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   Biotech / MedicalGeron Corp.


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From: Savant2/10/2016 3:08:34 PM
   of 3521
 
Geron to Present at the RBC Capital Markets Healthcare Conference

MENLO PARK, Calif., Feb. 10, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced that John A. Scarlett, M.D., President and Chief Executive Officer, is scheduled to present at the RBC Capital Markets 2016 Global Healthcare Conference in New York at 8:30 a.m. Eastern Time on Tuesday, February 23.

A live webcast of the presentation will be available through the Investor Relations pages of Geron's website and at veracast.com. Following the live presentation, the webcast will be archived and available for replay at the same address for a period of 30 days.

About Geron

Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.

CONTACT: Anna Krassowska, Ph.D. Investor and Media Relations 650-473-7765 investor@geron.com media@geron.com

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From: Savant2/17/2016 4:55:09 PM
   of 3521
 
Geron Announces Conference Call to Discuss Fourth Quarter and Annual 2015 Financial Results

MENLO PARK, Calif., Feb. 17, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) will announce its financial results for the fourth quarter and year ended December 31, 2015, on Thursday, February 25, 2016, after the market close. Geron's management will also host a conference call for analysts and investors on Thursday, February 25, 2016, at 4:30 p.m. Eastern Time to discuss the company's fourth quarter and annual results and events.

Participants can access the conference call live via telephone by dialing 877-303-9139 (U.S.); 760-536-5195 (international). The conference ID is 48851221. If accessing the conference call by telephone, please dial in at least 10 minutes early to minimize any delay in joining the call. A live audio-only webcast is also available at edge.media-server.com. The audio webcast of the conference call will be available for replay approximately one hour following the live broadcast through March 26, 2016.

About Geron

Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.

CONTACT: Anna Krassowska, Ph.D. Investor and Media Relations 650-473-7765 investor@geron.com media@geron.com

(MORE TO FOLLOW) Dow Jones Newswires

February 17, 2016 07:30 ET (12:30 GMT)

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From: Savant2/26/2016 11:21:31 AM
   of 3521
 
Geron Corporation Reports Fourth Quarter and Annual 2015 Financial Results

Conference Call Scheduled for 4:30 p.m. EST Today, February 25

MENLO PARK, Calif., Feb. 25, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today reported financial results for the fourth quarter and year ended December 31, 2015 and recent events.

Fourth Quarter and Year-End 2015 Results

For 2015, the company reported net income of $46,000, or $0.00 per share, compared to a net loss of $35.7 million, or $(0.23) per share, for 2014. For the fourth quarter of 2015, the company reported a net loss of $8.5 million, or $(0.05) per share, compared to a net loss of $8.9 million, or $(0.06) per share, for the comparable 2014 period. The company ended 2015 with $146.7 million in cash and investments.

Revenues for 2015 were $36.4 million compared to $1.2 million for 2014. Revenues for the fourth quarter of 2015 were $220,000 compared to $178,000 for the comparable 2014 period. Revenues for 2015 included the full recognition of the $35.0 million upfront payment from Janssen Biotech, Inc. (Janssen) as collaboration revenue upon the company's transfer of the imetelstat license rights and completion of technology transfer-related activities outlined under the imetelstat collaboration agreement with Janssen in the third quarter of 2015. The upfront cash payment was received in December 2014 and recorded as deferred revenue at that time.

Total operating expenses for 2015 were $36.9 million compared to $37.5 million for 2014. Total operating expenses for the fourth quarter of 2015 were $8.9 million compared to $9.2 million for the comparable 2014 period. Operating expenses for 2015 included restructuring charges of $1.3 million in connection with the company's organizational resizing announced in March 2015.

Research and development expenses for 2015 were $17.8 million compared to $20.7 million for 2014. Research and development expenses for the fourth quarter of 2015 were $4.0 million compared to $4.4 million for the comparable 2014 period. The decrease in research and development expenses in 2015 compared to 2014 primarily reflects the net result of lower personnel related costs due to the organizational resizing and reduced manufacturing costs for imetelstat drug product, partially offset by higher costs for the clinical development of imetelstat in collaboration with Janssen.

General and administrative expenses for 2015 were $17.8 million compared to $16.8 million for 2014. General and administrative expenses for the fourth quarter of 2015 were $4.9 million compared to $4.8 million for the comparable 2014 period. The increase in general and administrative expenses in 2015 compared to 2014 primarily reflects higher non-cash stock-based compensation expense.

