bencro wrote: Why do you think they tested CLT on GBM? ... ;-)
My take is that they could integrate the "
CLT for oncology" right into the TLC-2000 as a distinct option to avoid potential administrative overhead related to approvals (501(k), etc ....).
But worst case scenario, if they integrate it into a separate tool that requires HC/FDA approvals,
they already have all the data to satify them. The Jan 28 presentation might act as D paper requested by FDA/HC (Dr. Lilge once mentioned that when things are so innovative, FDA asks for peer-reviewed articles):
Two-photon luminescence lifetime imaging microscopy (LIM) to follow up cell metabolism and oxygen consumption during theranostic applications If so, it is legitimate that such requests have already been submitted by Theralase. Because it could be involved in a Ph. 1b brain cancer for example, it could have been asked to be put on a higher priority review:
November 30, 2017 In the Theralase conducted experiments, Theralase® CLT was used to pre-treat Glioblastoma Multiforme (“GBM”) Rat Glioma (“RG2”) brain cancer cells, in vitro. Six hours post treatment, GBM RG2 cells were then treated with PDT using a Sub Lethal Dose 50 (“LD50”) (dose of drug and light that normally kills 50% of the cells).
In other Theralase conducted experiments, Theralase® CLT was used to pre-treat human bladder cancer cells, in vitro, which were then treated with a LD50 PDT dose, achieving similar results as the GBM RG2 experiment (data not shown).
Post-treatment analysis of the GBM RG2 cancer cells, revealed that cancer cells that were pre-treated with Theralase® CLT and then treated with a PDT LD50 dose were destroyed 25% greater than cancer cells treated by PDT alone.
This data strongly suggests that Theralase® CLT technology reverses the Warburg Effect, changing the cellular metabolism of the cancer cells, and making them more susceptible to destruction by PDT.
Therefore, Theralase® CLT could be used to increase the efficacy of PDT anti-cancer treatments, while potentially decreasing the dose of PDC drug and / or light energy required, increasing safety and tolerability, while reducing treatment toxicity.
Some cancerous tumours are difficult to treat with ionizing radiation (X-rays), because they are prone to developing a natural immunity to this form of treatment.
Theralase® CLT has been proven effective, preclinically, to overcome this resistance to X-rays and increasing cancer cell death by X-ray treatment.
GBM RG2 cells were pre-treated in vitro with Theralase® CLT. Six hours post treatment, these same cancer cells were irradiated with X-rays. Post-treatment analysis demonstrated that GBM RG2 cancer cells pre-treated with Theralase® CLT then subjected to X-ray had a 20% greater cell kill versus cancer cells treated with X-ray alone, strongly suggesting that the reversal of the Warburg Effect is essential to overcoming resistance to X-rays and improving overall cancer cell kill.