Can't wait to hear more on the GBM indication, once NMIBC Ph. 2b is on the move.
Somehow I can't see safety concerns being much of an obstacle for Theralase's treatment for gbm. Like you say, TLD-1433 is safe, and transferrin occurs naturally in the body. There is a greater than 20X differential between gbm tumour uptake and that of healthy brain tissue. The amount of energy required to activate TLD-1433 is orders of magnitude smaller than ALA. Dark toxicity of TLD-1433 and take up by healthy tissue is negligible.
According to a 2015 article the prognosis for gbm is grim. It is treated initially by surgery and chemoradiation. Without treatment patients die soon after diagnosis. The median duration of patient survival for those who receive maximal treatment is 12 to 18 months.
The article noted that:
"GBM recurrence most often occurs in the form of a local continuous growth within 2–3 cm from the border of the original lesion."
"Choucair et al., reported that more than 90% of patients with glioma showed recurrence at the original tumor location and that multiple lesions developed in 5% after treatment."
"It has been suggested that GBM recurrence is inevitable after a median survival time of 32–36 weeks."
Recurrent Glioblastoma: Where we stand
The pre-clinical study by Theralase suggests that Theralase may be able to do much better than the current standard of care - destroying all of the cancer in the targetted area where recurrence is most likely.
The January, 2018 news release, revealed Theralase's current plan for it's phase 1b for gbm:
Theralase is in the process of developing two separate clinical treatment paths for patients diagnosed with GBM, with the aim of safely and effectively destroying their cancers with minimal side effects.
It is expected that the first Phase Ib GBM clinical study would generally involve the patient:
1. receiving primary treatment, such as: surgical debridement, temozolomide (oral chemotherapy drug) and / or radiation therapy
2. receiving the Theralase anti-cancer vaccine (created from the patient’s own tumour cells), post primary treatment, via subcutaneous or intramuscular injections, to stimulate the body’s immune system to destroy residual GBM cancer cells.
It is expected that the second Phase Ib GBM clinical study would generally involve the patient:
1. receiving an intravenous injection of Rutherrin®, a patented PDC (TLD-1433) drug formulation combined with transferrin
2. having the drug activated by laser light (via surgically inserted optical fibers) and/or ionizing radiation (using conventional trans-cranial (non-invasive) X-ray treatment), at 8 to 24 hours post-injection (allowing Rutherrin® to cross the blood brain barrier and be selectively absorbed into the GBM cancer cells).
3. receiving additional PDT and/or radiation treatments (Step 1 and 2) to destroy any residual tumours, as required.
4. receiving the Theralase anti-cancer vaccine (created from the patient’s own tumour cells), post treatment, via subcutaneous or intramuscular injections, to stimulate the body’s immune system to destroy residual GBM cancer cells.
5. There are an estimated 24,000 new cases of malignant gliomas diagnosed in the US annually, with more than 14,000 deaths. In the majority of cases, they recur following initial treatment, especially for GBM, the most common and lethal form of brain cancer.
fredgoodwinson wrote:
Thanks Eog - didn`t hear back from Lazer00 with his alleged toxicity issues but if TLD-1433 is safe Rutherrin is safer and a lot of preclinical work in GBM has confirmed this as per my previous post.
There are at least two other legs - vaccine and CLT - to TLT`s GBM Treatment.These were the further subject of separate papers at that International Congress (see below).
Paper 11070-110: A New Platform Technology RuVaCare™, an Extracorporeal Anti-Cancer Vaccine is Efficient in Breaking Immune Barrier to Target Cancer Cells
This paper discusses the successful application of Theralase®'s PDT technology as a cancer vaccine, known as RuVaCare™, and highlights the study's outcome and the significant increase of survival obtained in the RuVaCareTM vaccinated RG2-GBM model. RuVaCare™ was designed to break the suppressive tumours barriers and to selectively boost the activation of an effective immune response, specifically toward malignant cancer cells.
Paper 11070-353: Photobiomodulation Inhibits Warburg Metabolism and Potentiates a Dose Dependent Response By GBM Cells to Ruthenium-Based PDT
This paper discusses the impact of Photo Bio Modulation ("PBM") on the Warburg Effect and how it increases the efficacy of TLD-1433 in the destruction of GBM brain tumours.
If the PDT alone can push survival out beyond 5 years` then in combination with vaccine and CLT (leaving aside for now cannabis) results should be spectacular. PDT is repeatable not only within the 16 hour window of the therapeutic dwell-time but as a separate procedure at a later date. The serious prospect of a non-invasive treatment to defeat this terrible disease.