From: Savant | 11/15/2011 12:30:11 PM | | | | Geron to Focus on Its Novel Cancer Programs
Company Plans to Partner All Stem Cell Programs
MENLO PARK, Calif., Nov 14, 2011 (BUSINESS WIRE) -- Geron Corporation (GERN) today announced that, effective immediately, the Company will focus on its first-in-class oncology programs. As a consequence, the Company will discontinue further development of its stem cell programs and is seeking partners for these novel assets.
"In the current environment of capital scarcity and uncertain economic conditions, we intend to focus our resources on advancing our Phase 2 clinical trials of imetelstat and GRN1005. These two novel and promising oncology drug candidates target major unmet medical needs and have important clinical development milestones occurring over the next 20 months," said Geron's Chief Executive Officer, John A. Scarlett, M.D. "By narrowing our focus to the oncology therapeutic area, we anticipate having sufficient financial resources to reach these important near-term value inflection points for shareholders without the necessity of raising additional capital. This would not be possible if we continue to fund the stem cell programs at the current levels."
Imetelstat, Geron's lead telomerase inhibitor, is currently being evaluated in four Phase 2 clinical oncology studies for the following indications: non-small cell lung cancer, breast cancer, essential thrombocythemia and multiple myeloma. Geron expects top-line data from these trials to be available before the end of the fourth quarter of 2012. GRN1005, an LRP-directed peptide-drug conjugate, is entering two Phase 2 clinical trials this year, one for brain metastases arising from non-small cell lung cancer and the other for brain metastases from breast cancer. Geron expects top-line data from these trials to be available before the end of the second quarter of 2013.
The decision to narrow Geron's technology and therapeutic focus was made after a strategic review of the costs, value inflection timelines and clinical, manufacturing and regulatory complexities associated with the Company's research and clinical-stage assets. With this decision, Geron is eliminating 66 full-time positions, representing 38% of its workforce. As a result, the Company expects one-time cash expenditures of approximately $5 million in the fourth quarter of 2011 and approximately $3 million in the first half of 2012. Geron expects to end 2011 with cash and investments in excess of $150 million.
Geron is seeking partners with the technical and financial resources to enable further development of its stem cell programs. "Our employees, collaborators and shareholders can be proud of the pioneering role they have played to advance our stem cell technology into the clinic," said Dr. Scarlett. "Stem cells continue to hold great medical promise. We believe that our leadership role in the field and the quality of our stem cell assets -- which are widely recognized as being among the most innovative, comprehensive and advanced cell therapy programs in the world -- will be an important point of differentiation in our discussions to partner these assets." In order to facilitate transfer of these programs to partners, Geron will retain a core group of employees from its stem cell operations through the end of the second quarter of 2012.
Geron plans to close the GRNOPC1 trial for spinal cord injury to further enrollment, although it will continue to follow all enrolled patients, accruing data and updating FDA and the medical community on their progress. In this trial, GRNOPC1 has been well tolerated with no serious adverse events.
Conference Call Information
Geron's Chief Executive Officer, John A. Scarlett, M.D., will host a conference call for analysts and investors to discuss changes to the Company's business on Tuesday, November 15, 2011 at 6:00 a.m. Pacific Time, 9:00 a.m. Eastern Time.
Participants can access the conference call live via telephone by dialing 866-510-0705 (U.S.); 617-597-5363 (international). The passcode is 64257143. 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 media-server.com. The audio webcast of the conference call will be available for online replay approximately one hour following the live broadcast through November 30, 2011.
About Geron's Oncology Programs
Telomerase Inhibitor Program
Geron's proprietary nucleic acid chemistry platform is being used to generate potent and specific inhibitors of telomerase, an enzyme necessary for the indefinite replicative capacity of many cancers and cancer stem cells. Imetelstat, the Company's lead drug candidate in this program, is being evaluated in two randomized Phase 2 studies, one in metastatic breast cancer, and the other in advanced non-small cell lung cancer. These indications represent two of the leading causes of death from malignancy worldwide. Imetelstat is also being evaluated in a Phase 2 study of essential thrombocythemia, a myeloproliferative neoplasm, and in a Phase 2 study of multiple myeloma. Geron expects top-line data from these four Phase 2 trials to be available before the end of the fourth quarter of 2012.
