Geron Neue Forschungsresultate!!!
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meislo: Geron präsentiert Resultate auf der AACR
Meineserachtens dürften die Resultate schon vom April sein und nichts Neues beinhalten
Warten wir es ab.
9:40 AM -
9:55 AM 2976 - Vaccination of patients with hormone-refractory prostate cancer using telomerase RNA transfected DC: Results from a Phase I clinical trial
Zhen Su, Philipp Dahm, Jens Dannull, Christian deBeck, Alfonso Crisci, Doris Coleman, Donna Yancey, John Higgins, Donna Niedzwiecki, Eli Gilboa, Johannes W. Vieweg. Duke University Medical Center, Durham, NC.
Novel Vaccine Strategies
Washington Convention Center, Room 207
Hiob: Mensch meislo, "phase I clinical trials" sind nix.
meislo: Mensch Hiob
Ein weiterer Termin und der dürfte spannender werden denn hier geht es um den Inhibitoe GNR 163 und für dieses Produkt waren für dieses Jahr ein IND angesagt !!
12:00 PM -
4:00 PM R4615 - Preclinical safety and stability profile of GRN163, a highly potent and specific telomerase inhibitor
David B. Karpf, Max B. Yonker, James Trager, Ellen Wunder, Denise Nazzal, Allison C. Chin. Geron Corp., Menlo Park, CA.
Drug Mechanisms and Cell Death Responses
Washington Convention Center, Hall B-C
AACR July 11-14 Washington, DC
meislo: GNR 163
Abstract Number: R4615
Preclinical safety and stability profile of GRN163, a highly potent and specific telomerase inhibitor
David B. Karpf, Max B. Yonker, James Trager, Ellen Wunder, Denise Nazzal, Allison C. Chin. Geron Corp., Menlo Park, CA.
Telomerase is expressed by virtually all aggressive cancers, where its activity is required for the continued proliferation and lethal behavior of cancer cells. However, telomerase is not expressed by most normal tissues. It therefore represents an attractive molecular target for cancer therapy. GRN163 is a 13-mer thio-phosphoramidate oligonucleotide that is targeted to the template region of hTR, where it binds with high affinity and inhibits telomerase activity with low pM IC50 in biochemical assays, and low- to sub ìM IC50 in multiple different cancer cells tested without uptake enhancers. In in vivo studies in athymic mice and rats, GRN163 has demonstrated substantial efficacy against myeloma, lymphoma, malignant glioma, prostate cancer, and cervical cancer tumors following intra-tumoral, intracranial (IC), intraperitoneal (IP) or intravenous (IV) administration. In all of these studies the treatment has been very well tolerated, with no signs of toxicity or weight loss in parenteral dosing studies with doses as high as 20 mg/kg/d x 8 weeks (IP) or 10 mg/kg/d x 10 weeks (IV), or in IC infusion studies with doses up to 2.2 mg over 7-14 days. Two single ascending dose acute toxicity studies in mice demonstrated excellent tolerability up to doses of 1000 mg/kg. A 4-week GLP toxicity study revealed no toxicity in rats treated with IV doses as high as 10.5 mg/kg/d or IC doses as high as 0.105 mg/d. A 7-day GLP toxicity study in dogs has completed the in-life phase, and demonstrated excellent tolerability of IV doses as high as 12 mg/kg/d and IC doses up to 3.43 mg/d, with no signs of the immunostimulation or thrombocytopenia typically seen with bolus injections of phosphorothioate oligos. Labs and histopathology results from these studies will be presented at the meeting. Additionally, Geron has completed several studies to assess the stability of GRN163 in freeze-dried and liquid formulations, with the objective of challenging the stability of potential GRN163 drug product formulations under target and accelerated conditions. A 24-week accelerated stability study of GRN163 formulated in PBS has so far demonstrated good physical, chemical and biochemical stability following storage at 2-8° C up to 18 weeks, and at 37° C up to 6 weeks. In summary, GRN163 represents a highly potent and specific telomerase inhibitor with demonstrated anti-tumor efficacy in several preclinical models of cancer. Its high specificity for telomerase predicts that it should avoid the toxicities associated with most current cancer therapies. To date, GRN163 demonstrates appropriate stability in both liquid and freeze-dried formulations, and the preclinical safety data support the prediction that GRN163 may represent an effective and well-tolerated cancer treatment.
Presenter: David B. Karpf
Affiliation: Geron Corp., Menlo Park, CA . Email: firstname.lastname@example.org
Copyright © 2003 American Association for Cancer Research. All rights reserved.
Citation for abstracts scheduled for publication: Proceedings of the AACR, Volume 44, 2nd ed., July 2003.
Citation for abstracts not scheduled for publication: Proceedings of the AACR, Volume 44, 1st ed., March 2003.
Hiob: Ja und, was soll das sagen?
meislo: Hiob! Du verstehst es eben nicht
meislo: Possibe upcomming Geron News
1. Geron cloning patent interference resolved in Geron's favor.
[Geron can start collecting 100% of Ag cloning royalties, instead of sharing]
2. Formal phase 1 results from Duke.
[Geron can move on to Phase II/III]
3. GRN163 IND Filed.
[Geron can start another Phase I cancer treatment]
4. Major new partnership to co-develop in-vivo Cancer Vaccine.
[Cash and bring products to market much quicker]
5. Milestone payment from GTI Novartis when Geron gets Telomerase promoter patent.
[Some cash, and Geron name recognition]
6. Stem cell repaired Spinal cord results published.
[Enabling the paralyzed to walk again]
7. Patent on an additional hESC derived cell type.
[Suspected to be cartilage, to be used in fixing knees and other damaged joints and bones]
These 7 items were mentioned by Okarma on Feb 27, 2003 at the Bio CEO conf.
Since then, we've had a preliminary report on the Geron/Duke prostate clinical trial, but not the formal report, a preliminary report on rat spinal cords repaired with embryonic stem cell derived neurons, but the study has not yet been published, and a patent application on hESC derived cartilage, but the patent has not ybeen issued yet.
