| From: Savant | 11/4/2011 12:25:51 PM | | | | | | Geron Corporation Reports 2011 Third Quarter Financial Results and Events
MENLO PARK, Calif., Nov 03, 2011 (BUSINESS WIRE) -- Geron Corporation (GERN)
today reported financial results for the three and nine months ended September
30, 2011.
For the third quarter of 2011, the company reported a net loss of $19.5 million,
or $0.16 per share, compared to $18.3 million, or $0.19 per share, for the
comparable 2010 period. Net loss for the first nine months of 2011 was $65.0
million, or $0.52 per share, compared to $52.0 million, or $0.54 per share, for
the comparable 2010 period. The company ended the quarter with $180.8 million in
cash and investments.
Revenues for the third quarter of 2011 were $220,000, compared to $546,000 for
the comparable 2010 period. Revenues for the first nine months of 2011 were $2.2
million, compared to $2.5 million for the comparable 2010 period. Revenues for
the third quarter and year-to-date periods of 2011 and 2010 included funding from
collaboration agreements and royalty and license fee revenues under various
agreements.
Interest and other income for the third quarter of 2011 amounted to $237,000,
compared to $223,000 for the comparable 2010 period. Interest and other income
for the first nine months of 2011 was $820,000, compared to $619,000 for the
comparable 2010 period which reflects the increase in cash and investment
balances. The company has not incurred any impairment charges on its marketable
debt securities portfolio.
Total operating expenses for the third quarter of 2011 were $20.2 million,
compared to $18.7 million for the comparable 2010 period. Research and
development expenses for the third quarter of 2011 were $16.3 million, compared
to $13.7 million for the comparable 2010 period. General and administrative
expenses for the third quarter of 2011 were $3.8 million, compared to $5.0
million for the comparable 2010 period.
Total operating expenses for the first nine months of 2011 were $67.9 million,
compared to $54.0 million for the comparable 2010 period. Research and
development expenses for the first nine months of 2011 were $49.6 million,
compared to $40.7 million for the comparable 2010 period. General and
administrative expenses for the first nine months of 2011 were $18.3 million,
compared to $13.4 million for the comparable 2010 period.
Research and development expenses increased for the three and nine month periods
ending September 30, 2011, compared to the same periods in 2010, as a result of
higher clinical drug product purchases, increased clinical trial expenses related
to the enrollment of four oncology Phase 2 clinical trials of imetelstat and the
Phase 1 clinical trial for GRNOPC1 in patients with spinal cord injury and
start-up activities for two oncology Phase 2 clinical trials for GRN1005. The
company expects research and development expenses to increase in the future with
the initiation of the GRN1005 Phase 2 clinical trials in patients with brain
metastases and ongoing support of the imetelstat Phase 2 trials and the GRNOPC1
Phase 1 trial. The variations in general and administrative expenses for the
three and nine month periods ending September 30, 2011, compared to the same
periods in 2010, primarily reflected differences in non-cash stock-based
compensation expense recognized during the respective periods.
Third Quarter 2011 Highlights:
* Geron received its first disbursement under the Targeted Clinical Development
Award from the California Institute for Regenerative Medicine. In May 2011, CIRM
awarded $25.0 million to Geron to support the clinical development of GRNOPC1,
currently in a Phase 1 trial in patients with spinal cord injury. CIRM funding
will provide matching support in the form of a product-backed loan for clinical
trial costs, non-clinical studies, analytical development and the manufacture of
cells for clinical trials.
* The Stanford University and Santa Clara Valley Medical Center enrolled the
first Californian -- and fourth person overall -- in Geron's GRNOPC1 Phase 1
trial in patients with spinal cord injury. To date, GRNOPC1 has been well
tolerated with no serious adverse events.
* John A. Scarlett, M.D., was appointed as Geron's Chief Executive Officer and a
member of the board of directors. Dr. Scarlett brings over 25 years of executive
leadership experience in the pharmaceutical and biotechnology industry to Geron.