LRP-Directed Peptide-Drug Conjugate Program
Geron's LRP-directed peptide-drug conjugate program is based on molecules that deliver anti-cancer drugs to tumors in the brain, including metastases. In the conjugates, the anti-cancer drugs are linked to a peptide designed to be actively transported across the blood-brain barrier via lipoprotein receptor-related protein (LRP) pathways, predominantly LRP1. LRP1 is also upregulated in many tumors. GRN1005, the Company's lead drug candidate in this program, has three paclitaxel molecules linked to a proprietary 19 amino acid peptide, Angiopep-2. GRN1005 is entering two Phase 2 clinical trials this year, one for brain metastases arising from non-small cell lung cancer and the other for brain metastases from breast cancer. An estimated 200,000 patients in the United States are diagnosed each year with cancers that have metastasized to the brain. There are currently no approved drug therapies for treating brain metastases. Both studies are expected to start by the end of the 2011, with top-line data from these trials expected to be available before the end of the second quarter of 2013.
Oncology Discovery Program
Geron has an active discovery research program that uses proprietary chemistry to address important molecular targets in cancer. The goal of this program is to generate new IND candidates for Geron's clinical oncology pipeline.
About Geron's Cell Therapy Programs
Geron's human embryonic stem cell programs, for which the Company is seeking partnerships, include oligodendrocyte progenitor cells (GRNOPC1) for central nervous system disorders, cardiomyocytes (GRNCM1) for heart disease, pancreatic islet cells (GRNIC1) for diabetes, dendritic cells (GRNVAC2) as an immunotherapy vehicle and chondrocytes (GRNCHND1) for cartilage repair.
Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains 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 Geron's plans or expectations for or of: dates to begin or obtain top-line data from any of the Phase 2 oncology clinical trials; having sufficient cash to fund the Company for 20 months to reach milestone and value inflection points without the necessity of raising additional capital; expecting to end 2011 with $150 million in cash and investments; incurring one-time cash expenditures of approximately $5 million and $3 million in 2011 and 2012, respectively; Geron's ability to partner its stem cell business; clinical development; and future operating results and expenditures, constitute forward-looking statements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation: (a) regarding dates for Phase 2 clinical trial initiation or the availability of top-line data -- delays in enrollment, delays caused by institutional review boards or regulatory agencies, shortage of supply, dependence on clinical trial collaborators, or safety issues; (b) regarding financial expectations -- if any of (a) above, unanticipated expenses or charges may occur as a result of the resizing, or litigation were to occur, or if the Company determined it was in its best interest to raise additional capital; (c) regarding Geron's ability to partner its stem cell business -- third parties' reluctance to partner, Geron's intellectual property licensors' refusal to transfer intellectual property rights from Geron to a third party; and (d) those risks and uncertainties inherent in the development of potential therapeutic products, including without limitation, the protection of Geron's intellectual property rights. Additional information and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron's periodic reports filed with the Securities and Exchange Commission under the heading "Risk Factors," including the Annual Report on Form 10-K for the year ended December 31, 2010 and quarterly report on Form 10-Q for the quarter ended September 30, 2011. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
SOURCE: Geron Corporation
Geron Corporation Anna Krassowska, Ph.D. Investor and Media Relations 650-473-7765 info@geron.com |
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From: Savant | 11/29/2011 11:18:51 AM | | | | Research from BioMed Tracker and BIO claims that the cancer drug success rate is a mere 4.7 percent. Upon revealing the study, the agency's Oncologic Drugs Advisory Committee endorsed several FDA proposals for tightening the accelerated approval standards.
Studies from the Friends of Cancer Research advocacy group find that new cancer drugs are approved in just six months on average in the United States -- half the time it takes for the same drugs to be approved in Europe. "When we realized we were correct, we thought, 'No one is going to believe us because this goes against urban legend,'" said Ellen V. Sigal, chairwoman and founder of Friends of Cancer Research.
