RE: Another Phase I ??!!While the FDA clearance (is that somehow different from approval?) for two phase 1 trials is certainly good news, it is also certainly late news.
inequities
i emailed the FDA about this, since onc up until the recent US glio "clearance" news release had used the term "approval" to describe regulatory review in their previous news. (in fact, onc uses the term "approval" in the FAQ section of their website talking about clinical trials.)
https://www.integratir.com/faq.asp?ticker=t.onc&title=null#18
the FDA however, does not approve clinical trials - they only "give permission to proceed."
perhaps it is only a subtle difference, but the term “approval” certainly gives a more positive impression than "clearance".
As to all these phase I trials, Thompson is quoted in several places as suggesting this is part of onc’s “multi-pronged" clinical trial approach, namely mono/local therapy (glio trial), systemic/intravenous (UK trial) and combo treatments (chemo/rad UK & hoped for NCI).
The question to be answered is, imo, why haven’t they focused their very limited resources exclusively on progressing glio ph I & II trials, since based on its RAS activation, glio is expected to be most susceptible to reovirus infection and provide the best & most impactful clinical trial results – the existing treatment bar is very low, the safety factor compared to life expectancy (i.e., the risks vs. efficacy) should be optimal and it gets the commercial potential to be realized quickest.
Good glio results should move the share price up much higher, which would require fewer and less dilutive financings to raise the cash for the other systemic & combo trials, as well as providing more leverage in partnership negotiations. (they even supposedly have the manufacturing capability - all that would be missing is the distribution/marketing channels a large pharma can provide).
management's "strategy" does not appear to be the quickest, cheapest and therefore best way (at least in the interests of shareholders) to achieve commercial approval or a partnership, yet no one seems to bother demanding what the reasons are that management has chosen their "multi-pronged" approach instead.
The cult will say that all these phase I trials must mean that glio results are good, otherwise management wouldn’t expand beyond them & commit their scarce resources, yet at the same time, the company doesn’t bother providing any glio updates (or explanation why it took 3 years to get FDA glio clearance.)
then we have the much heralded prostate Ph II trial...
The histopathological results of the prostate trial have been hailed as good, yet only 6 patients were treated – if 4 of 6 prostate glands showed evidence of apoptic tumour cell death, and in another one the PSA level dropped by over 50%, why wasn’t this trial extended so it could possibly become made pivotal? Was it because the evidence of tumour cell death was insignificant? I don’t understand how results of an extremely limited phase II trial were needed to support application to commence a ph I systemic trial in the UK – when Thompson says, they had enough information from the 6 patients who is he trying to kid?
If the results were good or better, why not extend enrolment so that it might become pivotal with the goal of getting commercial approval? Failure to continue with this very limited but apparently “successful” ph II trial makes little sense and again has not been fully explained, yet few if any bother to demand why.
Perhaps onc management is going to emulate organetix strategy for success... conduct small (insignificant) trials and use alternative methods to get the word out about an earth-shattering treatment...
“we plan to use the multi-media already available. There are... patients, web sites, organizations and... specialists all over the world very well connected by e-mail and newsletters. The news media will also be used to expand the information knowledge base of our products. Word of mouth alone will be powerful and worldwide.”
https://www.organetixinc.com/product_sales.htm
that certainly appears to offer some on BIOEYE and her countless aliases using message boards to spread the sotry of reolysin by “word of mouth”.
btw, anyone else notice that the links to both SEC & SEDAR filings on onc's website don't seem to work?