Major Geron news since 3/15/03:
1. A new patent covering GRN163 and other telomerase inhibitors that may cure all types of cancer. 03/15/03
[Insures Geron will collect payments from the cancer treatments when they are released]
2. Duke/Geron TVAX preliminary results announced that tumor cells in the blood are reduced up to 1000 fold to undetectable levels. 04/07/03
[Geron's TVAX may prevent cancer from spreading, which is how most cancer victims die]
3. A new patent for pig cloning. 04/16/03
[Nice to have another Geron original NT patent, and pigs may be used for growing organs and other products for humans]
4. Publishing a paper on creating hematopoietic (blood and immune) cells from stem cells. 05/22/03
[May be used to prevent immune rejection and provide various blood products]
5. Erasing ALL of the debt, and filling the bank account with enough cash for nearly 3 more years. 05/27/03
[More time to develop and demonstrate Geron's science]
6. Presentation of Geron's science given at Needham Biotech conference, including a video of rats walking again after cut spinal cords were fixed with embryonic stem cell derived neurons. 06/03/03
7. Licensing the oligonucleotide IP bought from Lynx to Transgenomic. 06/04/03
[Got back the $1M cash that was spent on the Lynx IP by issuing shares to Transgenomic. Geron still owns the IP to use for GRN163 and other products]
8. Coverage initiated by Rodman & Renshaw with a $9.00 target. 06/09/03
[It took less than 6 trading hours to exceed the $9 target ($9.98 in pre-market the next morning)]
9. A new patent on purifying batches of cells created from stem cells. 06/10/03
[Makes hES derived cells much safer to transplant]
10. UK gives permission to Geron's UK facility to create new stem cell lines from leftover IVF eggs. 06/11/03
[Geron can now produce the wide range of cell types needed for human trials regardless of Republican wishes. Spinal cord repair is suspected to be the first human application]
11. AMA (260,000 doctors) endorses therapeutic cloning and embryonic stem cell research 06/17/03
12. Geron/Celera finished project to sequence, identify, and analyze genes associated with stem cells. 07/01/03
meislo: Na HIOB das war wohl nixxxxxx!!!
from Briefing dot com:
11:44 ET Geron Corp nearing valuation inflection point -- Rodman & Renshaw (GERN) 7.97 +0.79: Rodman & Renshaw believes that GERN shares are positioned to appreciate in the near-term as biotechnology investors become aware of the preclinical data from the co`s oncology and regenerative medicine programs. Notes that preclinical results of the co`s telomerase inhibitor, GRN163, will be presented at the upcoming AACR meeting on July 14. While the majority of products are early in development, firm believes GERN is nearing a significant valuation inflection point. Believes GERN could exceed its $9 target as a result of near-term news flow and the potential for a partnering agreement with big Pharma/biotechnology companies
Thursday July 10, 7:31 am ET
MENLO PARK, Calif.--(BUSINESS WIRE)--July 10, 2003--Geron Corporation (Nasdaq:GERN - News) announced today the publication of research results that advance the breadth of applications for human embryonic stem cells (hESCs) in Regenerative Medicine. Research funded by Geron in the laboratory of Dr. Jim McWhir and colleagues at the Roslin Institute in Edinburgh, Scotland and published today in the Summer 2003 issue of Cloning & Stem Cells demonstrates that osteoblasts (bone-forming cells) can be derived in vitro from hESCs. Such hESC-derived osteoblasts have potential applications in orthopedic tissue repair and in the treatment of osteoporosis.
The published study demonstrates that hESCs, when exposed in vitro to specific factors that stimulate bone formation, differentiate into cells that express molecular markers of bone-forming cells such as osteocalcin, parathyroid hormone receptor, and collagen 1. Importantly, x-ray diffraction analysis showed that the cells produce calcified nodules containing hydroxyapatite crystals -- the principal mineral component of bone.
"The derivation of osteoblasts from human embryonic stem cells reported today is the sixth cell type we have produced from hESCs that demonstrate normal in vitro molecular and biological properties, suggesting that these cell types should function normally when transplanted in vivo or used for drug discovery research," said Thomas B. Okarma, Ph.D., M.D., Geron's president and chief executive officer. "As we have shown previously with 1) cardiomyocytes for heart failure, 2) dopaminergic neurons for Parkinson's disease, 3) oligodendrocytes for spinal cord injury, 4) hematopoietic cells for transplantation applications, and 5) hepatocytes for drug discovery, these hESC-derived osteoblasts also display essential functional characteristics required for normal in vivo function. The successful derivation of osteoblasts will now enable the testing of these cells in animal models of non-union bone fracture as well as in systemic demineralization diseases such as osteoporosis. This accomplishment takes us another step towards realizing the promise of embryonic stem cells for the treatment of chronic disease."
Geron is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic products for applications in oncology and regenerative medicine, and research tools for drug discovery. Geron's product development programs are based upon three patented core technologies: telomerase, human embryonic stem cells and nuclear transfer.
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 such forward-looking statements in this press release regarding future applications of Geron Corporation's technology constitute statements involving risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, regulatory approvals and clearances, and the maintenance 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, including the quarterly report on Form 10-Q for the quarter ended March 31, 2003
FDA`s Lethal Impediment
The FDA stifles the discovery and avail-
ability of life-saving therapies by making the cost of getting them approved prohibitively expensive. The FDA is a major obstacle that prevents scientific findings from being translated into therapies to stave off age-related disease.
Compared to the advancement of
other technologies over the past 40 years,
medicine has progressed the slowest as
far as finding solutions for lethal diseases.
Those in the medical establishment may
debate this assertion, but the undeniable
fact is that for most types of cancer and
neurological diseases, there have been few
substantive improvements in survival, let
alone a cure.
Most of you remember attending funerals
in the 1960s to 1970s of those who perished
from cancer. If you thought the way I do, you
would have been certain that a cure for cancer
would have been found by year 2000. In fact,
the propaganda being released by the cancer
establishment at that time was that doctors
were on the verge of eradicating most cancers.
