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Dendreon Saga Heads Toward Climax, As Cancer Drug Aims to Prove It Prolongs Lives

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a 20 percent reduction in the risk of death at the time of the analysis, falling short of the minimum 22 percent improvement it needed to satisfy the FDA’s conditions to ship off an urgent application. Yet since history from the previous trial showed that Provenge patients tend to do better over time, and the data was within hailing distance of the goal at the final analysis, Dendreon was hopeful that the trial was still on track.

Still, this early peek came with a price. Because an interim look at the data of an ongoing trial has the potential to introduce bias, Dendreon now needs to clear a higher statistical bar in the final analysis to show that the end result truly isn’t a fluke. Exactly how high the bar has been raised, the company won’t say. (Last month, Forbes quoted some statisticians who say this tainted the integrity of the trial.)

By January of this year, the company was sounding upbeat about Provenge’s prospects again. Dendreon’s CEO, Mitchell Gold, told a crowd of investors in San Francisco that 304 men had died in the ongoing study, meaning enough deaths had occurred for the company to do the final survival analysis on whether Provenge patients did any better than those in the control group. The final data would be available by April 2009, Gold said.

“This is a very exciting time for us, and for patients,” Gold said at the JP Morgan Healthcare Conference. He later used a football analogy to describe the company’s situation. “We’re on the 10-yard line, we’re in the red zone, and we’ve got to punch it into the end zone now.”

Which brings us to today. This drug, and this company, remain so controversial that three expert oncologists I requested for interviews declined to speak on the record until after the results are in. The situation remains “too emotionally charged,” one doctor said.

Dendreon stock, meanwhile, is trading again in the range of $4. About 17 million shares were held in a short position in mid-March, out of a total of 98 million shares outstanding, according to NASDAQ data. That means plenty of people think Dendreon is bound to fall short of FDA approval once again. If the trial is positive, these people with short positions will need to rush into the market to buy shares to close out their positions and stem their losses. That process could unleash enormous buying pressure on the stock once again, driving it higher, Miller says.

Still, passions have cooled somewhat this year in the midst of a recession, and now that hedge funds aren’t able to use as much leverage as they did two years ago before the Dendreon panel vote, Miller says. Many investors will watch what the company says about the final data analysis, and then jump in to buy if it’s positive. “People are not as rabid as they were before. A lot of people are waiting to see about the data,” Miller says.

If Dendreon can somehow beat the odds, and break through with the first FDA approved therapy, it will be a watershed for the field of immune therapies for cancer, and possibly inject some life into the rest of the biotech sector. Dendreon has another immune-boosting program in its pipeline for breast cancer that has shown promising results, but has been stuck on the back burner until the company gets more resources to push it ahead.

But few people in the industry seem to be holding their breath for this kind of positive chain reaction. The whole thing could end with an anticlimactic thud. Bob Kirkman, the CEO of Seattle-based Oncothyreon (NASDAQ: ONTY), another developer of immune therapies for cancer put it this way:

“A positive result would be a major boost to the field, and I think everyone with a stake in cancer vaccines wishes them every success,” Kirkman says. “A negative result may not have a broad impact, since it would just confirm the conventional wisdom of the moment.”

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17 responses to “Dendreon Saga Heads Toward Climax, As Cancer Drug Aims to Prove It Prolongs Lives”

  1. This will be one of the more interesting days in biotech in 2009. I expect the conference room in Chicago where the data are to be presented to be absolutely packed.

    David Miller

  2. eric newland says:

    Hussain – if I remember – had a conflict of interest as he was involved in support of a competing prostate drug – and his vote was detrimental in the approval process.

  3. Mike Scott says:

    With the deepest respect to Eric Newland …

    (a) Dr. Hussain is a “she”, not a “he” and she has been involved in clinical research on nearly every significant prostate cancer drug that is or has recently been in development. That’s her job. She’s a specialized clinical researcher in prostate cancer! That’s not a conflict of interest. That IS her interest, and I have profound respect for her integrity.

    (b) More than half the panel at the CBER hearings had conflicts of interest because their future research funding was tied to the development of immunotherapeutics for treatment of cancer (but no one seems to recognize that that might bias their opinions). Mr Timmerman has pointed out in his article that one member of the panel did effectively admit that after the meeting.

  4. Paul Sanders says:

    What will be the extended life expectancy as a result of using Provenge and what will be its costs?

  5. Bob says:

    Another company betting the Easter egg basket on Prostate Cancer…

    I know the Federal Govt. is looking at these expensive treatments, that, at best increase life-span by a few months…

  6. mason says:

    will DNDN succeed in spite of itself? lol history tells me to bet against it. The company has issues, even if the science does not. Everything since they FDA shot them down has been last bid attempts to salvage stock market value, asking for another recount, if you will. They are snake oil IMHO.

  7. bob denver says:
  8. p3analyze says:

    nice summary but for a necessary correction:

    The interim analysis penalized hurdle of success for the upcoming final anlaysis of the ongoing IMPACT trial is a 22% improvement in median survival.