Interest and other income for 2015 was $677,000 compared to $373,000 for 2014. Interest and other income for the fourth quarter of 2015 was $196,000 compared to $100,000 for the comparable 2014 period. The increase in interest and other income for 2015 compared to 2014 primarily reflects higher cash and investment balances with the receipt of the $35.0 million upfront payment from Janssen and higher yields on the company's marketable securities portfolio.

Company Events

Publications and Presentations

-- The New England Journal of Medicine (NEJM) published two papers in which data from clinical studies of two hematologic myeloid malignancies, essential thrombocythemia (ET) and myelofibrosis (MF), suggest imetelstat may have disease-modifying activity by inhibiting the malignant progenitor cell clones responsible for the underlying diseases in a relatively select manner. The papers are available online in the September 3rd issue at www.NEJM.org. -- Three presentations describing clinical and non-clinical data on imetelstat were made at the 57th annual meeting of the American Society of Hematology in December 2015: -- Telomerase Inhibitor Imetelstat Therapy in Refractory Anemia with Ring Sideroblasts with or without Thrombocytosis (Abstract #55; oral presentation)Data were presented for safety and efficacy as of the May 10, 2015 data cut. Nine patients with a form of the myelodysplastic syndromes (MDS) known as refractory anemia with ring sideroblasts (MDS-RARS) were enrolled in the study cohort, classified as having either intermediate-1 or intermediate-2 risk disease by the International Prognostic Scoring System (IPSS). Six of nine (66.7%) patients had prior treatment with erythropoiesis stimulating agents (ESAs).Three of the eight (37.5%) patients who were dependent on red blood cell transfusions at study entry became transfusion independent, defined as not requiring transfusions for at least eight weeks. The median duration of transfusion independence was 28 weeks (range: nine weeks to 37 weeks).Adverse events were similar in nature to the adverse events reported in the MF clinical study published in the NEJM. -- Dynamics of Mutations in Patients with ET Treated with Imetelstat (Abstract #57; oral presentation)Data from further mutational analyses of patient samples from the clinical study in ET showed that imetelstat treatment suppressed allele burdens of multiple gene mutations in addition to the JAK2 V617F, CALR and MPL mutations. -- Activity of the Telomerase Inhibitor GRN163L (Imetelstat) on Acute Myeloblastic Leukemia Blasts Is Enhanced by DNA Methyltransferase Inhibitors Irrespective of TERT Promoter Methylation Status (Abstract #1267; poster presentation)Data from an in vitro study showed that imetelstat has activity against samples derived from patients with high risk leukemias, and that activity was enhanced by the demethylating agent 5-azacytadine, which is currently used in the treatment of some patients with high risk MDS or acute myeloid leukemia.

