Thursday, August 20, 2009

Geron blames air-bags for lack of progress?!?

IPBiz has posted on Geron many times, including some rather interesting patent stories. A post on TheStreet on August 19 concerning an FDA clinical hold on Geron tests included some rather interesting text.

First, one had a complaint about lack of achievement:

My beef with Geron is the company's chronic under-achievement, except when it comes to spending shareholders' money. One could say the same thing about Proposition 71 and CIRM.

Second, was an allusion to an excuse offered by Geron:

In this case, Geron promised to enroll the first paralyzed patients into its stem cell trial during the summer. That announcement was made in January. Yet August is rolling toward a hot and humid finish here in the Northeast, and the study is nowhere close to starting. Last month, the company told investors that car airbags were partly to blame for the delay. (Airbags protect drivers and passengers in accidents, making it hard to find traffic accident victims with paralysis severe enough to be eligible for the clinical trial, or so Geron CEO Tom Okarma said on his company's quarterly conference call.)

What can one say?

**Of the past, there is much of interest to patent attorneys in the interference between ACT and Geron.

From an IPBiz post in 2005:
Geron prevails in patent interference against ACT in stem cell area


Also: http://ipbiz.blogspot.com/2004/12/geron-obtains-another-stem-cell-patent.html

***One commenter at californiastemcellreport wrote:

Did Okarma really use an airbag excuse on an investor call?! Wow.
I thought I read somewhere that the delay was due to concerns about new animal results on dose escalation. If true, this could be a serious setback, but might not be.

I agree with Steve Johnson and Adam Feurstein though that Geron hasn't impressed in the execution department and unfortunately for investors and patients hoping for a cure, execution is 90% of success. Geron has received multiple passes for attempting to be first to the clinic with ES cells but it is looking like their inability to move forward has more to do with life science management than the pesky ES cell. Dose escalation studies and a strategy to overcome limitations should have been a no-brainer from the get go. To have this problem at the 11th hour is telling (if indeed that is the issue).

***From David Granovsky's blog:

Geron Corp. rose as much as 5 percent in Nasdaq trading after saying a hold placed by U.S. regulators on its plan for the first human embryonic stem-cell study was due to “non-proliferative” cysts in test animals.

Stephen Brozak, an analyst with WBB Securities LLC in Westfield, New Jersey, said investors would be reassured that the animals didn’t develop a type of tumor known as a teratoma.

“I think it provides people with a reasonable explanation,” Brozak said. “Everybody was afraid of the T- word, teratomas, and it clearly wasn’t that.”

1 Comments:

Blogger Stem Cell Blog said...

I'd like to fill in a ffew gaps in the info. Here is the good news

SPINAL CORD INJURY + ADULT STEM CELLS – A BRIEF HISTORY OF TREATMENT
http://repairstemcell.wordpress.com/2009/09/24/spinal-cord-injury-stem-cells-%e2%80%93-a-brief-history-of-treatment/

GERON FAILS TO DELIVER…AGAIN

By Adam Feuerstein of TheStreet.com
“I was wondering what your reaction is (if any) to the FDA's hold on Geron's(GERN Quote) spinal cord therapy. I own some, and not sure how to take the news.” was asked of Mt Feuerstein. His reply follows:

“The first thing I did after reading Tuesday's announcement was laugh because the delays and missteps in Geron's over-hyped embryonic stem cell trial for severe spinal cord injuries are pretty much working out the way I thought they would.

Ever notice how Geron does a great job of heralding the prospect of scientific achievements and breakthroughs, yet never seems to actually deliver on its promises?

In this case, Geron promised to enroll the first paralyzed patients into its stem cell trial during this summer.” That announcement was made in January. Yet August is rolling toward a hot and humid finish here in the Northeast, and the study is nowhere close to starting.

Last month, the company told investors that car airbags were partly to blame for the delay. (Airbags protect drivers and passengers in accidents, making it hard to find traffic accident victims with paralysis severe enough to be eligible for the clinical trial, or so Geron CEO Tom Okarma said on his company's quarterly conference call.)”

Via http://www.thestreet.com/story/10582806/1/biotech-stock-mailbag-geron-oculus-biosante.html?cm_ven=GOOGLEN

Btw, no one was as outspoken and adamant and early to define this fiasco as Don Margolis, founder of the Repair Stem Cell Institute, who wrote about Geron at donmargolis.com:
· Jan, 2009: GERON AGAIN CRIES WOLF - AND THE STOCK SHOOTS UP
· Feb, 2009: GERON-THE COMPANY WHO CRIED & CRIED & CRIED & CRIED WOLF
· March, 2009: GERON MARCHES ON
· …and says in Sept 2009: “Even for a master stock manipulator like CEO Okarma, to fake an 11th clinical trial in five years is unbelievable for anyone!”

9:01 PM  

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