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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 14, 1997
GERON CORPORATION
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(Exact name of registrant as specified in its charter)
Delaware
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(State or other jurisdiction of incorporation)
0-20859 75-2287752
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(Commission File Number) (IRS Employer Identification No.)
200 Constitution Drive, Menlo Park, CA 94025
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (650) 473-7700
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N/A
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(Former name or former address, if changed since last report)
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ITEM 5. OTHER EVENTS
On August 14, 1997, Geron Corporation, a Delaware corporation (the
"Company"), announced the cloning of the gene for the human telomerase catalytic
protein. This rarely-expressed gene is believed to play a key role in the
regulation of cell lifespan, functioning as part of a molecular clock of cell
aging, its absence imparting mortality to some cells, and its presence imparting
replicative immortality to others.
Further details regarding this announcement are contained in the
Company's press release dated August 14, 1997 attached as an exhibit hereto and
incorporated by reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
(c) EXHIBITS.
Exhibit 99.1 Geron Corporation Press Release dated August 14, 1997.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
GERON CORPORATION
(Registrant)
Dated: August 21, 1997 By: /s/ David L. Greenwood
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David L. Greenwood
Chief Financial Officer, Treasurer and
Secretary (Principal Financial and
Accounting Officer)
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INDEX TO EXHIBITS
Exhibits.
99.1 Geron Corporation Press Release dated August 14, 1997.
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EXHIBIT 99.1
Geron Corporation
200 Constitution Drive
Menlo Park. CA 94025
Tel: (650) 473-7700
Fax: (650) 473-7750
PRESS RELEASE
CLONING OF HUMAN TELOMERASE
GENE REPORTED IN SCIENCE
TELOMERASE PLAYS A KEY ROLE IN AGING AND CANCER
MENLO PARK, CA -- August 14, 1997 -- Geron Corporation (NASDAQ:GERN) and the
University of Colorado, Boulder today announced the cloning of the gene for the
human telomerase catalytic protein, believed to be the long sought after "holy
grail" of cell aging research. This rarely-expressed gene is believed to play a
key role in the regulation of cell lifespan, functioning as part of a molecular
clock of cell aging, its absence imparting mortality to some cells, and its
presence imparting replicative immortality to others. "The cloning of the active
center of telomerase is a major milestone that sets the stage for more fully
understanding the molecular genetics of aging and cancer," said Nobel Laureate
Thomas Cech, Ph.D., professor at the University of Colorado, Boulder.
Telomerase is an "immortalizing enzyme" that imparts replicative immortality
when expressed in reproductive and cancer cells. Cells that do not express the
enzyme are mortal. Previous research by Geron and its collaborating scientists
has shown that the aging of mortal cells appears to be controlled by a molecular
clock consisting of telomeres - a chain of repeated DNA segments found at the
ends of the chromosomes. Each time a mortal cell divides, a small segment of
telomeric DNA is lost, and in the absence of telomerase, the shortened telomeres
signal the cell to become senescent and stop dividing. Cells that have no
replicative limit, such as reproductive cells, express telomerase, an enzyme
that synthesizes telomeres allowing replicative immortality. Telomeres can
therefore be envisioned as "molecular clocks" that limit the lifespan of cells
and affect the aging process, while telomerase can be envisioned as the "key"
that "rewinds" the telomere clocks.
In the report today in Science, researchers from Geron Corporation and the
University of Colorado, Boulder collaborated to clone and sequence the catalytic
protein component of the telomerase enzyme, the portion that extends the
telomere. "The telomerase enzyme is a unique partnership of RNA and protein. The
protein component has convincing similarity to viral reverse transcriptases, and
therefore we have named the gene `human Telomerase Reverse Transcriptase
(hTRT)'," said Dr. Cech, senior author of the paper. It is the only reverse
transcriptase thought to be essential for normal human biology.
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"We believe that hTRT and the RNA component (hTR) make up the core, or
functional enzyme," adds Calvin Harley, Ph.D., Geron's vice president and chief
scientific officer. The discovery of the catalytic component of the enzyme in
humans establishes the significance of the hTRT protein over various earlier
reported telomerase associated proteins. "These other proteins may be associated
with the enzyme, but the broad evolutionary conservation of the TRT family of
proteins and the strong correlation of hTRT expression with the immortal state,
indicates that it is the key telomerase protein," said Dr. Harley, "We are
excited by the prospect of using the recombinant components in drug screening
for telomerase inhibitors and activators."
Telomerase has previously been shown to be active in all types of cancer
examined and not expressed in most normal tissues. Telomerase is therefore
thought to be unique among anti-cancer targets for it's universality and
specificity to cancer cells. Because telomerase is required for cancer cells to
keep proliferating, Geron is seeking to discover anti-cancer drugs designed to
inhibit telomerase. Such drugs are expected to lead to the death of the cancer
cells through resumed telomere shortening, with little to no effect expected on
normal cells and tissues.