User fees from the Prescription Drug User Fee Act of 1992 have helped provide the FDA with resources to shorten drug review times. The Act is up for reauthorization next year, and the Friends of Cancer Research argue that the speed of drug review times might not be as high a priority as achieving other objectives in advance regulatory science.
paragonreport.com
* I suppose from a business standpoint, switching the focus to cancer drugs makes sense, but it's a pity, for those in need, that stem cell research could help. |
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To: FJB who wrote (3331) | 12/12/2011 9:38:41 AM | From: Savant | | | Geron Initiates Phase 2 Trial of GRN1005 in Brain Metastases From Breast Cancer
MENLO PARK, Calif., Dec 12, 2011 (BUSINESS WIRE) -- Geron Corporation (GERN) today announced the initiation of GRABM-B (GRN1005 Against Brain Metastases -- Breast cancer), a Phase 2 clinical trial to evaluate GRN1005 in patients with brain metastases arising from breast cancer. GRN1005 is the company's lead LRP-directed peptide-drug conjugate (LRP-directed PDC) that consists of the cytotoxic drug, paclitaxel, linked to a peptide (Angiopep-2) that targets the LRP receptor to cross the blood-brain barrier (BBB) and to target tumors in the brain.
"There is a need for effective drugs for patients with cancer metastases in the brain," said Stephen M. Kelsey, M.D., Geron's Executive Vice President, Head of R&D and Chief Medical Officer. "We have been encouraged by the preliminary evidence of anti-tumor activity against brain metastases observed in the Phase 1 clinical trial of GRN1005, and we hope to confirm these results in the GRABM-B Phase 2 study in patients with brain metastases from breast cancer."
Phase 2 Clinical Trial Design (GRABM-B)
The purpose of the Phase 2 study is to assess the efficacy, safety and tolerability of GRN1005 in patients with brain metastases from breast cancer. The trial is designed to include 100 patients with HER2 positive or HER2 negative metastatic breast cancer (MBC) disease, who will be assessed in two separate cohorts of 50 patients each. Approximately half of the patients in each cohort will have received prior Whole Brain Radiation Therapy. GRN1005 will be evaluated as a single agent in patients with HER2 negative metastatic breast cancer. For patients with HER2 positive disease, GRN1005 will be assessed in combination with trastuzumab (Herceptin(R)), which is the standard-of-care therapy for HER2 positive extra-cranial MBC disease.
GRN1005 will be administered at a dose of 650 mg/m(2) by intravenous (IV) infusion every three weeks. The primary efficacy endpoint for the trial is intra-cranial response rate. Important secondary endpoints include duration of intra-cranial response, three month intra-cranial progression-free survival and six month overall survival.
Rationale for the Study
Cancer in the brain, particularly metastases, currently represents a significant unmet medical need, because drugs that might be effective against these tumor types are not able to efficiently cross the blood-brain barrier and enter the tumor. Preclinical and Phase 1 data indicate that GRN1005 transports paclitaxel into tumors inside the brain through LRP1-mediated transport. GRN1005 also has activity against tumors outside the brain.
Data on safety and tolerability, and preliminary evidence of anti-tumor activity of GRN1005 were documented in two separate Phase 1 multi-center, open-label, dose escalation clinical trials, conducted by Angiochem, Inc., in patients with heavily pre-treated progressing, advance-stage solid tumors and brain metastases (n=56; including breast cancer) and in patients with recurrent or progressive malignant glioma (n=63). Final data were presented at the 2011 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in November.
In patients with brain metastases from solid tumors, overall response rate was 20% (4/20) by one dimensional assessment when treated with a dose of 650 mg/m(2) of GRN1005 administered as single-agent therapy once every three weeks. The anti-tumor activity was observed against metastases inside the brain as well as in organs outside of the brain, such as the liver, lung and lymph nodes. Among the patients who responded to treatment with GRN1005, were patients who had previously progressed on taxane therapy.
Geron's clinical development plan for GRN1005 includes two Phase 2 clinical trials in patients with brain metastases arising from either breast cancer (GRABM-B) or non-small cell lung cancer (GRABM-L). Top-line data from both studies are expected to be available by the end of the second quarter of 2013.
For more information about the GRABM-B Phase 2 trial, please visit clinicaltrials.gov.