Clinical Development by Janssen

-- IMbarkTM. In September 2015, the first patient was dosed in a Phase 2 clinical trial to evaluate imetelstat in patients with MF. The trial, referred to as IMbarkTM, will assess the efficacy, safety and tolerability of two dose levels of single-agent imetelstat and is designed to enroll approximately 200 patients (approximately 100 patients per dosing arm) with intermediate-2 or high risk MF, as defined by the Dynamic International Prognostic Scoring System, who have relapsed after or are refractory to Janus Kinase (JAK) inhibitor treatment. Patients will be assigned randomly, on a 1:1 ratio, to one of two dosing arms -- 9.4 mg/kg or 4.7 mg/kg every three weeks. Patients will be blinded to the dosing arm assignment. Dose reductions for adverse events are allowed and will follow protocol-specified algorithms. An internal review of data from the trial is planned after approximately 20 patients per arm have been randomized and followed for at least 12 weeks in order to assess the adequacy of one or both of the initial dosing arms. As a result of this internal review, which is expected to occur in the second half of 2016, one or both dosing arms could continue as planned, be stopped or modified, or alternative doses could be selected.The co-primary efficacy endpoints for IMbarkTM are spleen response rate and symptom response rate. Spleen response rate is defined as the percentage of patients who achieve >= 35% reduction in spleen volume from baseline at the Week 24 visit, as measured by imaging scans and assessed at a central imaging facility and by an Independent Review Committee. Symptom response rate is defined as the percentage of patients who have >= 50% reduction in Total Symptom Scores from baseline at the Week 24 visit, based on patient-reported outcomes on a modified Myelofibrosis Symptom Assessment Form version 2.0 electronic diary. The primary efficacy analysis of the co-primary endpoints will occur after all treated patients have been followed for at least 24 weeks, and the data cut for this analysis is expected to occur in the second half of 2017. Formal clinical data from this trial is expected to be presented at a medical conference to be determined in the future.Further information about the trial, including participating medical centers around the world, can be found at clinicaltrials.gov. -- IMergeTM. In January 2016, the first patient was dosed in a Phase 2/3 clinical trial to evaluate imetelstat in patients with MDS. The trial, referred to as IMergeTM, will evaluate imetelstat in transfusion dependent patients with IPSS Low or Intermediate-1 risk MDS who have relapsed after or are refractory to prior treatment with an ESA.As designed, the trial consists of two parts, and a total of approximately 200 patients are expected to be enrolled. Part 1 of the trial is planned as a Phase 2, open-label, single-arm design to assess the efficacy and safety of imetelstat. Up to 30 patients are expected to be enrolled in Part 1, all of whom will receive imetelstat and be followed for safety, hematologic improvement and reduction in transfusion requirement. Before proceeding to Part 2, the data from Part 1 must support a positive assessment of the benefit/risk profile of imetelstat in these patients. The internal review of data from Part 1 to support advancing to Part 2 is expected to occur in the second half of 2016. Part 2 of the trial is planned as a Phase 3 double-blind, randomized, placebo-controlled design to compare the efficacy of imetelstat against placebo. Approximately 170 patients are expected to be enrolled in Part 2, who will be assigned randomly, in a 2:1 ratio, to receive either imetelstat or placebo.The primary efficacy endpoint is designed to be the rate of red blood cell transfusion-independence lasting at least eight weeks, defined as the proportion of patients without any red blood cell transfusion during any consecutive eight weeks since entry to the trial. A primary efficacy analysis is planned to occur 12 months after the last patient is enrolled.Further information about the trial, including participating medical centers around the world, can be found at clinicaltrials.gov.

Regulatory Designations

-- The United States Food and Drug Administration has granted orphan drug designation to imetelstat for the treatment of MF and for the treatment of MDS. In addition, the European Medicine Agency has granted orphan drug designation to imetelstat for the treatment of MF.

Conference Call

At 4:30 p.m. EST on February 25, 2016, Geron's management will host a conference call to discuss the company's fourth quarter and annual results as well as recent events.

Participants can access the conference call live via telephone by dialing 877-303-9139 (U.S.); 760-536-5195 (international). The passcode is 48851221. A live audio-only webcast is also available at edge.media-server.com. The audio webcast of the conference call will be available for replay approximately one hour following the live broadcast through March 25, 2016.

About Geron

Geron is a biopharmaceutical company supporting the clinical stage development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.

Use of Forward-Looking Statements

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From: Savant4/5/2016 12:56:14 PM
   of 3521
 
Geron to Present at the Needham Healthcare Conference

MENLO PARK, Calif., April 05, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced that John A. Scarlett, M.D., President and Chief Executive Officer, is scheduled to present at the 15th Annual Needham Healthcare Conference in New York at 8:40 a.m. Eastern Time on Tuesday, April 12, 2016.

A live webcast of the presentation will be available through the Investor Relations pages of Geron's website and at wsw.com. Following the live presentation, the webcast will be archived and available for replay at the same address for a period of 30 days.

About Geron

Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.

CONTACT: Anna Krassowska, Ph.D. Investor and Media Relations 650-473-7765 investor@geron.com media@geron.com

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From: tktrimbath6/30/2016 6:10:56 PM
   of 3521
 
My mid-year review of GERN

INTRO Here's my semi-annual exercise to see if I remember why I own the stocks I own, and so I can check back and see if their stories have changed. I post in case it helps others too.

Geron
GERN (market cap was $0.766B EOY2015 is $0.426B mid2016)
Geron is a leading edge biotech, and has been for over a decade. While originally they were diversified across four major technologies, they have spun off three of them (see my notes about AST on InvestorVillage.com) and are reduced to working on a cancer treatment based on managing telomerase. While that may sound restrictive, telomerase potentially could treat multiple cancers; and because it controls cell growth and death, could possibly treat auto-immune diseases, as I understand it. The treatment is in clinical trials, but is years away from possible approval. If they succeed, and if the treatment works for more than the first targeted cancer, then the company may finally live up to its potential. Innovative treatments, however, have to deal with the non-innovative FDA approval process. Alternatively, such an important breakthrough could achieve a compassionate status. If successful, they will be challenging an entrenched cancer industry what will have billions of dollars in revenue at risk potentially sparking an immense corporate immune response (as was witnessed in Dendreon's successful prostate cancer vaccine.)

