DAVID GRANOVSKY

Search for “geron”

A HISTORY OF THE GERON EMBRYONIC STEM CELL FIASCO

In BUSINESS OF STEM CELLS on November 15, 2011 at 1:27 am

http://geekcentricity.com/wp-content/uploads/2010/09/Fiasco.jpg

Embryonic stem cell treatment are now an unrealized potential.

Adult stem cell treatments are a realized potential.

To see if your condition can be treated with Adult stem cells, please fill out this form: http://bit.ly/PATIENTQUESTIONNAIRE

GERON GIVES UP on EMBRYONIC STEM CELLS!

In STEM CELLS IN THE NEWS on November 14, 2011 at 11:13 pm

THE

WAR

IS

OVER!!

GERON THROWS IN THE TOWEL!If stem cell treatments were a boxing match, Embryonic stem cell treatments would be the 500 lb Gorilla and Adult stem cell treatments would be the small, unknown underdog.   Today, that Gorilla threw in the towel!

Despite the huge disparity in their media coverage, with positive Embryonic stem cell potential articles outnumbering all Adult stem cell articles by 1,000 to one, only Adult stem cells have a proven history of safety and efficacy, only Adult stem cell treatments are available today.  Click here to see if your condition can be treated with Adult stem cells:

While Geron and the US media, big Pharma, the AMA and the FDA have all given Embryonic stem cell their full throated support, the number of patients helped with adult stem cells is in the 10s of thousands while the number of patients helped by Embryonic stem cells in zero.

HORSE FALLING DOWN DURING RACEIf Embryonic treatments were a horse race, Geron would be the strongest horse in the field.  Geron would be the horse who was 9/10 of the way around the track with all other competitors still milling about in the starting blocks.  So what would make that horse stop dead in his tracks, fall flat on his face and walk away from the race?

What does it mean for the other Embryonic focused companies when the front runner pulls out of the race?

What would cause the leading Embryonic stem cell Pharmaceutical company with multiple Embryonic stem cell products in development to end all of their Embryonic stem cell programs? 

Product Product Description Application Development Stage
GRNOPC1 Oligodendrocyte Progenitor Cells Spinal Cord Injury Phase I Clinical Trial
GRNCM1 Cardiomyocytes Heart Disease Preclinical
GRNIC1 Islets Type 1 Diabetes Research
GRNCHND1 Chondrocytes Osteoarthritis Research
Hepatocytes ADME Drug Screening Research
GRNVAC2 Mature Dendritic Cells Cancer Immunotherapy Product Research
Immature Dendritic Cells Immune Rejection Research
Osteoblasts Osteoporosis Research

via Geron.com

Perhaps their clinical trial patients developed cysts and tumors as do all Embryonic stem cell patients.  Perhaps Geron decided to end their trials before these tumors and cysts turned into cancer so they could still say their product “has been well tolerated with no serious adverse events.”

Perhaps Geron couldn’t figure out how to address the need for immunosuppressive drugs required to implant a human with ALL Embryonic stem cells when there are many Adult stem cells that have no rejection issues.

Perhaps Geron couldn’t determine how to deal with Embryonic stem cells carrying the genetic abnormalities and maladies of the donor.

Or perhaps they read some of the quotes from my articles going back to March of 2009:

  • To date, ESC research has been 100% fruitless (in regard to generating treatments) for well-funded + government supported scientists around the world for the last 11 years.
  • Dr James Thomson, father of ESC research said: “…[ESC] are not being used in any clinical applications yet, while alternatives such as adult stem cells figure in scores of therapies.”
  • Ian Wilmut, who led the team that cloned Dolly the sheep, abandoned his license to attempt human cloning, saying that the researchers “may have achieved what no politician could: an end to the [ESC] debate.”
  • Dr. Bernadine Healy, former director of the NIH in U.S. News & World Report: “…[ESC], once thought to hold the cure for Alzheimer’s, Parkinson’s, and diabetes, are obsolete….. In fact, adult stem cells, which occur in small quantities in organs throughout the body for natural growth and repair, have become stars despite great skepticism early on.
Or maybe they reviewed the timeline for Embryonic stem cell success and realized they couldn’t afford 50 YEARS OF RESEARCH!
Dr. Colin McGuckin, a noted UK embryonic research leader at Newcastle U. before departing for more useful RSC research in France announced:

