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New HCV Drug Celgosivir/MX-3253, oral alpha-glucosidase I inhibitor
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Pree announcement from Migenix
Dec 13, 2006
A phase II combination study in non-responder and partial responder patients commenced in November 2005, with full enrollment reached in June 2006 and top-line results of the study announced on November 6, 2006. A total of 57 patients were enrolled into the study (36 were non-responders and 21 were partial responders to prior pegylated alpha interferon-based HCV treatment). Patients were randomized into three treatment arms: (i) celgosivir plus peginterferon alfa-2b plus ribavirin ("triple combination"); (ii) celgosivir plus peginterferon alfa-2b ("double combination"); and (iii) celgosivir placebo plus peginterferon alfa-2b plus ribavirin ("control treatment"). Of the 36 non-responders, 30 patients completed the 12 weeks of treatment: 12 in the triple combination arm, 8 in the double combination arm, and 10 in the control treatment arm. The triple combination demonstrated clinical benefit in this non-responder patient population, achieving:
- a mean HCV viral load reduction of 1.2 log10 compared to a 0.4 log10 mean reduction in the control treatment arm; and
- a 33% Early Virological Response ("EVR") compared to a 10% EVR in the control treatment arm (EVR is defined as a 2 log10 or greater HCV viral load reduction at 12 weeks of treatment).
In the partial responder patient population, there were insufficient patients (n=3) in the triple combination arm for any conclusions to be drawn. The double combination did not show a meaningful difference in viral load compared to the control treatment in either the non-responder or partial responder patients.
The celgosivir combination therapies were well tolerated and resulted in no serious adverse events.
Additional data from this study are planned to be presented at one or more international medical or liver disease conferences in 2007. We also plan to submit an IND in the US in the second half of 2007.
In conjunction with the celgosivir non-responder study, a protocol was designed and approved by Health Canada to provide participants in the 12-week study with access to continued treatment for up to an additional 36 weeks (the "extension study"). In consultation with their physicians, patients could elect to continue on with their original treatment or, if on the double combination or the control treatments, could switch to the triple combination treatment. Of the 50 patients completing 12 weeks of treatment, 31 elected to continue treatment beyond 16 weeks with 30 of these either continuing with, or switching to, the triple combination. As of November 7, 2006: 2 patients had completed 48 weeks of treatment; 14 were between 24 and 48 weeks of treatment; 6 had not yet reached 24 weeks of treatment; and 9 patients had discontinued treatment.
The Phase II non-responder study and the extension study are supported in part through a Material Transfer License Option agreement with Schering-Plough Corporation ("Schering"). The agreement with Schering provides for (a) the supply of PEGETRON (peginterferon alfa-2b powder plus ribavirin), (b) certain technical and laboratory support and other services, and (c) certain limited rights for Schering's review of clinical trial results and for the negotiation of a license agreement. On December 7, 2006 we provided a summary of the study results to Schering for their exclusive review pursuant to the Material Transfer License Option agreement. No license terms have been negotiated with Schering to date.
In October 2006 we began a phase II combination study of celgosivir in patients with chronic HCV (genotype 1) infection who have not received prior treatment for their infection (the "treatment-naive" study"). The focus of this study is on viral kinetics, pharmacokinetics, safety and tolerability. Four-week interim and 12-week results from the study are expected in the first half of 2007.
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