World's 1st Human Clinical Trial of Embryonic Stem-Cells for Acute Spinal Cord Injury

[Justin]

GERON RECEIVES FDA CLEARANCE TO BEGIN
WORLD'S FIRST HUMAN CLINICAL TRIAL
OF EMBRYONIC STEM CELL-BASED THERAPY

Geron to Study GRNOPC1 in Patients with Acute Spinal Cord Injury

MENLO PARK, Calif., January 23, 2009 - Geron Corporation (Nasdaq: GERN) announced today that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury.

The clearance enables Geron to move forward with the world's first study of a human embryonic stem cell (hESC)-based therapy in man. Geron plans to initiate a Phase I multi-center trial that is designed to establish the safety of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries.

"The FDA's clearance of our GRNOPC1 IND is one of Geron's most significant accomplishments to date," said Thomas B. Okarma, Ph.D., M.D., Geron's president and CEO. "This marks the beginning of what is potentially a new chapter in medical therapeutics - one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells. The ultimate goal for the use of GRNOPC1 is to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord."

GRNOPC1, Geron's lead hESC-based therapeutic candidate, contains hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating and nerve growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury (Journal of Neuroscience, Vol. 25, 2005).

"The neurosurgical community is very excited by this new approach to treating devastating spinal cord injury," said Richard Fessler, M.D., Ph.D., professor of neurological surgery at the Feinberg School of Medicine at Northwestern University. "Demyelination is central to the pathology of the injury, and its reversal by means of injecting oligodendrocyte progenitor cells would be revolutionary for the field. If safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year."

The GRNOPC1 Clinical Program
Patients eligible for the Phase I trial must have documented evidence of functionally complete spinal cord injury with a neurological level of T3 to T10 spinal segments and agree to have GRNOPC1 injected into the lesion sites between seven and 14 days after injury. Geron has selected up to seven U.S. medical centers as candidates to participate in this study and in planned protocol extensions. The sites will be identified as they come online and are ready to enroll subjects into the study.

Although the primary endpoint of the trial is safety, the protocol includes secondary endpoints to assess efficacy, such as improved neuromuscular control or sensation in the trunk or lower extremities. Once safety in this patient population has been established and the FDA reviews clinical data in conjunction with additional data from ongoing animal studies, Geron plans to seek FDA approval to extend the study to increase the dose of GRNOPC1, enroll subjects with complete cervical injuries and expand the trial to include patients with severe incomplete (ASIA grade B or C) injuries to enable access to the therapy for as broad a population of severe spinal cord-injured patients as is medically appropriate.

Preclinical Evidence of Safety, Tolerability and Efficacy
Geron submitted evidence of the safety, tolerability and efficacy of GRNOPC1 to the FDA in a 21,000-page IND application that described 24 separate animal studies requiring the production of more than five billion GRNOPC1 cells. Included in the safety package were studies that showed no evidence of teratoma formation 12 months after injection of clinical grade GRNOPC1 into the injured spinal cord of rats and mice. Other studies documented the absence of significant migration of the injected cells outside the spinal cord, allodynia induction (increased neuropathic pain due to the injected cells), systemic toxicity or increased mortality in animals receiving GRNOPC1.

In vitro studies have shown that GRNOPC1 is minimally recognized by the human immune system. GRNOPC1 is not recognized in vitro by allogeneic sera, NK cells or T cells (Journal of Neuroimmunology, Vol. 192, 2007). These immune-privileged characteristics of the hESC-derived cells allow a clinical trial design that incorporates a limited course of low-dose immunosuppression and provide the rationale for an off-the-shelf, allogeneic cell therapy.

Also included in the IND application were published studies supporting the utility of GRNOPC1 for the treatment of spinal cord injury. Those studies showed that administration of GRNOPC1 significantly improved locomotor activity and kinematic scores of animals with spinal cord injuries when injected seven days after the injury (Journal of Neuroscience, Vol. 25, 2005). Histological examination of the injured spinal cords treated with GRNOPC1 showed improved axon survival and extensive remyelination surrounding the rat axons. These effects of GRNOPC1 were present nine months after a single injection of cells. In these nine-month studies, the cells were shown to migrate and fill the lesion cavity, with bundles of myelinated axons crossing the injury site.