(This misguided optimism was primarily
based on the premise that chemotherapy
was the solution.)
When it comes to therapies designed to
slow or reverse aging, the FDA still does not
officially recognize aging as a disease
process. That means when a company tries
to gain approval to market an anti-aging
therapy, it first has to overcome the hurdle
of educating the FDA that aging is indeed a
lethal disease. The new therapy then has to
show sufficient efficacy to warrant approval.
To date, no one has succeeded in convincing
the FDA to approve an anti-aging drug.
In today`s world of ever-expanding tech-
nological achievement, the fact that medicine
remains bogged down in a regulatory
quagmire is a disgrace. More than 6,000
Americans die every single day, yet most of
these deaths could be prevented if it were
not for the strangulation of innovation
caused by the FDA, State regulatory agen-
cies, HMOs and apathetic physicians.
In each issue of Life Extension magazine,
we seek to uncover therapies that have shown
efficacy in well-controlled studies, but have
not yet been translated into conventional
medical practice. We know our efforts have
lengthened the lives of tens of thousands of
Life Extension members, yet what we offer is
only the tip of the iceberg when one looks at
the many life-extending drugs that are denied
to human beings in need.
Does Geron have an effective
Geron Corporation was originally estab-
lished to develop anti-aging drugs. Their
research, however, led them to discover a
potentially effective cancer treatment
On March 18, 2003, Geron released
On March 18, 2003, Geron released
the results of a study that an experi-
mental cancer vaccine might be effec-
tive against all types of cancer. This
bold announcement was based on a
study published in the journal Cancer
Gene Therapy (March 2003).
Geron`s vaccine works in a relatively
simple manner. It programs powerful
dendritic immune cells to attack cells
that express high levels of an enzyme
called telomerase. It just so happens
that 85% of human tumor cells overly
express telomerase whereas normal
healthy adult cells express very low
and/or transient telomerase levels.
Using telomerase as the target for
dendritic cells, Geron`s vaccine was
shown to provoke a massive attack
against prostate and kidney cancer
cells as well as breast, melanoma and
Most cancer cells require high levels
of telomerase to prevent them from
undergoing a healthy cellular removal
process called apoptosis (,programmed
cell death). The concept of attacking
cells high in telomerase makes cancer
cells particularly vulnerable, because
if they try to hide from this vaccine
by making less telomerase, then they
will die via normal apoptosis.
There are 558,000 people in the
United States who will die of cancer
over the next 12 months. Most of
them know they are likely to die.
We believe these cancer-stricken
individuals should have the right to
access any potentially effective therapy
under the guidelines of an objective
yet humanistic formal scientific
protocol. While there is no assur-
ance that Geron`s new vaccine will
cure cancer, we vehemently oppose
the power given to the FDA to
withhold this and other potential
The cancer establishment maintains
that only carefully controlled studies
can establish safety and efficacy. This
sounds reasonable and Life
Extension agrees with this concept.
The reality, however, is that the
FDAs current clinical trial require-
ment has produced flawed data that
enabled bad drags to be approved
while potentially effective drugs are
It takes so long for a new drug to
make it through the FDA approval
process, that if Geron`s new drug is
effective, most cancer patients reading
this column today will perish long
before the vaccine ever became
available. A real world example of
this occurred with an anti-cancer
agent for childhood leukemia called
Vulmon. This drug was first studied
in 1972, but only attained FDA
approval in 1992.
A Phase I study of Geron`s telom-
erase vaccine is currently underway
in patients with prostate cancer at
Duke University in North Carolina.
As described in previous issues of
Life Extension magazine, there are
two fundamental problems with
Phase I studies. First of all, they usu-
ally mandate that cancer patients fail
all "proven" therapies first. As has
been repeatedly shown in published
scientific studies, most so-called
"proven" cancer therapies do not
cure the disease. Since Phase I stud-
ies only test for safety, extremely
small doses of the anti-cancer agent
are used. This dooms virtually all the
terminal cancer patients who partici-
pate in Phase I trials to certain
death, but it does supply the FDA
with the safety data it mandates. In
other words, as long as the patient
dies of their cancer and not the new
drug, it is now permissible to move
on from Phase I to Phase II studies
where a potentially effective dose of
the anti-cancer drug can be given.
How the FDA perpetuates the
It is clear that the bureaucratic
process is incredibly long for the
approval of anti-cancer and other ther-
in the treatment of life-threatening injury, the very same approval process
has geographic boundaries that create
inhumane and unacceptable delays for
approval of a critical drug in one coun-
try that may be a few miles away from
a country where the drug is already
studied, reviewed and accepted.
For example, it took years for
Taxotere, one of the most impressive
anti-cancer agents used to treat breast
and prostate cancer, to finally gain
FDA approval in the United States.
This occurred despite hundreds of
studies supporting its efficacy pub-
lished in the European literature that
were not acceptable to the FDA.
Ironically, now that Taxotere has
gained FDA approval for the treat-
ment of metastatic prostate cancer in
the USA, countries such as Germany
do not permit its use in the treat-
ment of prostate cancer because no
published papers on this subject have
emanated from Germany. This
becomes even more incredulous
when one realizes that the pioneering
research on Taxotere emanated from
Germany`s next-door neighbor
France. The approval agencies such
as the FDA here and its counterparts
abroad are allowing bureaucratic
ego, and perhaps economics, to
interfere with the saving of life.
Think about this! American and
German physicians and scientists are
engaged in a battle against a common
enemy (cancer) while the respective
regulatory agencies (those that approve
the use of a drug) of each country
use national borders to say "yes" or
"no" to a live-saving drug or therapy.
This is a violation of human rights
within so-called civilized societies.
People from all over the world should
unite in protest to such atrocity.
Not only do FDA policies delay
life-saving drugs from being approved,
but they often keep effective medica-
tions off the market forever! If a
small company like Geron were to
run out of money before they could
conclude the expensive clinical trials,
their vaccine research program could
come to a grinding halt. Contrast tiffs
with a libertarian policy of giving
dying cancer patients the choice to
try Geron`s new vaccine immediately.
