Imetelstat Clinical Trial Update - May 2011

BRIEF SUMMARY:
I decided to post the following information about the anti-cancer agent, IMETELSTAT (GRN163L). It should be considered as one additional treatment option for qualifying patients, and in my opinion, a very good option. As you will discover in the video produced by the Smithsonion Channel (listed below), there is a great deal of excitement about the new advances in the understanding and subsequent treatment strategy of cancer.
In the 1980's the discovery of "how chromosomes are protected by telomeres and the enzyme telomerase" took place by 3 scientists and subsequently received the 2009 Nobel Prize for
Physiology and Medicine for their work. The Nobel laureates were early Geron collaborators, Elizabeth H. Blackburn and Carol W. Greider, along with Jack W. Szostak.
Geron's work and that of others has shown that telomerase is not present, or is present at very low levels, in most normal cells and tissues, but that during cancer progression, telomerase is
abnormally reactivated in all major cancer types. Geron has shown that while telomerase does not cause cancer (which is caused by mutations in oncogenes and tumor suppressor genes),
the continued presence of telomerase enables cancer cells to maintain telomere length, providing them with indefinite replicative capacity. Geron and others have shown in various tumor
models that inhibiting telomerase activity results in telomere shortening and causes aging or death of the cancer cell. Although telomerase is expressed in nearly all cancer cells, it is not expressed in most normal cells. That gives telomerase the potential of being both a universal as well as a highly specific
cancer target. This specificity means that drugs and biologics that attack cancer cells by targeting telomerase may leave most other cells unaffected, and thus may have fewer side effects than conventional chemotherapeutic agents that typically affect both cancer and non-cancer cells.
< Previous passage excerpted from www.geron.com > Since the mid 1990's Geron has been plodding along with research into stopping cancer cells via telomerase inhibition and received FDA approval to began Phase I clinical trials in 2005. The results being reported have been nothing short of remarkable in the dose safety studies and also efficacy. The only notable side effect of Imetelstat is a dose related neutropenia. Imetelstat shows to inhibit cancer growth by inhibiting the enzyme needed to allow cancer to spread.

NEW ITEMS MADE TO THE DISCUSSION SINCE LAST UPDATE of April 2nd

Important: May 4, 2011 -- California CIRM has awarded Geron $ 25 million grant for regenerative medicine in their Phase I spinal cord injury trial
http://www.geron.com/investors/factsheet/pressview.aspx?id=1266

Highlights of the 2010 accomplishments included the following:

* Initiated randomized Phase 2 clinical trials of imetelstat (GRN163L) in non-small cell lung cancer and metastatic breast cancer.

* Opened single-agent Phase 2 clinical trials of imetelstat (GRN163L) in essential thrombocythemia and multiple myeloma.

* Presented final data from Phase 2 clinical trial of GRNVAC1 showing that targeting telomerase through a dendritic cell-based vaccine approach may prolong remission duration in some patients with high- risk AML, providing sufficient clinical rationale to move to GRNVAC2, an embryonic stem cell-based dendritic cell platform.

* Enrolled first patient in Phase 1 clinical trial of GRNOPC1 to assess the safety and tolerability of GRNOPC1 in patients with “complete” American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries.
* Presented clinical data from the Phase 1 trial of imetelstat (GRN163L) in combination with paclitaxel and bevacizumab in patients with breast cancer showing good tolerability and exposures of the drug, which exceeds levels that have been associated with tumor inhibition in several models of human cancers.
* Preclinical data publications demonstrated that imetelstat (GRN163L) inhibits multiple myeloma, breast and pancreatic cancer stem cell populations which can be associated with a survival benefit in animal models. Cancer stem cells, found in many types of cancer, are rare populations of malignant cells that resist chemotherapy and conventional anti-cancer agents making them important targets for novel therapies. Data demonstrates broad anti-cancer stem cell activity by imetelstat, thereby confirming preclinically the anti-cancer stem cell rationale for Geron’s Phase 2 clinical trials in patients with breast cancer and multiple myeloma.
* Preclinical study data presented by collaborators showing that GRNCM1 does not cause cardiac arrhythmias after transplantation into a rodent model of chronic heart damage.
* Preclinical data presented by collaborators on the small molecule telomerase activator, GRN510 (formerly TAT153), in an animal model of idiopathic pulmonary fibrosis. The data showed that administration of GRN510 increased telomerase activity in the lung tissue, reduced inflammation, preserved functional lung tissue, slowed disease progression and attenuated loss of pulmonary function.
* Identified process improvements for developing GRNIC1 resulting in increased c-peptide and endocrine hormone production.
* Entered into a global exclusive license with Angiochem, Inc. for rights to peptide technology to facilitate the transfer of anti-cancer compounds across the blood-brain barrier (BBB) to enable the treatment of primary brain cancers and cancers that have metastasized to the brain.
* Established multiple collaborations to develop hESC-derived cells for various potential therapies including, retinal pigmented epithelial cells for the treatment of macular degeneration, photoreceptors for retinitis pigmentosa, chondrocytes for the treatment of cartilage damage and joint disease and oligodendrocyte progenitor cells for multiple sclerosis, Alzheimer’s disease and Canavan disease.

