebo controlled study of nasally administered HIV therapeutic vaccine Vacc-4x in combination with Eurocine Vaccines` Endocine has been finalized in Q1 as planned and previously communicated. 24 patients were included, and 23 completed the study. No serious adverse events have been reported.
Analysis of the comprehensive data has started, and first results from the study are planned to be released during first half of May 2012.
###
About Eurocine Vaccines
Eurocine Vaccines is a publicly listed, clinical-stage company developing nasal vaccines that meet important medical needs. The vaccines are developed up to proof of concept (clinical phase I/II) and licensed to partners for further development and commercialization. The company's proprietary vaccine adjuvant technologies, which are a key element of the nasal vaccines, are also offered to license partners for development in various indications.
More information about Eurocine Vaccines, its research and products, is available at www.eurocine-vaccines.com
http://www.bionorpharma.com/en/News_archive/2012/All/Results…
Oslo 10.04.2012 - Bionor Pharma ASA (OSE: BIONOR) today announces that the placebo controlled study of nasally administered HIV therapeutic vaccine Vacc-4x in combination with Eurocine Vaccines` Endocine has been finalized in Q1 as planned and previously communicated. 24 patients were included, and 23 completed the study. No serious adverse events have been reported.
Analysis of the comprehensive data has started, and first results from the study are planned to be released during first half of May 2012.
###
About Eurocine Vaccines
Eurocine Vaccines is a publicly listed, clinical-stage company developing nasal vaccines that meet important medical needs. The vaccines are developed up to proof of concept (clinical phase I/II) and licensed to partners for further development and commercialization. The company's proprietary vaccine adjuvant technologies, which are a key element of the nasal vaccines, are also offered to license partners for development in various indications.
More information about Eurocine Vaccines, its research and products, is available at www.eurocine-vaccines.com
http://www.bionorpharma.com/en/News_archive/2012/All/Results…
Was für ein satter Anstieg heute!
Mandatory notification of Trade
(Oslo, 27 April 2012) Marianne Furru, Board member of Bionor Pharma ASA, has today purchased 100,000 shares
Marianne Furru, Board member of Bionor Pharma ASA, has today purchased 100,000
shares in Bionor Pharma ASA through the company Fular AS at an average price of
NOK 3.92 per share.
Following this transaction Marianne Furru holds indirectly 240,000 shares in
BIONOR.
...nachmachen, bitte...!
(Oslo, 27 April 2012) Marianne Furru, Board member of Bionor Pharma ASA, has today purchased 100,000 shares
Marianne Furru, Board member of Bionor Pharma ASA, has today purchased 100,000
shares in Bionor Pharma ASA through the company Fular AS at an average price of
NOK 3.92 per share.
Following this transaction Marianne Furru holds indirectly 240,000 shares in
BIONOR.
...nachmachen, bitte...!
Hier geht's offenbar auf zu neuen Höhen.
Wird wohl nix aus dem erhofften Rücksetzer.
Wird wohl nix aus dem erhofften Rücksetzer.
...heute neues Allzeithoch und NEWS...
Successfully results from clinical study with Vacc-4x and Endocine
Oslo 10.05.2012 - Successful Immunization and Safety Documented in Nasal Administration Study of the HIV Vaccine Vacc-4x together with Endocine
This New Option May Offer Easier Treatment Access for HIV Patients Globally
News Summary
* Vaccine related immune responses found in HIV patients given Vacc-4x
together with Endocine through nasal administration in a placebo controlled
study
* The study also documents safety by nasal administration
* Further analyses are ongoing, and will be published at a later stage
Bionor Pharma ASA, Eurocine Vaccines AB and
Oslo University Hospital today announced that vaccine related immune responses
are documented in patients given active vaccine in a nasal immunization study,
combining Bionor Pharma's Vacc-4x and Eurocine Vaccines' adjuvant Endocine. The
results are furthermore documenting safety by nasal administration of the
vaccine.
The clinical costs have been covered by a grant from The Research Council of
Norway (RCN) of US$ 1.2 million (NOK 6.9 million), under the GLOBVAC program.
Vacc-4x is a therapeutic HIV-vaccine based on four, slightly modified peptides
(building blocks of proteins) from conserved parts of the HIV-virus. Endocine is
an adjuvant shown to enhance the immune response to vaccine antigens delivered
nasally.
Researchers at Oslo University Hospital studied the effect of nasal delivery of
Vacc-4x in combination with Eurocine Vaccines' adjuvant Endocine, compared to
the effect of Endocine alone.
"We are pleased to report positive, preliminary results from the study,
indicating that Vacc-4x for HIV patients may be given by Nasal administration as
well as by injection," said Professor Dag Kvale, MD, Ph.D., Principal
Investigator at Oslo University Hospital. "These results are promising for HIV
patients globally, by potentially providing a new class of HIV treatment that`s
even easier to deliver."
"We are seeing these data as important, both for the Vacc-4x and for our other
vaccine candidates," said Steen Krøyer, CEO, Bionor Pharma ASA.
"Positive results from this study with nasally delivered combination of Vacc-4x
and Endocine can pave the way to help the growing number of HIV patients with
unmet medical needs," said Hans Arwidsson, CEO, Eurocine Vaccines AB.