Since telomeres and telomerase are involved in manifold disorders of aging,
including cancer, many additional applications of this new technology are
envisioned. "We are excited about moving this discovery into important new
diagnostic and drug discovery applications including telomerase as a product,
because introduction of telomerase activity into mortal cells should extend
their replicative lifespan," said Ronald Eastman, Geron's president and chief
executive officer. "In addition, we will use this new technology, along with our
recently issued patent on the RNA component, to strengthen our proprietary
position in telomerase biology. We have an issued U.S. patent on the RNA
component of human telomerase, and have received or licensed exclusively U.S.
patents claiming the TRAP assay for telomerase activity, a telomerase inhibitor
drug discovery screen, and telomerase-based diagnostic and prognostic methods
for cancer."
Co-authors with Dr. Cech on the Science article, "Telomerase Catalytic Subunit
Homologs from Fission Yeast and Human" from the Howard Hughes Medical Institute
at the University of Colorado include Toru M. Nakamura and Dr. Joachim Lingner.
Co-authors from Geron are Drs. Gregg B. Morin, Karen B. Chapman, Scott L.
Weinrich, William H. Andrews and Dr. Harley.
Geron Corporation is a biopharmaceutical company focused on discovering and
developing therapeutic and diagnostic products based upon the company's
understanding of telomeres and telomerase in cells, fundamental biological
mechanisms underlying cancer and age-related diseases.
###
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BACKGROUNDER
CLONING OF HUMAN TELOMERASE: IMPACT ON DRUG DISCOVERY FOR
CANCER AND OTHER AGE-RELATED DISEASES
The cloning of human telomerase marks a critical milestone in Geron's program to
develop new therapies for cancer and other age-related diseases by controlling
telomerase expression in cells. Telomerase is an enzyme essential to the
replicative immortality of cancer cells. At the same time, telomerase is "turned
off" in normal body cells, which consequently lose their replicative capacity
after a certain number of cell divisions, becoming old, senescent cells whose
behavior may contribute to a variety of age-related diseases.
Telomerase is a rare and complex enzyme that has both RNA and protein
components. Geron was the first to clone the RNA component of human telomerase,
and this work was published in the prestigious journal Science (September 1,
1995). Geron's latest accomplishment -- the cloning of the critical catalytic
protein component of human telomerase -- is likewise published in Science
(August 15, 1997). This accomplishment will accelerate Geron's efforts to (i)
discover new drugs that will inhibit telomerase function, potentially leading to
breakthrough therapeutics for cancer, (ii) strengthen Geron's technological lead
in telomerase-based cancer diagnostics, and (iii) discover new drugs that
re-express telomerase in aging cells under controlled conditions, potentially
leading to breakthrough therapies to treat numerous age-related diseases.
TELOMERASE EXTENDS CELLS' ABILITY TO DIVIDE
The discovery of the protein, named "hTRT" for human Telomerase Reverse
Transcriptase, is the result of a collaboration between Geron scientists and the
laboratory of Nobel Laureate Dr. Thomas R. Cech at the University of Colorado,
Boulder.
The function of telomerase is to add a specific repeating DNA sequence to the
ends of chromosomes, the "telomeres." The primary DNA synthesizing machinery
common to all cells cannot accomplish this task. Telomeres protect chromosomes
from degradation, position chromosomes within the nucleus, and interact with
telomerase to allow telomere synthesis, functions without which a dividing cell
cannot survive. In the absence of telomerase, telomeres progressively shorten
with each cell division, eventually reaching a critical length associated with
"senescence." Senescent cells exhibit a change in gene expression that
contributes to age-related pathologies. Telomeres can therefore be envisioned as
"molecular clocks" that limit the lifespan of cells and affect the aging
process, and telomerase can be envisioned as the enzyme that "rewinds" the
telomere clocks. A dramatic revelation of this new work is that the human
telomerase catalytic protein hTRT has been extraordinarily conserved throughout
evolution, suggesting that telomerase is one of the most ancient of enzymes in
eukaryotic cells. This evolutionary conservation is believed to reflect hTRT's
critical role in human cells.
A further surprise is that telomerase is a member of the important family of
reverse transcriptase enzymes. Reverse transcriptases, like that found in HIV-1,
use RNA rather than DNA to direct the synthesis of the complementary DNA.
Telomerase is the only known reverse transcriptase required for normal human
development. It is also unusual in that it requires a specific RNA, the
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telomerase RNA component, for its catalytic activity. This RNA component is
essential in combination with the catalytic protein for telomerase activity.
Recombinant and synthetic forms of the human telomerase RNA (hTR) were patented
by Geron in 1996. Geron's issued patent on hTR and its pending applications for
hTRT put Geron in a unique position to exploit telomerase for therapeutic drug
development and diagnostic applications.