Under this system, it could be possi-
ble to determine whether the vaccine
worked within months, as opposed to
the multi-year period currently man-
dated by the FDA. If it worked, then
millions of cancer patients lives
would be saved. If the vaccine faded,
then these terminally ill cancer
patients will have died, as they would
The FDA does have a "compas-
sionate use" exemption that allows
cancer patients access to experimental
therapies. The problem is that the
FDA mandates that these cancer
patients first fail so-called "proven"
therapies. When cancer cells are
exposed to "proven" therapies like
radiation or chemotherapy, they
routate in a way that causes them to
become super-resistant to future ther-
apies. The patient`s healthy cells
(including dendritic cells of the
immune system) are often seriously
impaked when exposed to these
"proven" therapies, thus making ther-
apies like Geron`s telomerase vaccine
less likely to be effective.
Ovarian cancer kills more than
14,000 women each year. What makes
this type of cancer so insidious is that
there are few early warning signs,
meaning the disease is usually well
advanced when diagnosed.
In May 2003, an announcement was
made about a drug called phenoxodiol
that induced cell death in 100% of ovarian
cancer cells, including those cells
resistant to chemotherapy drags such as
Taxol and carboplatin. The tests were
conducted on human cell lines at Yale
University School of Medicine.
Phenoxodiol was discovered when
scientists were studying the anti-cancer
properties of isoflavonoid plant
extracts. They used data collected
from tiffs research to synthesize phe-
noxodiol. This drug works by altering
a signal pathway in cancerous cells
that prevent them from undergoing
apoptosis (programmed cell death).
These findings indicate that the drug
could be successful at treating other
cancer types as well. The study was
published in the May 1, 2003, issue
As stated earlier in tiffs article,
FDA-mandated Phase I studies involve
giving advanced cancer patients low
doses of a new drag to verify safety.
The dose is usually so small that
the drug has no chance of curing
end-stage cancer victims. In the case of
phenoxodiol, five Phase I human trials
have been completed with few if any
side effects. Preliminary results of a
trial conducted at the Cleveland Clinic
found that more than half of the 10
patients tested on the experimental
drug showed some response. Each of
these patients had different types of
advanced cancer that did not respond
It is very difficult to kill cancer cells
once they have become resistant to
chemotherapy. That is because the
cancer cells not killed by chemo
develop multi-survival mechanisms
that make them extremely difficult
to eradicate. What has surprised
researchers at Yale was that phenox-
odiol killed all ovarian cancer cells
(in the laboratory setting), regardless
of their immunity to chemo agents
phase II trial using phenoxodiol
is under way at Yale for women with
chemo-resistant ovarian cancer. In
this Phase II study, a therapeutic
dose of the drug is given with the
hope of improving survival or achiev-
ing a complete response.
The researchers also tested phe-
noxodiol in mice and found that when
dosed at 20 mg/kg every day for six
days there was a three-fold reduction
in tumor mass compared to a control
group. No side effects were noted.
Phenoxodiol functions via several
unique mechanisms to induce cancer
cells to undergo programmed cell
death (apoptosis). Normal cells under-
go apoptosis in a controlled manner so
they can be replaced with healthier
functioning cells. Cancer cells, on the
other hand, have gene mutations that
prevent them from self-destructing.
The ultimate goal of a cancer therapy
is to induce malignant cells to undergo
apoptosis, instead of indefinitely pro-
liferating out of control.
Under today`s antiquated system, a
new drug cannot be marketed until it
has been thoroughly investigated in
clinical trials. These trials can take
many years to complete. The results of
these numerous trials are then submit-
ted in a new drug application to the
FDA. The FDA sends these results to
a committee for review. The commit-
tee may ask for more studies, reject the
application or recommend the drug be
approved. The FDA then takes the
committee`s report and decides
whether to approve the drug as safe
and effective. This can happen quickly,
or it can become bogged down in the
FDA/s regulatory quagmire. Until the
FDA reaches its final verdict, no mar-
keting can take place. It can take 10 or
more years after a promising cancer
drug has been discovered before the
FDA is even in a position to approve
it. One reason for this long delay is
that after the drug as been discovered,
money has to be raised to fund the
clinical studies and negotiations with
the FDA have to be completed to get
approval for the study design itself.
Every month, more than 1,000
women succumb to ovarian cancer.
Phenoxodiol was discovered in April
2002. If this drug turns out to be
even partially effective, the delay in
getting it into cancer victims` hands
would have caused thousands of
Saving cancer patients` lives
Large amounts of monies have
been spent on cancer research, yet
the findings from this research are
not being incorporated into clinical
oncology practice. To help remedy
this problem, The Life Extension
Foundation searches the peer-
reviewed scientific literature in order
to interpret and compile this data
into life-saying protocols.
We have completely updated our
reference book, Disease Prevention and
Treatment. This 1,500-page "edifice"
contains an abundance of informa-
tion about better ways to treat
cancer that are often overlooked by
oncologists. While this book pro-
vides novel guidance about many
different disorders, there are 295
pages dedicated to informing cancer
patients of what they should do to
improve their chances of achieving a
remission or complete response.
It is sad to think of how many
cancer patients die when potential
solutions to their disease are already
published in the scientific literature.
The new Disease Prevention and
Treatment reference book breaks
down the barriers of ignorance that
causes those with cancer and other
life-threatening diseases to die while
effective therapies already exist to
better treat their disease.
The research, writing and editing
of the 2003 edition of Disease
Prevention and Treatment consumed
tens of thousands of hours at a cost of
over one million dollars. Commercial
publishers do not spend this kind of
time or money producing health
books. It is our intense dedication to
finding solutions for our members`
health problems that motivated us to
publish such a comprehensive text.
Turn the next page to read specific
information about the new Disease
Prevention and Treatment book that
every Life Extension member should
have a copy of.
