Vacc-4x (Bionor), vaccino TERAPEUTICO: dati sulla fase IIB
Re: Vacc-4x (Bionor), vaccino TERAPEUTICO: dati sulla fase I
Scusate ma come si fa a dire che interromprere la HAART per mediamente 31 mesi é un risultato da poco?
Io credo che qualsiasi cosa riesca a mantenere per un po' di tempo il corpo senza dover continuamente somministrare farmaci vada bene.
In più se non é suscettibile a resistenze, si potrebbe rifare anche più volte no?
Io credo che qualsiasi cosa riesca a mantenere per un po' di tempo il corpo senza dover continuamente somministrare farmaci vada bene.
In più se non é suscettibile a resistenze, si potrebbe rifare anche più volte no?
Re: Vacc-4x (Bionor), vaccino TERAPEUTICO: dati sulla fase I
Comunicato stampa di Bionor sui dati finali della fase IIb della sperimentazione del vaccino terapeutico Vacc-4x:
Results for viral load on Vacc-4x
Oslo 15.02.2012 - 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
News Summary
• 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:
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, PhD, 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 1 H 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. (...)
(*) 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.
Results for viral load on Vacc-4x
Oslo 15.02.2012 - 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
News Summary
• 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:
- o Re-vaccination to reduce the viral set point further - aiming at a ‘functional cure’
o Immunization in the presence of Revlimid®, targeting patients that fail to regain immune competence (CD4 counts) while on ART
o Combining Vacc-4x and Vacc-C5 (*), which could potentially revolutionize HIV management
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, PhD, 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 1 H 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. (...)
(*) 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.
Re: Vacc-4x (Bionor), vaccino TERAPEUTICO: dati sulla fase I
Anche tralasciando il fatto che un discorso è la significatività statistica e un altro discorso è la significatività/utilità clinico-terapeutica (anche il famoso papocchio di vaccini sperimentato in Tailandia aveva dato risultati con qualche significatività statistica, ancorché tirata per i capelli, eppure è stato giustamente buttato in pattumiera), per quanto mi riguarda il principale effetto dei comunicati della Bionor, che ci prende per il naso da non so più quanti anni con i suoi giochini delle tre carte, è suscitarmi la domanda: dove avrà fognato, stavolta?Dora ha scritto:Comunicato stampa di Bionor sui dati finali della fase IIb della sperimentazione del vaccino terapeutico Vacc-4x [...]
Re: Vacc-4x (Bionor), vaccino TERAPEUTICO: dati sulla fase I
Non so. La mia impressione è che sia un'altra ensòla, quanto meno come serie di passaggi da vaccino preventivo, a terapeutico, a boh (nel "boh" metterei il mix con l'altro nuovissimo supervaccino Vacc-C5, che mi ricorda un po' questa nuova fase 1 appena iniziata dalla Barbarona). Senza dimenticare che, or non è molto, pareva che questo Vacc-4x fosse stato buttato in pattumiera e ora all'improvviso pare una meraviglia.Leon ha scritto:Anche tralasciando il fatto che un discorso è la significatività statistica e un altro discorso è la significatività/utilità clinico-terapeutica (anche il famoso papocchio di vaccini sperimentato in Tailandia aveva dato risultati con qualche significatività statistica, ancorché tirata per i capelli, eppure è stato giustamente buttato in pattumiera), per quanto mi riguarda il principale effetto dei comunicati della Bionor, che ci prende per il naso da non so più quanti anni con i suoi giochini delle tre carte, è suscitarmi la domanda: dove avrà fognato, stavolta?Dora ha scritto:Comunicato stampa di Bionor sui dati finali della fase IIb della sperimentazione del vaccino terapeutico Vacc-4x [...]
Comunque hanno promesso un articolo a breve e mi auguro che da lì si capisca qualcosa di più. Se poi arriveranno davvero a una fase III, quella sarà dirimente. No?
Re: Vacc-4x (Bionor), vaccino TERAPEUTICO: dati sulla fase I
che bello leggere queste notizie..spero solo che diventi realta'..e che anche noi prima o poi smettiamo di sognare.perche tutto diventera' realta'..magari non prendere la terapia..per tanto tempo..che bello non avere tanti effetti collaterali..sentirsi piu' liberi..speraimo bene.che la ricerca ci aiuti sempre piu'...