  • “For me, the unnecessary row over stem cells has obscured the very real issue that patients are waiting to be treated…The best estimates of the embryonic scientists in our own university in Newcastle is that embryonic stem cells may not be able to help people this side of 50 years. That’s my lifetime. And that’s worrying. We can’t wait that long.”
I do have to applaud their spin department.  It is a brilliant move to take the news story
“GERON GIVES UP ON EMBRYONIC STEM CELLS”
and spin it into
“GERON PUTS 100% FOCUS INTO CURING CANCER.” 
Even so, we are not fooled.  The red headed step child in the family always knows when they are neglected. 
They also published their press release at 4:05 Eastern so the regular stock market was closed and couldn’t react to the news. Unfortunately for them, their stock dropped over 20% in after hours trading.
Whatever the reason for Geron abandoning Embryonic stem cells, we can now finally exalt that THE WAR IS OVER and get on with Adult Stem Cell Treatments, the only stem cells to cure a human patient.

ADULT STEM CELL = ASC

  • SOURCE/DERIVED FROM•comes from blood, umbilical cords, bone marrow, placenta fat tissue, muscle, nasal neurological, breast milk, menstruation, dental pulp, and many more
  • PURPOSE IN BODY•they are the body’s natural healing cells
  • OBSTACLES+SIDE EFFECTS•~zero problems (virtually zero side effects)
  • TREATMENT HISTORY•used in bone marrow transplants to treat cancer for 40 years
  • TREATMENT HISTORY•can currently treat 130+ diseases safely and effectively (CP, MS, Autism, Diabetes, CHF, PAD, etc)
  • To see if your condition can be treated with Adult stem cells, please fill out this form: http://bit.ly/PATIENTQUESTIONNAIRE

via STEM CELLS 101

  • 100+ DISEASES treated around the world with adult stem cells!
  • 60-70% SUCCESS RATE typical therapeutic benefit on INCURABLE DISEASES!!
  • POTENTIAL CURES of Autism, Parkinson’s, AIDs, Diabetes, Heart Disease and more!
  • HUGE REWARDS of life extension!
  • SIGNIFICANTLY IMPROVED quality of life!

http://www.maniacworld.com/muhammad-ali-2.jpg

Geron to Focus on Its Novel Cancer Programs
Company Plans to Partner All Stem Cell Programs

MENLO PARK, Calif.–(BUSINESS WIRE)–Geron Corporation (Nasdaq: GERN) today announced that, effective immediately, the Company will focus on its first-in-class oncology programs. As a consequence, the Company will discontinue further development of its stem cell programs and is seeking partners for these novel assets.

“Our employees, collaborators and shareholders can be proud of the pioneering role they have played to advance our stem cell technology into the clinic”

“In the current environment of capital scarcity and uncertain economic conditions, we intend to focus our resources on advancing our Phase 2 clinical trials of imetelstat and GRN1005. These two novel and promising oncology drug candidates target major unmet medical needs and have important clinical development milestones occurring over the next 20 months,” said Geron’s Chief Executive Officer, John A. Scarlett, M.D. “By narrowing our focus to the oncology therapeutic area, we anticipate having sufficient financial resources to reach these important near-term value inflection points for shareholders without the necessity of raising additional capital. This would not be possible if we continue to fund the stem cell programs at the current levels.

…The decision to narrow Geron’s technology and therapeutic focus was made after a strategic review of the costs, value inflection timelines and clinical, manufacturing and regulatory complexities associated with the Company’s research and clinical-stage assets. With this decision, Geron is eliminating 66 full-time positions, representing 38% of its workforce. As a result, the Company expects one-time cash expenditures of approximately $5 million in the fourth quarter of 2011 and approximately $3 million in the first half of 2012. Geron expects to end 2011 with cash and investments in excess of $150 million.

Geron is seeking partners with the technical and financial resources to enable further development of its stem cell programs. “Our employees, collaborators and shareholders can be proud of the pioneering role they have played to advance our stem cell technology into the clinic,” said Dr. Scarlett. “Stem cells continue to hold great medical promise. We believe that our leadership role in the field and the quality of our stem cell assets — which are widely recognized as being among the most innovative, comprehensive and advanced cell therapy programs in the world — will be an important point of differentiation in our discussions to partner these assets.” In order to facilitate transfer of these programs to partners, Geron will retain a core group of employees from its stem cell operations through the end of the second quarter of 2012.