Production and Qualification of GRNOPC1
GRNOPC1 is produced using current Good Manufacturing Practices (cGMP) in Geron's manufacturing facilities. Geron's GRNOPC1 production process and clean-room suites have been inspected and licensed by the state of California. The cells are derived from the H1 human embryonic stem cell line, which was created before August 9, 2001. Studies using this line qualify for U.S. federal research funding, although no federal funding was received for the development of the product or to support the clinical trial.

Geron's H1 hESC master cell bank is fully qualified for human use and was shown to be karyotypically normal and free of measurable contaminants of human or animal origin. Production of GRNOPC1 from undifferentiated hESCs in the master cell bank uses qualified reagents and a standardized protocol developed at Geron over the past three years. Each manufacturing run of GRNOPC1 is subjected to standardized quality control testing to ensure viability, sterility and appropriate cellular composition before release for clinical use. GRNOPC1 product that has passed all such specifications and has been released is available for the approved clinical trial. The current production scale can supply product needs through pivotal clinical trials. The existing master cell bank could potentially supply sufficient starting material for GRNOPC1 to commercially supply the U.S. acute spinal cord injury market for more than 20 years.

Intellectual Property
The production and commercialization of GRNOPC1 is protected by a portfolio of patent rights owned by or exclusively licensed to Geron. Patent rights owned by Geron protect key technologies developed at Geron for the scalable manufacturing of hESCs, as well as the production of neural cells by differentiation of hESCs. The fundamental patents covering hESCs are exclusively licensed to Geron from the Wisconsin Alumni Research Foundation (WARF) for the production of neural cells, cardiomyocytes and pancreatic islets for therapeutic applications. The validity of these patents was recently confirmed by the U.S. Patent and Trademark Office in a re-examination proceeding. Geron funded the original research at the University of Wisconsin-Madison that led to the first isolation of hESCs. The production of oligodendrocytes from hESCs is covered by patent rights exclusively licensed to Geron from the University of California. These patent rights cover technology developed in a research collaboration between Geron and University of California scientists.

Conference Call and Video Webcast
Thomas B. Okarma, Ph.D., M.D., will host a conference call and video Webcast presentation for investors and the media at 60 a.m. PST/90 a.m. EST today. Participants can access the conference call via telephone by dialing 866-783-2145 (U.S.) or 857-350-1604 (international). The passcode is 89631672. The video Webcast presentation is available at http://phx.corporate-ir.net/phoenix....ventID=2077348. All participants are encouraged to view Dr. Okarma's presentation on the Internet. The video Webcast will also be accessible through a link that is posted on the home page of Geron's Web site at www.geron.com. Participants are encouraged to log on at least 15 minutes prior to the beginning of the presentation in order to download any necessary software. The video Webcast will be available for replay through February 23, 2009.

...

[Justin]

About Geron
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 (hESC) cell-based therapeutics. The company has received FDA clearance to begin the world's first human clinical trial of a hESC-based therapy: GRNOPC1 for acute 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 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 September 30, 2008.

CONTACTS:
Media: David Schull, Russo Partners, LLC, 858-717-2310, david.schull (at) russopartnersllc.com
At Geron: Anna Krassowska, Investor and Media Relations, 650-473-7765, info (at) geron.com

Copyright © 2009 Geron Corporation. All rights reserved.

[Justin]

hESC - Derived Therapies (GRNOPC1)

Geron has received clearance from the FDA to begin a Phase I multi-center trial that is designed to assess the safety and tolerability of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries.

Currently there are no sites enrolling patients for this study. When clinical trial sites are open for enrollment, their contact information will be posted on this page.

Patients eligible for the Phase I trial must have documented evidence of functionally complete spinal cord injury with a neurological level of T3 to T10 spinal segments and agree to have GRNOPC1 injected into the lesion sites between seven and 14 days after injury. Geron has selected up to seven U.S. medical centers as candidates to participate in this study and in planned protocol extensions. Several additional steps need to be completed prior to initiation of each of the clinical trial sites. These steps include clinical protocol review and approval by the IRB (institutional review board) of each participating medical center. Radiologists and spine surgeons must be trained to ensure uniformity of radiographic interpretation, GRNOPC1 administration and the application of follow-up assessments of safety and efficacy across trial sites. The sites will be identified as they come online and are ready to enroll subjects into the study.

Although the primary endpoint of the trial is safety, the protocol includes secondary endpoints to assess efficacy, such as improved neuromuscular control or sensation in the trunk or lower extremities. Once safety in this patient population has been established and the FDA reviews clinical data in conjunction with additional data from ongoing animal studies, Geron plans to seek FDA approval to extend the study to increase the dose of GRNOPC1, enroll subjects with complete cervical injuries and expand the trial to include patients with severe incomplete (ASIA grade B or C) injuries to enable access to the therapy for as broad a population of severe spinal cord-injured patients as is medically appropriate.

