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   Biotech / MedicalGeron Corp.


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To: FJB who wrote (3313)10/10/2011 3:39:49 PM
From: FJB
   of 3565
 
Pfizer stem cell study highlights sea change for a controversial field

October 10, 2011 — 9:28am ET | By John Carroll

While Advanced Cell Technology and Geron overcame years of adversity to pioneer the world's first clinical trials of embryonic stem cell treatments, the pharma giant Pfizer ( $PFE) has been working with British scientists to piece together their own study for a new ESC treatment for age-related macular degeneration. And a green light from regulators in the UK will help set the stage for a tidal change in the controversial ESC field as years of lab work and debate finally give way to a new phase of cutting-edge clinical studies.

The trials may move the stem cell field into a new era, but no one expects clinical data to blunt the enduring controversy that surrounds ESCs, which can only be developed from embryos. That link has enraged many religious and social conservatives. Any approved treatment that may lie a few years ahead is likely to retain the potential to provoke some people.

"It obviously is a difficult subject for some people and some people will definitely choose not to have this therapy even if it's available because they feel it's inappropriate for them. It's a personal choice," Paul Whiting, executive director of the Pfizer unit in charge of the prospective study, tells The Wall Street Journal.

Ellen Feigal, vice president of research and development at the California Institute for Regenerative Medicine, tells the Journal that the Pfizer study offers "tangible evidence" of the progress being made in the stem cell industry. Pfizer is working with researchers at University College London's Institute of Ophthalmology.

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To: The Ox who wrote (3312)10/13/2011 1:46:29 PM
From: FJB
   of 3565
 
Precision with stem cells a step forward for treating MS, other diseases

October 13, 2011
Scientists have improved upon their own previous world-best efforts to pluck out just the right stem cells to address the brain problem at the core of multiple sclerosis and a large number of rare, fatal children's diseases.

medicalxpress.com

Details of how scientists isolated and directed stem cells from the human brain to become oligodendrocytes – the type of brain cell that makes myelin, a crucial fatty material that coats neurons and allows them to signal effectively – were published in Nature Biotechnology by scientists at the University of Rochester Medical Center and the University at Buffalo.

Scientists injected the cells into the brains of mice that were born without the ability to make myelin. Twelve weeks later, the cells had become oligodendrocytes and had coated more than 40 percent of the brain's neurons with myelin – a four-fold improvement over the team's previous results published in Cell Stem Cell and Nature Medicine.

"These cells are our best candidates right now for someday helping patients with M.S., or children with fatal hereditary myelin disorders," said Steven Goldman, M.D., Ph.D., the leader of the team and professor and chair of the Department of Neurology at the University of Rochester Medical Center. "These cells migrate more effectively throughout the brain, and they myelinate other cells more quickly and more efficiently than any other cells assessed thus far. Now we finally have a cell type that we think is safe and effective enough to propose for clinical trials."

The first author and co-corresponding author of the paper is Fraser Sim, Ph.D., assistant professor of Pharmacology and Toxicology at the University at Buffalo, who did much of the work while he was a researcher at Rochester.

Sim and Rochester graduate student Crystal McClain ran extensive analyses looking at gene activity in different types of stem cells, leading to the conclusion that stem cells carrying a protein known as CD140a on their surface seemed to be most likely to become the desired cells – oligodendrocytes.

"Characterizing and isolating the exact cells to use in stem cell therapy is one key to ultimately having success," said Sim. "You need to have the right cells in hand before you can even think about getting to a clinical trial to treat people. This is a significant step."

Central to the team's success is its encyclopedic knowledge of the hundreds of molecules that direct brain stem cells to become the specific cell types of the adult brain. That knowledge is the product of a decade of work in the Goldman lab.

In the experiments described in Nature Biotechnology, for instance, the team was able to use a molecule called BMP4 to direct the stem cells to become support cells of the brain – astrocytes – while another molecule called Noggin led them to become oligodendrocytes.

