|My thoughts on the news that a fourth candidate has been enrolled|
Ok... finally some real news.... we have another candidate enrolled for the therapeutic dose part of the Phase 1b trial. It has been announced in a press release and not speculation.
What does that mean to me? After all it is about 5 months since the last candidate was enrolled.
1. Well first of all, at this rate it will be at least 1-2 years before this Phase 1b trial will be completed.
2. It has nothing to to with the fact that the tests are being conducted in Canada as such. The tests are being held in Toronto because that is where the company and expertise in this treatment is. Princess Margret Hospital is a pretty decent site for such a test. It has a great reputation in the area of Cancer treatment.
3. here is a great document that was written by Theralase back in August/17 and describes in pretty good clarity what the testing and procedure is for the testing overall and the results for the first 3 candiates (low dose).
This was written before the second part of the testing what completed for the first person enrolled in the therapeutic dose.
Theralase Technologies Inc. Corporate Presentation – 3Q2017
Times were pretty heady back then... we had started the second section of the trial... the first low dose part satisfied the safety and tolerability of the low dose and in fact showed efficacy.... All was good, speculation ran wild.
4. This is a cure for bladder cancer!!! Even the McFarland team had posted something like "Bladder Cancer days are numbered" I may not have the quote 100% accurate but that was the sentiment.
But September and October passed with no news of the 4th patient or future enrollment of candidates. The speculation and rumour ran wild...they were angry that such a slam dunk treatment was not being taken up by big Pharma, after all we killed bladder cancer on the first trial candidates...right????
5. Then in the first week of November... a very important document was finally published
Theralase Provides Interim Data Analysis on Anti-Cancer Treatment for First Four Patients Treated
here is a quote from the document
Interim Data Results: Ahhhh... this is not the slam dunk it appeared to be.
1. As previously reported, the first three patients treated at the MRSD successfully achieved the primary, secondary and exploratory outcome measures at 90 days post treatment.
2. Patient four treated at the Therapeutic Dose successfully achieved the primary, secondary and exploratory outcome measures at 90 days post treatment. During the 90 day cystoscopy analysis, patient number four’s bladder surface wall was observed to be red and inflamed. The patient will continue to be monitored to see if this condition resolves.
3. Although not a pre-defined outcome measure of the Study, patient one, two and three have successfully achieved the primary and secondary outcome measures at 180 days post treatment.
4. Although not a pre-defined outcome measure of the Study, patient one, two and three have not achieved the exploratory outcome measure at 180 days post treatment.
The bolding is mine for emphasis and to draw attention to the fact that there are issues here... It is not as cut/dried as treating mice. What worked for 90 days has not worked for 180 days. Were there was no significant problems of discomfort for the first 3 candidates at low dosage there seems to be issues with the 4th candidate at high dose...
So... it seems the cancer has recurred.... in patients 1,2,3 but the upside was that the disease was not made worse. Apparently the recurrance might be from other sources such as the upper urinary track.
6. I doubt that most speculators on this stock read this document to completion... just my feelings about it. I didn't read it as carefully as I did this time...my bad.
I have a strong science background in Chemistry. It is not in Cancer research but I think I can follow most jargon free discussions on most science subjects. That is what attracted me to Theralase and their treatment for bladder cancer... It made sense to me.
7. Now... if I were confronted with this type of information at 180 days into the tests... I doubt I would blast away with the enrollment and testing of additional candidates with the same procedure.
I would evaluate the information in detail with other members of the team and try to come up with a strategy to make things better. Insanity would be to try the same thing over and over again and expect things to be different.
8. The silence has not had a good effect on the stock price, that is obvious. But really what could they say? I find this announcement encouraging. Perhaps they will modify the procedure to get a better result... I imagine they would have had to get permission from FDA to do anything that was seriously different from past testing and that in itself would take time.
I am long in this stock... I have a significant holding that I have hung onto for over 1.5 years. I am not about to bail out on this company now.