Geron plans to close the GRNOPC1 trial for spinal cord injury to further enrollment, although it will continue to follow all enrolled patients, accruing data and updating FDA and the medical community on their progress. In this trial, GRNOPC1 has been well tolerated with no serious adverse events

Read more

Related articles:

A HISTORY OF THE GERON EMBRYONIC STEM CELL FIASCO November 15, 2011

EMBRYONICS’ BLEAK FUTURE AND BOTCHED PAST November 15, 2011

To see if your condition can be treated with Adult stem cells, please fill out this form:

GERON’S EMBRYONIC “WASTE OF TIME” CONTINUES…

In ALL ARTICLES on September 21, 2011 at 9:51 pm

Here’s an 867 word article I’d like to not waste your time with.

http://www.epiphanymarketing.com/blog/wp-content/uploads/2010/03/waste-of-time-283x300.jpg

The premise is:  “The study is not meant to determine whether the stem cells can cure or even improve the patients’ condition, but to find out if the treatment itself is safe. Researchers will be monitoring patients over the following months and years to look for side effects, including possible benign tumor growth if the stem cells start to replicate, or adverse immune reactions.”

So let’s not waste your time, I’ll give you the results right now:

EMBRYONIC STEM CELL = ESC

  • SOURCE/DERIVED FROM•comes from embryos
  • PURPOSE IN BODY•split for 7 weeks until you have a fetus the size of a thumbnail
  • OBSTACLES+SIDE EFFECTS•they create cysts and tumors, rejection requires immunosuppressive drugs for the ill patient, they carry the genetic anomalies of the donor, etc
  • TREATMENT HISTORY•can currently treat zero diseases, probably need to cure cancer first to use them

Read it if you want but that’s really “all she wrote.”  Then again, this will allow billions to be pumped into embryonic research for treatments over “the following months and years” despite this fact…

SCREW THE EMBRYOS, THEY’RE IRRELEVANT!

———————————————

———————————————

Paralyzed patient in major Geron stem cell study

Erin Allday, Chronicle Staff Writer, Wednesday, September 21, 2011

A Bay Area patient who recently suffered a serious spinal cord injury and is now paralyzed from the waist down joined the world’s first-ever embryonic stem cell study in humans last week, when Stanford doctors injected 2 million cells designed to replace damaged neurons in the patient’s spine.

The patient, who is not being identified, is the fourth person to be enrolled in the clinical trial being run by Menlo Park’s Geron Corp. and the first person in California. The patient, whose participation in the trial was revealed Tuesday, received the stem cell injection Saturday at Santa Clara Valley Medical Center and is now at the rehabilitation center there.

The study is not meant to determine whether the stem cells can cure or even improve the patients’ condition, but to find out if the treatment itself is safe. Researchers will be monitoring patients over the following months and years to look for side effects, including possible benign tumor growth if the stem cells start to replicate, or adverse immune reactions…

Read more

GERON ZOMBIE ARTICLES RISE FROM THE DEAD

In ALL ARTICLES on March 6, 2010 at 5:24 am

Can an article that died over a year ago, rise from the grave and start walking around on the internet?  This one did!  On first reading, I honestly could not even tell if the article was real or not…was old or new…

This seems to be an undated article from Reuters that reads like some of the articles that came out a year ago.  If you do a keyword search for “FDA” + “Geron” on Reuters.com, they show no such article that has come out recently.  Only the one’s from Jan/Feb 2009…
http://www.reuters.com/search?blob=fda+geron&pn=1

BUT if you google it, it comes up in the last 2 days and it seems to be on a handful of different papers…

BUT many of those papers are all a part of the Canada.com network…

very weird stuff!

The stock price in the article is off of course.  Geron was at $4.8 before the announcement over a year ago and then jumped to $8 before crashing back to $4 again…dashing the hopes of spinal cord victims and shareholders who were too slow to get out in time.

So I think someone may be doing a fake media campaign…raising articles from the dead like zombies…changing them slightly…removing the dates on them…posting them as “current” articles…impersonating both Reuters and their Health and Science Editor, Maggie Fox…

or maybe canada.com just got very confused…

but if this was purely accidental…

why were the dates removed from them?  All of them.

——————————————————

FDA allows first test of human stem cell therapy
By Maggie Fox, Health and Science Editor, ReutersComments (1)
Ampoules containing a medium for stem cell storage are displayed.
Ampoules containing a medium for stem cell storage are displayed.
Photograph by: Peter Macdiarmid, Reuters

WASHINGTON (Reuters) – The U.S. Food and Drug Administration has cleared the way for the first trial to see if human embryonic stem cells can treat people safely, a company involved in the controversial research on Friday.

