Data Update on GRNOPC1 spinal cord injury

Oct 20, 2011 07:30:02 (ET)

MENLO PARK, Calif., Oct 20, 2011 (BUSINESS WIRE) -- Geron Corporation (GERN, Trade )
 today announced two presentations on the company's ongoing Phase 1 clinical trial of its human
 embryonic stem cell-based therapy, GRNOPC1, in patients with spinal cord injury. Safety data
were presented at the Pre-Conference Symposia of the joint 2011 American Congress of
Rehabilitation Medicine and American Society of Neuro-Radiology Annual Meeting in Atlanta,
GA. A second presentation was given at the Working 2 Walk 2011 conference in Rockville,
MD. The presentations were given by Joseph Gold, Ph.D., Geron's Senior Director of
Neurobiology and Stem Cell Therapies and Linda Jones, P.T., M.S., Geron's Senior Clinical
Trials Manager for GRNOPC1. "We are pleased to report that the lowest intended dose of
 GRNOPC1 has been administered to four patients with complete thoracic spinal cord injuries,"
 said Stephen M. Kelsey, M.D., Geron's Head of Research & Development and Chief Medical
 Officer. "To date, GRNOPC1 has been well tolerated with no serious adverse events."
Phase 1 Clinical Trial Data
Data were presented on four patients with neurologically complete American Spinal Injury Association
(ASIA) Impairment Scale grade A thoracic spinal cord injuries, who received GRNOPC1 at a dose of
two million cells delivered by injection into the lesion site using a syringe positioning device designed by
 Geron. GRNOPC1 was administered between 7 and 14 days after injury. Low-dose tacrolimus was
 given for temporary immune-suppression from the time of injection for 46 days, at which point the dose
was tapered and withdrawn completely at 60 days.
Endpoints of the trial are safety and evaluation of neurological function, using standardized testing at
specified timepoints to monitor sensory and lower extremity motor function. The trial protocol also includes
 multiple MRI scans. Initial follow-up of patients is one year. One patient in the trial has completed the
Day 365 follow-up visit. The most recent patient to be enrolled in the clinical trial has completed the Day
30 follow-up. After one year the patients enter a period of long-term follow-up that includes annual in-
person visits for the first five years and subsequent yearly check-ups via telephone for an additional nine
years.
Safety data to date from the trial has shown:
-- No surgical complications during or after the procedures.
-- No adverse events related to the injection procedures or to GRNOPC1.
-- A few mild adverse events related to tacrolimus.
-- No evidence of cavitation in the spinal cord at the injury sites on MRI.
-- No unexpected neurological changes.
-- No evidence of immune responses to GRNOPC1.
GRNOPC1 was delivered to four spinal cord injured patients at a dose of two million cells without
complications from either the cells or the surgical procedure itself, and without any negative effects on
 the spinal cord or neurological function of the patients to date. The only side-effects observed were due
 to the immunosuppressive drug tacrolimus, which is administered for the first two months after injection
of GRNOPC1. Furthermore, there is no evidence to date of immune rejection of GRNOPC1, an allogeneic
 cell therapy, including after withdrawal of immunosuppressive drug.
About GRNOPC1
GRNOPC1 contains hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating
, nerve growth stimulating and angiogenic properties leading to restoration of function in rodent models of
acute spinal cord injury. Preclinical studies have shown that administration of GRNOPC1 significantly
improved locomotor activity and kinematic scores of rodents with spinal cord injuries when injected seven
days after the injury. Histological examination of the injured spinal cords treated with GRNOPC1 showed
 improved axon survival and extensive remyelination surrounding the rodent axons. For more information
 about GRNOPC1, visit www.geron.com/GRNOPC1Trial/ . For further information about the Phase 1
clinical trial, including location of clinical sites, visit http://clinicaltrials.gov/ct2/show/NCT01217008 .
About Spinal Cord Injury
Spinal cord injury is caused by trauma to the spinal cord that results in a loss of motor control, sensatory
 perception, bowel and bladder control, and numerous other voluntary or involuntary body functions. A
 traumatic blow to the spine can fracture or dislocate vertebrae that may cause bone fragments or disc
material to injure the nerve fibers and damage the oligodendrocyte cells that insulate the nerve fibers in the
 spinal cord. Most human spinal cord injuries are contusions (bruises) rather than lacerations to the cord.
 Every year approximately 12,000 people in the U.S. sustain spinal cord injuries. There are currently no
approved therapies for the treatment of spinal cord injury.
About Geron
Geron is developing first-in-class biopharmaceuticals for the treatment of cancer and chronic degenerative
 diseases. The company is advancing anti-cancer therapies through multiple Phase 2 clinical trials in
different cancers by targeting the enzyme telomerase and with a compound designed to penetrate the
 blood-brain barrier. The company is developing cell therapies from differentiated human embryonic stem
 cells for a range of indications, with the first product in a Phase 1 clinical trial for spinal cord injury. For
 more information, visit www.geron.com .
This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions
 of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this
 press release regarding potential applications of Geron's human embryonic stem cell technologies and
 GRNOPC1 constitute forward-looking statements that involve risks and uncertainties, including, without
 limitation, risks inherent in the development and commercialization of potential products, uncertainty of
clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon
collaborators and protection of our intellectual property rights. Actual results may differ materially from the
 results anticipated in these forward-looking statements. Additional information on potential factors that
 could affect our results and other risks and uncertainties are detailed from time to time in Geron's periodic
reports, filed with the Securities and Exchange Commission, including the quarterly report on Form 10-Q
 for the quarter ended June 30, 2011.
SOURCE: Geron Corporation