About the Study and the Results
The single blinded, randomized, placebo-controlled, immunogenicity study
included 24 patients, all receiving conventional HIV medicine (antiretroviral
therapy, ART). 18 patients received active, nasal vaccine (both Vacc-4x and the
adjuvant Endocine) at either of three different dose levels of Vacc-4x, and 6
patients received Endocine only (control group). All patients were given weekly
nasal drops for four weeks (one patient was withdrawn at week 6, without reasons
related to the study). The final study visit was scheduled at week 8. Overall,
the treatment was very well tolerated, although some reported mild and transient
sensations in the nose the same day.
Only the patients given active nasal vaccine (with Vacc-4x) increased their
vaccine related immune responses during the 8 weeks study period. This outcome
was further confirmed by a skin test (DTH).
These results support that immunization of HIV-infected individuals by nasal co-
administration of Vacc-4x and Endocine adjuvant is safe and is able to
strengthen vaccine related immune responses. Dose-related differences are
currently under evaluation, and additional data including antibody production in
mucosal secretions will be analyzed and published at a later stage.
About the HIV vaccine Vacc-4x
Vacc-4x is a therapeutic HIV-vaccine based on four, slightly modified peptide
sequences from conserved (stable) parts of the HIV-virus, which doesn`t change
even if the virus mutates (is changing). The chosen peptides have been modified
to increase immunogenicity of the vaccine. The product has broad patent
protection.
About Eurocine Vaccines
Eurocine Vaccines is a publicly listed, clinical-stage company developing nasal
vaccines that meet important medical needs. The vaccines are developed up to
proof of concept (clinical phase I/II) and licensed to partners for further
development and commercialization. The company's proprietary vaccine adjuvant
technologies, which are a key element of the nasal vaccines, are also offered to
license partners for development in various indications.
More information about Eurocine Vaccines, its research and products, is
available at www.eurocine-vaccines.com
Successfully results from clinical study with Vacc-4x and Endocine
Oslo 10.05.2012 - Successful Immunization and Safety Documented in Nasal Administration Study of the HIV Vaccine Vacc-4x together with Endocine
This New Option May Offer Easier Treatment Access for HIV Patients Globally
News Summary
* Vaccine related immune responses found in HIV patients given Vacc-4x
together with Endocine through nasal administration in a placebo controlled
study
* The study also documents safety by nasal administration
* Further analyses are ongoing, and will be published at a later stage
Bionor Pharma ASA, Eurocine Vaccines AB and
Oslo University Hospital today announced that vaccine related immune responses
are documented in patients given active vaccine in a nasal immunization study,
combining Bionor Pharma's Vacc-4x and Eurocine Vaccines' adjuvant Endocine. The
results are furthermore documenting safety by nasal administration of the
vaccine.
The clinical costs have been covered by a grant from The Research Council of
Norway (RCN) of US$ 1.2 million (NOK 6.9 million), under the GLOBVAC program.
Vacc-4x is a therapeutic HIV-vaccine based on four, slightly modified peptides
(building blocks of proteins) from conserved parts of the HIV-virus. Endocine is
an adjuvant shown to enhance the immune response to vaccine antigens delivered
nasally.
Researchers at Oslo University Hospital studied the effect of nasal delivery of
Vacc-4x in combination with Eurocine Vaccines' adjuvant Endocine, compared to
the effect of Endocine alone.
"We are pleased to report positive, preliminary results from the study,
indicating that Vacc-4x for HIV patients may be given by Nasal administration as
well as by injection," said Professor Dag Kvale, MD, Ph.D., Principal
Investigator at Oslo University Hospital. "These results are promising for HIV
patients globally, by potentially providing a new class of HIV treatment that`s
even easier to deliver."
"We are seeing these data as important, both for the Vacc-4x and for our other
vaccine candidates," said Steen Krøyer, CEO, Bionor Pharma ASA.
"Positive results from this study with nasally delivered combination of Vacc-4x
and Endocine can pave the way to help the growing number of HIV patients with
unmet medical needs," said Hans Arwidsson, CEO, Eurocine Vaccines AB.
About the Study and the Results
The single blinded, randomized, placebo-controlled, immunogenicity study
included 24 patients, all receiving conventional HIV medicine (antiretroviral
therapy, ART). 18 patients received active, nasal vaccine (both Vacc-4x and the
adjuvant Endocine) at either of three different dose levels of Vacc-4x, and 6
patients received Endocine only (control group). All patients were given weekly
nasal drops for four weeks (one patient was withdrawn at week 6, without reasons
related to the study). The final study visit was scheduled at week 8. Overall,
the treatment was very well tolerated, although some reported mild and transient
sensations in the nose the same day.
Only the patients given active nasal vaccine (with Vacc-4x) increased their
vaccine related immune responses during the 8 weeks study period. This outcome
was further confirmed by a skin test (DTH).
These results support that immunization of HIV-infected individuals by nasal co-
administration of Vacc-4x and Endocine adjuvant is safe and is able to
strengthen vaccine related immune responses. Dose-related differences are
currently under evaluation, and additional data including antibody production in
mucosal secretions will be analyzed and published at a later stage.
About the HIV vaccine Vacc-4x
Vacc-4x is a therapeutic HIV-vaccine based on four, slightly modified peptide
sequences from conserved (stable) parts of the HIV-virus, which doesn`t change
even if the virus mutates (is changing). The chosen peptides have been modified
to increase immunogenicity of the vaccine. The product has broad patent
protection.