For more information about this trial, please click here for the full press release and background information.

For more information about GRNOPC1, please click here.

We do not maintain a mailing list for distribution of information. If you would like to join our email distribution list for press releases, which will inform you about significant company developments, please send your name and email address to Geron at info (at) geron.com.

[Justin]

San Diego Business Journal

Agency to Loan Up to $210M for Stem Cell Research Link
BIOTECH: The Push Is on to Meet July Application Deadline
By HEATHER CHAMBERS - 6/22/2009
San Diego Business Journal Staff

Northern California biotech Geron made history this year when it received FDA approval to test its stem cell therapy in people with spinal cord injuries. Now that the federal ban on using government money to support embryonic stem cell research has been lifted, local scientists hope to see their early stage research reach the clinic, too.

Before the federal government decides on the process for approving applicants, the state will begin loaning money to for-profit biotechs with promising new applications for stem cell research.

San Diego scientists are pushing to meet a July 16 application deadline for state funding that will give their research a chance to reach the clinic in just four years.

The so-called Disease Team grants, awarded by the voter-created California Institute for Regenerative Medicine, provide funding for interdisciplinary teams working toward a common goal, such as stem cell treatments for Parkinson’s disease.

San Francisco-based CIRM intends to commit up to $210 million to support as many as 12 awards. It received 73 preliminary requests for funding, with 15 of those associated with for-profit businesses, and selected 32 applicants to submit final plans, according to CIRM spokesman Don Gibbons.

Support For Businesses

He says the stem cell agency, which has endured criticism for its lack of funding for-profit endeavors, will support the work of companies alongside nonprofit biomedical institutions.

For the first time in its four-year history, the state’s stem cell agency could grant loans of between $3 million and $20 million to for-profit applicants. Eventually, a business would have to pay back the loan plus interest, but only if it succeeds in getting a product onto the market. The loan program was championed by multimillionaire real estate developer Robert Klein II, who serves as chairman of the stem cell agency’s governing board, and was passed by CIRM’s 29-member governing board in September.

The goal of the loan program is to fund the translation of research into research tools, medical diagnostics and devices, and therapeutic products.

“It’s like a bank that’s interested in stem cells, essentially,” said Eugene Brandon, product development manager for Novocell, which is developing stem cell therapies for type 2 diabetes and is based in the Sorrento Valley area.

The loans target what’s known in the industry as the “valley of death,” where promising, early stage research goes to die without the necessary funding to move it into the clinic.

For Novocell, the loans provide an opportunity for moving its research into the clinic at a much faster pace. It aims to one day provide insulin-producing cells for people with type 2 diabetes.

Novocell has received $6.3 million in state stem cell agency funding through three research grants. It plans to coordinate with researchers from UC San Francisco to conduct preclinical studies that would support an FDA application for human trials, according to Brandon.

While venture capital funding has stalled in the stem cell arena, mostly due to risk and ethical and moral concerns, businesses are hopeful that they’ll receive a healthy infusion of funds.

Gibbons says CIRM has enough in the bank to fund projects through 2010.

CIRM was established with the passage of Proposition 71, which provided $3 billion in funding for stem cell research. Its governing board has approved 294 research and facility grants totaling $761 million, making CIRM the world’s largest source of funding for human embryonic stem cell research, according to its Web site.

The agency plans to announce recipients of its Disease Team grants in December.

“We’ve got money in the bank; it’s a question of how (the governing board) wants to spend it,” he said.

San Diego Business Journal, Copyright © 2009, All Rights Reserved.

[Justin]

Geron Scientists and Collaborators Publish Data Showing Functional Dendritic Cells Can Be
Derived from Human Embryonic Stem Cells Using Scalable Production Methods

Study Supports Potential for Off-the-Shelf Dendritic Cell Vaccine Development

July 06, 2009 07:30 AM Eastern Daylight Time, LINK

MENLO PARK, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq:GERN) today announced the publication of data demonstrating that dendritic cells (DCs) scalably manufactured from human embryonic stem cells (hESCs) exhibit the normal functions of naturally occurring human DCs found in the bloodstream. These findings support the use of hESC-derived DCs in therapeutic vaccine applications for cancer and other diseases. Substituting standardized, off-the-shelf hESC-derived DCs for current approaches using DCs obtained from individual patients may result in more cost effective and reliable approaches to cancer immunotherapy.

