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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

« Once And For All | Main | Like, Er, Fine Wine. I Hope. »

July 28, 2005

A Tale of Two Trials

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Posted by Derek

After presenting some disappointing data at the spring ASCO meeting, Novartis and Schering AG's tyrosine kinase inhibitor for colon cancer (PTK/ZK) looked to be in trouble. The "CONFIRM-1" trial showed no real benefit from using the drug on top of standard chemotherapy, but "CONFIRM-2" was also underway. That one looked for efficacy in patients who had already failed first-line therapy, and the results are now in: no survival benefit. The financial markets weren't happy, but weren't too surprised - that second trial was a tougher one to reach significance in, given the nature of the patient population.

It's a real whimper of an ending for a drug that some were once touted as the next Avastin. Schering AG kept tossing billion-dollar sales projections around for a while there, and kept trying to put the best face on things even as the bad news started coming in. Their earlier press release on the CONFIRM-1 data, for example, is a model of the Power of Positive Thinking, and is worth a look in light of today's announcement.

It started off with the headline "First results from PTK/ZK CONFIRM 1 trial. . .show positive drug effects in advance colorectal cancer." As you read further, you got to a figure of 17% reduction in risk of disease progression for the combination therapy, as opposed to the standard regimen, "as assessed by investigators." "Assessment by central review," however, showed a 12 per cent reduction, which didn't even reach statistical significance. Halfway down the first page, and the wheels have come off completely, but you'd never know it from reading the bold print at the top.

The chances of PTK/ZK reaching the market have to be close to zero. I know that at one point the companies were looking to go into non-small cell lung cancer, but I wouldn't hold out much hope there, either. As usual when a heavily studied drug candidate goes into the trash, I'd like to remind everyone that all the money that Novartis and Schering AG spent on this, and it was surely a lot, is burned up and gone. This was a Phase III failure, about as expensive as it comes. That cost will be reflected in the price of the next things that either company gets to the market, depend on it. They'll have to make it up somewhere; it's the nature of our industry.

As fate would have it, some other negative clinical data came out today. A study in the New England Journal of Medicine has shown, rather definitively, that the popular herbal supplement echinacea seems to have no effect on colds at all. That's rather in contrast to the signage over on the herbal medicine shelves at my local pharmacy, when I think about it.

Ah, but now that this trial has been run, what are the chances of my being able to go to that drug store next week, next month, next year, and see echinacea promoted as being good for colds? Do I hear. . .close to one hundred per cent? Of course! Herbal medicine companies are made of sterner stuff than we are over here in the artificial non-holistic world. They won't let a little thing like lack of efficacy slow them down.

Comments (5) + TrackBacks (0) | Category: Cancer


COMMENTS

1. The Novice Chemist on July 28, 2005 10:12 PM writes...

I read some of the notes from that echinacea trial on the way in to work today -- I'm stunned! They were actually giving people colds, as opposed to finding patients. Good grief! What kind of incentive do you get for being that patient?


What's the over/under on the time until a comment from our good friend? I say 12 hours. My choice: under.

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2. Kay on July 29, 2005 7:13 AM writes...

Are you suggesting that the legacy pharmas are learning how to spin their data in press releases? This is the traditional approach in biotech, and it accounts for many of the sector's problems with investors: based on past behavior, guilty until proven innocent.

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3. PharmaChemist on July 29, 2005 8:12 AM writes...

Novice chemist, I'm doubling up on the under.

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4. jeff on July 29, 2005 9:48 AM writes...

When I was an undegrad student the Medical center at my school would run flu vaccine trials over spring break.

They would infect the subjects (half w/ placebo) with the flu and then put them up in a hotel for a week while they took nasal lavages.

There was a lot of competition to get into these studies. A decent honorarium, plus hotel and room service and all the movies that you wanted to watch for a week was a nice deal for us starving students. Even with the Flu!

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5. jsinger on July 29, 2005 9:51 AM writes...

They were actually giving people colds, as opposed to finding patients. Good grief! What kind of incentive do you get for being that patient?


I think that's more the norm than the exception. For a short-lived illness with minor symptoms, how would you recruit properly-staged patients? And, as suffering goes, I'd demand far less for a cold than to undergo some of the crazy sample collection procedures I see in papers...

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