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Viacyte Case Geron share price will rise

I'm not going into detail on Geron suing Viacyte over patent infringement. It looks like Geron may win. The lawyer at Geron buys 50,000 shares in early Oct. Indicates that the case is going in Geron favor.

Remember the new CEO who has a history of selling to big pharma every time he takes over a new company.
The European court ruling today, Geron benefits with other U.S. based stem cell companies.

Geron price rises and or Geron gets bought out, not the whole company but pieces.

Will be buying more shares and selling cover calls on any price spike. Also will sell a few shares on any price spike.

Geron's Goals for 2012

Regulatory acceptance for OPC1 SC1 thoracic dose escalation Q1/2012

Regulatory acceptance for OPC1 SC1 cervical cohort Q1/2012

Declaration of IND Candidacy for GRN510 Q1/2012

PFS data in imetelstat Phase 2 in NSCLC Q2/2012

PFS data in imetelstat Phase 2 in Breast Cancer Q2/2012

ORR data in imetelstat Phase 2 in Multiple Myeloma Q2/2012

Hematologic response rate in imetelstat Phase 2 in ET Q2/2012

ORR data GRN1005 NSCLC brain mets Phase 2 Q4/2012

ORR data GRN1005 Breast Cancer brain mets Phase 2 Q4/2012.
2012 will be a very important year for Geron. With a new CEO who is a deal maker. The four phase 2 trials ending in Dec of 2012 and results will be reported then. I'm hoping for a $5 to $10 share price.  I will be buying a few more shares on the dips and will sell a few shares and or sell some covered calls on the rips up.

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Geron initiate randomized Phase 2 in Breast Cancer

Oct 14th Geron initiates randomized Phase 2 clinical trial of imetelstat in breast cancer. Enrollment of the first patient using a telomerase inhibitor drug GRN163L. The results will be known the end of 2012.

The high for the was on Wed. Oct 12th of $2.38, the low of $2.18 was on Mon. Oct 10th. The avg. volume is going down. The one year update on Oct 16th, on there Phase 1 GRNOPC1 looks like no great news. I'm basing this on no increase in volume or price. I hope I'm wrong.