About Eurocine Vaccines
Eurocine Vaccines is a publicly listed, clinical-stage company developing nasal
vaccines that meet important medical needs. The vaccines are developed up to
proof of concept (clinical phase I/II) and licensed to partners for further
development and commercialization. The company's proprietary vaccine adjuvant
technologies, which are a key element of the nasal vaccines, are also offered to
license partners for development in various indications.
More information about Eurocine Vaccines, its research and products, is
available at www.eurocine-vaccines.com
Antwort auf Beitrag Nr.: 43.146.247 von COLTOROC am 10.05.12 11:57:54Und, hast Du shares?
Leider läuft diese party ohne mich.
Leider läuft diese party ohne mich.
...und sie steigt und steigt...
...heute neues Allzeithoch mit 4,68 NK...
...heute neues Allzeithoch mit 4,68 NK...
Antwort auf Beitrag Nr.: 43.195.268 von COLTOROC am 22.05.12 10:12:31Was ist da los??
...heute schon mal 4,79 NOK...
und sie steigt weiter heute!
First Human Study of HIV Vaccine Vacc-C5 to begin
Oslo 29.05.2012 - Animal Studies Indicate Similar Generation of Immune Responses as Those in HIV Patients who Naturally Suppress the Infection
News Summary
Open, clinical study, dose escalating, phase I/II, with Bionor Pharma`s second therapeutic HIV vaccine to begin at Oslo University Hospital.
Researchers hope Vacc-C5 will prevent hyperactivation of immune system that leads to AIDS, and possibly thereby make patients able to control HIV replication without the need for medication.
The study will investigate whether humans develop antibodies to HIV as a result of vaccination with Vacc-C5, and if these antibodies have same properties as antibodies found in “long term non progressors,” in other words patients who live with HIV but are able to naturally suppress the virus.
Bionor Pharma ASA announced today that the first study of Bionor Pharma’s Vacc-C5 is now approved to begin at Oslo University Hospital. Vacc-C5 is a therapeutic HIV vaccine developed to slow down or stop induction of immune hyperactivation, a feature that drives the production of HIV and is damaging the immune system, leading to AIDS. Vacc-C5 also may have the potential to be a preventive vaccine, alone or in combination with Vacc-4x.
The phase I/II study will use Vacc-C5 at three different dose levels, in order to evaluate safety and provide a determination for the optimal dose of the vaccine, when given intradermally (in the skin) or intramuscularly.
“The pre-clinical studies of Vacc-C5 in rabbits, and sheep, as well as data confirming an association between high antibody levels and slow progression of HIV in humans have generated considerable interest,” said Dag Kvale, MD, PhD, Principal Investigator at Oslo University Hospital. “We look forward to see how people living with HIV respond when on Vacc-C5.”
The study seeks to recruit 36 patients who have been infected with HIV for at least one year. Study participants must have been stable on antiretroviral therapy (ART, traditional HIV medicine) for at least six months with a viral load of less than 50 copies per milliliter. The primary endpoint of the trial is to evaluate safety of the vaccine at three different dose levels. Secondary endpoints include measuring specific antibody and T-cell responses to Vacc-C5 and to evaluate T-cell activation markers. Vacc-C5 will be given in combination with two different adjuvants, (that enhance the immune response), either GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) or Alhydrogel (an aluminum-based treatment).
How Vacc-C5 is considered to Work, in Comparison to Vacc-4x
Vacc-C5 generates antibodies based on modified, manufactured (synthetic) peptides from the C5 region (of gp 120) at the HIV-virus surface. Data suggest that anti-C5 antibodies may play a crucial role for Natural Viral Suppressors, a group of people who are able to control the HIV infection without the need of HIV medication.
Bionor Pharma has filed a patent application covering Vacc-C5.
The further strategy is to use Vacc-C5 in combination with Vacc-4x since Vacc-4x already has via T-cell (killer cell) responses shown to lower the viral load set point (stabilized virus level) by statistically significant levels compared to placebo.
“Where Vacc-4x appears to kill virus-producing cells, Vacc-C5 has the potential to reduce the damaging immune activation,” said Birger Sørensen, EVP Head of Vaccines. “Looking ahead, we’re very excited to study the two vaccines in combination, pending that safety and dosing are confirmed in this trial.”
Bionor plans on studying the two treatments Vacc-4x and Vacc-C5 in combination.
Objectives and indications
Vacc-C5 has potential both as part of a preventive vaccine, and as a therapy, by preventing or reversing immune collapse in chronically infected patients.
Researchers believe the antibodies induced by Vacc-C5 can be beneficial at all stages of HIV infection by slowing down or halting the disease progression, and by significantly reducing the production of virus.
Theoretically, Vacc-C5 could be used at any point in patient treatment, forming a part (together with Vacc-4x) of both therapeutic and preventive therapy:
1. Treatment of existing patients at risk of immune collapse
• Newly infected patients
• Patients developing treatment-resistant HIV strains
• Patients intolerant of existing therapies
2. As a preventative vaccine for high risk populations
Early Research Provides Clue to New Strategy for HIV Management
Bionor Pharma started its research on Vacc-C5 by testing blood samples from HIV-infected patients. These demonstrated significant antibody reactivity to Vacc-C5 in blood from Natural Viral Suppressors.