The study, authored by Geron scientists and collaborators Prof. Waldmann and Dr. Fairchild at the Sir William Dunn School of Pathology, University of Oxford, appears online in advance of print in the journal Regenerative Medicine. The abstract of the publication is available at http://www.futuremedicine.com/doi/abs/10.2217/rme.09.25

Dendritic cells (DCs) are immune cells that detect pathogens (e.g. viruses or bacteria) and activate other immune cells (called T-cells) to launch an immune attack against the pathogen. DCs reside in small numbers within most tissues, particularly where there is contact with the external environment, such as the skin or gut. DCs will engulf and digest a foreign pathogen and present pieces of pathogen proteins (known as antigens) on the cell surface. The presentation of antigen by DCs activates the T-cell immune response directed against that pathogen. In a similar manner, dendritic cells can also educate the immune system to initiate an immune response against aberrant cells in the body, such as tumor cells.

The data in the Regenerative Medicine publication show that immature hESC-derived DCs are able to take up, process and present antigens, and then, following maturation in the manufacturing process, are able to migrate, produce pro-inflammatory cytokines and induce specific immune responses to both tumor and viral antigens in vitro. These data show that hESC-derived DCs display the functions of human DCs taken from the bloodstream.

The potential for DCs to stimulate potent and specific immune responses is being explored in clinical trials of DC vaccination protocols for the treatment of malignant and infectious diseases. “We are using a DC platform with our cancer vaccine directed against telomerase, GRNVAC1, currently in Phase II studies in AML,” said Thomas B. Okarma, Ph.D., M.D., Geron's president and chief executive officer. “However, GRNVAC1 and other therapies currently in development, use DCs that are generated from individual patients. Autologous cell treatments are costly to manufacture and difficult to control. Variation between individuals and the effects of their disease and prior treatments can affect vaccine potency. We are therefore developing a second generation cancer vaccine, GRNVAC2, based on DCs derived from hESCs to generate a scalable, reliable, off-the-shelf product, free from individual patient variability.”

“The data in the current study demonstrate that DCs derived from hESCs are immunogenic and can be developed as a scalable and consistent source of DCs for immunotherapies,” said Jane S. Lebkowski, Geron’s senior vice president and chief scientific officer for regenerative medicine. “Importantly, the production protocol is defined, and does not use serum or feeder cells, an important condition for large scale production and therapeutic development.”

The defined protocol for generating hESC-derived DCs described in the current study is a stepwise process in which hESCs are first differentiated into monocytic cells, and then converted to immature DCs. Subsequent exposure to a cocktail of maturation factors generates mature hESC-derived DCs that express surface proteins and morphological characteristics typical of mature DCs derived from peripheral blood monocytes (PBM).

The data in this study show that mature hESC-derived DCs produce a number of cytokines important for T-cell stimulation, including IL-12p70, and stimulate allogeneic T-cell proliferation when co-cultured with peripheral blood mononuclear cells in a mixed leukocyte response (MLR) assay. Another key function of DCs is their ability to migrate from the site of antigen uptake to the lymph nodes in response to chemical signals. Migratory response of mature hESC-derived DCs was comparable to PBM-derived DCs in an in vitro chemotactic assay using the chemokine MIP3β.

When a dendritic cell presents an antigen to a T-cell in vivo, it stimulates the T-cell to produce inflammatory cytokines and causes antigen-specific T-cell proliferation. In the current study using mumps, cytomegalovirus, and telomerase antigens in three separate series of experiments, the hESC-derived DCs stimulated antigen-specific T-cell proliferation in each case, a prerequisite for effective in vivo immunotherapy.

“We are very enthusiastic about these data,” said Paul J. Fairchild, Ph.D., Co-Director of the Oxford Stem Cell Institute, within the James Martin 21st Century School, University of Oxford. “Allogeneic dendritic cells have great potential as a new vaccine and immunotherapy platform that could have therapeutic value across a range of infectious diseases as well as cancer.”

Geron holds a broad-ranging intellectual property portfolio relating to DC-based immunotherapies. The portfolio includes a worldwide exclusive license to patents owned by the University of Oxford covering the differentiation of DCs from hESCs, and Geron’s own patent filings for optimized and scalable production methods of hESC-derived DCs. It also includes co-exclusive rights to patents owned by the Rockefeller University covering methods relating to maturation of DCs in vitro as well as patents owned by Duke University covering the introduction of antigen encoding mRNA into dendritic cells for immunotherapeutic applications. These co-exclusive rights were conveyed to Geron in a 2004 license agreement with Argos Therapeutics (formerly Merix BioScience, Inc.). In addition, Geron owns intellectual property rights covering key aspects of scalable manufacturing of hESCs as well as a license to foundational hESC patents held by the Wisconsin Alumni Research Foundation.