I have a sufficiently large holding that my finances would be significantly improved with the success of the stock, the treatment, and the company. There is entrenched support for the company as evidenced by the market cap of more than half a billion dollars. Such a high market valuation for an unproven treatment limits some of the upside potential because some of it is already priced in. After decades of waiting, it may only take a few more years for approval.

DISCLOSURE LTBH since 1999 and continuing to hold (though I sold much, partly for diversification, partly to raise funds.)
(I've also collected links to the other discussion boards and my other stocks over on my blog trimbathcreative.wordpress.com

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From: Savant7/26/2016 1:51:45 PM
   of 3521
 
RT...GERN was such an early pioneer... genengnews.com

Growing Old Gracefully: Male Hormone Reverses Cell Aging (Page 1 of 1)



  • Click Image To Enlarge +

    Researchers may have found a way to stimulate the cellular "fountain of youth" molecule. [NIH]
    The impact of the telomerase enzyme’s discovery cannot be overstated, as its importance to cell biology was recognized in 2009 with the awarding of the Nobel Prize in Physiology or Medicine. Over the years, researchers have come understand more closely the molecular mechanisms this protein utilizes during the cell cycle and maturation, leading it too often to be referred to as the “fountain of youth” molecule. Now, a recent study by investigators in the U.S. and Brazil has shown that male sex hormones can stimulate production of the telomerase enzyme—providing potential therapeutic avenues for various genetic diseases.

    This novel strategy was tested in with genetic diseases, such as aplastic anemia and pulmonary fibrosis, which have known mutations in the telomerase gene. The researchers believe that the approach they took in this new study may help combat the damage caused to patients by telomerase deficiency.

    "One of the processes associated with aging is a progressive shortening of telomeres, DNA-protecting structures at the ends of chromosomes, like the plastic tips on shoelaces," explained co-author Rodrigo Calado, M.D., Ph.D., professor at the University of São Paulo's Ribeirão Preto Medical School (FMRP-USP). "Each time a cell divides, its telomeres get shorter. Eventually, the cell can't replicate anymore and dies or becomes senescent. However, telomerase can keep the length of telomeres intact, even after cell division."

    Scientists often use telomere length as a laboratory measure of a cell's age. Interestingly, some cells avoid aging by using telomerase to lengthen their telomeres through the addition of DNA sequences, thereby maintaining their capacity to multiply and "stay young."

    Embryonically, where tissues are still in their formative stages, telomerase is expressed by practically every cell. After this period, only cells that are constantly dividing, such as hematopoietic (blood-forming) stem cells, which can differentiate into a variety of specialized cells, continue to produce telomerase.

    "Aplastic anemia is one of the diseases that can be caused by telomerase deficiency," Dr. Calado noted. "Bone marrow stem cells age prematurely and fail to produce enough red blood cells, white blood cells, and platelets, making the patient dependent on blood transfusions and more susceptible to infections."

    Previous work done by Dr. Calado and his colleagues showed that androgens, which are converted into estrogens in humans, bound to female hormone receptors in the telomerase gene promoter region and thereby stimulated expression of the enzyme in cells.

    "The study we've just published was designed to find out whether the effect we'd observed in the lab also occurred in humans, and the results indicate that it does," Dr. Calado remarked.

    The findings from this study were published recently in The New England Journal of Medicine in an article entitled “Danazol Treatment for Telomere Diseases.”

    Instead of estrogen, the researchers treated the patients with the androgen danazol, a synthetic male hormone, because it has long been used as a drug in cases of congenital anemia and offers the advantage of stimulating an increase in the mass of hemoglobin (red blood cells), which estrogen cannot do. Treatment with this steroid was tested for 2 years in 27 patients with aplastic anemia owing to telomerase gene mutations.

    "In a healthy adult, telomere length varies from 7000 to 9000 base pairs on average. A normal person's telomeres lose 50 to 60 base pairs per year, but a patient with telomerase deficiency can lose between 100 and 300 base pairs per year," stated Dr. Calado. "In the patients who received danazol, telomere length increased by 386 base pairs on average over 2 years."

    Additionally, the researchers found that hemoglobin mass rose from 9 grams per deciliter (g/dL) to 11 g/dL on average. A person without anemia normally has between 12 and 16 g/dL, but the improvement observed in these subjects was sufficient to rid them of transfusion dependency.

