The trials were designed involving discussions with potential partners etc.
And will include the data that they wish to see.
There are lot of excellent results from the BIT 225 010 Phase II Human Trial:
"rapid reduction in plasma virus levels during the second phase of viral decay, compared to cART alone."
"The rates of decline of the plasma HIV-1 viral loads were statistically greater in the BIT225 group compared to placebo (-0.047 & - 0.022 log10/Day, respectively, P < 0.02 from T-test, Wilcox-test and ANCOVA models). "
"Preliminary analyses of blood immune cell populations showed changes in specific immune cell populations in the BIT225 group compared to cART alone."
"Statistically significant differences (P<0.05) were observed between treatment groups in levels of subpopulations of CD4 and CD8 T cells as well as in CD16/56 NK cells, a key cell type combatting viral infection."
"Statistically significant differences (P<0.05) in the change from baseline were observed between the BIT225 and placebo (cART alone) for several immune activation and inflammatory markers including sCD14, sTNF-RII and IL-15. These changes are consistent with those seen in earlier trials and suggest a possible immune modifying effect of BIT225 when used with cART."
Dr Michelle Miller, Biotron’s Managing Director, said;
“The positive outcomes from this trial further our understanding of BIT225. The blood (plasma) viral load data in particular should be highlighted, as it suggests that BIT225 is having an impact on a critical phase of viral decay when latent reservoirs are established.
Current cART is efficient at rapidly and durably reducing virus levels in the blood,
but this does not translate into clearance of latent reservoirs.
The observed changes to immune markers and cells further the results from the previous 009 trial and suggest the utility of targeting viroporins as a new class of antiviral drugs.
The results reported here are preliminary, and ongoing analysis of the BIT225-010 study,
as well as its companion study, BIT225-011 in HIV-1 chronically infected individuals,
will be reported when complete. We would like to thank the principal investigators, trial sites, CROs,
and most importantly, the trial participants who enrolled in the study.”
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