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Oncolytics Biotech Inc. Message Board

  • d2foxes d2foxes May 16, 2013 11:15 AM Flag

    One thing is not so clear

    At least to me. Why have we not heard any updates on the PII trials that have been going on for years? The US PII H&N is a 14 patient trial and has been going on for more than 3-1/2 years. The reo + gemcitabine panc trial has been going on for 3-1/2 years. The protocol didn't call for multi year followup.

    I've read where some think the secrecy is a negotiating ploy in partnership talks. Or ammunition to suddenly drop on the shorts. But these are open label trials. ONC should know what the data is. Any pharma in ongoing partnership talks would know it too. And I would think any short with a large position could get an opinion from one of the research teams involved.

    Matt said in Feb that the market is not paying enough attention to these other PII trials. The implication was that the data was a positive that was being ignored. So why wouldn't we inform the market about these hidden values? More than a few of us expected to see something at ASCO.

    I am at a loss as to why we have not heard updates. Can someone post a cogent explanation?

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    • Hammerbag,

      They have released all of the data related to the primary endpoints. There have multiple posters and PRs on the NSCLC trial. The same is true of the GEM panc Reo trial. They have had a PR and data release for the SCCLC trial. They have had posters and PRs for the PI MCR hitting its endpoint.

      I think what you are asking is: why have they not presented the valuable data, i.e. survival numbers. As far as I can tell they are holding valuable data sets to help with financings. Think about it, prior to the H&N and SCCLC waterfall plots that they used to propel the last fanancing, when was the last time they served up any high value data (that could double the SP like it did). I don't mind that they are playing it close to the vest. Ultimately, this increases the chance that they can finish the job without much more dilution. Partners doing DD can't see much more than we can. There is no way they can see survival numbers that aren't public.

      What I am most curious about is the randomized panc and ovarian. These are the exceptions as far data release. We know absolutely nothing about these (except mayor Brenan's case). These are both randomized and have both had their monitroing periods extended to incredibly long time frames relative to how long they would typically go on for. Might they be treating these like potenital registration trials? The NCIC didn't start analogues of these when they started their other PIIs. I wish I knew but they do seem to be treating these differently.

      • 1 Reply to nomenome91
      • gnome - I was not referring to mature results not the early release a year and a half ago that 8 patients had SD or better for 12weeks, etc. but what's happened in the 76 weeks since then. As you say the valuable data. I'm surprised that a pharma in partnership talks would be denied information from open label trials. How can they make a reasonable offer if they don't know what they're bidding on?

        I can remember way back Brad saying partnership talks would happen when they had PII results. And then later making a sarcastic remark that pharma wanted to see post approval first Qs revenues before dealing. To me that suggested they had looked at ONC's data to that point and said "not enough yet.". Or at least had looked at the data. Do the suppliers of the other doublet/triplet trial components have no access to the data either? And aren't some of our PIs also concurrently runing trials for the very phamas who might become our partners? Not exactly at arm's length.

        I can see your rationale of building the strongest hand for the showdown but IMO it'll take a lot more to get the shareprice to $6-$7 from &2.75 than from $4.50-$4.75 which is where we might be if the "secret" trial information is great and was known.

    • "But these are open label trials. ONC should know what the data is. Any pharma in ongoing partnership talks would know it too. And I would think any short with a large position could get an opinion from one of the research teams involved."

      Have you ever heard of Non-Disclosure Agreements? Anyone directly involved with ONCY would be required to sign such an agreement before they do any form business or involve themselves in any clinical trials with ONCY.

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