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(CTRV) Commences Screening for CMX157 Phase 1 in HBV
http://www.streetinsider.com/Corporate+News/ContraVir+Pharma+(CTRV)+Commences+Screening+for+CMX157+Phase+1+in+HBV/11435348.html
ContraVir Pharmaceuticals, Inc. (Nasdaq: CTRV) announced that it has commenced screening healthy volunteers for enrollment into the Phase 1 portion of the Company's Phase 1/2a multiple ascending dose clinical study of CMX157, ContraVir's novel, highly potent lipid conjugate of tenofovir for treating hepatitis B virus (HBV) infection. In order to facilitate enrollment, the study is being conducted by several leading academic medical centers in Thailand, a country in which the incidence of HBV is very high.
The Phase 1 portion of the study will enroll 50 healthy volunteers assigned to one of five sequential, ascending CMX157 dosing cohorts. Participants will receive two weeks of a once-daily dose of either 5, 10, 25, 50 or 100 mg of CMX157 or placebo; eight per cohort receiving CMX157 and two per cohort receiving placebo. The objectives of the study are to evaluate the safety, tolerability and pharmacokinetic profile of CMX157. Initiation of each higher dose cohort will proceed following review of the data from the previous cohort. An independent review will be conducted by a data safety and monitoring board (DSMB) between the 25 mg and 50 mg cohorts (the midpoint of the Phase 1 portion of the study).
Following this DSMB review, ContraVir will initiate the Phase 2a portion of the study in parallel with the continuing Phase 1 portion. The Phase 2a will enroll 60 treatment-naïve patients with chronic HBV infection to compare CMX157 to tenofovir DF (TDF, marketed by Gilead Sciences as Viread®). This portion of the study will also consist of a sequential dose escalation, with 10 patients per cohort receiving four weeks of a once-daily dose of either 5, 10, 25, 50 or 100 mg of CMX157, and two patients per cohort receiving 300 mg of TDF, the standard dose of Viread®. As in the Phase 1 portion of the study, initiation of each higher dose cohort will follow review of the data from the previous cohort and there will be a DSMB review between the 25 mg and 50 mg CMX157 cohorts.
James Sapirstein, CEO of ContraVir, stated, "Our Phase 1/2a clinical trial of CMX157 will allow ContraVir to continue building the safety database for CMX157, which was shown to be safe and well tolerated in a completed Phase 1 study, as well as evaluate its antiviral activity compared to Viread at clearing HBV infection in our first head-to-head, proof-of-concept clinical study. The high potency of CMX157 against HBV in vitro suggests its potential to provide better efficacy and improved safety at a lower dose than Viread®. We expect the first healthy volunteer to be dosed in the current Phase 1 portion in the coming weeks, followed by initiation of the Phase 2a portion of the study in the second quarter 2016."
ContraVir Pharmaceuticals, Inc. (Nasdaq: CTRV) announced that it has commenced screening healthy volunteers for enrollment into the Phase 1 portion of the Company's Phase 1/2a multiple ascending dose clinical study of CMX157, ContraVir's novel, highly potent lipid conjugate of tenofovir for treating hepatitis B virus (HBV) infection. In order to facilitate enrollment, the study is being conducted by several leading academic medical centers in Thailand, a country in which the incidence of HBV is very high.
The Phase 1 portion of the study will enroll 50 healthy volunteers assigned to one of five sequential, ascending CMX157 dosing cohorts. Participants will receive two weeks of a once-daily dose of either 5, 10, 25, 50 or 100 mg of CMX157 or placebo; eight per cohort receiving CMX157 and two per cohort receiving placebo. The objectives of the study are to evaluate the safety, tolerability and pharmacokinetic profile of CMX157. Initiation of each higher dose cohort will proceed following review of the data from the previous cohort. An independent review will be conducted by a data safety and monitoring board (DSMB) between the 25 mg and 50 mg cohorts (the midpoint of the Phase 1 portion of the study).
Following this DSMB review, ContraVir will initiate the Phase 2a portion of the study in parallel with the continuing Phase 1 portion. The Phase 2a will enroll 60 treatment-naïve patients with chronic HBV infection to compare CMX157 to tenofovir DF (TDF, marketed by Gilead Sciences as Viread®). This portion of the study will also consist of a sequential dose escalation, with 10 patients per cohort receiving four weeks of a once-daily dose of either 5, 10, 25, 50 or 100 mg of CMX157, and two patients per cohort receiving 300 mg of TDF, the standard dose of Viread®. As in the Phase 1 portion of the study, initiation of each higher dose cohort will follow review of the data from the previous cohort and there will be a DSMB review between the 25 mg and 50 mg CMX157 cohorts.
James Sapirstein, CEO of ContraVir, stated, "Our Phase 1/2a clinical trial of CMX157 will allow ContraVir to continue building the safety database for CMX157, which was shown to be safe and well tolerated in a completed Phase 1 study, as well as evaluate its antiviral activity compared to Viread at clearing HBV infection in our first head-to-head, proof-of-concept clinical study. The high potency of CMX157 against HBV in vitro suggests its potential to provide better efficacy and improved safety at a lower dose than Viread®. We expect the first healthy volunteer to be dosed in the current Phase 1 portion in the coming weeks, followed by initiation of the Phase 2a portion of the study in the second quarter 2016."
it is useless to compete with taf, they should aim for a complete cure which is not really hard to get. hbv sufferers have to get free of to be sucked for life by vampire pharmacy companies.
1 Comments
I agree but better cheap TAF than TDF, simple.
Is this just some version of Tenofovir like TAF or it's gonna be something more ?
3 Comments
It is very comparable to TAF. Better cell membrane penetration, very little free plasma tenofovir, hence no burden on kidney Tubuli cells.
good to know, maybe competition will enforce lower prices on both.
good to know, maybe competition will enforce lower prices on both.
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