Conference Call
At 6:00 a.m. PDT / 9:00 a.m. EDT on Friday, November 4, John A. Scarlett, M.D.,
Geron's chief executive officer, and David L. Greenwood, Geron's president and
chief financial officer, will host a conference call to discuss the company's
third quarter and year-to-date results.
Participants can access the conference call via telephone by dialing 800-706-7748
(U.S.) or 617-614-3473 (international). The passcode is 53572623. A live
audio-only Webcast is also available through a link that is posted on the Events
page in the Investors section of Geron's Website at geron.com. The
audio Web broadcast of the conference call will be available for replay until
December 5, 2011.
About Geron
Geron is developing first-in-class biopharmaceuticals for the treatment of cancer
and chronic degenerative diseases. The company is advancing anti-cancer therapies
through multiple Phase 2 clinical trials in different cancers by targeting the
enzyme telomerase and with a compound designed to penetrate the blood-brain
barrier (BBB). The company is developing cell therapies from differentiated human
embryonic stem cells, with the first product in a Phase 1 clinical trial for
spinal cord injury. For more information, visit geron.com.
Use of Forward-Looking Statements
This news release may contain forward-looking statements made pursuant to the
"safe harbor" provisions of the Private Securities Litigation Reform Act of 1995.
Investors are cautioned that statements in this press release regarding potential
applications of Geron's telomerase, oncology, and human embryonic stem cell
technologies, including plans and expectations for future clinical development
and future operating results and expenditures, constitute forward-looking
statements that involve risks and uncertainties, including, without limitation,
risks inherent in the development and commercialization of potential products,
the uncertainty and preliminary nature of clinical trial results or regulatory
approvals or clearances, need to raise additional capital, dependence upon
collaborators and protection of our intellectual property rights. Actual results
may differ materially from the results anticipated in these forward-looking
statements. Additional information on potential factors that could affect our
results and other risks and uncertainties are detailed from time to time in
Geron's periodic reports filed with the Securities and Exchange Commission,
including Geron's 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, except as required by law,
Geron disclaims any obligation to update these forward-looking statements to
reflect future events or circumstances.
Financial table follows.
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
THREE MONTHS ENDEDNINE MONTHS ENDED
SEPTEMBER 30,SEPTEMBER 30,
(In thousands, except share and2011201020112010
per share data)
------------------------------------------
Revenues from collaborative agreements$--$203$300$653
License fees and royalties2203431,8871,812
------------------------------------------
Total revenues2205462,1872,465
Operating expenses:
Research and development16,34513,72849,64440,662
General and administrative3,8115,02118,25113,359
------------------------------------------
Total operating expenses20,15618,74967,89554,021
------------------------------------------
Loss from operations(19,936)(18,203)(65,708)(51,556)
Unrealized gain (loss) on derivatives, net291(97)570133
Interest and other income237223820619
Losses recognized under equity method investment--(243)(503)(1,135)
Interest and other expense(114)(24)(178)(76)
----------- ------------ ------------- ------------ --
Net loss$(19,522)$(18,344)$(64,999)$(52,015)
== =========== ==== ========== ==== =========== ==== ========== ==
Basic and diluted net loss per share$(0.16)$(0.19)$(0.52)$(0.54)
== =========== ==== ========== ==== =========== ==== ========== ==
Shares used in computing basic and diluted net loss per share125,101,17797,476,668124,259,69896,400,276
== =========== ==== ========== ==== =========== ==== ========== ==
CONDENSED CONSOLIDATED BALANCE SHEETS
SEPTEMBER 30,DECEMBER 31,
(In thousands)20112010
--------------
(Unaudited)(Note 1)
Current assets:
Cash, restricted cash and cash equivalents$34,768$46,764
Current marketable securities108,127140,599
Other current assets4,4097,654
--------------
Total current assets147,304195,017
Noncurrent marketable securities37,92133,911
Property and equipment, net2,2473,088
Deposits and other assets9321,568
--------------
$ 188,404$ 233,584
====== ============= =======
Current liabilities$10,003$40,849
Noncurrent liabilities3,194--
Stockholders' equity175,207192,735
--------------
$ 188,404$ 233,584
====== ============= =======
Note 1: Derived from audited financial statements included in the company's
Annual Report on Form 10-K for the year ended December 31, 2010.