"These cells are very responsive to cues in their local environment," said Goldman. "It's crucial to select the right type of stem cell, but it's just as important to create an environment with the molecular signals necessary to produce the type of cell needed for a particular condition or illness."

The current work focuses on the creation of myelin; besides it loss in multiple sclerosis and childhood disorders, myelin loss plays a role in diseases as diverse as cerebral palsy, diabetes, high blood pressure, and some cases of stroke. While Goldman's team has had previous success remyelinating the brains of mice born without the substance, the new results identify a specific subset of cells that appear to be the most efficient yet at producing myelin and improve the hope of developing cell therapy as a way to treat these diseases.

An eventual treatment of a disease like M.S. might involve injecting stem cells to create myelin in the brains of patients. Along those lines, Martha Windrem, Ph.D., an author of the paper and assistant professor in Rochester's Department of Neurology, has developed methods to inject cells in such a way that they migrate throughout a large swath of the brain, laying down myelin on neurons as they go.

"Another approach," says Sim, "might involve using certain medications to turn on these cells already present in the brains of patients and thereby create new myelin. The use of the new techniques described in this work will permit us to better understand how human cells behave in the brain and help us predict which medications may be successful in the treatment of myelin loss."

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From: Savant10/17/2011 10:41:02 AM
   of 3565
 
Spinal Cord Injury Medical Leader Dr. Edward Wirth Joins InVivo Therapeutics as
Chief Science Officer

Moves from Geron Corporation to Lead Human Studies in Biomaterial Scaffold for
Acute Spinal Cord Injury

CAMBRIDGE, Mass., Oct 17, 2011 (BUSINESS WIRE) -- Ushering in a new era in the
treatment of spinal cord injuries (SCI), InVivo Therapeutics Holdings Corp.
(otc/bb:NVIV), announced today that world-renowned spinal cord injury (SCI)
researcher Edward Wirth, M.D., Ph.D., will join InVivo as its Chief Science
Officer (CSO) effective December 5, 2011.

As CSO, Dr. Wirth will lead InVivo's first human clinical study for acute SCI
using the Company's proprietary scaffold without drugs or cells. With the
10-patient pilot study awaiting FDA approval to begin in early 2012, InVivo's
treatment represents a promising new hope for SCI patients.

"I've been impressed with the cutting-edge work and laboratory data developed by
the InVivo team, and I firmly believe the use of InVivo's platform of implantable
biopolymer scaffold technologies is the future of SCI treatment," Dr. Wirth said.
"I am honored to join a group of world renowned scientists including 2008
Millennium Laureate Bob Langer and 1993 Nobel Laureate Sir Richard Roberts. I am
focused on lending my expertise toward further development of this revolutionary
technology. It has already shown outstanding promise in the lab, and in my
opinion has enormous clinical potential."

Dr. Wirth led the world's first human embryonic stem cell clinical trial as
Medical Director for Regenerative Medicine at Geron Corporation. He is one of the
world's foremost experts in SCI and regenerative medicine. Dr. Wirth has
dedicated the last 20 years of his life to studying the crucial role that cell
therapies may play in helping patients with devastating and irreversible SCIs.

Said InVivo Chief Executive Officer Frank Reynolds, "We believe Dr. Wirth's
confidence in our biomaterials for the treatment of SCI represents a shift in how
spinal cord injuries will be treated going forward. Whether providing
neuroprotection or supporting cells for regeneration, we believe that
biomaterials will be at the forefront of the first effective treatments for the
spinal cord."

"Our research has consistently shown that in order to fully deliver on the
promise of tissue regeneration, stem cells must have the structural support of
biomaterials," said InVivo Medical Director Dr. Jonathan Slotkin, M.D., clinical
neurosurgeon and expert in complex spinal surgery. "Dr. Wirth joining our team is
continued validation of this technology and paradigm shift. His valuable
expertise will enable us to move quickly in bringing to market the next
generation of SCI treatment technologies."