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Update on Phase 1 GRNOPC1 Spinal Cord injuries

U2FP, Working 2 Walk, Oct 16th at 9:45AM at Hilton Rockville, Washington D.C.  Joseph Gold PhD Senior Director at Geron will give a update on Phase 1 Safety Trial of Human Embryonic Stem-Cell GRNOPC1 in subjects with neurologically complete, subacute spinal cord injuries. Geron is up 5% I think people are hoping for good news Sunday. The volume is not there, yet. Will sell some puts if we get to $3 before the Oct 16th update. If there is an increase in volume say 2 million+ shares a day before update I will not sell puts.

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Geron and ACTC leading the stem cell revolution

This is from Michael J. Ray's blog on Seeking Alpha. I'm long both Geron and ACTC.

 One cannot initiate a discussion of stem cell companies without starting with Geron (GERN). Geron is a company that develops biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure, and diabetes. GERN’s pipelines run fairly deep and besides stem cell technologies it has multiple Phase 2 trials dealing with cancer therapies. That being the case, the real catalyst for the company is the Phase 1 clinical trial dealing with treatment of spinal cord injuries with stem cells. If GERN is going to be the catalyst that starts this medical revolution then it will begin in this trial.

paralysis in many patients. In animal models, Geron was able to show improved functional behavior using GRNOPC1 at the injury site seven days after injury. After much review, the FDA then granted approval for a clinical trial and Phase 1 testing of GRNOPC1 in patients with spinal cord injury began in October 2010. Two clinical sites were opened for patient enrollment in 2010, and the remaining 5 were opened in 2011.

What GERN has done is to derived Oligodendrocyte progenitor cells (GRNOPC1) from Human Embryonic Stem Cell (hESCs). Oligodendrocytes are naturally occurring cells in the nervous system that have several functions. They produce myelin (insulating layers of cell membrane) that enables the cells to conduct electrical impulses, plus they also produce neurotrophic factors that support the maintenance of nerve cells. When these Oligodendrocytes are lost in spinal cord injuries, the results are a loss of the myelin and neuronal function that in the end will cause 

In late July 2011, Geron stated that a second subject was enrolled and received GRNOPC1 in the ongoing Phase 1 clinical trial. The treatment was administered by investigators at Northwestern Memorial Hospital and Northwestern University Feinberg School of Medicine. The company also went on to state that the preliminary data from the first two patients showed no safety concerns or serious adverse events. That being the case, Geron received clearance from the FDA to expand the eligibility criteria for the trial to allow inclusion of a wider range of patients.

million. The company also stated that the cash reserve plus the income Geron receives will be sufficient to fund the current level of operations through at least December 2012. Geron also states that future capital requirements will be substantial as several trials are moving forward.

For the second quarter of 2011, the company reported a net loss of $21.1 million. Net loss for the first six months of 2011 was $45.5 million and the company ended the quarter with $192.2 million in cash and investments. The total operating expenses for the second quarter of 2011 were $21.9 million which broke down to research and development expenses of $16.5 million and general and administrative expenses of $5.3 

So will Geron be the one who will strike first with its stem cell therapy? Phase 1 trials have been going on for awhile and so far all we have really heard is that the therapies are safe but we are still unsure as to how effective they are. It is obvious that the trial is very ambitious and if successful will be a game changer, but one must worry if the company will run out of funding before they get to that point. It will be most interesting to watch as events unfold in this company’s future.

commercialization of human embryonic and adult stem cell technology in the field of regenerative medicine. In early 2010 the FDA granted orphan drug status to Advanced Cell for an embryonic stem cell derived treatment for a specific form of blindness, Stargardt’s Macular Dystrophy.