The study was performed in collaboration with Professor Robert Redfield at the University of Maryland, Baltimore, USA, using ELISA tests on blood samples from a total of 57 HIV-infected patients, of which 43 were HIV natural viral suppressors with very low viral load. Reactivity to Vacc-C5 was significantly greater in these patients compared to patients with medium/high viral load. The study showed statistically significant difference in reactivity towards Vacc-C5 between the two groups (p=0,018).
This study confirms that antigens identified previously by the Company are directly associated with the antibodies of Natural Viral Suppressors. The immunogenicity of Vacc-C5 has recently also been confirmed in animal studies.
These studies received partial funding from the Research Council of Norway.
About Bionor Pharma ASA
Bionor Pharma is a leading vaccine company, listed at Oslo Stock Exchange. The Company's investments in developing therapeutic vaccines exceed US$70 million. Bionor's vaccines are based on the proprietary technology platform developed following more than two decades of research on peptides. The vaccines are designed to safely activate each person's immune system to combat viral diseases.
HIV/AIDS
Global leader in developing HIV vaccine: The Company's lead investigational product, the therapeutic HIV vaccine Vacc-4x, has in a completed phase IIb multinational (USA, Germany, UK, Spain and Italy), placebo controlled, double-blind study, shown a statistically significant reduction in viral load.
Step towards long lasting HIV viral control with Vacc-4x: Conventional HIV medication (antiretroviral therapy, ART) is not a cure, but blocks virus production only while patients take this medication. ART must therefore be a lifelong treatment. In contrast, Bionor Pharma’s therapeutic vaccine aims to induce long lasting virus control by training immune cells to seek out and kill virus-producing cells. The observed 64% CTL induced reduction (reduction by killer cells) in viral load set point in patients who received Vacc-4x compared to placebo in the phase IIb study therefore represents a step towards long-lasting viral control. Because most patients who are given ART are known to stop taking it for various reasons (high costs, limited access, development of resistance, and serious adverse events), Bionor believes Vacc-4x could be a vital treatment option that can stabilize patients if they stop taking ART.
HIV vaccine inducing antibodies: Bionor`s second therapeutic HIV vaccine, Vacc-C5 is developed to induce antibodies to HIV that can reduce viral production (lowering the set point) and the harmful hyperactivation of the immune system that leads to AIDS. Subsequent to the Vacc-C5 phase I/II trial, Bionor intends to combine Vacc-4x with Vacc-C5, which could form the basis for both a therapeutic and a preventative vaccine.
Global HIV challenge: According to the UN organization UNAIDS, 34 million people were living with HIV in 2010. Approximately three million new people are infected annually. Only one out of six HIV-infected patients currently has access to ART treatment. According to recent CDC studies, less than 25 percent of people prescribed conventional HIV medicine stay on the treatment.
Pharmaceutical sales to treat HIV are US$ 10.6 billion (NOK 63 billion) annually, and treatment cost per patient is approx. US$ 15,000 (NOK 90,000) per year.
Pathways to market for Bionor Pharma`s HIV vaccines
Bionor researchers will investigate various independent pathways to market for the HIV vaccine candidates Vacc-4x and Vacc-C5, through further clinical studies starting this year:
1. Vacc-4x revaccination in patients who participated in the phase IIb study, with the aim of reducing viral load even further by killing of virus producing cells.
2. Vacc-4x combined with Revlimid® (lenalidomide), in patients with a weakened immune system which does not recover despite being seemingly well controlled on ART.
3. Vacc-C5 clinical trial phase I/II, to document whether Vacc-C5 increases HIV antibodies in humans. The company aims to subsequently study Vacc-C5 in combination with Vacc-4x, a treatment that potentially can eradicate and prevent HIV and thereby revolutionize HIV treatment.
Nasal administration of Vacc-4x: A placebo controlled study with Vacc-4x at Oslo University Hospital demonstrated safety and successful immunization in treated patients by nasally delivered vaccine. This option may offer easier treatment access for HIV patients globally. Further analyses are ongoing, and will be published at a later stage.
VACCINES FOR OTHER VIRAL DISEASES
The Company's innovative technology platform is also well suited to develop vaccines for other viral diseases, such as Influenza, HCV (Hepatitis C), HPV (Human Papilloma Virus) and CMV (Cytomegalovirus).
Vacc-Flu (Universal Influenza vaccine) and Vacc-HCV (Hepatitis C vaccine) are in preclinical phase of development.
More information about Bionor Pharma, its research and products, is available at www.bionorpharma.com.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act). Vacc-C5 and Vacc-4x are investigational treatments that have not been approved for marketing by any regulatory authority.
# # #
Bionor Pharma ASA, Oslo: +47 23 01 09 60/ Bionor Pharma laboratories: +47 35 90 85 00
Steen Krøyer, CEO
Birger Sørensen, EVP, Head of Vaccines
Vidar Wendel-Hansen, CMO
USA Contact:
David Sheon 202 422-6999
dsheon@WHITECOATstrategies.com
http://www.bionorpharma.com/en/News_archive/2012/All/First+H…
Oslo 29.05.2012 - Animal Studies Indicate Similar Generation of Immune Responses as Those in HIV Patients who Naturally Suppress the Infection
News Summary
Open, clinical study, dose escalating, phase I/II, with Bionor Pharma`s second therapeutic HIV vaccine to begin at Oslo University Hospital.
Researchers hope Vacc-C5 will prevent hyperactivation of immune system that leads to AIDS, and possibly thereby make patients able to control HIV replication without the need for medication.
