| From: Savant | 8/18/2016 1:06:14 AM | | | | | | 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: Savant | 9/12/2016 9:17:34 AM | | | | | | 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: Savant | 11/7/2016 10:10:27 AM | | | | | | Geron Announces November Investor Conference Presentation Webcasts
MENLO PARK, Calif., Nov. 07, 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 following investor conferences:
-- Stifel 2016 Healthcare Conference in New York at 9:30 a.m. ET on Tuesday, November 15, 2016. -- Piper Jaffray 28th Annual Healthcare Conference in New York at 12:30 p.m. ET on Wednesday, November 30, 2016. A live audio webcast of each presentation will be available through the Homepage and Investor Relations section of Geron's website under Events. Following the live presentations, the webcasts will be archived and available for replay 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: Savant | 12/7/2016 10:07:47 AM | | | | | | Geron Reports Imetelstat Presentations at American Society of Hematology Annual Meeting
MENLO PARK, Calif., Dec. 06, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced four presentations of exploratory preclinical and clinical data related to the imetelstat program at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition held in San Diego, California from December 3-6, 2016. The presentations are available on Geron's website at www.geron.com/presentations.
"The imetelstat data presented at ASH this year indicate the potential application of imetelstat in multiple myeloid malignancies," said John A. Scarlett, M.D., Geron's President and Chief Executive Officer. "These presentations reflect the ongoing work by academic scientists, clinical investigators and our colleagues at Janssen to advance the imetelstat program, and support the clinical trials being conducted by Janssen in patients with myelofibrosis and myelodysplastic syndromes, who are in need of new treatment options."
Oral Presentation
Title: The preclinical efficacy of a novel telomerase inhibitor, imetelstat, in AML - a randomized trial in patient-derived xenografts (Abstract #578)
Academic scientists presented data of imetelstat's activity in human acute myeloid leukemia (AML) xenograft models. The preclinical data demonstrated that imetelstat prolonged overall survival of AML xenografts derived from nine out of 15 individual patient samples compared to saline-treated controls, with robust responses associated with favorable cytogenetic risk groups and mutations in molecular pathways controlling DNA damage. The effects on normal human hematopoiesis were modest and predominantly seen in the B-lymphocyte lineage with relative preservation of myeloid and stem cell populations. These data build on previously published preclinical work conducted in patient-derived models of AML and suggest potential application of imetelstat in the treatment of AML.
Poster Presentations
Title: Characterization of Disease, Treatment Patterns, and Outcomes of Patients with Myelofibrosis: Analysis of 2 United States Commercial Claims Databases (Abstract #4769)
Janssen presented an analysis of treatment patterns and outcomes of patients with myelofibrosis (MF) diagnosed between 2006 and 2015 from two United States medical health insurance claims databases. The analysis suggests that many MF patients (43%) received no treatment or supportive care, and only a fraction received ruxolitinib in spite of a favorable median overall survival associated with frontline treatment (30 months compared with 22 months for patients receiving other treatments). Among patients who failed or discontinued frontline ruxolitinib, the median overall survival was seven months, which underscores the need for new treatment options for this disease.
Title: Dynamics of Telomere Length Reflect the Clonal Suppression Seen with the Telomerase Inhibitor Imetelstat in Patients with Essential Thrombocythemia (Abstract #1938)
Academic scientists and clinical investigators from the prior Geron-sponsored proof-of-concept study in patients with essential thrombocythemia (ET) presented new clinical data on telomere length dynamics following treatment with imetelstat. The data showed that in 10 out of 13 ET patients, telomere length in granulocytes was higher after nine months of treatment with imetelstat, and the change correlated with the reduction of JAK2V617F mutational burden. These observations suggest that imetelstat may suppress neoplastic clones and favor recovery of normal hematopoiesis in these patients providing further evidence of the potential disease-modifying activity of imetelstat in hematologic myeloid malignancies.
Title: Telomerase Inhibition with Imetelstat Eradicates -catenin Activated Blast Crisis Chronic Myeloid Leukemia Stem Cells (Abstract #3065)
Academic scientists presented a preliminary investigation into the potential impact of imetelstat on leukemia stem cells in non-clinical models of chronic myeloid leukemia (CML) in blast crisis. The preclinical data suggest that imetelstat plus dasatinib, a standard treatment for CML, may inhibit self-renewal of blast crisis cells in vitro compared with normal bone marrow progenitors. In mouse xenograft models of blast crisis CML, imetelstat treatment reduced the number of leukemia progenitor cells detected in bone marrow and decreased expression of -catenin, which is believed to be required for the self-renewal of leukemic stem cells in CML. This is the first report of data to suggest that imetelstat might inhibit proliferation of malignant progenitors in CML.
