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TOPIC: DOV, OA partnership question

DOV, OA partnership question 27 Jul 2016 17:13 #7500

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DOV
In response to your post #7403 I posed the following question.
***I also found it interesting that a OA partnership seems dependent on stat sig results but Cytori claimed the trial isnt powered to achieve such a result.
A miscommunication ?***
In your above mentioned post you seemed to express that "if" the results for OA reached stat sig several partners were interested.

I you have a moment can you expand on your thought process here ?

Are you hoping for even better results that the trial was powered for ?

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DOV, OA partnership question 28 Jul 2016 08:00 #7501

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Hedge, I cannot remember the exact words that were used. Was it "if the data is good, there are several companies that are interested" or was it "IF the data is statistically significant in all areas of measurement, then there are several companies interested." We did talk about the 24 week data and the placebo effect. This led to the comment the primary end point of pain on walking would not be used as the primary end point in a Phase III trial. The tone was as if there was regret that it had been used in this trial because of the strong placebo effect.

I think any decision to partner with Cytori will be dependent on a number of data points from the ACT-OA trial. If the pain on walking end point does not reach statistical significance P<.05, but other measures demonstrate strong cell effect, then there should be interest. As you have stated, you can't fake an MRI. If the cartilage increased in mass and created more space between the bones, that is the holy grail (that is a quote).

The company did say the ACT-OA was not powered to demonstrate statistical significance. Of course, this was not clearly stated before the trial began, it was only stated in the press release about the 24 week data. To quote Hedrick, "The preliminary 24-week limited unblind of the data was indeed suggestive of a cell effect over and above placebo early in the follow-up period."

In my 7403 post, I was trying to be clear that a partnership is not a slam dunk. Poor data could kill the interest. At the same time, I wanted to convey that the interest level is strong among those companies that have signed the NDA and have seen more early data than we have. That was the purpose of the partial unblinding at 24 weeks. Am I hoping for even better results than the trial was powered for? Hell yeah!

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DOV, OA partnership question 28 Jul 2016 10:05 #7503

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I went back to the record at clinicaltrials.gov and there it shows the following :

Primary Outcome Measures:
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain on Walking [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Observed Pain Scores on 50-foot Walk Test [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
Number of Observed OARS130 Responders [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
VAS Assessments [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
Patient Global Assessment [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
Use of Rescue Medication [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
SF-36 Questionnaire [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
MRI Osteoarthritis Knee Score [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
Adverse Events, Serious Adverse Events, and UADEs [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]


So- if I understand this correctly- the Primary endpoint is - KOOS & pain on walking at 12 weeks ?????
when the placebo effect is still the strongest??? That does not seem very smart :whistle:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

DOV, OA partnership question 28 Jul 2016 13:38 #7507

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I see, thank you DOV

Crazy, right Fas, typical sloppy trial design :bash:

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DOV, OA partnership question 28 Jul 2016 13:59 #7510

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myownhedgefund wrote:
Crazy, right Fas, typical sloppy trial design :bash:


That is how they make their bonuses. :grin:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
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