Geron Corp, a California biotechnology company, said it plans a clinical trial to try to use the stem cells to regrow nerve tissue in patients with crushed, but not severed, spinal cords.

The issue of human embryonic stem cell research has been a political touchstone, with anti-abortion forces backed by former president George W. Bush arguing the technique involves the destruction of human embryos. Advocates say it could transform medicine.

“For us, it marks the dawn of a new era in medical therapeutics. This approach is one that reaches beyond pills and scalpels to achieve a new level of healing,” Geron Chief Executive Dr. Thomas Okarma said in a telephone briefing.

Shares of Geron rose more than 53 percent to $8 in mid-morning trading on Nasdaq after touching $8.38.

Geron will recruit eight to 10 recently injured patients and inject them with small numbers of human embryonic stem cells manipulated to become the oligodendrocyte cells that insulate nerves, and that produce compounds to stimulate the growth of nerve cells.

Okarma said there was no political significance to the announcement coming the same week as President Barack Obama took office. Obama has been widely expected to lift restrictions on federal funding and support of human embryonic stem cell research.

An FDA spokeswoman said, “Before FDA allowed the study to proceed, Geron worked with FDA to address important scientific questions.”

CHEAP AND EASY

Okarma said the treatment should eventually become cheap and easy to mass produce because the cells can be grown in vats. He believes the cells may be useful for other diseases such as multiple sclerosis, in which nerve cells are stripped of their insulating sheaths, and perhaps strokes.

Financial analysts celebrated. Stephen Brozak and Daniel Mallin of WBB Securities LLC said it could “as important to drug therapy as the discovery of … penicillin.”

Dr. Robert Lanza of the rival Massachusetts-based Advanced Cell Technology, which is also seeking to create therapies using human embryonic stem cells, called the decision a “huge advance for the entire field”. This sends a message that we’re ready at last to start helping people,” he said.

Stem cells are the body’s master cells, giving rise to all the tissues, organs and blood. Embryonic stem cells are considered the most powerful kinds of stem cells, as they have the potential to give rise to any type of tissue.

Researchers are also trying to find ways to use so-called adult stem cells, taken from bone marrow and elsewhere in the body, and have learned how to transform ordinary skin cells into stem-like cells. But scientists argue that no one knows which route will work so all avenues must be pursued.

The Phase I trial will be designed to show that patients do not develop tumors, or damage to their nervous systems. But Okarma believes it will also indicate whether the stem cells might repair the damaged spinal cords.

“These are living cells that will divide, make more of themselves and migrate throughout the lesion after injection,” he said.

While the patients will get low doses of immune-suppressing drugs for the first two months, Okarma is confident the cells will escape immune system recognition and patients will not have to endure the treatments that organ and tissue transplant recipients usually do. Treatment on the first patient should begin this summer.

Okarma said the company has a strong balance sheet, free of debt, and “ample to fund the company through this trial”.

(Additional reporting by Susan Heavey, Doina Chiacu and Toni Clarke; Editing by Alan Elsner and Julie Steenhuysen)

© Copyright (c) Reuters
——————————————————————————————-
From:
  1. FDA allows first test of human stem cell therapy

    – 12:49am

    23 hours ago – The US Food and Drug Administration has cleared the way for the first trial to see if human embryonic.
    http://www.thestarphoenix.com/business/fp/allows+first+test…/story.html

  2. Stem cell transplants show promise for MS: Study

    - 12:48am

    23 hours ago – FDA allows first test of human stem cell therapy · Crackdown urged on ‘rogue’ stem cell clinics · Stem cells offer new hope to CF patients
    http://www.thestarphoenix.com/business/fp/Stem+cell…show…/story.html

    1. FDA allows first test of human stem cell therapy

      The US Food and Drug Administration has cleared the way for the first trial to see if human embryonic.
      http://www.thestarphoenix.com/business/allows+first…/story.htmlCached
    2. Stem cell transplants show promise for MS: Study

      Feb 20, 2010 FDA allows first test of human stem cell therapy · Crackdown urged on ‘rogue’ stem cell clinics · Stem cells offer new hope to CF patients
      http://www.thestarphoenix.com/health/h1n1/Stem+cell…/story.htmlCached
    3. Researchers find safer way to make stem cells