For longer life,
Just as we were going to press, the FDA released news of` an intitiative to speed
the identification and development of new cancer drugs. It appears that the FD.4
is in the beginning stages of a long overdue reform of Byzantine bureaucracy in
order to properly fulfill its public service mission. We have printed the news
release in its entirety on this page. As you will read, what the FD.4 proposes is
not nearly enough. The FDA, in essence, is trying to put out a forest.fire with a
NCI and FDA Announce Joint Program to Streamline Cancer
Under an agreement between the Food and Drug Administration (FDA) and the National Cancer
Institute (NCl), which is part of the National Institutes of Health (NIH), the two agencies will share
knowledge and resources to facilitate the development of new cancer drugs and speed their delivery
FDA Commissioner Mark McClellan, M.D., Ph.D., and NCI Director Andrew yon Eschenbach, M.D., said
today that they will establish a multi-part Interagency Agreement to enhance the efficiency of clinical
research and the scientific evaluation of new cancer medications. The planned agreement, to be
announced formally at this week`s meeting of the American Society of Clinical Oncology in Chicago, will
enhance existing programs and add new joint programs to the existing close cooperative relationship
between NCl and FDA, both of which are part of the Department of Health and Human Services (HHS).
This new collaboration between two key HHS agencies means that federal researchers and regulators
will be working together more effectively than ever before," said HHS Secretary Tommy Thompson. "The
result will be a more unified, integrated, and efficient approach to the technology development and
approval process at a critical time for a disease that affects too many lives," Secretary Thompson said.
The agreement offers potential benefits for the more than one million Americans who are diagnosed
with cancer each year. "The FDA is committed to finding better ways to get safe and effective treatments
to patients with life-threatening diseases as quickly as possible," said McClellan. "At a time when the
opportunities to reduce the burden of cancer are greater than ever, sharing tools and resources with
our colleagues at the National Cancer Institute will help us fulfill that mission," he said.
"The effort between NCI and FDA in cancer therapies is a prototype that should inform and eventually
be applied across all areas of research," said NIH Director Elias A. Zerhouni, M.D. "Dr. McClellan and
I are committed to NIH and FDA working closely to find innovative ways to more rapidly make the fruits
of our discoveries available to the public."
"The collaboration will help the two agencies take full advantage of their combined knowledge base at a
time when many new kinds of anti-cancer agents are in the pipeline," said von Eschenbach. "Molecularly
targeted drugs and other novel agents offer great promise, but they also present new challenges that
require more collaboration between those involved in their discovery and development," he said.
(end of article)
(missed this sidebar)
What the public thinks about the FDA---
Beginning May 8, 2003, Life Extension initiated an Internet poll on a website (www. deathdock.com) that has about 400,000 new visitors each month. The people visiting this site are not part of any anti-FDA group, nor were they exposed to anti-FDA propaganda. These people were asked a simple question as to whether terminally ill cancer patients should have the right to any drug that might save their life. After 22,506 votes were tabulated, here are the results:
Terminally ill cancer patients
Should have access to any drug that might save their life: 89%
Should only have access to drugs approved by the FDA: 11%
We live in a constitutional republic where the people`s wishes are supposed to be adhered to (as long as they don`t infringe on the rights of others). If 89% of the American public thinks terminal cancer patients should have access to any drug that could save their life, then there is no reason for the law not to be changed to allow this. Companies that engaged in fraud could be prosecuted under consumer protection
laws that already exist. The FDA could post its opinion about the safety and efficacy of purported cancer therapies on their website (www. fda.gov). The civil litigation risks to companies that knowingly said bogus products would preclude large-scale unsavory activities that a minority of Americans fear. The greater fear Americans face is being diagnosed with cancer only to find out that a potential cure is too
many years away to save their lives.
Of interest was an identical poll on Life Extension`s website (www. lef. org) in which 98% of people voted to allow cancer patients to have access to any drug that might save their life. This is not surprising considering health conscious people`s animosity towards the FDA.
meislo: News zu GNR 163 wie angekündigt
Monday July 14, 7:30 am ET
MENLO PARK, Calif.--(BUSINESS WIRE)--July 14, 2003--Geron Corporation (Nasdaq:GERN - News) today reported new preclinical data on both the safety and stability of its telomerase inhibitor anti-cancer drug, GRN163. The in vivo and in vitro studies were presented on July 14 at the 94th Annual Meeting of the American Association for Cancer Research (AACR) in Washington, D.C. The results demonstrate excellent safety and tolerability of daily intravenous (IV bolus) dosing in rats for 4 weeks and, in a separate study, in dogs for 7 days, as well as good tolerability of continuous intracranial delivery for the same time periods in both species. Moreover, a series of stability studies demonstrated that GRN163 has appropriate stability in both liquid and powder formulations.
It has been widely recognized that an effective telomerase inhibitor could be an important anti-cancer drug, because cancer cells rely on the enzyme telomerase to continue to replicate. A specific telomerase inhibitor can potentially be effective with few side effects, because telomerase is expressed in essentially all cancer cells but not in most normal human cells. Geron has previously published data on GRN163 that show it to be highly effective at specifically inhibiting telomerase with little or no toxicity, as well as being highly stable, potent, and bioavailable. The current studies were designed to evaluate more formally the systemic and local tolerability of the compound, preparatory to initiating its entry into clinical testing.
"We looked at continuous intracranial delivery and daily IV treatment in both the rat and canine GLP toxicity studies and identified doses for each that appear to be completely devoid of toxicity," said David B. Karpf, M.D., Geron's executive medical director of oncology, who presented the data at the AACR meeting. "If there were toxicity due to telomerase inhibition, these studies would have shown it, because GRN163 inhibits rat and dog telomerase as potently as it inhibits human telomerase. No laboratory abnormalities were seen at any dose level in either study. Even the highest dose given to the dogs, 12 mg/kg per day by bolus IV injection, did not produce any meaningful activation of complement (a group of proteins in normal blood serum and plasma that can cause damage to normal tissues) or any evidence of immune stimulation, both of which are commonly seen with most oligonucleotide drugs currently in development. In fact, it is largely to avoid the complement activation effect that these other oligonucleotide drugs are usually administered by continuous IV infusion, as opposed to intermittent IV injections. The absence of toxicity seen with bolus dosing in the IV dog study indicates that GRN163 may be able to be administered as intermittent IV injections. This treatment schedule will be more convenient for patients and physicians than a continuous IV infusion."
