The grapevine is afire with the Geron news and there are many interpretations out there of what it means and why it happened.
Based on several accounts from folks who remain anonymous, here is the most probable prediction of what happened to lead us to yesterday’s announcement.
Geron has been worried for a long time about its finances (aren’t all biotechs worried in this way, all the time?), but this concern has been heightened more recently and was the reason that former CEO Okarma was replaced with John Scarlett. Mr. Scarlett is viewed as a pragmatist who is most committed to and experienced with cancer research products. Scarlett’s cancer background is unlikely to be coincidental and it doesn’t take a genius to imagine why Geron is now solely focused on cancer research.
Okarma was a stem cell guy, while Scarlett is a cancer guy. The leadership of Geron wanted to focus on cancer and had made this decision months ago as reflected in their choice of new CEO. However, they wanted to wait to see if there were any signs of efficacy of their stem cell drug GRNOPC1 before making a final decision about their stem cell program. While GRNOPC1 appears safe, the Phase I Trial’s first 4 patients reportedly have not shown any signs of efficacy. Importantly, of course, a Phase I Trial is not designed to evaluate efficacy, but one can hope, right? When Geron saw no signs of efficacy, which likely was unrealistic of them to hope for in a Phase I Trial, nonetheless that was the final nail in the coffin of their stem cell program.
While some may blame and already are stigmatizing Scarlett for this decision, what I’m hearing would suggest that the initiation of the process that ultimately led to the decision to end the stem cell program preceded his hiring and actually guided his hiring, but simply wasn’t finalized until the trial did not show clear efficacy. However, I think it is safe to say he certainly did not save the stem cell program and in the end may have been the one who pulled the plug.
Given the situation, Geron’s decision may well have been premature and their GRNOPC1 product may actually have proven to be save and effective, but now we might never know. I hope someone steps in and continues the work!
“Given the situation, Geron’s decision may well have been premature and their GRNOPC1 product may actually have proven to be save and effective, but now we might never know.” ….that could go right under the definition of “clinical” in a dictionary….
Oh well…. I guess unless the problem bites you in the ass it easy to have a detached response.
Stem-cell trials halted over funding concerns
Geron said stem cells “continue to hold great medical promise” but the decision was taken after a “strategic review” of costs.
Daniel Heumann, a board member of the Christopher and Dana Reeves Foundation which aims to cure spinal cord injury by funding new paths of research, said: “I’m disgusted. It makes me sick. To get people’s hopes up and then do this for financial reasons is despicable. They are treating us like lab rats.”
Read more: http://www.edmontonjournal.com/technology/Stem+cell+trials+halted+over+funding+concerns/5719316/story.html#ixzz1dtLJBf2H
Story link…
15 November 2011 Last updated at 13:25 ET
Liver implant gives boy ‘another chance of life’
http://www.bbc.co.uk/news/health-15744176
One minute everyone wants safety, the next minute everyone wants efficacy…which is it? Here’s a perfect example. Something works but we’ll make up any excuse not to deliver it to the patient population, meanwhile, I can name a multitude of medications on the market with side effects that will make you cringe.
I guess the medical regulators can talk it over at their next luncheon.
Liver implant gives boy ‘another chance of life’
Doctors in London say they have cured a baby boy of a life-threatening disease which was destroying his liver.
They implanted cells which acted like a temporary liver, allowing the damaged organ to recover.
The team at King’s College Hospital in south London say the technique is a world first.
Clinical trials
The question now is whether the technique could be used to benefit other patients with acute liver failure. The team at King’s is urging caution – a large clinical trial is needed to test the effectiveness of the technique.
A key benefit over a liver transplant is that Iyaad will not need to take anti-rejection drugs known as immuno suppressants.
Andrew Langford, Chief Executive of the British Liver Trust, said: “The principle of this new technique is certainly ground-breaking and we would welcome the results of further clinical trials to see if it could become a standard treatment for both adults and children.
“Sadly, we have reached a breaking point with our transplant list in the UK, where approximately 100 people die waiting for a donor liver to become available each year.”
Scarlett was more of an endocrine, get it sold kind of guy – his only gig in oncology was at Proteolix for just a couple of years.
If I remember correctly, Geron took out exclusive licenses on WiCell’s hESC patent to create stem cell therapies in the most promising areas: spinal cord injury, Parkinson’s disease, and cardiac damage. They should not be allowed to hold on to exclusive rights to work they are not pursuing. Fine, Geron doesn’t have to play, but they can’t go home with the ball.
I read the situation the same way you do. Having seen similar things from the inside, this is the most likely scenario.