About Brain Metastases and Breast Cancer
There are nearly 200,000 new cases per year in the United States of cancers arising in other organs that metastasize to the brain. Breast cancer is the primary tumor type in 15-20% of patients with brain metastases and is second only in incidence to brain metastases from lung cancer. There are currently no drugs approved for brain metastases, which represent a major unmet medical need.
Drugs are unable to reach the brain because of the blood-brain barrier (BBB). Cytotoxic drugs such as paclitaxel that are effective against breast cancer cannot reach the brain at clinically therapeutic levels, which is why tumors in the brain, such as cancer metastases, are very difficult to treat. Transport across the BBB and into tumors is critical for developing effective treatments for cancers in the brain.
About GRN1005
GRN1005 (previously known as ANG1005) is an LRP-directed peptide-drug conjugate (LRP-directed PDC) being developed for the treatment of cancers in the brain. GRN1005 is designed to deliver cytotoxic drug across the BBB and into tumors by exploiting a native mechanism by which essential substances, such as lipids and hormones, are actively transported into the brain through receptors. GRN1005 is comprised of three molecules of paclitaxel linked to a proprietary 19 amino acid peptide (Angiopep-2) that is designed to target the lipoprotein receptor-related protein 1 (LRP1), one of the most highly expressed receptors on the surface of the BBB. Binding to LRP1 facilitates receptor-mediated transport, or transcytosis, across the BBB into the brain tissue. LRP1 is also up-regulated in many tumors, therefore once in the brain, GRN1005 may gain entry into tumor cells using the same receptor by a process known as endocytosis. GRN1005 is a prodrug, which becomes activated in cells after it is cleaved by esterases to release active paclitaxel from the peptide.
About Geron
Geron is developing first-in-class therapies for the treatment of cancer. The company is advancing a telomerase inhibitor, and a peptide-drug conjugate to penetrate the blood-brain barrier through multiple Phase 2 clinical trials in different indications. For more information about the company, visit geron.com.
Forward Looking Statements
Except for the historical information contained herein, this press release contains 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: Geron's plans or expectations for or of: dates to begin or obtain top-line data from the Phase 2 oncology clinical trials of GRN1005; clinical success of GRN1005; and the anti-tumor or paclitaxel-like activity of GRN1005, constitute forward-looking statements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation: (a) regarding dates for Phase 2 clinical trial initiation or for the availability of top-line data - delays in enrollment, delays caused by institutional review boards or regulatory agencies, shortage of supply, dependence on clinical trial collaborators, or safety issues; (b) regarding the activity of GRN1005 - those risks and uncertainties inherent in the development of potential therapeutic products, including without limitation, successful clinical trial results. Additional information and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron's periodic reports filed with the Securities and Exchange Commission under the heading "Risk Factors," including the Annual Report on Form 10-K for the year ended December 31, 2010 and quarterly report on Form 10-Q for the quarter ended September 30, 2011. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
SOURCE: Geron Corporation
Geron Corporation Anna Krassowska, Ph.D., 650-473-7765 Investor and Media Relations info@geron.com |
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From: tktrimbath | 12/31/2011 1:34:43 PM | | | | My semi-annual review of Geron
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 $0.195B) Geron is one of the most leading edge biotech companies that aims to treat critical diseases and ailments through nuclear transfer (cloning), telomerase management, and stem cell administration. They are an old startup without any active products, except for what is involved in clinical trials. I had hopes for their stem cell nerve regeneration clinical trial and was disappointed when they cancelled the study. The stock suffered appreciably. Their technologies and patent portfolios (particularly the cloning patents) are impressive. Management seems to be mature in the handling of potentially socially sensitive treatments. If they succeed, their products and services will revolutionize may types of severe afflictions, including cancer. Unfortunately, they are only in phase II at best, and therefore probably have years before an FDA approval and revenues. As Dendreon (DNDN) proved, innovative medical practices meet significantly higher regulatory and financial hurdles.
I think the most appropriate stock valuation is based on the present value of future revenues discount for risk. Currently in general the market is valuing future revenues as nearly zero or risk as nearly 100%. Even a battered biotech like Dendreon has a market cap of over $1B, which suggests that an FDA approval for a Geron treatment could produce a Geron market cap that is five times above today's valuation. Apply your own discounts as you see appropriate. I think the discount is balanced by the fact that any single treatment would most likely legitimize the other treatments in the pipeline.
