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Vaxin First-in-Man Phase I Clinical Trial Initiated in Hepatitis B Patients
Vaxin First-in-Man Phase I Clinical Trial Initiated in Chronically Infected Hepatitis B Patients
GAITHERSBURG, MD--(Marketwired - Jul 27, 2015) - Vaxin Inc., a clinical stage vaccine and immunotherapeutics company, today announced that it has enrolled the first patient into a phase I clinical trial of HepTcell™ (FP-02.2), the company's immunotherapeutic compound to treat people chronically infected with the hepatitis B virus (HBV). The multi-center trial will be conducted at seven sites within the United Kingdom, and aims to recruit 72 patients with chronic HBV infection.
The trial is a randomized, double-blind, placebo-controlled dose-escalation study. The primary endpoints are safety and tolerability. Secondary endpoints include immunogenicity and antiviral factors. HepTcell will be tested as an add-on treatment to the patient's standard of care. Current therapy standards include treatment with antiviral drugs which act to control virus replication but are unable to eliminate the virus and therefore require long-term treatment. The combined treatment strategy aims to stimulate immune responses to a level that would increase the low clinical cure rates observed in patients treated with antiviral therapy alone. Initial results are expected in Q4 2016.
HepTcell is a peptide-based immunotherapeutic incorporating Vaxin's proprietary Densigen™ technology. This product candidate comprises nine long peptides covering conserved regions of core, polymerase and surface proteins from HBV, each linked to a fluorocarbon tail which acts to enhance immune responses. Using a bioinformatics platform, HepTcell has been designed to elicit T cell responses to each of the major infecting HBV genotypes, as well as in an ethnically diverse population, thereby allowing applicability across a world-wide market. Treatment with HepTcell aims to restore functional T cell immune responses to the hepatitis virus in HBV-infected subjects where the natural immune responses are lacking or poor.
Professor Mark Thursz, MD PhD, a world expert in the treatment of hepatitis from Imperial College London, and chief investigator, said, "We are very excited to start this multi-center clinical study. Treatments like HepTcell that are designed to restore the immune response, offer a long-term treatment solution to chronically-infected hepatitis B patients, potentially allowing them to stop their antiviral medication."
"This is a continuation of the exciting work we obtained through the acquisition of Immune Targeting Systems earlier this year," said Bill Enright, CEO of Vaxin. Enright continued, "Pre-clinical development and manufacturing was co-funded through the UK's innovation agency, Innovate UK (formerly Technology Strategy Board) for £2.0 million ($3.1 million), and a parallel funding commitment of $16 million from Vaxin investors."
http://www.marketwired.com/press-release/vaxin-first-man-phase-i-clinical-trial-initiated-chronically-infected-hepatitis-b-patients-2041899.htm
GAITHERSBURG, MD--(Marketwired - Jul 27, 2015) - Vaxin Inc., a clinical stage vaccine and immunotherapeutics company, today announced that it has enrolled the first patient into a phase I clinical trial of HepTcell™ (FP-02.2), the company's immunotherapeutic compound to treat people chronically infected with the hepatitis B virus (HBV). The multi-center trial will be conducted at seven sites within the United Kingdom, and aims to recruit 72 patients with chronic HBV infection.
The trial is a randomized, double-blind, placebo-controlled dose-escalation study. The primary endpoints are safety and tolerability. Secondary endpoints include immunogenicity and antiviral factors. HepTcell will be tested as an add-on treatment to the patient's standard of care. Current therapy standards include treatment with antiviral drugs which act to control virus replication but are unable to eliminate the virus and therefore require long-term treatment. The combined treatment strategy aims to stimulate immune responses to a level that would increase the low clinical cure rates observed in patients treated with antiviral therapy alone. Initial results are expected in Q4 2016.
HepTcell is a peptide-based immunotherapeutic incorporating Vaxin's proprietary Densigen™ technology. This product candidate comprises nine long peptides covering conserved regions of core, polymerase and surface proteins from HBV, each linked to a fluorocarbon tail which acts to enhance immune responses. Using a bioinformatics platform, HepTcell has been designed to elicit T cell responses to each of the major infecting HBV genotypes, as well as in an ethnically diverse population, thereby allowing applicability across a world-wide market. Treatment with HepTcell aims to restore functional T cell immune responses to the hepatitis virus in HBV-infected subjects where the natural immune responses are lacking or poor.
