| 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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| From: Savant | 7/31/2012 1:25:19 PM | | | | | | Geron beats by $0.01, misses on revs
Reports Q2 (Jun) loss of $0.14 per share, $0.01 better than the Capital IQ Consensus Estimate of ($0.15); revenues fell 71.9% year/year to $0.13 mln vs the $0.48 mln consensus. Total operating expenses for the second quarter of 2012 were $18.6 million, compared to $21.9 million for the comparable 2011 period. Research and development expenses for the second quarter of 2012 were $12.8 million, compared to $16.5 million for the comparable 2011 period. General and administrative expenses for the second quarter of 2012 were $5.8 million, compared to $5.3 million for the comparable 2011 period. |
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| From: Savant | 7/31/2012 1:32:52 PM | | | | | | July 3rd.. Geron Corp Registers Mixed-Securities Shelf For Up To $200M
Last Update: 7/3/2012 5:22:13 PM |
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