PanGenetics announced today that the company has received formal regulatory approval to initiate clinical evaluation of the company’s CD40 antagonist antibody, PG102
Utrecht, The Netherlands & Cambridge, UK | October 06, 2008 | The multi-centre trial in Hungary and Serbia will recruit patients with active psoriatic arthritis, and is designed as a double blind, placebo controlled, single ascending dose study.
The primary objective of the Phase I study is to evaluate the safety and tolerability of PG102. The study design includes evaluation of pharmacodynamic and clinical parameters, to provide further insight into the immuno-modulatory mechanisms of PG102. The study will commence in the next few weeks and the results of the study, which includes an extended follow-up period, are expected in the fourth quarter of 2009.
A precursor of this antibody was previously successfully evaluated in an open label study in Crohn’s Disease patients. The experience from this earlier study, combined with a comprehensive preclinical package, provided the basis for the Clinical Trial Authorizations.
Kevin Johnson, CEO of PanGenetics, commented: “For any small company, initiating a clinical study is a significant milestone, and in this instance underscores our ability as a clinical development organization in a challenging and evolving regulatory environment”.
About PanGenetics B.V.
PanGenetics is a clinical development company that specializes in taking antibodies from the late research stage through to clinical proof of concept. The company is headquartered in Utrecht, the Netherlands with an office near Cambridge in the UK. PanGenetics employs a lean business model with most development activities outsourced to specialist providers. The most advanced programs of PanGenetics are PG102, a CD40 antagonist that has already shown promise in an open label Crohn’s study, and PG110, an anti-Nerve Growth Factor antibody for use in chronic pain. The company’s management, board and advisors comprise many of the world’s leading antibody developers. www.pangenetics.com
About PG102
The CD40 pathway is one of the best studied immunological pathways that is involved in the regulation of the immune system, particularly maturation of B cells. PG102 is a functional antagonist of human CD40 and has a unique mechanism of action in that it down-regulates signalling without interfering with the binding of CD40 ligand to CD40. This activity has been confirmed in several in vivo proof of concept studies of the rodent and chimaeric precursor molecules to PG102, including a model of multiple sclerosis.
A phase I/II open-label, single-dose study of the chimaeric precursor has been conducted in patients with moderate to severe Crohn’s Disease. Safety and pharmacodynamic results, including measures of disease activity, were derived from the study. The results of this study support the development of PG102, a de-immunized version of the chimaeric antibody, towards a potent and safe antagonist of ongoing B cell responses.
SOURCE: PanGenetics B.V.
Post Views: 53
PanGenetics announced today that the company has received formal regulatory approval to initiate clinical evaluation of the company’s CD40 antagonist antibody, PG102
Utrecht, The Netherlands & Cambridge, UK | October 06, 2008 | The multi-centre trial in Hungary and Serbia will recruit patients with active psoriatic arthritis, and is designed as a double blind, placebo controlled, single ascending dose study.
The primary objective of the Phase I study is to evaluate the safety and tolerability of PG102. The study design includes evaluation of pharmacodynamic and clinical parameters, to provide further insight into the immuno-modulatory mechanisms of PG102. The study will commence in the next few weeks and the results of the study, which includes an extended follow-up period, are expected in the fourth quarter of 2009.
A precursor of this antibody was previously successfully evaluated in an open label study in Crohn’s Disease patients. The experience from this earlier study, combined with a comprehensive preclinical package, provided the basis for the Clinical Trial Authorizations.
Kevin Johnson, CEO of PanGenetics, commented: “For any small company, initiating a clinical study is a significant milestone, and in this instance underscores our ability as a clinical development organization in a challenging and evolving regulatory environment”.
About PanGenetics B.V.
PanGenetics is a clinical development company that specializes in taking antibodies from the late research stage through to clinical proof of concept. The company is headquartered in Utrecht, the Netherlands with an office near Cambridge in the UK. PanGenetics employs a lean business model with most development activities outsourced to specialist providers. The most advanced programs of PanGenetics are PG102, a CD40 antagonist that has already shown promise in an open label Crohn’s study, and PG110, an anti-Nerve Growth Factor antibody for use in chronic pain. The company’s management, board and advisors comprise many of the world’s leading antibody developers. www.pangenetics.com
About PG102
The CD40 pathway is one of the best studied immunological pathways that is involved in the regulation of the immune system, particularly maturation of B cells. PG102 is a functional antagonist of human CD40 and has a unique mechanism of action in that it down-regulates signalling without interfering with the binding of CD40 ligand to CD40. This activity has been confirmed in several in vivo proof of concept studies of the rodent and chimaeric precursor molecules to PG102, including a model of multiple sclerosis.
A phase I/II open-label, single-dose study of the chimaeric precursor has been conducted in patients with moderate to severe Crohn’s Disease. Safety and pharmacodynamic results, including measures of disease activity, were derived from the study. The results of this study support the development of PG102, a de-immunized version of the chimaeric antibody, towards a potent and safe antagonist of ongoing B cell responses.
SOURCE: PanGenetics B.V.
Post Views: 53