Prior to his work with Geron Corporation (GERN), Dr. Wirth held appointments at
Rush-Presbyterian St. Luke's Medical Center and at the University of Chicago.
From 1997 to 2002, Dr. Wirth led the team at the University of Florida that
performed the first human embryonic spinal cord tissue transplants in the U.S.,
demonstrating the feasibility and safety of implanting embryonic spinal cord
cells into patients. Dr. Wirth received a Ph.D. in neuroscience and an M.D. from
the University of Florida, and earned a B.A. in physics from Rollins College in
Winter Park, Fla.

For more information about InVivo Therapeutics' technologies, visit
invivotherapeutics.com.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is focused on utilizing polymers as a platform
technology to develop treatments to improve function in individuals paralyzed as
a result of traumatic spinal cord injury. The company was founded in 2005 on the
basis of proprietary technology co-invented by Robert Langer, ScD. Professor at
Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who is
affiliated with Massachusetts General Hospital. In 2011, the company earned the
prestigious David S. Apple Award from the American Spinal Injury Association for
its outstanding contribution to spinal cord injury medicine. The publicly traded
company is headquartered in Cambridge, Mass. For more details, visit
invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical
facts may constitute forward-looking statements within the meaning of the federal
securities laws. Any forward-looking statements contained herein are based on
current expectations, but are subject to a number of risks and uncertainties. The
factors that could cause actual future results to differ materially from current
expectations include, but are not limited to, risks and uncertainties relating to
the Company's ability to sell additional shares of common stock and warrants to
purchase common stock at additional closings, the Company's ability to develop,
market and sell products based on its technology; the expected benefits and
efficacy of the Company's products and technology in connection with spinal cord
injuries; the availability of substantial additional funding for the Company to
continue its operations and to conduct research and development, clinical studies
and future product commercialization; and, the Company's business, research,
product development, regulatory approval, marketing and distribution plans and
strategies. These and other factors are identified and described in more detail
in our filings with the SEC, including our Form 10-K and Form 10-Qs and our
current reports on Form 8-K. We do not undertake to update these forward-looking
statements made by us.

SOURCE: InVivo Therapeutics Holdings Corp.

SS|PR
Lisa Kornblatt, 847-415-9330
lkornblatt@sspr.com

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From: FJB10/18/2011 1:06:39 PM
1 Recommendation   of 3565
 
European court bans stem-cell patents

By Andrew Jack in London
October 18, 2011 5:56 pm
ft.com

Europe’s top court has ruled that stem cells from human embryos cannot be patented, dealing a blow to the commercial development of such treatments within the European Union and potentially driving research elsewhere.

On Tuesday the European Court of Justice upheld
the opinion of the EU’s advocate general in a long-running case originally brought by Greenpeace, the environmental watchdog, against Oliver Brüstle, a scientist investigating the use of stem cells to treat neurological disorders including Parkinson’s disease.

Human embryonic stem cells are extracted from surplus in vitro fertilised eggs donated for research after fertility treatment. These cells are then modified and injected into patients for treatment.

The
legal decision, which could trigger calls for fresh legislation, means that while there are no ethical restrictions on academic embryonic stem cell research in Europe, it will be more difficult to patent and commercialise any discoveries that are made. In contrast, companies in the US can patent embryonic stem cells. President Barack Obama overturned a long-running ban, which had been in place because of ethical concerns, of federal funding for stem-cell research in 2009.

Prof Brüstle, director of the Institute for Reconstructive Neurobiology at Bonn University, whose 1997 patent was the object of the original legal challenge, told the Financial Times: “We are creating a no-man’s-land for intellectual property in Europe between Asia and the US. There are no incentives for European companies to operate because they don’t get protection.”