The study will investigate whether humans develop antibodies to HIV as a result of vaccination with Vacc-C5, and if these antibodies have same properties as antibodies found in “long term non progressors,” in other words patients who live with HIV but are able to naturally suppress the virus.
Bionor Pharma ASA announced today that the first study of Bionor Pharma’s Vacc-C5 is now approved to begin at Oslo University Hospital. Vacc-C5 is a therapeutic HIV vaccine developed to slow down or stop induction of immune hyperactivation, a feature that drives the production of HIV and is damaging the immune system, leading to AIDS. Vacc-C5 also may have the potential to be a preventive vaccine, alone or in combination with Vacc-4x.
The phase I/II study will use Vacc-C5 at three different dose levels, in order to evaluate safety and provide a determination for the optimal dose of the vaccine, when given intradermally (in the skin) or intramuscularly.
“The pre-clinical studies of Vacc-C5 in rabbits, and sheep, as well as data confirming an association between high antibody levels and slow progression of HIV in humans have generated considerable interest,” said Dag Kvale, MD, PhD, Principal Investigator at Oslo University Hospital. “We look forward to see how people living with HIV respond when on Vacc-C5.”
The study seeks to recruit 36 patients who have been infected with HIV for at least one year. Study participants must have been stable on antiretroviral therapy (ART, traditional HIV medicine) for at least six months with a viral load of less than 50 copies per milliliter. The primary endpoint of the trial is to evaluate safety of the vaccine at three different dose levels. Secondary endpoints include measuring specific antibody and T-cell responses to Vacc-C5 and to evaluate T-cell activation markers. Vacc-C5 will be given in combination with two different adjuvants, (that enhance the immune response), either GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) or Alhydrogel (an aluminum-based treatment).
How Vacc-C5 is considered to Work, in Comparison to Vacc-4x
Vacc-C5 generates antibodies based on modified, manufactured (synthetic) peptides from the C5 region (of gp 120) at the HIV-virus surface. Data suggest that anti-C5 antibodies may play a crucial role for Natural Viral Suppressors, a group of people who are able to control the HIV infection without the need of HIV medication.
Bionor Pharma has filed a patent application covering Vacc-C5.
The further strategy is to use Vacc-C5 in combination with Vacc-4x since Vacc-4x already has via T-cell (killer cell) responses shown to lower the viral load set point (stabilized virus level) by statistically significant levels compared to placebo.
“Where Vacc-4x appears to kill virus-producing cells, Vacc-C5 has the potential to reduce the damaging immune activation,” said Birger Sørensen, EVP Head of Vaccines. “Looking ahead, we’re very excited to study the two vaccines in combination, pending that safety and dosing are confirmed in this trial.”
Bionor plans on studying the two treatments Vacc-4x and Vacc-C5 in combination.
Objectives and indications
Vacc-C5 has potential both as part of a preventive vaccine, and as a therapy, by preventing or reversing immune collapse in chronically infected patients.
Researchers believe the antibodies induced by Vacc-C5 can be beneficial at all stages of HIV infection by slowing down or halting the disease progression, and by significantly reducing the production of virus.
Theoretically, Vacc-C5 could be used at any point in patient treatment, forming a part (together with Vacc-4x) of both therapeutic and preventive therapy:
1. Treatment of existing patients at risk of immune collapse
• Newly infected patients
• Patients developing treatment-resistant HIV strains
• Patients intolerant of existing therapies
2. As a preventative vaccine for high risk populations
Early Research Provides Clue to New Strategy for HIV Management
Bionor Pharma started its research on Vacc-C5 by testing blood samples from HIV-infected patients. These demonstrated significant antibody reactivity to Vacc-C5 in blood from Natural Viral Suppressors.
The study was performed in collaboration with Professor Robert Redfield at the University of Maryland, Baltimore, USA, using ELISA tests on blood samples from a total of 57 HIV-infected patients, of which 43 were HIV natural viral suppressors with very low viral load. Reactivity to Vacc-C5 was significantly greater in these patients compared to patients with medium/high viral load. The study showed statistically significant difference in reactivity towards Vacc-C5 between the two groups (p=0,018).
This study confirms that antigens identified previously by the Company are directly associated with the antibodies of Natural Viral Suppressors. The immunogenicity of Vacc-C5 has recently also been confirmed in animal studies.
These studies received partial funding from the Research Council of Norway.
About Bionor Pharma ASA
Bionor Pharma is a leading vaccine company, listed at Oslo Stock Exchange. The Company's investments in developing therapeutic vaccines exceed US$70 million. Bionor's vaccines are based on the proprietary technology platform developed following more than two decades of research on peptides. The vaccines are designed to safely activate each person's immune system to combat viral diseases.
HIV/AIDS
Global leader in developing HIV vaccine: The Company's lead investigational product, the therapeutic HIV vaccine Vacc-4x, has in a completed phase IIb multinational (USA, Germany, UK, Spain and Italy), placebo controlled, double-blind study, shown a statistically significant reduction in viral load.