About Geron

Geron is a biopharmaceutical company that is developing first-in-class therapeutic products for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes. The products are based on our core expertise in telomerase and human embryonic stem cells. For more information about Geron, 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 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, 2009.

©2009 Business Wire

[Justin]

First human trial using embryonic stem cells delayed by FDA.

The New York Times /Bloomberg News (8/19, B8) reports, "The Geron Corporation said on Tuesday that regulators had held up its study of a therapy," called GRNOPC1, "for injured spinal cords before even one patient could be enrolled, delaying the first human trial using embryonic stem cells." The FDA ordered Geron to halt its study after the company "shared data from dose escalation studies in animals" with the agency, the company said. Geron insists that it "will work closely with the FDA to facilitate their review of the new data and to release the clinical hold."

"The product is derived from human embryonic stem cells, and the company says it has tested the drug in 24 separate studies involving rats and mice," the AP (8/18) reported. The company received FDA approval for "human testing in January, and since then, Geron said it has been studying different doses of the stem cell treatment, and testing it against other neurodegenerative diseases." For the halted trial, Geron "plans to recruit patients who recently became paraplegics" to be "injected with GRNOPC1 within two weeks of their injury." Participants will be monitored for "improvement in sensation and movement."

AMA Morning Rounds // Copyright © 2009 by Custom Briefings

[Justin]

News Release

Geron Comments on FDA Hold on Spinal Cord Injury Trial LINK

MENLO PARK, Calif., August 27, 2009 - 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.

About Geron

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. 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 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 June 30, 2009.

CONTACTS:

At Geron: Anna Krassowska
Investor and Media Relations
650-473-7765
info (at) geron.com

[Justin]

Geron Selling Off Embryonic Stem Cell Technology

Orthopedics This Week
Biloine W. Young • Mon, Jan 23rd, 2012
Copyright 2009 - 2012 RRY Publications

After nearly $450 million of equity raised and a record breaking $40 million FDA submission, Geron is throwing in the towel regarding its ground breaking embryonic stem cell therapy to treat nerve damaged patients.

Under the FDA trial, Geron had treated four patients—total.

Roughly a year ago the company fired its long time CEO Thomas Okarma and last week new Geron CEO John Scarlett told industry executives at the J.P. Morgan Healthcare Conference in San Francisco that his company had recruited St. Louis-based broker Stifel Nicolaus to help it sell off its cell therapies, according to a report in Fierce Biotech.

In 2010, Geron officials announced that the firm intended to stop clinical trials in spinal injury patients and sell its embryonic stem cell therapy program. According to theFierce Biotech writer Suzanne Elvidge on January 12, Geron is in active discussions with potential partners. The stem cell programs are, at the present time, in preclinical and clinical development and include potential therapies for central nervous system disorders, heart disease, diabetes, immunotherapy and cartilage repair.

Geron officials indicated that it will tighten the firm’s focus on its cancer therapies. It has two agents in Phase II clinical trials, with results expected in late 2012. If these are successful, Phase II proof-of-concept data will give the company a solid scientific base to seek further partnerships or collaborations.

"Every company has to make decisions about what it can do, not just what it aspires, or would like to do," Scarlett told Bloomberg. The official indicated that Geron has enough money to get through the clinical trials this year without seeking further funding, and the sale of the cell therapies could further boost funding.

[laid up doc]

spinal cord injuries (not unlike like disc injuries) are so heterogeneous and involve so many biochemical changes that i'm not sure we know enough to properly design studies for embryonic stem cells.

i certainly HOPE there is a role... but i'm not overly optimistic given that we really haven't found anything at all that changes outcomes in SCI beyond good supportive care (which is what we do in a lot of things right?) and aggressive prevention of the chronic issues that quad and paraplegic patients face.

one of my med school classmates fell off a balcony at the end of 3rd year of med school and is now a C6ish quad from SCIWORA... he's an amazing dude, did a PM&R residency then spinal cord fellowship, and now is a SCI rehab doc, also back here in our hometown (he also went to my high school). he's friggin Superman though - certainly not a typical SCI patient.