Christoph Then, of Greenpeace in Germany, which brought the case on the grounds that human life should not be patented, said: “We think it was a necessary clarification because there was no harmonisation in Europe about what should be considered a human embryo.”

The ECJ supported advocate general Yves Bot’s interpretation that – in the absence of clear EU legislation – the potential for life existed much earlier and thus that stem cells from human embryos could not be patented. The Warnock Committee’s report, a UK analysis of stem cell research, said life began 14 days after fertilisation.

Several leading researchers warned the judgment would destabilise stem-cell research across Europe. But others said it affected a relatively narrow field as most trials instead used adult stem cells.

Only two pharmaceutical companies,
Geron and ACT, are at present testing embryonic stem-cell therapies in patients. Others investigating their potential include Cellectis and Pfizer. This contrasted with the more than 2,700 trials using adult stem cells unaffected by the ruling, said Professor Chris Mason, chair of regenerative medicine bioprocessing at University College, London. “Patent lawyers have been anticipating this for a number of years. We’ll engineer around it,” he said.

Tony Peatfield, director of corporate affairs at the Medical Research Council, the UK government funding agency, which has earmarked £130m for the field over the next four years, said: “This seems to be a very disappointing conclusion. It’s likely this decision will hamper inward industry investment.”

Richard Willoughby, a partner at the law firm Rouse, said: “The upshot of the [ruling] is that it makes it quite difficult to obtain patents for therapeutics based on embryonic stem cells in the EU, something which has implications for industry and patients.”

Julian Hitchcock, a patent specialist with the law firm Field Fisher Waterhouse, said: “The ruling may actually present an opportunity for researchers who in the past have complained that their work is held back by the fear of inadvertently infringing a patent.”

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From: FJB10/18/2011 3:05:48 PM
1 Recommendation   of 3565
 
Geron Presentations at the ASCO 2008 Annual Meeting

BY: ADMIN | DATE: OCTOBER 18, 2011 | CATEGORIES: BREAST CANCER

New Data on Activity of GRN163L in T-cell Prolymphocytic Leukemia Cells

MENLO PARK, Calif. — Geron Corporation (Nasdaq:GERN) today announced two presentations of its anti-cancer drug, GRN163L, given at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

Geron is currently testing GRN163L in four clinical trials with 15 U.S. medical centers recruiting patients with solid tumors, chronic lymphoproliferative disease, multiple myeloma and non-small cell lung cancer. New combination trials in breast cancer and multiple myeloma at additional trial sites are scheduled to initiate in the coming months. Geron is also conducting a multi-center Phase II trial of GRNVAC1, a telomerase therapeutic vaccine, in high risk acute myelogenous leukemia (AML) patients. We expect Merck & Co., Inc., under license from Geron, to initiate a therapeutic vaccine trial targeting telomerase in patients with non-small cell lung and prostate cancers.

GRN163L Exhibits Rapid and Selective Cytotoxicity in T-PLL Cells

T-cell prolymphocytic leukemia (T-PLL) is an aggressive lymphoproliferative disease characterized by resistance to chemotherapy, high telomerase activity and very short telomeres (Roth, et. al., Leukemia, 21:2456-2462, 2007). In a poster presentation authored by Geron scientists and collaborators from the University Hospital, Essen, Germany and the University Hospital, Bern, Switzerland, T-PLL cells from patients were selectively killed in dose-dependent fashion by seven-day incubations with GRN163L. Annexin staining confirmed a dose-dependent increase in apoptosis caused by exposure to GRN163L. Normal T-cells were unaffected by GRN163L, and a mismatch control oligonucleotide had no effect on the viability of the leukemic cells.

The results demonstrate selective cytotoxicity of GRN163L on T-PLL cells leading to rapid leukemic cell death and provide the rationale for clinical trials of GRN163L in patients with T-PLL.