"These results presented at the AACR meeting confirm our confidence in GRN163, which we and our collaborators have consistently shown to inhibit telomerase in cells and in animals bearing human tumors," said Thomas B. Okarma, Ph.D., M.D., Geron's president and chief executive officer. "In all of the cancer types we have tested so far, GRN163 is effective at doses that cause no gross toxicity. We are encouraged that these much more stringent GLP toxicity studies have confirmed that GRN163 is very well tolerated when delivered intravenously to animals, because the systemic approach is clearly more feasible for treating most cancers. We look forward to completing our preclinical animal testing and beginning the clinical development of GRN163."
GRN163 Results To Date
A summary of the published data follows, highlighting Geron's work on telomerase inhibition and recent developments with GRN163.
Geron scientists have designed GRN163 to have significant advantages over earlier-generation oligonucleotide drug candidates reported elsewhere. GRN163 inhibits purified telomerase at extremely low concentrations and appears not to inhibit other critical enzymes. This suggests that, unlike most other cancer therapies today, GRN163 should have little or no toxicity in normal (telomerase-negative) tissue. These predictions are confirmed in the GLP toxicity studies presented today.
GRN163 is one of a family of thio-phosphoramidate (NPS) oligonucleotide compounds, designed to combine the best features of phosphoramidate (NP) and phosphorothioate (PS) oligonucleotides. Compared to PS compounds, NPS oligonucleotides are more stable and specific telomerase inhibitors. Moreover, they also are more acid resistant than similar NP compounds. The thio-phosphoramidate chemistry used to synthesize GRN163 results in improved cellular uptake and biodistribution, resistance to degradation, and enhanced binding affinity to telomerase.
Because GRN163 works like a small molecule drug and interferes directly with the function of the telomerase enzyme, it can be much shorter than most antisense oligonucleotide therapeutics. In fact, GRN163 is only 13 nucleotides long.
Geron and its collaborators so far have tested GRN163 in vitro on 13 different types of human cancers, and demonstrated dramatic inhibition of telomerase activity in all of them. Continued treatment results in senescence and apoptosis (death) of the tumor cells. In contrast, a number of normal cell lines treated at higher concentration showed no toxicity. Geron and its collaborators have also tested GRN163 in animal models of human prostate cancer, multiple myeloma, lymphoma and malignant glioblastoma (brain cancer), and demonstrated anti-tumor effects at doses that are not associated with any apparent toxicity. Studies in additional tumor types are underway.
Geron has broad proprietary rights in its telomerase platform technology, including issued patents to the sequence of the RNA component of human telomerase (hTR), oligonucleotides derived from hTR, such as GRN163, and the use of these oligonucleotides to treat cancer in patients through telomerase inhibition. More broadly, Geron has over 120 issued patents worldwide on various aspects of telomere biology, telomerase and telomerase inhibition and oligonucleotide chemistry, and more than 110 pending patent applications. Geron acquired the intellectual property portfolio covering NP and NPS oligonucleotides from Lynx Therapeutics in 2002.
About Geron Corporation
Geron is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic products for applications in oncology and regenerative medicine, and research tools for drug discovery. Geron's product development programs are based upon three patented core technologies: telomerase, human embryonic stem cells and nuclear transfer.
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 such forward-looking statements in this press release regarding future applications of Geron's technology constitute forward-looking statements involving risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, need for regulatory approvals or clearances, and the maintenance 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, including the quarterly report on Form 10-Q for the quarter ended on March 31, 2003.
Additional information about the company can be obtained at www.geron.com.
Investor and Media Relations
David L. Greenwood, 650/473-7765
meislo: Hallo Biomedi gibt es Dich noch?
Geron Announces Publication of Data on Systemic Administration and Mechanism of Action of Its Telomerase Inhibitor Anti-Cancer Drug
Tuesday July 15, 7:31 am ET
MENLO PARK, Calif.--(BUSINESS WIRE)--July 15, 2003--Geron Corporation (Nasdaq:GERN - News) announced today the publication of detailed data on cell and animal testing of GRN163, its telomerase inhibitor anti-cancer drug. The results include the demonstration that GRN163 suppresses the growth of human prostate cancer when administered systemically to mice. The paper, authored by researchers at Geron and Kyowa Hakko Kogyo, Ltd., appears in the July 15, 2003 issue of Cancer Research.
The new paper describes experiments in which cells from a human prostate cancer were implanted into the flanks of mice, which were then treated by the intraperitoneal infusion of GRN163 over an 8-week period. Tumor growth rate in the treated animals decreased significantly compared to the control animals, and the treated animals showed no gross toxicity. In addition, the paper documents and extends Geron's early reports that GRN163 is an efficient inhibitor of telomerase in a variety of cultured human tumor cell lines, including those from breast, renal, prostate, lung, colon, cervix, and the hematologic system. The paper also presents data showing that GRN163 acts as a direct enzyme inhibitor by binding tightly to the active site of telomerase in a sequence-dependent manner.
"This publication in Cancer Research documents why we are enthusiastic about the prospects of GRN163 for the treatment of cancer," said Thomas B. Okarma, Ph.D., M.D., Geron's president and chief executive officer. "It is rare to identify a druggable target in oncology that is as restricted to cancer cells as telomerase - even rarer to develop a drug that binds so specifically to its target. These combined characteristics make GRN163 a very exciting molecule to advance into clinical studies."
