clinical trials
Quality Management : Clinical Trials in Biopharmaceuticals.
Company : Roche
Drug Name: Bitopertin (Treatment for Schizophrenia)
Positive phase II proof-of-concept data with RG1678 in patients with predominantly negative symptoms of schizophrenia were presented at an international medical meeting . Based on these promising results, a global phase III program was initiated including a total of six studies investigating RG1678 in combination with standard of care antipsychotic drugs in patients with either negative symptoms or residual positive symptoms of schizophrenia. Running the studies for both indications in parallel allowed a better understanding of the effect of RG1678 on a broad spectrum of symptoms and its value in the management of patients at different phases of their disease.
RG1678( Bitopertin) is a glycine transporter type 1 (GlyT1) inhibitor that increases levels of the neurotransmitter glycine by inhibiting its reuptake from the synaptic cleft. Glycine acts as a required co-agonist along with glutamate at N-methyl-D-aspartate receptors. Dysfunction of NMDA receptors may play a key role in the pathogenesis of schizophrenia and modulation of glutamatergic signalling via increased concentrations of glycine in the synaptic cleft may help potentiate NMDA receptor function and improve the symptoms of schizophrenia. Bitopertin is administered orally at 10 mg or
In a Phase II proof-of-concept study patients on RG1678 experienced a significant improvement in the change of the Negative Symptom Factor Score from baseline within 8 weeks. The first patient was randomized into the phase III program in November 2010.Phase III trials are currently underway and expected to be completed by 2015.
Company: Roche Drug Name : Trastuzumab ( trade names Herclon, Herceptin) (Treatment of Breast Cancer)
Herceptin (trastuzumab) is a humanised monoclonal antibody, designed to target and block the function of HER2, a protein produced by a specific gene
Company : Roche
Drug Name: Bitopertin (Treatment for Schizophrenia)
Positive phase II proof-of-concept data with RG1678 in patients with predominantly negative symptoms of schizophrenia were presented at an international medical meeting . Based on these promising results, a global phase III program was initiated including a total of six studies investigating RG1678 in combination with standard of care antipsychotic drugs in patients with either negative symptoms or residual positive symptoms of schizophrenia. Running the studies for both indications in parallel allowed a better understanding of the effect of RG1678 on a broad spectrum of symptoms and its value in the management of patients at different phases of their disease.
RG1678( Bitopertin) is a glycine transporter type 1 (GlyT1) inhibitor that increases levels of the neurotransmitter glycine by inhibiting its reuptake from the synaptic cleft. Glycine acts as a required co-agonist along with glutamate at N-methyl-D-aspartate receptors. Dysfunction of NMDA receptors may play a key role in the pathogenesis of schizophrenia and modulation of glutamatergic signalling via increased concentrations of glycine in the synaptic cleft may help potentiate NMDA receptor function and improve the symptoms of schizophrenia. Bitopertin is administered orally at 10 mg or
In a Phase II proof-of-concept study patients on RG1678 experienced a significant improvement in the change of the Negative Symptom Factor Score from baseline within 8 weeks. The first patient was randomized into the phase III program in November 2010.Phase III trials are currently underway and expected to be completed by 2015.
Company: Roche Drug Name : Trastuzumab ( trade names Herclon, Herceptin) (Treatment of Breast Cancer)
Herceptin (trastuzumab) is a humanised monoclonal antibody, designed to target and block the function of HER2, a protein produced by a specific gene