After completion of successful studies in multiple cell lines, two animal rodent studies were conducted to demonstrate safety and feasibility in-vivo. The studies were reviewed and approved by an accredited Institutional Animal Care and Use Committee (IACUC).
A very fast growing, highly metastatic breast cancer was chosen as the cell line of choice. Approximately 500,000 cells were injected below the skin of the thigh and allowed to grow until it reached a small measurable volume.
At that time treatments were started. The psoralen was mixed with the energy converters and directly injected into the tumor. The injection was followed by a low level X ray. The treatment was conducted 3 times a week for up to 4-6 weeks. At regular intervals the tumor volume and body weight were measured.
The representative treatment groups were as follows:
- Normal saline
- X-Ray and Psoralen only
- X-Ray and Energy Converter only
- X-Ray and Energy Converter and Psoralen
Additionally, body weight was measured as an indicator of gross systemic toxicity – weight loss can be an indication of acute toxicity.
Displayed below are the weight data collected during the study conduct. Each line represents the average weight of each group that was treated in the study. Note that all the groups have similar weight profiles, and that in particular the groups under treatment did not lose weight compared to the (untreated) controls, suggesting no significant toxicity was caused by the treatment.