GRN163 is one of a family of thiophosphoramidate (NPS) oligonucleotide compounds, designed to combine the best features of phosphoramidate (NP) and phosphorothioate (PS) oligonucleotides. Compared to PS compounds, NPS oligonucleotides are more stable and specific telomerase inhibitors. Moreover, they are more acid resistant than similar NP compounds. Geron acquired the intellectual property portfolio covering NP and NPS oligonucleotides from Lynx Therapeutics in 2002.
Geron is a biopharmaceutical company focused on developing, and commercializing therapeutic and diagnostic products for applications in oncology and regenerative medicine, and research tools for drug discovery. Geron's product development programs are based upon three patented core technologies: telomerase, human embryonic stem cells and nuclear transfer.
Biomedi: Geron @meislo
meislo: Hi Biomedi Schön von Dir zu hören
238 von meislo 17.07.03 00:16:02 Beitrag Nr.: 10.132.538 10132538
Dieses Posting: versenden | melden | drucken | Antwort schreiben GERON CORP. (DEL.) DL-001
Es fällt auf das kleinere Biotechfirmen wie auch Biotechs die noch keine Gewinne erwirtschaften aber auf Grund der guten News in den letzten Monaten gut bis sehrgut gelaufen sind, von den Investoren zur Zeit gemieden werden. Die Kurse fallen unter nicht zu hohem Volumen, was nicht gerade auf Verkaufsdruck schliessen lässt, dennoch fliesst das Geld in die grossen der Branche. Wie lange das andauert und wie tief die Kurse noch falen kann man nicht eindeutig sagen aber die Sommermonate waren eigentlich selten gute Monate für Biotechwerte im allgemeinen, da es auch eine nachrichtenlose Zeit ist und die grossen Konferenzen alle gelaufen sind.
Was dann hilft ist noch ein Blick auf den Chart und der steht im Moment eher auf der Schatten- als auf der Sonnenseite. Ich denke das es noch ein Stück abwärts gehen kann und Eile nicht geboten ist.Der MACD wie auch die Stochastik drehen in Richtung Süden und es sieht nicht so aus als würde sich das morgen schon ändern.
Aber sicher weiss man das bei Biotech nie so genau
Kicky: auch hier Erfolge bei Krebsforschung
Geron Corporation (Nasdaq: GERN ) announced today the publication of detailed data on cell and animal testing of GRN163, its telomerase inhibitor anti-cancer drug. The results include the demonstration that GRN163 suppresses the growth of human prostate cancer when administered systemically to mice. The paper, authored by researchers at Geron and Kyowa Hakko Kogyo, Ltd., appears in the July 15, 2003 issue of Cancer Research. The new paper describes experiments in which cells from a human prostate cancer were implanted into the flanks of mice, which were then treated by the intraperitoneal infusion of GRN163 over an 8-week period. Tumor growth rate in the treated animals decreased significantly compared to the control animals, and the treated animals showed no gross toxicity. In addition, the paper documents and extends Geron's early reports that GRN163 is an efficient inhibitor of telomerase in a variety of cultured human tumor cell lines, including those from breast, renal, prostate, lung, colon, cervix, and the hematologic system. The paper also presents data showing that GRN163 acts as a direct enzyme inhibitor by binding tightly to the active site of telomerase in a sequence-dependent manner.
meislo: Quartalszahlen von Geron
Neues Patent soll neuartige Telomerasehemmstoffe erfolgreich vor Konkurrenz schützen
alles über Elliott-Wellen - Anzeige -
Hier informieren !
Wie alle Unternehmen die sich mit Stammzellenforschung beschäftigen gehört auch die amerikanische Geron Corporation "bisher" noch in die Kategorie spekulatives Investment, doch dies könnte sich schon sehr bald ändern. Die jüngsten Erfolge in diesem Forschungszweig haben den spekulativen Charakter von Geron schon deutlich schrumpfen lassen und dies sollte sich künftig noch fortsetzen. Die Geron Corporation zählt wenn es um die Etablierung von Stammzellentherapien geht auf jeden Fall zu den aussichtsreichsten Unternehmen in einem diesem zukunftsträchtigen Forschungsgebiet.
Seit der Gründung im Jahr 1990 gelang es der Gesellschaft, die sich mit der Entwicklung und Vermarktung von therapeutischen und diagnostischen Produkten in den Bereichen Onkologie und regenerative Medizin beschäftigt, drei sich ergänzende Plattform Technologien aufzubauen. Vorerst setzt Geron bei der Entwicklung und Vermarktung potenzieller Produkte und Technologien zwar noch auf strategische Partner, doch in absehbarer Zeit sollen diese eigenständig entwickelt und unabhängig von Partnern vermarktet werden. Im Geschäftsbereich Onkologie konzentriert sich Geron auf die Hemmung des Enzyms Telomerase.
Erst heute konnte Geron in einer Pressemitteilung die erneute Ausgabe eines wichtigen U.S. Patents in Verbindung mit seinen Telomerasehemmstoffen bekannt geben. Das Patent mit der Nummer 6.608.036 beinhaltet 19 Ansprüche im Hinblick auf bestimmte Oligonukleotidwirkstoffe die auf die RNA der humanen Telomerase zielen, an diese binden und dadurch die Entstehung des Enzyms, das bei der Krebsentwicklung eine bedeutende Rolle spielt, verhindern.
Die Telomerase ist ein Enzym das in über 30 verschiedenen Krebsarten und in mehr als 80 Prozent aller bisher untersuchten Tumoren in relativ hohen Konzentrationen nachgewiesen werden konnte. Man weiß heute, dass die Aktivierung der Telomerase für das unbegrenzte Wachstum vieler Tumorzellen sowie deren Metastasierung, also die Ausbreitung der Krebszellen im gesamten Körper, verantwortlich ist. Die Hemmung der Telomerase sollte also in solchen Tumoren dazu führen, dass sich die Telomere in den Krebszellen verkürzen.
