RE: A few questions from the audiencesharkfood
thanks very much for posting
i have some questions & comments open to anyone re: thompson's comments
“It is however a true orphan virus as there is no pathology associated with this particular virus in its wild state. And it is thought that that is the case because it is delivered in such low dosage where you are exposed to it in the environment or location specific. So it doesn’t produce any pathology. So it’s really said to be asymptomatic. And if you test the adult population, you will find anywhere between seventy and one hundred percent of that population will have neutralizing antibodies to this virus. So it is considered to be one of the most common environmental viruses that people have been exposed to.”
His careful description here about the pathology of reovirus is interesting.
He states that there is no pathology associated with the reovirus found naturally in the environment because of the low dosage or location specific exposure.
He has created the perfect segue to discuss the pathology found in clinical trials – yet doesn’t mention it here after establishing the context? Why not seize that opportunity?
“In working with a live infectious agent this is different kind of process than they are used to when looking at small molecules.”
Who is the “they” he is referring to?
“Our program has been really at looking at a variety of different routes of administration. Either alone or with chemo therapies and we’ll be finishing that up primarily this quarter actually. And based on the results we get with that we will be determining what our active phase 2 program will be.”
Obviously trying to appear non-threatening to companies that provide chemo & radiation front line treatment forms while trying to attract interest from them. Unfortunately, it seems he hasn’t attracted much interest from either to date.
"We will be announcing late this quarter what our actual phase program will be. We are looking at probably at least four and possibly up to six phase 2 programs initiating next year. Part of the reason for that is you have a product that very is broadly active in certain animals and in vitro and it really has been a challenge for us deciding on which indications to focus on for phase 2 but that will be done this quarter.”
Trying to explain away the delay in deciding indications for phase II by implying an abundance of riches – yet given the very limited funds available to such an amazing management developing such an amazing treatment, the focus should have been on the one (or perhaps two) indications – glioblastoma or pancreatic, that the animal studies & pre-clinical trials suggested would offer the best & biggest results for the buck, from day one.
Instead, he is farting around with shareholder money conducting extremely limited phase I trials that enrolled a TOTAL of 36 patients over 6 years with extremely limited results!!!
Simply inexcusable.
His predictions about initiating six phase 2 trials next year, if true (and probably even if not true) means get ready for some dilutive financing with Brad & the pumpers’ favorite hedge fund. They’ve completed 3 extremely small trials in 6 years, and now he wants to give the impression they are going to start perhaps 6 phase II trials in the next year? - yea, that’s bound to happen given his track record. LOL
“We have finished several, three actually small local intratumoural studies. And this is where you tend to start out with viral therapies. It perceived that it is safer to inject locally than it is to administer systemically which you may or may not concur with. But that’s how we perceived it as well.”
I find this comment rather unusual – his audience is not primarily scientists but money managers who likely know less about the viral therapies than regular oncy MB readers – yet Brad engages them on a science level, suggesting they may think (contrary to how he perceived it) that it is safer to administer a live virus systemically throughout the entire body than injecting it locally into a tumour.
Combined with his earlier failure to comment about the pathology of reovirus found in prostate clinical trials conducted to date while discussing the pathology of the reovirus found in the environment, he has me wondering about why he chose the words he did (and I believe despite his bland delivery and foot in mouth disease, he does choose his words deliberately, sometimes even telling the audience his lawyers have reviewed them before he gives his little talks).
Could he really be saying that the perception that it is safer to inject locally than administer systemically has not been born out by the intratumoral prostate studies to date and that is the real though unstated reason for the very limited enrolment & results of these trials?
“But you know you have all those other tumours around so it’s a little overstated to call a tumour shrinking in one are a complete response when the patient still has progressive disease.”
Gosh, golly, gee – what a great guy Brad is for going out of his way to explain to his audience how much integrity and professionalism he has by not trying to overstate the results, while overstating them!!!!!
Brad you are the greatest!!! I’m sure you scored really big points with your audience on that one and we shareholders thank you for your underpromise/overdeliver approach!!!! Sort of like your comment that nothing material happening in the company?
