Innogenetics - Hepatitis B - phase I results
Innogenetics completes first US clinical trial on time: Excellent safety and tolerability results of hepatitis B therapeutic vaccine phase I study
Gent (Belgium), March 31, 2005 – Innogenetics announced today that it has successfully completed its first clinical study in the United States under Investigational New Drug status (IND).
In April 2004, Innogenetics took over sponsorship of a phase I safety and tolerability study under US IND for the hepatitis B therapeutic vaccine candidate, acquired from Genencor, based on Epimmune’s polyepitope technology.
Final results of the phase I study showed that intramuscular injection with either a 0.4-mg or 4-mg dose of this DNA vaccine, administered every 4 weeks over a period of 12 weeks (a total of 4 doses), was safe and well tolerated in all healthy volunteers.
As planned, the next steps in the clinical evaluation program will be to deliver the hepatitis B polyepitope using a DNA vaccine and a viral vector in order to maximize the immune response.
Notes to the Editor
Hepatitis B virusHepatitis B virus (HBV) is one of the most common chronic viral infections in the world. It is estimated that 2 billion persons have been infected with the hepatitis B virus. No less than 350 million persons, representing 6% of the world’s population, are unable to clear the virus and become chronic HBV carriers. Chronic infection often leads to life-threatening liver pathologies such as cirrhosis, with an increased risk for hepatocellular carcinoma.
At present, only chronically infected HBV patients with liver inflammation are treated with (pegylated) interferon, lamivudine, and adefovir. Several hundred thousand HBV patients are currently being treated with these agents worldwide. Although these drugs can significantly reduce the viral load (number of viral particles circulating in the body), patients are rarely able to completely clear the virus. Furthermore, in the majority of the cases, resistance to current antiviral drugs develops rapidly, resulting in viral rebound and an increased risk of disease progression. Recent studies have underlined the importance of the immune system in the control and elimination of hepatitis B infection. Therefore, there is a clear need for new treatments to help patients to resolve or control the infection. Therapeutic vaccination is one such approach.
Clinical trials
Medication that has been proven effective in preclinical (non-human) experiments, must be validated by clinical studies, conducted according to GCP (Good Clinical Practice). These studies are subdivided into four developmental phases, that generally include a pharmacological study phase (phase I), a phase of explorative efficacy studies (phase II), a confirmative studies phase (phase III), and a therapeutic administration study phase (phase IV). Preclinical animal studies are performed before studies on humans are initiated.
If preclinical toxicity studies in animals reveal no harmful effects, a phase I study is usually then performed on a limited number of healthy human volunteers to determine the highest tolerated dose and to explore the safety, kinetics, interactions, and pharmacological effects of various doses.
In clinical phase IIa studies, efficacy is tested on a limited group of patients, and the optimal administration regimen (dose, frequency) is determined. Often, a phase IIb study with a larger number of patients is required, or a combined phase IIb/III, in order to be able to make statistically justifiable recommendations with regard to the administration regimen.
In a phase III study, efficacy and safety of a single or a limited number of drug regimens are evaluated by applying them in a sufficiently large number of patients (usually a few hundred). Efficacy and safety of the new treatment are compared with a placebo or with the existing standard treatment. Usually, several complementary phase III studies are performed simultaneously. The reports of the phase I to III studies are part of the drug registration file. Studies commenced after closing the registration file but before the product is released on the market are sometimes grouped under the name phase IIIb studies.
Phase IV begins when the product is approved for release on the market. Studies on large numbers of people may be helpful after a product is brought into circulation, for instance, in order to trace rare side effects.
Gent (Belgium), March 31, 2005 – Innogenetics announced today that it has successfully completed its first clinical study in the United States under Investigational New Drug status (IND).
In April 2004, Innogenetics took over sponsorship of a phase I safety and tolerability study under US IND for the hepatitis B therapeutic vaccine candidate, acquired from Genencor, based on Epimmune’s polyepitope technology.
Final results of the phase I study showed that intramuscular injection with either a 0.4-mg or 4-mg dose of this DNA vaccine, administered every 4 weeks over a period of 12 weeks (a total of 4 doses), was safe and well tolerated in all healthy volunteers.
As planned, the next steps in the clinical evaluation program will be to deliver the hepatitis B polyepitope using a DNA vaccine and a viral vector in order to maximize the immune response.
Notes to the Editor
Hepatitis B virusHepatitis B virus (HBV) is one of the most common chronic viral infections in the world. It is estimated that 2 billion persons have been infected with the hepatitis B virus. No less than 350 million persons, representing 6% of the world’s population, are unable to clear the virus and become chronic HBV carriers. Chronic infection often leads to life-threatening liver pathologies such as cirrhosis, with an increased risk for hepatocellular carcinoma.
At present, only chronically infected HBV patients with liver inflammation are treated with (pegylated) interferon, lamivudine, and adefovir. Several hundred thousand HBV patients are currently being treated with these agents worldwide. Although these drugs can significantly reduce the viral load (number of viral particles circulating in the body), patients are rarely able to completely clear the virus. Furthermore, in the majority of the cases, resistance to current antiviral drugs develops rapidly, resulting in viral rebound and an increased risk of disease progression. Recent studies have underlined the importance of the immune system in the control and elimination of hepatitis B infection. Therefore, there is a clear need for new treatments to help patients to resolve or control the infection. Therapeutic vaccination is one such approach.
Clinical trials
Medication that has been proven effective in preclinical (non-human) experiments, must be validated by clinical studies, conducted according to GCP (Good Clinical Practice). These studies are subdivided into four developmental phases, that generally include a pharmacological study phase (phase I), a phase of explorative efficacy studies (phase II), a confirmative studies phase (phase III), and a therapeutic administration study phase (phase IV). Preclinical animal studies are performed before studies on humans are initiated.
If preclinical toxicity studies in animals reveal no harmful effects, a phase I study is usually then performed on a limited number of healthy human volunteers to determine the highest tolerated dose and to explore the safety, kinetics, interactions, and pharmacological effects of various doses.
In clinical phase IIa studies, efficacy is tested on a limited group of patients, and the optimal administration regimen (dose, frequency) is determined. Often, a phase IIb study with a larger number of patients is required, or a combined phase IIb/III, in order to be able to make statistically justifiable recommendations with regard to the administration regimen.
In a phase III study, efficacy and safety of a single or a limited number of drug regimens are evaluated by applying them in a sufficiently large number of patients (usually a few hundred). Efficacy and safety of the new treatment are compared with a placebo or with the existing standard treatment. Usually, several complementary phase III studies are performed simultaneously. The reports of the phase I to III studies are part of the drug registration file. Studies commenced after closing the registration file but before the product is released on the market are sometimes grouped under the name phase IIIb studies.
Phase IV begins when the product is approved for release on the market. Studies on large numbers of people may be helpful after a product is brought into circulation, for instance, in order to trace rare side effects.
posted at 10:52 a.m.
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