Peregrine Inc. presents results from HCV/ HIV Phase 1b trial

[J220]

Peregrine Inc. presents results from HCV/ HIV Phase 1b Bavituximab trial. They report:

 "Transient antiviral activity (maximum reduction in HCV and/or HIV viral load of  > 0.5 log from baseline) was observed in all dose levels."

Also:

"Signs of on therapy HCV and HIV antiviral activity were observed in all treatment groups."

Here's the poster link (in PDF): http://www.peregrineinc.com/images/stories/pdfs/easl_hcv.pdf

Looks good so far! Could this be it, could this be what we've all been waiting for???

[MitchMiller]

The web site implies the test went for a year.  .5 log reduction for HIV is not commercially viable.  Seems like a failure to me.

I believe the standard expectation of current ARVs is patients should achieve a 1-log reduction in viral load within 1 to 2 months of beginning therapy.

[J220]

The web site implies the test went for a year.  .5 log reduction for HIV is not commercially viable.  Seems like a failure to me.

I believe the standard expectation of current ARVs is patients should achieve a 1-log reduction in viral load within 1 to 2 months of beginning therapy.

You are forgetting these are phase I results, designed to test mainly for safety and tolerability, not final effectivness- that will  come later at higher dosages. So right now, to see some therapeutic effects at even these low doses, when they have not reached maximum tolerated dose or maximum effective dose (MTD and MED), this is why this is significant.

[Cosmicdancer]

Good point J220.  The highest dosing level was 6 mg, given intravenously once a week for 8 weeks.  That sounds quite low, compared to the hundreds of mg's most of us take daily of ARVs.  Only 1 of the 6 patients reported any adverse events at that level (asthma), which may have been a pre-existing condition.  At the 6 mg dose, 5 of the 6 patients (83%) had at least a .4 log decline in HIV viral load.  At the 3 mg dose, 3 of the 9 patients (33%) had at least a .4 log decline in HIV viral load. 

The study lasted for about 4 months, there was a 4 week screening period, 8 weekly injections, and then a one month follow up period.  They noted that "Bavituximab did not exhibit appreciable accumulation following multiple-dose administration once weekly for eight weeks". 

One of the conclusions of the study was that the "data supported the initiation of a 12-week phase 2 study to determine the early virological response (EVR) rate of bavituximab given in combination with ribavirin to treatment naive patients with Hep C."  It doesn't mention a phase 2 study in people with HIV, although the data supports doing further study at higher doses.

[freaky_dream]

wrong thread...