DISCLOSURE LTBH since 1999 and continuing to hold because I may have enough stock if they succeed, and may have time to buy more at these low prices as they make progress and if I have discretionary cash (which I don't - let me check my lottery tickets) or if I have to rebalance my portfolio (like if DNDN was bought out for $120, ok how about $60). (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: Casaubon | 4/22/2012 1:15:04 PM | | | | DePinho and Sahin recently published on the adaptive mechanisms provoked by anti-telomerase therapy:
Cell, 2012, v.148, p.651
If anyone is interested in discussing the ramifications to GERN, I would be interested in participating in that conversation. Topics of interest would include how the FDA would respond to the potential for driving a resistance mechanism, given the potential for a sustained positive response in a subset of patients. Also, of interest would be potential oxidative defense drugs, which could be utilized in combination with anti-telomerase therapy, to potentially increase the efficacy of GRN163L. |
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From: Savant | 5/3/2012 10:36:35 AM | | | | Geron beats by $0.03, beats on revs Reports Q1 (Mar) loss of $0.15 per share, $0.03 better than the Capital IQ Consensus Estimate of ($0.18); revenues fell 16.9% year/year to $1.25 mln vs the $0.7 mln consensus. Research and development expenses for the first quarter of 2012 were $15.1 million, compared to $16.8 million for the comparable 2011 period. The decrease in research and development expenses reflected reduced personnel-related costs and lower scientific supplies expenses resulting from the discontinuation of the company's stem cell programs, partially offset by increased clinical trial expenses for the enrollment of four Phase 2 clinical trials of imetelstat and two Phase 2 clinical trials of GRN1005 and increased drug product purchases and manufacturing costs related to imetelstat and GRN1005. |
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From: tktrimbath | 6/30/2012 10:56:08 AM | | | | 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 $0.226B) Geron is the leading edge of biotech, in my opinion. They are advancing technologies for cloning, nuclear transfer, stem cells, and telomerase. Done right they can repair damage, grow organs, and control the life and death cycle of cells. They are engaged in at least 6 phase two clinical trials for cancer treatments. They own an impressive patent portfolio. Management seems to properly understand and manage public perception and the debate around some of the more sensitive issues. They have little or no debt. They could redefine medicine, using the body to tend the body in ways that exceeds Dendreon's achievements technically, clinically, and financially.
But, they survive on dilution and must continue to do so for years unless licensing fees become more significant; they cancelled a stem cell clinical trial that attempted to regrow damaged nerves, or at least increase nerve function. The stem cell portion of the business is effectively up for sale, which decreases their internal diversification. I've held them for so long that I start to wonder about the age of their patents within their portfolio.
I conduct this exercise to see if the story has changed. Geron has made progress, but disruptive technologies are slowed in their move through the conventional regulatory bureaucracy. Dendreon was delayed by years. Geron seems to have encountered similar resistance. I think they set a record number of pages for the stem cell trial, which produced an incredibly tight set of trial conditions. I don't know of any significant competitor, but delays do not benefit the company and, if the treatments are successful, delays don't benefit the patient population.
There's little else to say for now, but if they announce positive results a lot will be said in the media. Of course, I thought that about the nerve treatment study, but they didn't produce the necessary positive results.
DISCLOSURE LTBH since 1999 and continuing to hold because I may have enough stock if they succeed, and may have time to buy more at these low prices as they make progress if I have discretionary cash (which I don't - let me check my lottery tickets). Unfortunately, I may have to sell if I can't find a job or sell my house. (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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To: tktrimbath who wrote (3337) | 6/30/2012 8:04:09 PM | From: Casaubon | | | Unfortunately, I have to disagree at this point. GERN has become just another biotech oncology cr@pshoot. The scientific literature supports multiple mechanisms by which this might pan out. However, clinically relevant results have been hard to come by. Let's hope the tumor initiating cell/DNA damage repair mechanisms plays out clinically in the next six months, or this things circling the bowl. |
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