Re: Vacc-4x (Bionor), vaccino TERAPEUTICO: dati sulla fase I
Bionor ha appena avanzato domanda di brevetto per un vaccino, che al momento si chiama Vacc-HIV, e che dovrebbe essere sia terapeutico, sia preventivo.Dora ha scritto:Non so. La mia impressione è che sia un'altra ensòla, quanto meno come serie di passaggi da vaccino preventivo, a terapeutico, a boh (nel "boh" metterei il mix con l'altro nuovissimo supervaccino Vacc-C5, che mi ricorda un po' questa nuova fase 1 appena iniziata dalla Barbarona). Senza dimenticare che, or non è molto, pareva che questo Vacc-4x fosse stato buttato in pattumiera e ora all'improvviso pare una meraviglia.Leon ha scritto:Anche tralasciando il fatto che un discorso è la significatività statistica e un altro discorso è la significatività/utilità clinico-terapeutica (anche il famoso papocchio di vaccini sperimentato in Tailandia aveva dato risultati con qualche significatività statistica, ancorché tirata per i capelli, eppure è stato giustamente buttato in pattumiera), per quanto mi riguarda il principale effetto dei comunicati della Bionor, che ci prende per il naso da non so più quanti anni con i suoi giochini delle tre carte, è suscitarmi la domanda: dove avrà fognato, stavolta?Dora ha scritto:Comunicato stampa di Bionor sui dati finali della fase IIb della sperimentazione del vaccino terapeutico Vacc-4x [...]
Comunque hanno promesso un articolo a breve e mi auguro che da lì si capisca qualcosa di più. Se poi arriveranno davvero a una fase III, quella sarà dirimente. No?
Si tratta di una combinazione di Vacc-4x + Vacc-C5, che ha l'obiettivo di rinforzare la protezione data dai due vaccini presi singolarmente (fonte: Bionor Pharma News).
Non so bene perché, ma si rafforza l'impressione di un'affinità (formale, naturalmente) con l'anti-Tat + anti-Env.
Re: Vacc-4x (Bionor), vaccino TERAPEUTICO: dati sulla fase I
Ma questo significa che non l'hanno ancora testato vero? Regostrano solo il brevetto e poi devono ancora comunciare tutto l'eterno iter?
Re: Vacc-4x (Bionor), vaccino TERAPEUTICO: dati sulla fase I
No, hanno finito la fase IIb, quindi sono molto avanti. Gli manca la fase III per la commercializzazione (la fase IV sono gli studi post commercializzazione). Se passa la fase II è fatta ma finchè non la si vede iniziare non si possono fare pronostici: moltissime molecole arrivano alla fase II senza riportare i risultati sperati e allora le sperimentazioni ripartono da I, con giusto delle varianti (vedi il vaccino della Ensoli, dopo più di un decennio di sperimentazioni ha ricominciato una nuova fase I adesso). Anche questo vaccino della Bionor ha avuto problemi e ha presentato dei risultati inferiori alle aspettative iniziali (era stato caricato di speranze), tuttavia quel che è uscito fin'ora è ancora commercializzabile, quindi presumo che si inizierà la fase III, sebbene non si puo' escludere che possano partire in contemporanea fasi I di riformulazioni o/o ricombinazioniJago83 ha scritto:Ma questo significa che non l'hanno ancora testato vero? Regostrano solo il brevetto e poi devono ancora comunciare tutto l'eterno iter?
Re: Vacc-4x (Bionor), vaccino TERAPEUTICO: dati sulla fase I
Penso che stiano seguendo due, anzi tre strade:skydrake ha scritto:Anche questo vaccino della Bionor ha avuto problemi e ha presentato dei risultati inferiori alle aspettative iniziali (era stato caricato di speranze), tuttavia quel che è uscito fin'ora è ancora commercializzabile, quindi presumo che si inizierà la fase III, sebbene non si puo' escludere che possano partire in contemporanea fasi I di riformulazioni o/o ricombinazioni
1) Vacc-4x, con due trial aperti (gli unici due trial di Bionor elencati in ClinicalTrial.gov): A) Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV (fase 2) e B) Intranasal Modified Vacc-4x Gag Peptides With Endocine as Adjuvant (fase 1-2).
2) Vacc-C5 Humoral vaccine (http://www.bionorimmuno.com/en/Vaccines/HIV_Vacc-C5/), che non è ancora in sperimentazione clinica, ma che a fine maggio Bionor ha comunicato che in fase clinica sta per entrarci (First Human Clinical Study of HIV Vaccine Vacc-C5 Approved to Begin).
3) Vacc-4x + Vacc-C5, che è quello che vogliono brevettare adesso.