Phase I Study of GRN163L in Refractory, Advanced Solid Tumors

Interim analysis of an ongoing Phase I study of GRN163L in refractory, advanced solid tumor patients was presented by Geron scientists and collaborating principal investigators from the University of Chicago and Wayne State University. Data were presented on 28 patients, each of whom had received at least one infusion of GRN163L at doses ranging from 0.4 – 4.8 mg/kg. A total of 175 doses were administered as of May 12, 2008. Patients had received up to nine prior therapies with more than half receiving four or more.

The plasma half-life was approximately three hours and Cmax appeared to be linear with dose. Dose-limiting toxicity (thrombocytopenia) was observed in one patient at the 3.2 mg/kg dose and in two patients out of 14 at the 4.8 mg/kg dose. No objective responses have been seen at these dose levels.

The maximum tolerated dose of GRN163L has not been established in this heavily pretreated patient population. Dose escalation will continue with evaluation of intermittent dosing schedules to minimize platelet effects. Measurement of hair follicle telomerase activity has been incorporated into the protocol as dose escalation continues in order to define the pharmacokinetic-pharmacodynamic relationship for GRN163L in this patient population.

Geron is developing first-in-class biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes. The company is advancing an anti-cancer drug and a cancer vaccine that target the enzyme telomerase through multiple clinical trials. Geron is also the world leader in the development of human embryonic stem cell-based therapeutics, with its spinal cord injury treatment anticipated to be the first product to enter clinical development. 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 telomerase technology 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 maintenance 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, including the quarterly report on Form 10-Q for the quarter ended March 31, 2008.

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To: The Ox who wrote (3312)10/19/2011 5:37:10 PM
From: FJB
1 Recommendation   of 3565
 
Geron’s Embryonic Stem Cell Clinical Trial for Spinal Cord Injury – Video


57:29 run time
youtu.be

Dr. Jane Lebkowski, executive vice president and chief scientific officer at Geron Corporation, gave the keynote address for the 2011 CIRM Bridges Trainee Meeting. Last year, Geron began the first clinical trial in the world using human embryonic stem cells. CIRM recently approved a $25 million loan to Geron to assist in this trial. The embryonic stem cells used in the trial are being tested as a potential therapy for spinal cord injury. Lebkowski reviewed the work leading up to the trial and gave the latest update on its progress. Lebkowski was introduced by Art Torres, vice chair of the CIRM Governing Board, and Pat Olson, executive director of CIRM scientific activities.

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To: FJB who wrote (3319)10/20/2011 11:54:32 AM
From: Savant
1 Recommendation   of 3565
 
4 enrolled & injected..no probs>>
Geron Presents Clinical Data Update From GRNOPC1 Spinal Cord Injury Trial    MENLO PARK, Calif., Oct 20, 2011 (BUSINESS WIRE) -- Geron Corporation (GERN)  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 geron.com. For further information about  the Phase 1 clinical trial, including location of clinical sites, visit  clinicaltrials.gov.    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  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.  

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From: FJB10/20/2011 5:39:52 PM
   of 3565
 
Geron Presents Clinical Data Update From GRNOPC1 Spinal Cord Injury Trial (multi-line version<G>)

PRESS RELEASE

Oct. 20, 2011, 7:30 a.m. EDT



MENLO PARK, Calif., Oct 20, 2011 (BUSINESS WIRE) -- Geron Corporation GERN -0.46% 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 clinicaltrials.gov .

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.

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From: FJB10/25/2011 8:31:45 AM
   of 3565
 
Geron Corporation ( GERN) is a biopharmaceutical company, it develops biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure, and diabetes. Geron has substantial insider buying, which could signal deep value. This stock is off by over 55% so far in 2011. The current price is $2.26 with an analyst 1 year price target of $7.33, which could mean 224.34% upside potential. This potential upside is reflected not only in the analysts consensus, but also in insider buying. Geron Corp. has a market cap of $297 million and an enterprise value of $155 million, and has no profit as of yet. The operating cash flow is -$52 million and leveraged free cash flow is -$45 million. On the balance sheet, however, total cash is $152 million and no debt, which shows great potential for managing money. A good reason to look at this stock as a possible buy is the fact that a director just bought 50,000 shares, or $101,500 worth of stock at a price of $2.03 per share.