      Stem cell transplants show promise for MS: Study · FDA allows first test of human stem cell therapy · Crackdown urged on ‘rogue’ stem cell clinics
      http://www.thestarphoenix.com/technology/internet/…/story.htmlCached
    4. Blindness researchers get hefty grant

      Researchers find safer way to make stem cells · Obama to lift ban on stem cell research soon: Aide · FDA allows first test of human stem cell therapy ...
      http://www.thestarphoenix.com/health/Blindness…hefty…/story.htmlCached
    5. Genes, sun combine in origins of MS: Study

      Stem cell transplants show promise for MS: Study · FDA allows first test of human stem cell therapy · Nutrients: where to find them and why you need them
      http://www.thestarphoenix.com/Health/…/1734280/…/story.htmlCached

    Show all results from www.thestarphoenix.com »

  3. Stem Cell News Blog – Latest Stem Cell News, Information and

    - 12:54am

    54 minutes ago – FDA allows first test of human stem cell therapy. WASHINGTON (Reuters) – The U.S. Food and Drug Administration has cleared the way for the first trial to
    stemcelldaily.com/

  4. Researchers find safer way to make stem cells

    - 12:49am

    19 hours ago – Stem cell transplants show promise for MS: Study · FDA allows first test of human stem cell therapy · Crackdown urged on ‘rogue’ stem cell clinics
    http://www.timescolonist.com/sports/winter-sports/Researchers…/story.html

  5. Genes, sun combine in origins of MS: Study

    - 12:49am

    5 hours ago – Stem cell transplants show promise for MS: Study · FDA allows first test of human stem cell therapy · Nutrients: where to find them and why you need them
    http://www.calgaryherald.com/life/diversions/Genes+combine…/story.html

  6. “Good” cholesterol may guard against MS disability

    13 hours ago – Stem-cell transplant ‘reason for optimism': MS patient · Electric britches fight deadly itches · FDA allows first test of human stem cell therapy · Genes,
    http://www.theprovince.com/sports/high-school-zone/Good…/story.html?id…;

THE EMBRYONIC STEM CELL HOAX: A HISTORY OF THE GERON SCANDAL

In ALL ARTICLES on February 20, 2010 at 11:43 pm

02/20/2010

THE EMBRYONIC STEM CELL HOAX: – A HISTORY OF THE GERON SCANDAL

-

For six years, the American people’s understanding of stem cells has been overwhelmed by rampant misinformation and deception. We were led to believe the future of medicine lies in Embryonic Stem Cells (ESC) and that Repair (adult) Stem Cells (RSC) are “snake oil.”
-
These skewed stories of ESC hope and RSC failure intentionally misled the American people in general and forced spinal cord patients to pay for the false-hope of ESC treatments in order to line the pockets of the  ESC promoters.
-

 

GERON RULED BY POLITICAL AGENDA

In BUSINESS OF STEM CELLS on February 17, 2010 at 11:41 pm

This is from the UK Times. -dg

02/17/2010

Geron engineered stem cell application so Obama could announce approval

When the US Food and Drug Administration agreed to approve the world’s first trial of a therapy based on human embryonic stem cells just over a year ago, the timing of its announcement was intriguing.

The Bush Administration had been highly obstructive of embryonic stem cell research, imposing a ban on most federal funding of such studies, which Barack Obama had pledged to overturn. Then, just days after President Obama’s inauguration, the FDA suddenly decided that the time was right to give Geron Corporation permission to start its patient trials.

It certainly looked like more than a coincidence, and the decision was widely interpreted as evidence of a sea change in the US Government’s attitude to stem cell research. But the FDA insisted that the timing was incidental — it had simply ruled on Geron’s application 30 days after it was received, as it was required to do.

It now turns out that the timing was more than a coincidence. When I met up with Geron’s chief executive, Tom Okarma, in London this week, he revealed that the announcement was deliberately planned for the immediate aftermath of President Obama’s inauguration. But it was the company, not the FDA, which set this in motion: Geron deliberately timed its application so it would be decided just after President Bush left office, so that the Obama Administration would be able to announce it.

Dr Okarma told me:

“Many people hypothesised the first time that the lifting of the hold was due to the Administration change. We have no information and no indication that that was the case. We engineered the timing, because our final submission was timed such that the 30-day window occurred after the inauguration of President Obama. That was our design, not really an Administration change. That was our timing. We did not want this to come up under the Bush Administration. We designed it.”

