Pilot Acute Safety Evaluation of Innocell™ Cancer Immunotherapy in Canine Subjects.

BACKGROUND: We are developing cancer immunotherapy based on the use of autologous tumor tissue that has been rendered replication-incompetent but maintains phenotype and metabolic activity post-preparation. AIM: The aim of this study was to evaluate safety and tolerance to injection of the inactivated tumor cell and adjuvant preparation (Innocell™) within 24 hours of administration in a pilot study in canine patients with solid organ tumors. Methodology. Three canine patients demonstrating accessible solid organ tumors of various types were assessed in this study. The local site injection was monitored post-treatment. Clinical signs of adverse reactions were monitored for 24 hours post-treatment. Blood samples were taken pre-treatment and at 8 and 24 hours post-treatment for all subjects. One subject provided samples at 7 days post-treatment. All blood samples were analyzed for cytokine content for both immune system-associated and tumor-associated cytokines. RESULTS: No signs of adverse reactions at the site of injection or systemically were observed in the study period. A slight fever and lethargy were reported in one subject by the owner post-vaccination. Immune system-associated cytokine levels in two of the three animals were elevated post-treatment. Tumor-associated cytokine levels in all three subjects declined post-treatment from baseline levels with the effect most prominent in the subject with a non-excised tumor. CONCLUSION: Subcutaneous injection of the inactivated tumor cells and adjuvant was well tolerated in this pilot study. Cytokine responses observed were in line with the intended use of the treatment in stimulating immune response without adverse clinical observations. Additional evaluation is warranted.

Acute Effects of Near Infrared Light Therapy on Brain State in Healthy Subjects as Quantified by qEEG Measures.

OBJECTIVE: Recent investigation suggests that near infrared (NIR) light may improve symptoms from mild traumatic brain injury. In addition, quantitative electroencephalography (qEEG) has shown measures correlating with concussion: P300, reaction time, and amplitude. The objective of this study was to determine whether NIR light treatment has an acute effect on brain state in healthy patients as measured by EEG. METHODS: A total of 31 healthy volunteers, between the ages of 14 and 65, underwent qEEG event-related response tests before and after a 20-min NIR light head treatment. The treatment device is composed of 784 NIR GaAIAs LEDs covering 360 cm2 on the head in a cap covering occipital, left temporal, right temporal frontal, and parietal lobes. The fluence rate was 1 J/cm2·min for a power density of 16.67 mW/cm2. Peak spectral wavelength at steady-state temperature (42.2°C) is 903 nm. The device delivered a total dose of 20 J/cm2. Two to four months later, 18 subjects returned for a second round of qEEG measurements, with a 20-min rest period in place of the NIR light treatment as a control arm. RESULTS: Change in reaction time significantly differed between treated and control, with a mean of 23.8 msec improvement compared with controls (p = 0.035). Amplitude increased an average of 0.81 µV in treatment versus 0.22 µV in controls and did not reach significance. However, subanalysis of 14 treated subjects and 8 controls displaying initially low amplitude showed a mean increase in amplitude of 1.83 µV (30%) in treated subjects versus 0 µV in controls (p = 0.08). P300 measures did not show significant differences between groups. CONCLUSIONS: The data suggest that NIR light may have an acute effect on reaction time and amplitude in certain subject subsets. There were no adverse events registered across the 31 subjects in the treatment group, nor in the 18 evaluable control group subjects.