“From that we followed on with a small T2 prostate study there were no Severe Adverse Events in this study either and the primary endpoints were efficacy but they were not registration endpoints. The goal was histopathology. We were looking at what type of tumour death were induceded by the virus. We were looking at a number of different immune issues that we thought might be interesting. And as a secondary issues we were looking at safety. We didn’t have any evidence at all of bystander cell death outside the tumour.. Which was important for us going into glioblastoma. We were quite concerned about bystander tissue which in that case was brain.”
Is he now trying to suggest that the glio delay was due to having to wait to examine whether there was any bystander cell death outside of the prostate tumour?
“Five of six patients actually showed tumour death . Prior to this we saw apoptotic cell death but this was the first indication where we had other types of cell death and quite widespread necrosis in two of those patients and we actually had a clinical response in the old fashioned sense, which wasn’t planned for. The patient’s gland and PSA levels went back to normal.”
That is our Brad – not planning for success – just continuing on with at his normal bureaucratic snail's pace – don’t want to be too efficient or effective which might require him to actually have to compete and deliver results!!
“We have two glioma studies which are both intratumoural. The first we have just announced the completion of phase 1 dose escalation arm. Went from 10^7 to 10^9 and And TTIB50. Thos upper dosage was selected because the concentration was three times higher than the upper concentration range planned for our US study. So that was the reason for that particular dosage scheme… We are about to initiate enrollment in an approved phase 1 2 study in the United States. It uses an alternative form of delivery, infusion. Again the standard of care is using infusion rather than direct injection and that will be the subject of that study which should start enrolling very soon.”
what is special about 3 times higher than the upper dosage concentration range planned for the US study? Why couldn’t it be 2 times, or 4 times? Is he trying to say they tried to compensate for an inferior standard of care (direct injection) by injecting 3 times the virus to see if it was safe? I wonder who chose the inferior direct injection form of delivery? Is that perhaps the explanation for the enrolment problems and why it took over 3 years to enroll 12 patients????
“When working with a virus it is a stutter step process. ???? interesting because it has a large patient population. Probably 80% of patients can’t be treated by local therapy. In this particular case we did tox. studies on rodents, canines and extensive studies in primates unfortunately and never reached an MTD"
is he afraid that someone in the audience is a member of PETA and will throw blood on him or boycott investing in biotech because he uses animals in testing?
why sound apologetic for using primates to test what is supposedly a potentially revolutionary treatment to reduce/eliminate the scourge of suffering from cancer in humans? Just to avoid offending some fringe lunatics who would rather save a few primates than make progress against the suffering inflicted by a dreaded human disease? Comes across to me as someone who is as concerned with pathetic pandering as he is in advancing cancer treatment. perhaps next he will agree to refuse using primates to test? yea, thats the ticket!
“We have one combination study on going at the moment right now. The phase 1 component of this study will be completed this quarter. The phase 1 will be followed immediately after that. Again we are looking at combination radiotherapy and reovirus. In this particular patient group they are palliative and this is their last radiation dose. They are getting treated with 20 grades of radiation in five days Monday too Friday and they get virus on Tuesday and Thursday. And the phase 1A component Tuesday and Thursday looking at different dosages. Once that’s completed we are looking for increasing frequency of the virus with slightly less palliative patients They will be getting 36 grades over 12 fractions which is essentially the same radiation dose when you do your calculation. Its radiation data, the phase 1A component of this study will be part of the package we are getting together to justify glioblastoma studies. We will have combination data that can go on to justify that.”
So does this mean the 3+ year US glio delay will go on until the combo study has completed its phase “1A”
“We have an anticipated burn rate of about a million Canadian dollars a month. The |Canadian dollar is now worth more than it used to be so its not too far from the American dollar. We have around 32 million dollars in the bank at this time.”
He doesn’t clarify whether the anticipated burn rate includes the 6 phase II trials planned – given the burn rate for the 36 patient combined total for phase I trials, most reasonably competent financial people would quickly conclude it doesn’t. and why provide funds in $Cdn when all their current & planned trials will be in the US & UK? Does he think his audience won’t figure in the 15% discount and realize they have just over $27M US to fund all these ongoing & planned trials, like he apparently does? amateurish hucksterism imo, for something he apparently wants investors to take seriously.