So a loose end is tied up. Geron’s trial, incidentally, was subsequently delayed, following the discovery of cysts in experimental animals given its stem-cell spinal injury therapy. The company now hopes to start trials in the third quarter of this year.

VIA http://timesonline.typepad.com/science/2010/02/geron-engineered-stem-cell-application-so-obama-could-approve-it.html

Geron’s Stem Cell Trial

In BUSINESS OF STEM CELLS on November 3, 2009 at 11:07 am

[For more articles on the long, sordid and somewhat pathetic history of Geron's embryonic stem cell clinical trial to treat spinal cord injury, click here]

Spinal Cord Injury

Geron Corporation’s Stem Cell Trial

Monday November 2, 2009

Geron Corporation is a company based in Menlo Park, CA and the first biotech company in the USA to be granted permission for a clinical trial of regenerative medicine using embryonic stem cells, in humans. While permission was granted in January 2009, the trials were put on hold until last Friday (October 30, 2009) when the latest round of preclinical trials using animals revealed some side effects that warranted further investigation.

According to the Geron News Release, test animals receiving the treatment, GRNOPC1, developed a higher number of cysts at the area of spinal cord injury than in previous studies. However, the FDA has agreed to allow the studies to continue, since the cysts appear to be non-proliferative, confined to the injury site, and not associated with any serious adverse effects or SUSARS.

GRNOPC1 consists of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells (OPCs). Oligodendrocytes are cells of the nervous system that produce the myelin shealth, which insultates the axons of nerve cells. Injection with the cells was shown to enhance remyelination of the spinal cord in adult rats. Demyelination after spinal cord injury contributes to loss of neural function. Rats treated with GRNOPC1 seven days after injury exhibited substantially better recovery and improved locomotor ability.

Geron expects re-initiation of the clinical trial in late 2010. Since the treatment must be applied shortly after injury, anyone wanting to participate in a clinical trial must agree to injections within 7 to 14 days of spinal injury…

via Geron Corporation’s Stem Cell Trial.

Geron Clone? SEC says CellCyte Genetics lied to inflate stock price

In BUSINESS OF STEM CELLS on September 9, 2009 at 7:23 am

SEC: Bothell biotech firm lied to inflate stock price

By LEVI PULKKINENSEATTLEPI.COM STAFF

Federal regulators filed complaints Tuesday against (CellCyte Genetics Corp.) a Bothell-based biotechnology company, saying management of the firm defrauded investors by inflating claims about a stem cell technology it was developing.

In a statement to media, a Securities and Exchange Commission spokesperson alleged that CellCyte Genetics Corp. misled investors into believing the technology was headed for human trials when in fact the company’s product remained in the early stages of development.

SEC officials allege stock promoters hired by CellCyte then spread the false information to investors, driving the stock price to $7.50-a-share before it plummeted back to less than a dime.

The complaints, filed in federal district court in Seattle, allege that in multiple public filings with the SEC and in other investor materials CellCyte falsely claimed it had received U.S. Food and Drug Administration approval to begin human clinical trials with a special stem cell compound to repair the heart, the spokesperson said.

The SEC alleges that CellCyte did not know how to properly formulate the stem cell compound, had never tried experiments with the compound to repair organs and had not satisfied any of the FDA requirements to begin human clinical trials.

In addition to the corporation, the SEC named in the suit CellCyte’s then-Chief Scientific Officer Ronald Berninger, of Mukilteo, who allegedly approved or participated in the drafting of false and misleading statements.

CellCyte and Berninger agreed to a settlement, without admitting or denying the SEC’s allegations, in which they each consented to a permanent injunction, according to the news statement. Berninger also agreed to pay a $50,000 penalty and be barred from serving as an officer or director of a public company for five years.

Speaking Tuesday, CellCyte attorney Steve Fogg noted that the company did not pay a financial penalty and emphasized that the decision to settle with the SEC carried no admittion of guilt. Fogg said the company is no longer pursuing the technology at issue in the complaint.

“Given that they’re moving forward with a separate technology, it just made sense to settle this lawsuit,” said Fogg, adding that “nobody cashed in on CellCyte stock who was an officer or director of CellCyte.”