If Geron is not moving at the pace you want, then you might want to consider fast acting Advanced Cell Technology (ACTC). Advanced Cell is a biotechnology company focused on the development and 

Later that same year the company was cleared by U.S. regulators to test a therapy made from embryonic stem cells in patients with macular degeneration. Advanced Cell wasted little time and by July 2011 the company announced the dosing of the first patients in each of its two Phase 1/2 clinical trials for Stargardt's macular dystrophy and dry age-related macular degeneration (dry AMD). These patients were treated at the David Geffen School of Medicine at UCLA and at UCLA's Jules Stein Eye Institute. Notice that the trial is Phase1/2 thereby speeding up the trials. Both the Stargardt's trial and the dry AMD trial will enroll 12 patients each, with cohorts of three patients each receiving an ascending dosage of the stem cells as the trials move forward. The initial dosing was relatively small (50,000 cells) and the early indications were that the patients tolerated the surgical procedures well. In late September 2011, the independent Data and Safety Monitoring Board (DSMB) overseeing the Company’s two trials authorized ACTC to move forward with enrolling and treating the next set of patients in each of the trials.

what is going on in Europe. At the same time the DSMB made its announcement, Advanced Cell received clearance from the U.K. Medicines and Healthcare products Regulatory Agency to begin similar Phase 1/2 clinical trial for Stargardt’s Macular Dystrophy. It should also be known that the European Medicines Agency previously granted Orphan Drug designation for the company's RPE cell product for use in treating SMD. At this point it should be noted that macular degeneration in the U.S. is a $30 billion market with relatively no competition. Add a European market to the mix and the numbers go even higher. To add fuel to the fire one has to consider a recent statement from the CEO when he stated,What should be taken away from this is that the pre-clinical animal findings were extremely successful and if this carries forward in humans then the sky is the limit for the company. Also this is the first time that any testing in Asia had been mentioned. And if all that is not enough, one must also consider the Advanced Cell’s Phase II-approved Myoblast autologous adult stem cell therapy for the treatment of chronic heart failure advanced cardiac disease, myocardial infarction, and ischemia; as well as the Hemangioblast (HG) program for the treatment of blood and cardiovascular diseases which is currently in preclinical development.

If that was not enough, then on top of the U.S. trials one must consider 

As wonderful as all Advanced Cell’s programs sound, there are still lots of risks with the company. The company basically has no revenue and for the second quarter of 2011; net cash used in operations was $3.2 million. Needless to say the expenses will only increase as the company pushes forward on its clinical trials. Advanced Cell ended the 2011 second quarter with cash and cash equivalents of $16.1 million and will burn through that rather quickly. Add to this a couple newly filed lawsuits and a 1.7 billion share count and we find Advanced Cell in a race for funding. Advanced Cell has stated that several top pharmaceutical companies are closely following the trials and if the company can prove it can eliminate macular degeneration, it is almost certain it will get a joint venture or even a buyout. Until such time though, investors will have to wait and see if this company will be the spark that lights the fires of stem cell revolution.

For now, it will have to suffice to say that we are extremely pleased and believe that these trials will validate our earlier pre-clinical findings. In the meantime, we have begun to set our sights on expanding our clinical trials to in Europe, having been recently approved to begin our SMD trial in the United Kingdom, and various countries in Asia.

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Stem cell treatment for Spinal Cord Injury has Man moving toes

Unfortunately it's not Geron's treatment, but at Beijing Puhua International Hospital. The treatment was on Osama, age 33, male from Libya. The treatment was four neural stem cell injections via lumbar puncture, self stem cell activation and proliferation program, physical therapy and TCM. Out of all that I only understood the physical therapy part. Improvement was made with his sensation and his movements of his toes. Before the therapy he had no sensation or desire for his urination and could not control it. After the treatment he has a sensation when he is urinating and can control 50%. This story should be good for Geron. It's the same science. Geron needs to get the FDA to raise the number of stem cell to 10 million at least. Now it's only 2 million stem cell. Geron should see results like Osama had with an increased dose. With any luck Geron should get it raise by 2nd Q of 2012.

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