Table 3

Hormonal findings in AAV1-FS344–treated cynomolgus macaques. Hormonal concentrations were followed in each cynomolgus macaque after gene transfer. FSH, LH, estradiol, and testosterone showed little change from baseline. Concentrations from each individual animal can be traced by number. Empty slots at 15 months were the result of previous necropsies (PN). The widest variations were seen in the male testosterone concentrations. The baseline values of testosterone were low as seen in some vivarium-housed macaques. Those with low values remained in the same range after gene transfer. Each value represents a single animal, reported in the same order at each test interval. The broad fluctuations of some hormone concentrations are consistent with findings in macaques held in vivariums.

Time pointAnimal no.FSH (ng/ml)LH (ng/ml)Estradiol (pg/ml)Testosterone (ng/ml)
MalesFemalesMalesFemalesFemalesMales
Baseline10.531.70.340.5749.080.13
20.741.392.211.0317.658.28
30.390.351
40.340.180.12
5 Months10.521.650.680.5174.220.27
20.421.390.782.3561.39.02
30.50.554.99
40.360.251.67
15 Months1PN1.21PN0.6472.01PN
20.292.420.232.3456.545.48
3PNPNPN
40.450.427.42