Biotech failure, 2002 Message Board

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Biotech / Medical : Biotech failure, 2002

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To: scaram(o)uche who wrote (128)	5/13/2003 5:58:47 AM
From: Icebrg	Read Replies (1) of 130

When I see these phase III failures I always want to ask: "How could they advance so far without knowing?" and "Was there any way for us to "guess" that there was an increased risk involved with this trial?" One would normally expect that once a drug has advanced into a registration phase III trial, the exploratory work has been concluded and that the sole purpose of the new trial is to prove beyond any doubt, that the use of the drug will bring a positive risk/benefit outcome. That is unfortunately not always the case. I have read through the last couple of years PR from QLT and Xenova and listened to QLT's CC of yesterday. There are some disturbing facts about this story. Evidently Xenova drove the development of Tariqidar through three limited phase IIa trials and then licensed the drug to QLT for 10 mUSD (thank you so much). QLT (not being, but apparently believing they were cancer experts) decided to take the drug "immediately" into two fairly large registration trials (!) in NSCLC. Which has landed them where they are now - some 20 mUSD poorer and with a lot of cake on their faces. The most surprising or I shall perhaps say disappointing fact is that the study was stopped due to safety concerns. The DSMC concluded that there was a general increase in the "normal" type of chemotherapy induced sideeffects in the Tariquidar group. (Evidently it is not only the PGP-pumps in the cancer cells that are effected). I feel that this type of negative response was something that should have been picked up before the phase III trials were commenced. Especially considering the circumstances (MDR-effects being very tough to beat). If there was any efficacy or not is too early to tell, they say. So, there doesn't seem to have been much of an efficacy benefit either. Short summary of the project's status so far: The drug appears to increase the "normal" chemotoxic side-effects and we are not yet sure if it brings any real benefits. I think that the clinical development head at QLT will end up with not only some cake in the face but also a couple of eggs. It appears that they didn't do the proper background checks on the drug before proceeding into phase III. During the CC they tried to suggest that the reason for the interim look was that - as there wasn't enough clinical phase II data - they wanted an extra check before they continued to spend funds on the trial. No doubt the right approach, but still something of an admission of an own goal. If I had been an investor in QLT having put in the money in the hope of positive Tariquidar results, I would be feeling pretty disgusted by now. Luckily QLT is one of those profitable biotech companies, so they will be able to weather this storm, but no doubt this business leaves the management looking less than good. Erik

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