Step towards long lasting HIV viral control with Vacc-4x: Conventional HIV medication (antiretroviral therapy, ART) is not a cure, but blocks virus production only while patients take this medication. ART must therefore be a lifelong treatment. In contrast, Bionor Pharma’s therapeutic vaccine aims to induce long lasting virus control by training immune cells to seek out and kill virus-producing cells. The observed 64% CTL induced reduction (reduction by killer cells) in viral load set point in patients who received Vacc-4x compared to placebo in the phase IIb study therefore represents a step towards long-lasting viral control. Because most patients who are given ART are known to stop taking it for various reasons (high costs, limited access, development of resistance, and serious adverse events), Bionor believes Vacc-4x could be a vital treatment option that can stabilize patients if they stop taking ART.
HIV vaccine inducing antibodies: Bionor`s second therapeutic HIV vaccine, Vacc-C5 is developed to induce antibodies to HIV that can reduce viral production (lowering the set point) and the harmful hyperactivation of the immune system that leads to AIDS. Subsequent to the Vacc-C5 phase I/II trial, Bionor intends to combine Vacc-4x with Vacc-C5, which could form the basis for both a therapeutic and a preventative vaccine.
Global HIV challenge: According to the UN organization UNAIDS, 34 million people were living with HIV in 2010. Approximately three million new people are infected annually. Only one out of six HIV-infected patients currently has access to ART treatment. According to recent CDC studies, less than 25 percent of people prescribed conventional HIV medicine stay on the treatment.
Pharmaceutical sales to treat HIV are US$ 10.6 billion (NOK 63 billion) annually, and treatment cost per patient is approx. US$ 15,000 (NOK 90,000) per year.
Pathways to market for Bionor Pharma`s HIV vaccines
Bionor researchers will investigate various independent pathways to market for the HIV vaccine candidates Vacc-4x and Vacc-C5, through further clinical studies starting this year:
1. Vacc-4x revaccination in patients who participated in the phase IIb study, with the aim of reducing viral load even further by killing of virus producing cells.
2. Vacc-4x combined with Revlimid® (lenalidomide), in patients with a weakened immune system which does not recover despite being seemingly well controlled on ART.
3. Vacc-C5 clinical trial phase I/II, to document whether Vacc-C5 increases HIV antibodies in humans. The company aims to subsequently study Vacc-C5 in combination with Vacc-4x, a treatment that potentially can eradicate and prevent HIV and thereby revolutionize HIV treatment.
Nasal administration of Vacc-4x: A placebo controlled study with Vacc-4x at Oslo University Hospital demonstrated safety and successful immunization in treated patients by nasally delivered vaccine. This option may offer easier treatment access for HIV patients globally. Further analyses are ongoing, and will be published at a later stage.
VACCINES FOR OTHER VIRAL DISEASES
The Company's innovative technology platform is also well suited to develop vaccines for other viral diseases, such as Influenza, HCV (Hepatitis C), HPV (Human Papilloma Virus) and CMV (Cytomegalovirus).
Vacc-Flu (Universal Influenza vaccine) and Vacc-HCV (Hepatitis C vaccine) are in preclinical phase of development.
More information about Bionor Pharma, its research and products, is available at www.bionorpharma.com.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act). Vacc-C5 and Vacc-4x are investigational treatments that have not been approved for marketing by any regulatory authority.
# # #
Bionor Pharma ASA, Oslo: +47 23 01 09 60/ Bionor Pharma laboratories: +47 35 90 85 00
Steen Krøyer, CEO
Birger Sørensen, EVP, Head of Vaccines
Vidar Wendel-Hansen, CMO
USA Contact:
David Sheon 202 422-6999
dsheon@WHITECOATstrategies.com
http://www.bionorpharma.com/en/News_archive/2012/All/First+H…
Es gab gute news.
...das wollen wir nicht verschweigen...
...Mandatory notification of trade
Oslo, 18.08.2012 - Jerome Zeldis, Board member of Bionor Pharma ASA, has yesterday purchased 100,000 Bionor shares at a price of NOK 3.45 per share...
...Mandatory notification of trade
Oslo, 18.08.2012 - Jerome Zeldis, Board member of Bionor Pharma ASA, has yesterday purchased 100,000 Bionor shares at a price of NOK 3.45 per share...
...und weiter gehts...
Mandatory notification of Trade
Oslo 17.09.2012 - Communications Director of Bionor Pharma ASA, Hilde Aalling Syvertsen, has today purchased 50,000 BIONOR shares at an average price of NOK 3.6662 per share.
Hilde Aalling Syvertsen's holding after the purchase is 758,000 BIONOR shares.
...wenn hier bald die Bombe platzt, ist von den deutschen Micheln mal wieder so gut wie keiner vorne mit dabei...
...erst wenns dann groß im " Der Aktionär" steht, rennt die Herde los...
Mandatory notification of Trade
Oslo 17.09.2012 - Communications Director of Bionor Pharma ASA, Hilde Aalling Syvertsen, has today purchased 50,000 BIONOR shares at an average price of NOK 3.6662 per share.
Hilde Aalling Syvertsen's holding after the purchase is 758,000 BIONOR shares.
...wenn hier bald die Bombe platzt, ist von den deutschen Micheln mal wieder so gut wie keiner vorne mit dabei...
...erst wenns dann groß im " Der Aktionär" steht, rennt die Herde los...