SOURCE: Geron Corporation
Geron Corporation
Anna Krassowska, Ph.D., 650-473-7765
Investor and Media Relations
info@geron.com |
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| From: Savant | 11/14/2011 12:00:52 PM | | | | | | RT..
Ground breaking studies out of Japan earlier this month showed the vast reach of
stem cell medicine. A research team at Japan's RIKEN Center for Developmental
Biology successfully used stem cells to synthesize a fully functioning organ
entirely from scratch. The team somehow managed to take mouse stem cells and
transformed them into a working pituitary gland, which is a small organ that
lives at the base of your brain and produces hormones that help you grow.
The Bedford Report |
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| From: Savant | 11/15/2011 8:23:11 AM | | | | | | Geron Presents Final Phase 1 Clinical Data on GRN1005 at AACR-NCI-EORTC
Nov 15, 2011 07:30:01 (ET)
MENLO PARK, Calif., Nov 15, 2011 (BUSINESS WIRE) -- Geron Corporation (GERN, Trade ) today announced the final results of two Phase 1 clinical trials of GRN1005, the company's lead LRP-directed peptide-drug conjugate (LRP-directed PDC), in patients with brain metastases from solid tumors and patients with malignant glioma, demonstrating preliminary but encouraging single agent clinical activity in both indications. Geron expects to initiate two Phase 2 clinical trials of GRN1005 before the end of the year in patients with brain metastases arising from breast cancer (Study GRN1005 Against Brain Metastases -- Breast Cancer; GRABM-B) or non-small cell lung cancer (Study GRN1005 Against Brain Metastases -- Lung Cancer; GRABM-L).
The final results from the Phase 1 studies of GRN1005 were presented at the 2011 AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics in San Francisco, CA.
"Geron's focus is on innovative anti-cancer therapies that can have a significant impact on patient outcomes. Cancer in the brain currently represents a substantial unmet medical need, because drugs that might be effective against those tumors are not able to efficiently cross the blood-brain barrier and enter the tumor," said Stephen M. Kelsey, M.D., Geron's Executive Vice President, Head of R&D and Chief Medical Officer. "The Phase 1 data showed that GRN1005 can penetrate brain tissue and brain tumors in patients, and is well tolerated, with encouraging evidence of anti-tumor activity against brain metastases. Importantly, GRN1005 also has activity against cancers outside the brain, and so may control extra-cranial disease, which may be cause of death in patients who have brain metastases. We expect to initiate our Phase 2 program before the end of the year with the dosing of a first patient in our clinical trial of brain metastases from breast cancer."
Phase 1 Trial Designs
GRN1005 (previously known as ANG1005) is the conjugation of the cytotoxic drug paclitaxel to an LRP-directed peptide (Angiopep-2). GRN1005 was evaluated in two separate Phase 1 multi-center, open-label, dose escalation clinical trials, conducted by Angiochem, Inc., to identify the maximum tolerated dose (MTD) and obtain data on safety and tolerability, and preliminary evidence of anti-tumor activity in patients with heavily pre-treated progressing, advance-stage solid tumors and brain metastases (n=56; including breast, lung, skin and ovarian cancer) and in patients with recurrent or progressive malignant glioma (n=63; glioblastoma multiforme, anaplastic glioma, astrocytoma ependymoma).
In the Phase 1 studies, GRN1005 was administered by intravenous (IV) infusion on Day 1 of a 21 day treatment cycle. Dosing ranged from 30 -- 700 mg/m(2).