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 malignant progenitor cell 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: tktrimbath | 12/31/2016 9:06:11 PM | | | | | | My end of 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 $0.426B mid2016 is $0.329B EOY2016)
Geron is developing leading edge biotechnologies based on telomerase, a protein that helps control cell death. The drug is in clinical trials for treating "hematologic myeloid malignancies", which I translate as blood disorders. The potential is very large because controlling cell death has the potential to encourage cells to die on demand, thereby treating cancers; or convincing them not to destroy themselves, which can be an issue in auto-immune disorders.
They are in phase 2 clinical trials, but the data have underwhelmed the investment community.
At one time, the company had four major technologies in development. Now, they are down to one major technology. Diversification within a company is not a guarantee. The clinical trials continue, but I must admit that their past performance is affecting my expectations of their future performance. I am considering selling GERN to buy AST, which happens to be advancing one of Geron's other spun-off technologies.
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: Savant | 2/22/2017 10:49:43 AM | | | | | | Geron Announces Conference Call to Discuss Fourth Quarter and Annual 2016 Financial Results
MENLO PARK, Calif., Feb. 22, 2017 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) will announce its financial results for the fourth quarter and year ended December 31, 2016, on Wednesday, March 1, 2017, after the market close. Geron's management will also host a conference call for analysts and investors on Wednesday, March 1, 2017, at 4:30 p.m. Eastern Time 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 conference ID is 53505663. 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 through the Investors section of our website at www.geron.com or 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 April 1, 2017.
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: Savant | 3/2/2017 10:35:56 AM | | | | | | Geron Announces Presentation at American Association for Cancer Research Annual Meeting
MENLO PARK, Calif., March 02, 2017 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced an abstract submitted by Janssen Research & Development, LLC describing non-clinical data on imetelstat has been accepted for presentation as a poster at the 2017 American Association for Cancer Research (AACR) Annual Meeting to be held in Washington, D.C. from April 1-5, 2017. The abstract is available on the AACR website at www.aacr.org.
Abstract Title: Telomerase inhibitor imetelstat in combination with the BCL-2 inhibitor venetoclax enhances apoptosis in vitro and increases survival in vivo in acute myeloid leukemia (Abstract #1101)
AACR Session Title: Combination Therapy 1
Session Date: Monday, April 3, 2017
Session Time: 8:00 a.m. ET - 12:00 p.m. ET
In accordance with AACR policies, abstracts submitted to the AACR Annual Meeting are embargoed from the time of submission. To be eligible for presentation at the AACR Annual Meeting, information contained in the abstract, as well as additional data and information to be presented at the Annual Meeting, may not be made public before the abstract has been presented in connection with the AACR Annual Meeting. |
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| From: tktrimbath | 6/30/2017 8:46:25 PM | | | | | | My semi-annual review of GERN - Mid 2017
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 $0.329B EOY2016 is $0.433B Mid2017)
Once upon a time, Geron was developing four major disruptive biotechnologies, all that had something to contribute to better and longer lives (Geron, as in gerontology). Now, they've sold off all (see Asterias for stem cell work) except one, telomerase. By properly controlling telomeres, the molecules that help regulate cell death, there is the potential to gain some control over diseases where cells don't die properly (cancer), or cells die too easily (auto-immune disorders.) Their prime clinical trials are aimed at treating hematological disorders (blood disorders).
The good news is that they've entered phase 2/3 clinical trials. Unfortunately, they've taken about two decades to get here, have experienced dilution, and haven't exceeded clinical expectations. With a market cap of close to half a billion dollars, any treatment will have to bring in great revenues to greatly increase the share price. Fortunately, even though hematological disorders don't make headlines (unless they're reworded), proof of the technology can suggest expanding into those other disorders mentioned above.
I don't expect the stock to move much until better and more conclusive clinical trial data elicits a more positive response within the investment community. Psychology plays a role in long term biotechs, especially in ones that have a long history of not meeting technological expectations.
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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