In a separate action, the SEC has accused ex-CellCyte CEO Gary Reys, of Freeland, of approving the company’s fraudulent SEC filings. Federal regulators are seeking injunctive relief, a monetary penalty and an order barring Reys from serving as an officer or director of a public company.

A few other sources of this info:

SEC Whacks CellCyte Genetics & Bosses
Courthouse News Service – ‎29 minutes ago‎ – SEATTLE (CN)
SEC: Bothell biotech co lied about breakthrough to inflate stock price
KOMO News – Martha Kang – ‎6 hours ago‎ – SEATTLE
SEC accuses CellCyte Genetics, former top execs of fraud
TechFlash – Eric Engleman – ‎8 hours ago‎
SEC Charges CellCyte With Stem Cell Fraud
Xconomy – Luke Timmerman – ‎14 hours ago‎
SEC sues CellCyte, former execs for lying to investors
FierceBiotech – Calisha Myers – ‎14 hours ago‎
SEC accuses CellCyte, execs of fraud
Bizjournals.com – ‎14 hours ago‎
SEC Charges Seattle-Area Biotech Company With Fraudulently Hyping
PharmaLive.com (press release) – ‎15 hours ago‎
BRIEF-US SEC charges CellCyte for fraudulently touting stem cell
Forbes – Julie Vorman – ‎16 hours ago‎
SEC sues CellCyte and its executives
Seattle Times – ‎17 hours ago‎

Geron Gives Reason for FDA Hold; Shares Rise

In BUSINESS OF STEM CELLS on August 27, 2009 at 1:07 pm

Geron Gives Reason for FDA Hold on Stem-Cell Trial; Shares Rise

By Rob Waters

Aug. 27 (Bloomberg) — 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.

The Food and Drug Administration cleared Geron in January to test its stem-cell treatment in patients with spinal cord injuries. The company, based in Menlo Park, California, announced the regulatory hold on Aug. 18.

The microscopic cysts seen in an early experiment in a few animals that received the cell-based treatment, GRNOPC1, were found in larger numbers of animals in a recent study. The cysts weren’t linked to complications, the company said in a statement today. A more recent study of rats using a new batch of test chemicals showed no cysts, the company said.

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.” Brozak has a “strong buy” rating on the shares.

Geron rose 12 cents, or 1.7 percent, to $7.05 at 11 a.m. New York time in Nasdaq Stock Market composite trading, and traded as high today as $7.28. The shares fell 10 percent after the company announced the FDA’s hold on Aug. 18.

via Geron Gives Reason for FDA Hold on Stem-Cell Trial; Shares Rise – Bloomberg.com.

GERON SAYS: PRODUCT PRODUCED CYSTS

In STEM CELLS IN THE NEWS on August 27, 2009 at 8:15 am
Geron Comments on FDA Hold on Spinal Cord Injury Trial

MENLO PARK, Calif.–(BUSINESS WIRE)–Geron Corporation (Nasdaq:GERN) today provided additional comments on the recent clinical hold on its Spinal Cord Injury IND.

As biologic therapeutics advance in clinical trials, it is common practice to optimize product characteristics, improve manufacturing efficiency and scale, and to test the product in multiple disease models. As part of these ongoing efforts at Geron with respect to GRNOPC1, various animal studies were, and continue to be, performed to characterize the product’s effects in vivo. In previous animal studies of GRNOPC1 using materials that passed release specifications, a very low frequency of injected animals developed microscopic cysts in the regenerating injury site. These cysts were non-proliferative, confined to the injury site, and had no adverse effects on the animals. No animals developed teratomas or any other ectopic structure. Cysts of much larger size appear in the spinal cord scar tissue of up to 50% of patients with spinal cord injury.

A just completed animal study showed a higher frequency of cysts, although their characteristics were similar to the cysts seen in previous studies: non-proliferative, confined to the injury site, smaller than the injury cavity and not associated with adverse clinical outcomes.

As part of our ongoing product improvement efforts, new candidate markers and assays for product release have been identified that are linked with cyst formation across all animal studies in which cysts were found. Importantly, a manufactured lot of GRNOPC1 that was assessed using these markers and assays showed no cysts in another recently concluded animal study in spinal cord injured rats.

We have submitted these data to the FDA and are in discussions with the agency to answer its questions and proceed with the clinical trial. We are committed to the optimization of all our hESC-based products as we improve the manufacturing process and identify improved product release criteria.

Follow

Get every new post delivered to your Inbox.

Join 2,989 other followers

%d bloggers like this: