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Open-Label Bites Drug Duo

By Brian Orelli, PhD - Updated Apr 5, 2017 at 7:56PM

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Pfizer and Celldex have to make the best of a bad situation.

Pfizer (NYSE:PFE) and Celldex Therapeutics are in a sticky situation, but they're making the best of it.

They've had to change their clinical trial for their brain cancer drug, CDX-110, in midstream -- never a good sign -- but at least they've got a good excuse. The phase 2b part of their phase 2b/3 combination was an open-label, two-arm controlled trial. That's clinical speak for: The patients knew that they were getting either standard of care, Schering-Plough's (NYSE:SGP) Temodar, or that plus CDX-110. Since there was no placebo and the patients knew which arm they were in -- that's the open-label part -- most patients in the Temodar-alone arm dropped out of the trial.

To try and salvage the experiment, Pfizer and Celldex changed the trial to a single-arm phase 2 trial: Everyone's getting Temodar plus CDX-110. However, now the companies will have to run a separate phase 3 trial, assuming the results are positive.

There are two ways for investors to look at this change:

  1. Open-label trials are difficult to evaluate. They make it much harder for investors to predict whether the drug will pass pivotal phase 3 trials using data from a non-blinded phase 2.
  2. The fact that so many patients ditched the trial when they were assigned to the standard-of-care arm means that there's potentially a great market. Apparently patients are looking for more than just the current standard of care.

Considering that Temodar is on its way to becoming a blockbuster, with $760 million in sales through the first nine months of the year, I'm inclined to look at this as a positive. If CDX-110 can improve the survival results of Temodar by just a little bit, there's clearly a large market for the drug.

Of course the potential delay could be costly. According to clinicaltrials.gov, Novartis' (NYSE:NVS) Gleevac recently completed a phase 3 trial testing the already-approved drug in the same type of brain cancer. Eli Lilly (NYSE:LLY) also has a phase 3 trial testing its drug candidate enzastaurin against Bristol-Myers Squibb's (NYSE:BMY) CeeNU for a similar tumor type. Those trials are for recurring brain cancer, but they'll likely try for a front-line indication should they prove successful in these trials.

Only time will tell what the competitive landscape will look like when CDX-110 is finally up for approval a few years from now, but Pfizer and Celldex are certainly doing their best to get to that point as quickly as possible.

More Foolishness:

Pfizer and Eli Lilly are Motley Fool Income Investor recommendations. Pfizer is also an Inside Value selection and the Fool owns shares. Try any of our Foolish newsletters today, free for 30 days.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool has a disclosure policy.

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Pfizer Inc. Stock Quote
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