TELOMERASE INHIBITORS FOR CANCER: INDUCING THE DEATH OF CANCER CELLS Geron
targets telomerase in its anti-cancer program because the enzyme is believed to
be required for the unlimited replicative growth of cancer cells. The ideal
cancer target is a cellular process essential for cancer cells but not for
normal cells. Unfortunately, most current cancer therapies target the primary
DNA synthesizing and cell division machinery essential for both cancer and
normal cells. As a result, most current treatment regimens cause severe side
effects. In contrast, telomerase is not active in most normal cells, so it is
believed that a telomerase inhibitor will have a reduced side effect profile.
Unlike the few normal cell types that express telomerase transiently and/or at
very low levels, cancer cells have a constant and relatively high expression of
telomerase. Cancer cells also lack growth control and so keep dividing even when
their telomeres are critically short, leading to cell death following telomerase
inhibition. Normal cells, even those few that express telomerase, stop dividing
when telomeres reach a critically short length, so telomerase inhibition therapy
should not negatively impact normal cells. No other known cancer target has the
level of specificity of telomerase.
In addition to this specificity, telomerase is active in all cancers studied. A
telomerase inhibitor should therefore be active against all cancers that express
telomerase. No other known cancer target that has been described as specific to
cancer has this universality. The specificity and universality of telomerase
make it an ideal cancer target and present an important new opportunity to
develop a new class of cancer drugs. Geron's goal is to develop small molecule,
orally deliverable inhibitors of telomerase.
TELOMERASE ACTIVATORS FOR AGE-RELATED DISEASES: DELAYING SENESCENCE IN NORMAL
CELLS Understanding the mechanisms that control telomerase expression will,
Geron scientists believe, also allow Geron to discover telomerase activator
drugs that alleviate certain deleterious effects of normal human aging. Because
telomerase is not expressed in most normal cells, telomeres are gradually lost
in most human cells with age. Eventually, the telomeres become critically short,
and the cells stop dividing and senesce. Geron believes its cloning of the hTRT
gene will enable it to create recombinant products and discover small molecule
products that allow telomerase to be expressed in a controlled manner in any
cell. Expressing telomerase in a cell should lengthen telomeres, extend
replicative capacity, and thereby postpone cell senescence. In effect, these
cells will have a capacity to maintain their normal function longer, alleviating
certain effects of human aging.
In addition, Geron's discoveries allow for recombinant hTRT protein and hTR RNA
components to be used in new and improved drug screens for telomerase inhibitors
or activators. By identifying cellular components that interact with hTRT and
hTR, Geron expects to identify additional new drug targets as well.
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TELOMERASE-BASED CANCER DIAGNOSTICS
Because telomerase activity is expressed in cancer cells but not normal cells,
the hTRT protein should have broad utility in the field of cancer diagnostics.
Geron and its collaborators have already developed techniques to detect
telomerase activity in cells (the TRAPeze(TM) assay kit sold by Oncor), measure
telomere length (the TeloQuant(TM) assay kit soLD by PharMingen), and detect
activation of hTRT and hTR RNAs. Antibodies to hTRT have also been developed
that can detect the hTRT protein, leading to new product opportunities for the
diagnosis, prognosis, and monitoring of cancer patients.
With the discovery of the human Telomerase Reverse Transcriptase protein, Geron
has increased its lead in telomere and telomerase research, and in the discovery
and development of novel therapeutics and diagnostics for cancer and other
age-related diseases. Geron has protected its proprietary position in the field
with patent filings on this discovery which complement its issued U.S. Patents
claiming the TRAP assay for telomerase activity, a telomerase inhibitor drug
discovery screen, the telomerase RNA component, and diagnostic and prognostic
methods for cancer in which telomerase activity is detected or measured to
detect cancer cells or to prognose the likely disease outcome.
The Company desires to take advantage of the "safe harbor" provisions of the
Private Securities Litigation Reform Act of 1995. Specifically, the Company
wishes to alert readers the matters discussed in this white paper may constitute
certain forward-looking statements that are dependent on certain risks and
uncertainties. Actual results may differ materially from the results anticipated
in these forward-looking statements. Additional information on potential factors
that could affect the Company's results are included in the Company's Quarterly
Report on Form 10-Q for the quarter ended March 31, 1997.
Editor: If you would like a full copy of the Science article dated August 15,
1997, titled "Telomerase Catalytic Subunits from Fission Yeast and Human: A
Unique Branch of Reverse Transcriptases," please contact Science, News and
Information Office, at 202/326-6440.
Note: This release moved over Business Wire August 14, 1997.
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The Company desires to take advantage of the "safe harbor" provisions of the
Private Securities Litigation Reform Act of 1995. Specifically, the Company
wishes to alert readers the matters discussed in this press release may
constitute certain forward-looking statements that are dependent on certain
risks and uncertainties. Actual results may differ materially from the results
anticipated in these forward-looking statements. Additional information on
potential factors that could affect the Company's results are included in the
Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 1997.
Contact:
Ronald Eastman Carole Melis/Mike Jackman
President & CEO StratiPoint Group
415 473-7700 415 326-0420