    "On completion of the protocol, the medication was interrupted, and we observed a fall in all counts. Several patients resumed the medication with smaller doses, individually adjusted to minimize side effects," Dr. Calado said.

    In a new protocol currently in progress at the University of São Paulo's Ribeirao Preto Blood Center, the same kind of approach is being tested with nandrolone, an injectable male hormone.

    While the results of the current study suggest that drugs can be used to reverse one of the biological drivers of aging, it is not yet clear whether the benefits of such treatment would surpass the risks in healthy people, especially if the treatment involves the use of sex hormones.


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    To: Savant who wrote (3478)8/4/2016 12:00:55 PM
    From: Savant
       of 3521
     
    RT... brain tissue grown from stem cells

    msn.com

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    From: Savant8/18/2016 1:06:14 AM
       of 3521
     
    RT..Corneas from stem cells..
    Lab grown corneas....now...& by Y10K...they'll be able to grow/make any body part..

    Stem cells>>

    msn.com

    More than 500 million people around the world are either visually impaired or blind, but thanks to a technique developed by a team of Japanese scientists at Osaka University, there may be hope for a new treatment. The breakthrough, published in the journal Advanced Healthcare Material, demonstrates their success in growing a key part of the eye in a petri dish — the cornea.The inside of your eye is a highly organized and complex system, composed of three basic layers that have an important function needed for visual processing, including the cornea as the outermost layer. These cells deteriorate with age, which is why figuring out how to regenerate CECs is the key to maintaining functional eyesight. All researchers need is a small sample of skin to regenerate corneal endothelial cells (CECs), which are responsible for keeping the window of the eye clear and preventing it from swelling.

    After growing CECs in a petri dish over the course of several weeks, researchers implanted them in sheep that were born without corneas. The sheep’s vision was restored to 98 percent. After 28 days, the sheep’s eyes didn’t reject the CECs or become inflamed, proving to the team their lab-grown corneas were near identical to that of one naturally grown. They have yet to implant them into humans, but once they do, it may open up a huge door for the visually impaired, who are in need of a medical procedure to regain their eyesight.

    “For years, we didn’t have anything to offer these patients — we’d transplant a cornea, it would work for a few weeks, then the blindness would return. It’s devastating,” Dr. Edward Holland, director of cornea services at the Cincinnati Eye Institute who was not involved in the study, said in an interview. “This takes the stem cell procedure to another level, giving us more options to offer patients.

    In preliminary trials earlier this year in March 2016, the same research team grew sheaths of corneas for rabbits. Sheets of petri-grown corneas were implanted into the eyes of blind bunnies. Once the stem cells took hold of the rest of the rabbits’ eyes, their eyesight was completely restored and researchers published their findings in the journal Nature. Beyond corneas, researchers hope to grow retinas, lenses, and other key components of the eye for those who were born with or developed visual impairment

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    From: Savant9/12/2016 9:17:34 AM
       of 3521
     
    Geron Provides Update on Imetelstat Trials Being Conducted by Janssen

    Conference Call Scheduled for 8:00 a.m. EDT Today, September 12

    MENLO PARK, Calif., Sept. 12, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today provided updates on the clinical trials being conducted by Janssen Research & Development, LLC, of the telomerase inhibitor imetelstat. Planned internal reviews of initial data from both trials have been completed by Janssen, and both trials are continuing in order to evaluate additional and more mature data.

    IMbark(TM)

    IMbark(TM) (NCT02426086) was originally designed as a Phase 2 clinical trial to evaluate two dose levels of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered every three weeks) in approximately 200 patients (approximately 100 patients per dosing arm) with Intermediate-2 or High risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a JAK inhibitor. The co-primary efficacy endpoints for the trial are spleen response rate and symptom response rate at 24 weeks. To date, over 90 patients have been enrolled in the trial across both dosing arms.