seekingalpha.com

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To: FJB who wrote (3315)10/26/2011 10:30:35 AM
From: FJB
   of 3565
 
Geron Announces Presentation At ECTRIMS/ACTRIMS

Non-Clinical Data Supports Use of GRNOPC1 in Multiple Sclerosis

October 25, 2011 07:33 AM Eastern Daylight Time
MENLO PARK, Calif.--( EON: Enhanced Online News)--Geron Corporation (Nasdaq: GERN) today announced data on the use of GRNOPC1, oligodendrocyte progenitors derived from human embryonic stem cells, for myelin repair in a non-human primate model. The data supports further investigation of the potential therapeutic use of GRNOPC1 in central nervous system (CNS) disorders where the central or contributing pathology is destructive removal of myelin from nerve axons, such as observed in multiple sclerosis (MS), myelitis and spinal cord injury. GRNOPC1 is currently in a Phase 1 clinical trial in patients with spinal cord injury.

“These new data confirm and extend previous results showing that GRNOPC1 can promote remyelination in rodents and non-human primates”

The new data were presented at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis, in Amsterdam, by Prof. Jeffery D. Kocsis, Ph.D., from Yale University School of Medicine. The work was performed in collaboration with scientists at Geron.


The studies utilized a non-human primate model where demyelinated lesions, such as seen in multiple sclerosis, were induced chemically in the spinal cord. GRNOPC1 was injected into the demyelinated spinal cord lesions one week after chemical induction. The lesion sites from six monkeys were analyzed using light and electron microscopy at various timepoints up to one year after injection of GRNOPC1 to look for evidence of cell survival and remyelination of nerve axons. In the first few weeks after implantation, the injection sites contained maturing transplanted cells indicative of a premyelinating phenotype with evidence of variable numbers and degrees of remyelinated axons. By four months post implantation, GRNOPC1 had induced extensive and thick myelin around the formerly denuded axons. Human cells were detected at the lesion site, providing evidence for survival of transplanted GRNOPC1. There was no evidence of abnormal tissue, tumor formation or other pathologies associated with the injection of GRNOPC1. Neurological exams of the injected animals were normal. The data showed in the non-human primate that GRNOPC1 can survive at the lesion site and progressively promote remyelination of axons.

“These new data confirm and extend previous results showing that GRNOPC1 can promote remyelination in rodents and non-human primates,” said Jane Lebkowski, Ph.D., Geron’s Chief Scientific Officer. “These results provide further support for the potential of GRNOPC1 to provide therapeutic benefit in a number of central nervous system diseases, such as MS and myelitis.”

About GRNOPC1

Oligodendrocytes produce myelin, an insulating layer made up of protein and fatty substances that forms around nerves in the CNS to enable them to conduct electrical signals. Without myelin, many of the nerves in the brain and spinal cord cannot function properly. Oligodendrocytes are lost in CNS disorders such as spinal cord injury and MS.

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. Non-clinical studies have shown that administration of GRNOPC1 seven days after injury significantly improved locomotor activity and kinematic scores of rats with spinal cord injuries compared to untreated controls. Histological examination of the injured spinal cords treated with GRNOPC1 showed improved axon survival and extensive remyelination surrounding the rat axons. Geron is conducting a Phase 1 clinical trial to assess the safety of GRNOPC1 in patients with complete, thoracic spinal cord injuries. In addition, Geron has established collaborations with academic groups to evaluate GRNOPC1 in models of other CNS disorders. For more information about GRNOPC1, visit www.geron.com/GRNOPC1Trial/.

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, with the first product in a Phase 1 clinical trial for spinal cord injury. For more information, visit www.geron.com.

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