Phase 1 Results
Safety:
-- GRN1005 was generally well tolerated, with toxicity similar in nature to paclitaxel.
-- The MTD was determined to be 650 mg/m(2) administered by IV infusion once every three weeks.
-- Dose-limiting toxicity was due to neutropenia (a low count of neutrophils, a type of white blood cell). At the MTD, the frequency of severe neutropenia was greater than generally observed for naked paclitaxel, but was of short duration and manageable by cytokine growth factors.
-- Other toxicities included peripheral neuropathy, thrombocytopenia (a low platelet count) and gastrointestinal events (diarrhea, nausea, vomiting and stomatitis).
-- Infusion reactions of any grade with any dose were infrequent.
-- No central nervous system (CNS) toxicity was observed in patients assessed by neurocognitive testing and neurological examination.
-- No liver toxicity was observed in these studies.
-- No immunogenicity to GRN1005, assessed by anti-drug antibody production, was observed.
Clinical activity:
-- In patients with brain metastases from solid tumors, overall response rate (number of patients who had sufficient tumor shrinkage to qualify as partial or complete response) was 20% (4/20) by one dimensional assessment when treated at the MTD of 650 mg/m(2) administered once every three weeks. This included patients who had previously progressed on taxane therapy. Anti-tumor activity was observed against metastases inside the brain as well as in organs outside of the brain, including the liver, lung and lymph nodes.
-- In patients with recurrent malignant glioma, best response rate was 6% (1/17) by two dimensional assessment when treated at MTD of 650 mg/m(2) administered once every three weeks. In addition, one patient treated at 700 mg/m(2) dose achieved complete response (CR) and another patient treated at 420 mg/m(2) dose achieved PR.
Malignant glioma sub-study:
-- A sub-study was conducted in nine patients with malignant glioma to gather clinical evidence that GRN1005 crossed the BBB and entered the tumor. In this sub-study, patients received GRN1005 four to six hours prior to debulking surgery.
-- GRN1005 and free paclitaxel were detected in the primary brain tumor samples, indicating that GRN1005 successfully crossed the BBB and entered the tumor.
-- Plasma GRN1005 concentrations were greater than plasma paclitaxel concentrations consistent with the prodrug property of GRN1005 being systemically available for LRP1 receptor-mediated transcytosis across the BBB and into tumor cells.
-- GRN1005-associated paclitaxel concentrations in the excised tumor samples were greater than those reported for naked paclitaxel administration and well above those required for cytotoxicity.
Phase 2 Clinical Program
Geron's clinical development plan for GRN1005 includes two Phase 2 clinical trials in patients with brain metastases arising from either breast cancer or NSCLC. Top-line data from both studies are expected to be available by the end of the second quarter of 2013.
About Brain Metastases
There are approximately 200,000 new cases per year in the United States of cancers arising in other organs that metastasize to the brain. There are currently no drugs approved for brain metastases, which represent a major unmet medical need.
Over 95% of drugs, including cytotoxic drugs such as paclitaxel, cannot reach the brain at clinically therapeutic levels, which is why diseases of the brain, such as brain cancers, are very difficult to treat. Drugs are unable to reach the brain because of the blood-brain barrier (BBB). Transport across the BBB and into tumors is critical for developing effective treatments for cancer in the brain.
About GRN1005
GRN1005 is an LRP-directed peptide-drug conjugate (LRP-directed PDC) being developed for cancers in the brain. GRN1005 is designed to deliver cytotoxic drug across the BBB and into tumors by exploiting a natural 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 gains 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 now active paclitaxel from the peptide.
Geron in-licensed GRN1005 from Angiochem, Inc. in December 2010.
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, please visit www.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 any of the Phase 2 oncology clinical trials; clinical success of GRN1005; the anti-tumor or paclitaxel-like activity of GRN1005; 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 the activity of GRNO1005--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: 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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