ArmaGen plans First in Human clinical trial
SANTA MONICA, CA, USA I April 10, 2009 I ArmaGen’s lead therapeutic is a genetically engineered fusion protein of a neurotrophin and an engineered monoclonal antibody. The antibody crosses the human blood-brain barrier (BBB) and acts as a molecular Trojan horse to carry into brain the attached neuroprotective neurotrophin. In preparation for filing of the IND in 2009, ArmaGen has completed Phase 0 GLP Toxicology and Safety Pharmacology in 56 Rhesus monkeys; no toxicity was observed at any dosage level, and the high dose established a no observable adverse effect level for human testing. The GLP safety pharmacology and toxicology is reported in the 2009 Pharmaceutical Research. ArmaGen has executed a collaboration agreement with a Contract Manufacturing Organization, and cGMP manufacturing of the IgG-neurotrophin fusion protein has begun. A First in Human Phase I clinical trial of the IgG-neurotrophin will begin following completion of the cGMP manufacturing. This clinical trial will test the safety and pharmacokinetics of the first IgG-neurotrophin fusion protein to enter human clinical trials.
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ArmaGen plans First in Human clinical trial
SANTA MONICA, CA, USA I April 10, 2009 I ArmaGen’s lead therapeutic is a genetically engineered fusion protein of a neurotrophin and an engineered monoclonal antibody. The antibody crosses the human blood-brain barrier (BBB) and acts as a molecular Trojan horse to carry into brain the attached neuroprotective neurotrophin. In preparation for filing of the IND in 2009, ArmaGen has completed Phase 0 GLP Toxicology and Safety Pharmacology in 56 Rhesus monkeys; no toxicity was observed at any dosage level, and the high dose established a no observable adverse effect level for human testing. The GLP safety pharmacology and toxicology is reported in the 2009 Pharmaceutical Research. ArmaGen has executed a collaboration agreement with a Contract Manufacturing Organization, and cGMP manufacturing of the IgG-neurotrophin fusion protein has begun. A First in Human Phase I clinical trial of the IgG-neurotrophin will begin following completion of the cGMP manufacturing. This clinical trial will test the safety and pharmacokinetics of the first IgG-neurotrophin fusion protein to enter human clinical trials.
Post Views: 63