Da die Verkürzung dieser Zellbestandteile in normalen Zellen für die Alterung und letztlich für den Zelltod verantwortlich ist, hofft man bei Geron Telomeraseinhibitoren als neue Krebstherapeutika einsetzen zu können. In gesunden Zellen kommt Telomerase wenn überhaupt, dann nur in sehr geringen Mengen vor, weshalb bei den innovativen Geronwirkstoffkandiaten auch kaum zytotoxische Nebenwirkungen zu befürchten sind.
In mehreren Studien testet man bei Geron derzeit die beiden Schlüsselprodukte GRN163 und GRNB719 dieser neuen Wirkstoffklasse. Das neue Patent schützt nicht nur die Oligonukleotidwirkstoffkandidaten selbst, sondern stellt auch die Methoden zum Einsatz dieser Verbindungen in Patienten unter Patentschutz. Mit der Ausgabe des neuen Patents sind die Telomeraseinhibitoren zum Einsatz gegen das Krebswachstum nun erst einmal bis 2020 vor unliebsamer Konkurrenz geschützt.
Würde Gerons Vision GRN163 in einer nicht allzu fernen Zukunft auf den Markt zu bringen Realität werden, stünde Geron damit ein Milliardenmarkt offen. Nach Schätzungen der American Cancer Society wurden im Jahr 2000 etwa 1,2 Millionen neuer Krebsfälle diagnostiziert. Die jährlichen Kosten die mit Krebs assoziiert sind belaufen sich alleine in den USA auf kaum vorstellbare 107 Milliarden USD. Eine erste Phase 2 Studie mit GRN168 wird gerade in Kooperation mit dem National Cancer Institute durchgeführt.
Erst im Juli konnte Geron einen erneuten Studienerfolg mit dem Telomeraseinhibitor GRN163 vermelden. Die Daten wurden sowohl im Wissenschaftsmagazin Cancer Research als auch auf dem Jahrestreffen der Association for Cancer Research in Washington D.C. präsentiert und brachten der Geron Aktie damals einen nicht unerheblichen Kursgewinn ein. Die Telomerasetechnologie, für die Geron mittlerweile ein beachtliches Patentportfolio von mehr als 200 Patenten und Patentanträgen aufbauen konnte, ist aber nur eine von drei Schlüsseltechnologien denen sich das Unternehmen sehr erfolgreich widmet. Geron zählt vor allem auch im Bereich Stammzellenforschung und Kerntransfer mit zu den erfolgversprechendsten Unternehmen weltweit.
Ein erst vor wenigen Wochen ausgegebenes Patent für von Geron entwickelte ganz besondere hES-Zellen (hES sind humane embryonale Stammzellen) sprechen für das Unternehmen im Bereich Stammzellenforschung. Die Zellen von denen hier die Rede ist sind so ganz besonders, da sie eine besitmmte Gensequenz tragen, die nur dann ausgeprägt, also in ein Protein übersetzt wird, wenn die Stammzellen den Differenzierungsprozess nicht abgeschlossen haben. Durch den Nachweis dieses Proteins kann Geron dann die undifferenzierten Zellen von den therapeutisch wirksamen differenzierten Zellen unterscheiden und in einem nachfolgenden Schritt abtrennen. Damit hat Geron erstmals eine Technologie in Händen, die der zellbasierten Therapie auf Basis humaner embryonaler Stammzellen (hES-Zellen) tatsächlich die Sicherheit verleiht nur therapeutisch wirksame Zellen zum Einsatz zu bringen.
Die letzten Wochen und Monate brachten ein wahre Erfolgwelle für Geron, vor allem die erfolgreichen Ergebnisse der Stammzellendifferenzierung sprechen dafür, dass diese Therapie schon bald ihren spekulativen Charakter verlieren könnte. Schließlich trugen acht Prozent aller differenzierten Zellen auf ihrer Oberfläche den CD34 und CD35 Oberflächenrezeptor, was in etwa der Anzahl entspricht, die man in normalen hämatopoetischen Geweben wie Knochenmark, peripherem Blut und Nabelschnurblut findet.
Potenzielle Investoren sollten allerdings bedenken, dass es sich bei Geron derzeit noch um ein Einprodukt-Unternehmen handelt. Lediglich der Telomerasehemmer GRN-163 befindet sich in beginnender Phase II, die Stammzellentherapie muss den Sprung in die klinische Entwicklung erst noch vollziehen. Doch die jüngsten Forschungen sprechen eher für einen Erfolg, denn für eine Niederlage.
Simone A. Hörrlein
Staatl. gepr. Lebchem (TUM)
Kicky: Geron erhält Patent für Mittel gegen Krebszellen-
"The patent claims cover the oligonucleotide drugs as well as methods of using them to inhibit growth of cancer cells in patients," noted David J. Earp, J.D., Ph.D., Geron's vice president of intellectual property. "It will provide patent coverage for these compounds through 2020, subject to any available extension."
Geron recently reported progress in the pre-clinical testing of these oligonucleotide drugs, including GRN163, which act by inhibiting the telomerase enzyme, in the July 2003 issue of Cancer Research and at the 2003 Annual Meeting for the Association for Cancer Research held in Washington D.C.
Kicky: heute auf 15 dann 13,8
NEW YORK, Sept 23 (Reuters) - Shares of Geron Corp. (GERN,Trade) rose about 40 percent on Tuesday to their highest level in nearly two years after the biotechnology company's chief executive reported optimistic results from early-stage testing of its experimental anti-cancer therapies.
Chief Executive Thomas Okarma, speaking at a life sciences conference after the close of trading on Monday, said Geron believes it has "clinically validated" its approach to fighting cancer by generating an immune response to an enzyme in cancer cells called telomerase.
The Menlo Park, California-based company currently has three oncology programs in development, with the most advanced in an early stage trial of a prostate cancer vaccine.
Okarma said the vaccine safely induced strong anti-cancer immune responses in all patients in the very small-scale trial without a single adverse reaction.
Geron in April released results of its low-dose testing of 12 advanced cancer patients. Okarma on Monday discussed initial results of its 12-patient high-dose study.
ORCH auch am Kommen ,Volume change nur 1200%