The following message was updated on 11/25/2022 2:05:16 PM.
CC:3-32 extp'ltes to max time to reach 4of3 phenotypes by~30 enrolled by Dec 22-xxx
-Using 12 to 13 enrolled as of Sept 8 CC
-Two phenotypes at 4 or more (fibroid and diffuse
myeloid interpolated at 4 or more, leaving lympho-myeloid at 3)
-or 1 lympho-myeloid average every 4.0 months elapsed or 1 every 7.5 to 8.0 enrolled)
to reach 4 lympho type would be in Dec 2022 based on months elapsed
rate or in June or July 2023 based on enrolled elapsed rate
NAV3-32, our comparison study of tilmanocept imaging to joint biopsy, this
trial remains in active recruitment. As we've announced and discussed
previously, the preliminary results of this trial are promising. Our aim is to
recruit patients with each of the 3 pathotypes of RA to obtain comparative
imaging and pathology results. And the trial is designed so that we enroll a
minimum of 4 subjects in each of these 3 pathotypes of RA, fibroid, diffuse
myeloid and lympho-myeloid. So overall trial size has been expected to range
between 12 to 24.
To date, we have achieved the minimum or more in 2 out of 3 of the pathotype
buckets, with patients having had both their imaging and joint biopsies
completed. The primary objective of this study is to assess the relationship
between joint-specific tilmanocept uptake values and the pathobiology of
RA-involved joint tissue. Knowledge of an individual RA patient's pathotype may
be clinically important because it may predict to which RA therapy a patient is
likely to respond.
There is a growing body of literature suggesting that those patients with the
fibroid type of RA are much less responsive to the anti-TNF alpha drugs. And so
a means of determining whether or not a patient has this particular pathotype
is seen as extremely important to a number of key opinion leaders in
As of this time, there is no reliable way of assessing a patient's pathotype of
RA other than by doing an invasive biopsy. And we have hypothesized that tilmanocept
could provide this information. We previously discussed those preliminary
results that I mentioned on the first 11 patients. These results indicated that
tilmanocept uptake in RA inflamed joints is able to discretely differentiate
patients with the fibroid pathotype, i.e., those with low macrophage
involvement from those having either the diffuse myeloid or the lympho-myeloid
pathotypes of RA, i.e., those with high macrophage involvement.
7 of the subjects had relatively low levels of tilmanocept uptake. All 7 of
these subjects were found to have the fibroid pathotype. Of the remaining 4
subjects, 3 have the diffuse myeloid pathotype and 1 had the lympho-myeloid.
Furthermore, those subjects with either one of these 2 pathotypes had, on
average, more than 3x the tilmanocept uptake as the average subject with the
fibroid pathotype. So we have been able to clearly classify patients as either
fibroid or non-fibroid based on our imaging results taken before the biopsy in
those 11 cases.
These data also provides support for one of our indications in the Phase III
trial, the ability to predict from a baseline scan alone whether a patient is
likely to receive a meaningful clinical benefit from an anti-TNF alpha therapy,
since, as I mentioned, there's increasing evidence that if a patient has a
fibroid pathotypes of RA, they are less likely to receive significant clinical
benefit from anti-TNF alpha therapy.