Geron Webcast of Mar 29, 2011
http://phx.corporate-ir.net/phoenix.zhtml?c=67323&p=irol-eventDetails&Event Id=3915265&WebCastId=1103792&StreamId=1653784
This webcast show cased the oncology program of Phase II trials for Breast, NSCLC, and upcoming brain cancer trials due to metastatic breast or non-small lung cancer. It is presented by the oncology team, a special event, and they discuss how these clinical trials were designed. One of the slides indicated that the enrollment of the trials are ahead of schedule.
Webcast lasts 75 minutes and will be available until mid May.. Let me know if any there are any slides you may want from the presentation. Very impressive.
&&&&&&&
Randomized Phase II trials are now under way for NSCLC, and MBC; and, single ARM Phase II trials for ET and AML.

You can do your own web search on the past clinical trials of GRN163L (Imetelstat). A good starting place is www.geron.com <site map>, <cancers>
The clinical trials can be found as a group by searching www.clinicaltrials.gov search for < Geron imetelstat >

Other web links available are:
http://www.thefreelibrary.com/Geron+Gives+Five+Presentations+on+Telomerase+ Inhibitor+Imetelstat+at...-a0224501114
http://www.cancer.iu.edu/news/article.php?id=2654
TOPIC: Decoding Immortality
http://www.smithsonianchannel.com/site/sn/show.do?show=137613

ARTICLES TO REVIEW:

TOPIC: Telomerase Inhibition Comment: Neuroblastoma is the topic of article but mechanism is effective in most tumors.
http://neuroblastoma.ca/blog/treatment/telomerase-inhibition/

TOPIC: Know more about Clinical Trials
http://cancerinfo.cancer.iu.edu/cancerportal/public/treatment/clinicaltrial s.php
http://cancerinfo.cancer.iu.edu/cancerportal/public/morerss.php

The reason I bring this to your attention is because there are trials accepting patients meeting specific criteria. Below I have posted the trials started in the past 9 months and are still actively recruiting. There are only a limited number of patients for each trial and time is of essence. If you have a relative / friend that can put you up whenever a dosing needs to be performed or if you live in the general area.

Good luck to you all. Dave (aka playtowin59)

Link to the total of the clinical trials undertaken: http://clinicaltrials.gov/ct2/results?term=imetelstat

The Clinical Trials which are Still Recruiting are Individually listed below:

Diagnosis: Treating Young Patients With Refractory or Recurrent Solid Tumors or Lymphoma
Sponsor: Children's Oncology Group and Nat'l Cancer Institute
Clinical Trial Location available: None posted, as yet
Link: http://clinicaltrials.gov/ct2/show/NCT01273090?term=brain+tumor&lup_s=10%2F 13%2F2010&lup_d=90

Major Sponsor of following Clinical Trials: Geron

Diagnosis: HER2+ Breast Cancer
Clinical Trial Location available: Indianapolis, Indiana
link: http://clinicaltrials.gov/ct2/show/NCT01265927?term=geron&rank=13

Diagnosis: Locally Recurrent Or Metastatic Breast Cancer
Clinical Trial Locations available:
Alabama,California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Michigan, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia,, Washington

Link: http://clinicaltrials.gov/ct2/show?term=geron&rank=5 & http://clinicaltrials.gov/ct2/show/study?term=geron&rank=2&show_locs=Y

Diagnosis: Patients With Essential Thrombocytothemia (ET)
Clinical Trial Location available Houston, Texas, United States, 77030
Link: http://clinicaltrials.gov/ct2/show?term=geron&rank=4

Diagnosis: Non-small Cell Lung Cancer (NSCLC) Stage IIIb, Stage IV, or recurrent locally advanced disease
Clinical Trial Locations available:
Alabama, California, Colorado, Florida, Illinois,
Maryville, Illinois, Kansas, Kentucky, Maryland, Montana, North Carolina, Oregon, South Carolina, Tennessee, Texas, Texas, Washington

Link: http://clinicaltrials.gov/ct2/show/study/NCT01137968?term=geron&rank=3&show _locs=Y#locn

Diagnosis: Multiple Myeloma and been previously treated but failed to achieve at least a partial response
Clinical Trial Location available: Baltimore, Maryland, United States, 21231
http://clinicaltrials.gov/ct2/show/NCT01242930?term=geron+cancer&rank=4

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