    To inform an assessment of the appropriate dose and schedule for relapsed or refractory MF patients in IMbark(TM) , Janssen conducted a planned internal interim review of safety, efficacy and pharmacokinetic data from 20 patients from each dosing arm who have been followed on the trial for at least 12 weeks. Based on this first internal review at the early 12-week time point, the following has been determined by Janssen:

    -- The safety profile was consistent with previous imetelstat clinical trials in hematologic myeloid malignancies. No new safety signals were identified. -- Activity in the 4.7 mg/kg dosing arm does not warrant further investigation of that dose and this arm will be closed to new patient enrollment. An amendment to the trial protocol is planned to allow eligible patients in this arm to increase their dose to 9.4 mg/kg per investigator discretion. -- In the 9.4 mg/kg dosing arm, even though at the week 12 data assessment an insufficient number of patients met the protocol defined interim criteria, this arm warrants further investigation because encouraging trends in the efficacy data were observed. Patients already enrolled in this arm may continue to receive imetelstat. New enrollment in this arm will be suspended while the trial continues in order to obtain additional and more mature data that includes a longer follow-up of patients at 24 weeks, consistent with the co-primary efficacy endpoints. The number of patients enrolled to date is expected to be sufficient to inform potential future development of this dose. -- Janssen plans to conduct an additional internal data review in the second quarter of 2017 to include a longer follow-up of patients at 24 weeks. Potential outcomes of the second internal review at the 24-week time point could include resuming enrollment in the 9.4 mg/kg dosing arm, with or without changes to the dosing regimen; adding a new dosing arm; or closing the trial. -- Any protocol amendments will be subject to review by health authorities around the world. IMerge(TM)

    IMerge(TM) (NCT02598661) is a Phase 2/3 clinical trial evaluating imetelstat in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The clinical trial is in two parts: Part 1 is a Phase 2, open-label, single-arm design in approximately 30 patients and Part 2 is a Phase 3, randomized, double-blind, placebo-controlled design in approximately 170 patients. The primary efficacy endpoint is the rate of red blood cell transfusion-independence lasting at least 8 weeks. Part 1 of the trial is fully enrolled.

    Janssen has conducted an initial internal review of efficacy, safety and pharmacokinetic data from a subset of patients from Part 1 of IMerge(TM) and this review indicated that emerging safety and efficacy in IMerge(TM) is consistent with data reported from the pilot study conducted at Mayo Clinic in MDS patients. IMerge(TM) will continue unmodified at this time.

    Further assessment of data from IMerge(TM) is expected to occur in the second quarter of 2017 to include longer follow-up of all patients enrolled in Part 1. A decision on whether to move forward to Part 2 of IMerge(TM) will be based on an assessment of the benefit/risk profile of imetelstat in these patients. If Janssen decides to move forward with Part 2, the Phase 3 clinical trial is expected to be open for patient enrollment in mid-2017.

    Janssen expects to submit data from Part 1 of IMerge(TM) to be considered for presentation at a medical conference in the future.

    Conference Call

    At 8:00 a.m. EDT on September 12, 2016, Geron's management will host a conference call to review outcomes from the internal data reviews of IMbark(TM) and IMerge(TM) . Participants can access the conference call live via telephone by dialing 877-303-9139 (U.S.); 760-536-5195 (international). The passcode is 80522983. A live audio-only webcast is also available on the company's website at www.geron.com under Events and at edge.media-server.com. The audio webcast of the conference call will be available for replay approximately one hour following the live broadcast through October 13, 2016.

    About Imetelstat

    Imetelstat (GRN163L; JNJ-63935937) is a potent and specific inhibitor of telomerase that is administered by intravenous infusion. This first-in-class compound, discovered by Geron, is a specially designed and modified short oligonucleotide, which targets and binds directly with high affinity to the active site of telomerase. Preliminary clinical data suggest imetelstat has disease-modifying activity by inhibiting the progenitor cells of the malignant clones associated with hematologic malignancies in a relatively select manner. Most commonly reported adverse events in imetelstat clinical studies include fatigue, gastrointestinal symptoms and cytopenias. Patients in these studies also experienced elevated liver enzymes, which resolved to normal or baseline in the majority of patients followed after imetelstat treatment was withdrawn. Imetelstat has not been approved for marketing by any regulatory authority.

    About the Collaboration with Janssen

    On November 13, 2014, Geron entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., to develop and commercialize imetelstat for oncology, including hematologic myeloid malignancies, and all other human therapeutics uses. Under the terms of the agreement, Geron received an upfront payment of $35 million and is eligible to receive additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. All regulatory, development, manufacturing and promotional activities related to imetelstat are being managed through a joint governance structure, with Janssen responsible for these activities.

    About Geron

    Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.

    Use of Forward-Looking Statements

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    From: hollyhunter10/3/2016 9:33:16 AM
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    Indicators show bullish cross in MACD and Stochastic oscillator.

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