Professor Mark Thursz, MD PhD, a world expert in the treatment of hepatitis from Imperial College London, and chief investigator, said, "We are very excited to start this multi-center clinical study. Treatments like HepTcell that are designed to restore the immune response, offer a long-term treatment solution to chronically-infected hepatitis B patients, potentially allowing them to stop their antiviral medication."
"This is a continuation of the exciting work we obtained through the acquisition of Immune Targeting Systems earlier this year," said Bill Enright, CEO of Vaxin. Enright continued, "Pre-clinical development and manufacturing was co-funded through the UK's innovation agency, Innovate UK (formerly Technology Strategy Board) for £2.0 million ($3.1 million), and a parallel funding commitment of $16 million from Vaxin investors."
http://www.marketwired.com/press-release/vaxin-first-man-phase-i-clinical-trial-initiated-chronically-infected-hepatitis-b-patients-2041899.htm
I think even removing majority of infected cells is not enough to stop reinfection if specific immunity is not rebuilded. I guess studyforhope has something to tell about it.
Birinapant has 100% success clearing hbv in infected host. the only problem is ths C.palsy, all they need is to find out which dosage is safe and effective. i would rather have cerebral palsy than dying in Liver Cancer and Cirhosis. C.palsy can be reversible when the medication is stopped.
I guess it's not a problem to test average amount of infected cells with biopsy, HBsAg quantitive gives some picture as well, not 100% accurate for HBe- but some information.
Birinapant can be dangerous in patients with big amount of infected cells or naturally weak cells.
Why birinapant may be not potent enough ? I always thought it's just designed to remove infected cells. Is it something else ?
If the principally available methods are optimally combined, about 80% of chronic HBV patients could be seroconverted to hbsAB positiv. But the drugs are in the hand of different companies for individual development and under the rigid rules that authorities have set for trials. The. NAPs are the most potent compounds, but need to be optimized in terms of chemistry, dosing and duration and need a combo with Ifn or much better thymosin alpha applied long enough to stabilize a high hbsAB. And a third compound is likely needed additionally in the majority of cases to achieve long term stability. This will not be an antiviral, but rather an immune effectiveness enhancer of class II reserve Tcell immunity, like birinapant. We also already know that BIRINAPANT alone will not be potent enough, at least in safe doses, but it has a dramatic enhancing effect. Thus, the pieces for hbsag seroconversion are in reach for mankind, but they need to be brought together and optimized and the duration and the necessary monitoring of antibody levels to restart therapy if a regrowth of the virus from ultra minute to small amounts of reinfected cells can be seen. The lack of effective class I epitopes in most e ag negative patients will make unsupervised permanent internal TCell control very difficult to achieve.
The only seemingly partially effective therapeutic vaccine, the Cuban hbsag/core particle mix will be helpful in the efforts to stabilize the seroconversion, but by itself will not achieve more than interferon mono as was shown on the Bangladeshi trial.
The interfering RNA companies will not contribute substantial progress, their blockage is insufficient and will not lead to a meaningful reduction of infected cell number. Their hopes of reducing the hbsag low enough to ignite a curative immune response appear to vanish if you take a look on the struggles that replicor faces in spite of their much much higher capacity to reduce the surface antigen.
The only seemingly partially effective therapeutic vaccine, the Cuban hbsag/core particle mix will be helpful in the efforts to stabilize the seroconversion, but by itself will not achieve more than interferon mono as was shown on the Bangladeshi trial.
The interfering RNA companies will not contribute substantial progress, their blockage is insufficient and will not lead to a meaningful reduction of infected cell number. Their hopes of reducing the hbsag low enough to ignite a curative immune response appear to vanish if you take a look on the struggles that replicor faces in spite of their much much higher capacity to reduce the surface antigen.
with all your knowledge and experience that half of us can hardly understand, do you feel we are close to a cure?
so seems that at the moment only Replicor is closest to functional cure cuz showed some results ?
Based on the results of many fruitless vaccine trials, this is likely going to add to the graveyard.
Peptides are much less immunogenic than particles, even with a fluorocarbon tail. The immune system is on the lookout for invaders, not small debris.
Peptides are much less immunogenic than particles, even with a fluorocarbon tail. The immune system is on the lookout for invaders, not small debris.
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