Hier geht es übrigens zur Newsübersicht auf der homepage von BIONOR:
http://www.bionorpharma.com/en/News/All/?folderpagesize=10
http://www.bionorpharma.com/en/News/All/?folderpagesize=10
Fourth Quarter and Full-Year Results 2012
Oslo, 15 February 2013 - Bionor Pharma ASA today announced financial results for fourth quarter and full year 2012 and provided highlights of key developments during fourth quarter 2012 and current status and outlook.
http://www.bionorpharma.com/en/News/2013/Financial/Fourth+Qu…
Oslo, 15 February 2013 - Bionor Pharma ASA today announced financial results for fourth quarter and full year 2012 and provided highlights of key developments during fourth quarter 2012 and current status and outlook.
http://www.bionorpharma.com/en/News/2013/Financial/Fourth+Qu…
Seit zwei Tagen steigt Bionors Aktienkurs bei gleichzeitig hohen Umsätzen stark an!
Ist die Erteilung des Patents für Vacc-HIV der Grund?
Ist die Erteilung des Patents für Vacc-HIV der Grund?
Nun hat sich der Grund für die heftige Kursbewegung aufgeklärt:
Bionor meldet in den News seiner Webseite, dass die Phase II klinischen Tests von Impfstoff Vacc-4X zusammen mit Celgenes Revlimid erfolgreich waren!
Bionor meldet in den News seiner Webseite, dass die Phase II klinischen Tests von Impfstoff Vacc-4X zusammen mit Celgenes Revlimid erfolgreich waren!
@ollihat,
danke für den Hinweis. Die Aktie bleibt spannend!
Glückauf!
danke für den Hinweis. Die Aktie bleibt spannend!
Glückauf!
Bionor Pharma Positioned for Execution of the Kick, the Kill and the Boost Strategy, Aiming Towards a Functional Cure for HIV
Oslo, Norway, 8 November 2013
Bionor Pharma ASA (OSE: BIONOR) announced today results from the third quarter and first nine months of 2013.
mehr: http://www.bionorpharma.com/en/News/2013/Financial/Bionor+Ph…
Auszug:
The Vacc-4x Reboost Phase II and Vacc C5 Phase I/II trials are progressing according to plan and the Company is able to reconfirm its outlook that results are expected to be available in Q1 2014.
Part B of the Vacc-4x and lenalidomide enrollment into the Phase II trial has slowed down in last part of October and is longer than anticipated due to screening failures (patients who did not meet inclusion criteria). Results from trial will be available eight months after last patient in (LPI) which is expected in December or January at the latest. Data from the part B is then expected in Q3 2014.
Newsübersicht:
http://www.bionorpharma.com/en/News/All/?folderpagesize=10
Oslo, Norway, 8 November 2013
Bionor Pharma ASA (OSE: BIONOR) announced today results from the third quarter and first nine months of 2013.
mehr: http://www.bionorpharma.com/en/News/2013/Financial/Bionor+Ph…
Auszug:
The Vacc-4x Reboost Phase II and Vacc C5 Phase I/II trials are progressing according to plan and the Company is able to reconfirm its outlook that results are expected to be available in Q1 2014.
Part B of the Vacc-4x and lenalidomide enrollment into the Phase II trial has slowed down in last part of October and is longer than anticipated due to screening failures (patients who did not meet inclusion criteria). Results from trial will be available eight months after last patient in (LPI) which is expected in December or January at the latest. Data from the part B is then expected in Q3 2014.
Newsübersicht:
http://www.bionorpharma.com/en/News/All/?folderpagesize=10
Die aktuelle Pipelineübersicht:
Sehr gute, ausführliche Analyse auf investing.com zu Bionor (von Oktober 2013 als pdf-download):
http://c3352932.r32.cf0.rackcdn.com/pdfaabf51c94463efb09b609…
http://c3352932.r32.cf0.rackcdn.com/pdfaabf51c94463efb09b609…
Bionor Präsentation vom 14.01.2014 anlässlich der Biotech Showcase in San Francisco:
http://www.bionorpharma.com/filestore/BionorPharmaBiotechSho…
http://www.bionorpharma.com/filestore/BionorPharmaBiotechSho…
11. Febr. 2014
Bionor Pharma’s Phase II Vacc-4x Data Published in The Lancet Infectious Diseases
Therapeutic HIV Vaccine, Vacc-4x, Reduced Viral Load in HIV Patients Compared to Placebo in Largest Randomized, Placebo-controlled Study of its Kind in Recent History, Published in Lancet Infectious Diseases
See more at:
http://www.bionorpharma.com/en/News/2014/Scientific/Bionor+P…
Bionor Pharma’s Phase II Vacc-4x Data Published in The Lancet Infectious Diseases
Therapeutic HIV Vaccine, Vacc-4x, Reduced Viral Load in HIV Patients Compared to Placebo in Largest Randomized, Placebo-controlled Study of its Kind in Recent History, Published in Lancet Infectious Diseases
See more at:
http://www.bionorpharma.com/en/News/2014/Scientific/Bionor+P…
Positive Results from Bionor Pharma’s vaccine Vacc-C5 Phase I, First Time in Man trial
Oslo, Norway, 24 February 2014
Bionor Pharma ASA (OSE: BIONOR) announces that results from its Phase I, first in man, trial of Vacc-C5. The trial met its primary endpoint which was safety. The trial also demonstrated that Vacc-C5 was able to generate C5 antibodies with effect of boosting, particularly in the top dose group.
