I think this is actually good news. GDC-0449 was already evaluated for PK and safety and this study would not have been done if the PK data were bad. I can't imagine why they are doing another PK study unless the route of administration or formulation is different. I suspect (and am hoping) it was done because of an overwhelming and positive result. We'll know soon enough.
I hope this doesn't sound too ignorant but I am curious since a PK study has already been done: Could suspending the study and doing a second PK analysis address the possibility that patients are becoming resistant to the drug over time?
Any idea how long it typically takes for companies to evaluate the data? My guess is that even though PK was previously evaluated for BCC, I would guess it would have to be evaluated for each type of cancer being studied but that is a total guess without any industry knowledge. Hopefully some who are knowledgeable will comment further about what to expect.
We sure can hope that this turns out to be good news and that the results are similar to those experienced with BCC because if so, you know we will fly on the news. Anything that helps those suffering from the #1 cancer killer would be fantastic news from the humanitarian side of things, not to mention how great the news would be for those of us who happen to be invested in Curis. I would guess the suspension could mean nothing and we may never find out why it was suspended.
I just noticed that the study was suspended and was going to post it until I saw that you already did.
Anyone know what this means? Could it be a good thing? On the surface, it would seem that it wouldn't be good as it relates to the lung cancer studies but could it be the result of things going very well and they want to evaluate the results for a fast track approval? To me that could be the only way this could turn out to be a positive thing but I don't know if this type of thing happens all the time or not.
It is the 2nd lung cancer study that has now been suspended. Here is what is posted at the site:
"A Study of Hedgehog Pathway Inhibitor GDC-0449 in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists
This study has been suspended.
( Enrollment has been voluntarily suspended while interim pharmacokinetic analyses are conducted. This action is not related to safety. )"
My comment: The other study just says suspended and doesn't give any type of information but this suspension gives some information although not nearly enough IMO. The other study that was suspended was a phase 2 study used in combination with other drugs while this one was a phase 1 using only GDC0449. Always more questions than answers with this type of investment.
I think that in this kind of study where very different type of cancers are treated, it is important to look at in which cancer types the drug is giving some results and in which no effect is seen. I think that the whole study has been designed for that.
It was suspended for an interim review of the results...not an uncommon event with cancer drugs. If the results are good and there is an unmet need, it could result in discussions with the FDA for accelerated approval. There is obviously an unmet need here. ("Refractory to Standard Therapy or for Whom No Standard Therapy Exists.")