See more at: http://www.bionorpharma.com/en/News/2014/Scientific/Positive…
Oslo, Norway, 24 February 2014
Bionor Pharma ASA (OSE: BIONOR) announces that results from its Phase I, first in man, trial of Vacc-C5. The trial met its primary endpoint which was safety. The trial also demonstrated that Vacc-C5 was able to generate C5 antibodies with effect of boosting, particularly in the top dose group.
See more at: http://www.bionorpharma.com/en/News/2014/Scientific/Positive…
27. Febr. 2014
Bionor Pharma Announces Approval of REDUC Trial Bionor Pharma ASA announces that the Company has received approval from the Danish Regulatory Agency for its REDUC trial.
The REDUC trial is a combination of Bionor Pharma’s lead vaccine candidate Vacc-4x and the Histone DeAcetlyase inhibitor (HDACi) Istodax® (romidepsin). Bionor Pharma further announces that the Company today has entered into a Supply Agreement with Celgene Corp (NASDAQ: CELG). for supply of Istodax® for the REDUC trial. This agreement secures Bionor Pharma free supply of study drug of Istodax®.
The REDUC (“Kick and Kill”) trial’s objective is to address one of the core issues with the treatment of HIV, which is that some HIV infected cells hide in so-called latent reservoirs. The reservoirs are unaffected by conventional HIV medication and invisible to the immune system. HDACi have the potential to activate (“Kick”) these latently infected cells. This will make the HIV infected cells visible to the immune system; the immune response generate by Vacc-4x will be able to attack and eliminate (“Kill”) the infected cells.
"We and others have shown that HIV can be kicked into activation by use of HDAC inhibitors” said Professor Lars Østergård, Aarhus University Hospital. “The next natural step towards a cure against HIV is to combine such kick strategy with a kill-strategy. The Vacc-4x vaccine is one of the most advanced kill strategies and combining an HDACi with Vacc-4x represent the obvious choice. The results obtained from the REDUC study are likely to be of major scientific impact in the hunt for a cure for HIV."
About the REDUC trial
The REDUC trial will study the combination of the HDAC inhibitor Istodax® and Vacc-4x in HIV patients on combination antiretroviral therapy (cART). The first phase of the study will establish the optimal dose of Istodax® based on safety and the effect on the latent reservoir. The second phase will include vaccination with Vacc-4x followed by treatment with Istodax® once a week for three weeks. Patients will then have a protocol specified cART treatment interruption for 18 weeks.
During this period without cART the control of HIV replication will be evaluated to see if the virus load continues to be suppressed by the immune system. Bionor Pharma is the study sponsor and Department of Infectious Diseases Q, Aarhus University Hospital, Denmark with Lead investigator Professor Lars Østergaard will be conducting the study. Enrollment of patients into the study is planned for Q2 2014. -
See more at: http://www.bionorpharma.com/en/News/2014/Scientific/Bionor+P…
Bionor Pharma Announces Approval of REDUC Trial Bionor Pharma ASA announces that the Company has received approval from the Danish Regulatory Agency for its REDUC trial.
The REDUC trial is a combination of Bionor Pharma’s lead vaccine candidate Vacc-4x and the Histone DeAcetlyase inhibitor (HDACi) Istodax® (romidepsin). Bionor Pharma further announces that the Company today has entered into a Supply Agreement with Celgene Corp (NASDAQ: CELG). for supply of Istodax® for the REDUC trial. This agreement secures Bionor Pharma free supply of study drug of Istodax®.
The REDUC (“Kick and Kill”) trial’s objective is to address one of the core issues with the treatment of HIV, which is that some HIV infected cells hide in so-called latent reservoirs. The reservoirs are unaffected by conventional HIV medication and invisible to the immune system. HDACi have the potential to activate (“Kick”) these latently infected cells. This will make the HIV infected cells visible to the immune system; the immune response generate by Vacc-4x will be able to attack and eliminate (“Kill”) the infected cells.
"We and others have shown that HIV can be kicked into activation by use of HDAC inhibitors” said Professor Lars Østergård, Aarhus University Hospital. “The next natural step towards a cure against HIV is to combine such kick strategy with a kill-strategy. The Vacc-4x vaccine is one of the most advanced kill strategies and combining an HDACi with Vacc-4x represent the obvious choice. The results obtained from the REDUC study are likely to be of major scientific impact in the hunt for a cure for HIV."
About the REDUC trial
The REDUC trial will study the combination of the HDAC inhibitor Istodax® and Vacc-4x in HIV patients on combination antiretroviral therapy (cART). The first phase of the study will establish the optimal dose of Istodax® based on safety and the effect on the latent reservoir. The second phase will include vaccination with Vacc-4x followed by treatment with Istodax® once a week for three weeks. Patients will then have a protocol specified cART treatment interruption for 18 weeks.
During this period without cART the control of HIV replication will be evaluated to see if the virus load continues to be suppressed by the immune system. Bionor Pharma is the study sponsor and Department of Infectious Diseases Q, Aarhus University Hospital, Denmark with Lead investigator Professor Lars Østergaard will be conducting the study. Enrollment of patients into the study is planned for Q2 2014. -
See more at: http://www.bionorpharma.com/en/News/2014/Scientific/Bionor+P…
Bionor Pharma Announces That the Combination of Vacc-4x + Revlimid(R) Is Safe and Increases CD4 Counts in People Living With HIV
http://finance.yahoo.com/news/bionor-pharma-announces-combin…
http://finance.yahoo.com/news/bionor-pharma-announces-combin…
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