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“improvement”
That is a bombshell word for Alzheimers treatment.
Page 39 charts.
Match those and we are rich!
Even a tie would be huge win.
Ease of application, minimal side affects, much cheaper.
Levanemab news added $15 billion to Biogen’s market cap and they only are sharing its revenue with Aisie.
Yes a “biweekly” infusion will be both soul sucking and very very expensive on top of the actual medication.
Taking a daily pill with no significant side affects sounds both a no big deal event and with no administration cost.
But that voucher could be used to get an accelerated approval of the AD NDA.
Other than McFarlane do we know for a fact the others will be there and ready to interact.
Or are they just listed as co investigators.
So a year and a half ago the share price hit $25 on the excellent Phase 2 PDD data.
Obviously a larger Phase 3 trial would be required to confirm the results prior to submitting a NDA.
The addressed market only one tenth that of AD.
So now we are waiting for the Phase 2b/3 top line data for AD.
The data if strong and consistent with or better than the much smaller Phase 2a data an NDA is a strong possibility.
If we reached $25 on a much earlier trial for an indication with only one tenth the market potential of AD is it not unreasonable to see the potential for a $250 share price, if the AD community grabs the news and pushes it to the mainstream media.
I don’t expect specific details at the upcoming CTAD presentation on Monday.
However during Q&A there will be at least one question about it and Missling will use the opportunity to say how much he is looking forward to the presentation ??
Anavex is one of only three Phase 3 trial top line results being presented at CTAD.
The biggest AD clinical trial conference of the year.
Every attendee focusing their careers on AD will attend every one of these rubber meets the road presentations, along with every stock analyst specializing in that space.
Success with Sigma 1 agonist will be the end of their amyloid focused careers and they know it.
Unfortunately a15 minute time slot hardly enough for a deep dive in the data.
But if all primary and secondary endpoints met that will be a clear enough signal.
However we know at least Lilly and Biogen should be very interested in acquiring a promising AD compound showing strong Phase II results. Do they want to wait too long then find the other has cut a deal and they are dead in that multi billion dollar therapy space.
This is such a huge potential market there will be more than two potential bidders so if you snooze you lose. Why take that chance.
Dave
During optinization trials of GRNVAC1 there was an attempt to use a Treq suppresser but the one they tried did not significantly improve the vaccine's effectiveness.
However it would definitely seem to be an avenue that should continue to be pursued.
Cancerfoe has on occassion still visited the revised Yahoo board but I think he finds the new format rather stifling like myself. He definitely is the best poster we've got and would be a tremendous loss if he doesn't return. I'm hoping when the real trial results come out he will rejoin the discussion.
Tantoguy I doubt we will hear from. He has less tolerance for idiots and feels his time is better spent elsewhere. He really knows his stuff and I wish he would help us all out.
Bob
Solo
I'm flattered that you would want to hear what I think of Telomolecular but to be truthful I've got my hands full trying to keep up with all what Geron has going.
I would be careful of any company trying to get into Telomerase without an agreement with Geron. Geron has controlling IP on Telomerase and will bite back if encroached upon.
Although I will sound like Micro the development period for new biotechnology approaches usually takes a lot more time and money than you might hope for, often driven by the FDA requiring extremely thorough testing. Think 2,500+ spinal injured rats.
All of this time consuming research without revenue has to be supported with massive amounts of cash raised from sources that may ultimately take over the company or run it into the ground through naked shorting. Most institutional investors will avoid a company with potential substantial revenue years in the future.
I've been heavily into Geron for almost ten years, and even with fantastic possibilities and excellent progress everything they have achieved has taken twice the time I expected. At times they were almost dead and ultimately were saved by the first results on GRNVAC1. The stock hit a low of $1.41 but shortly before it hit that number I bought quite a bit at $1.78 because one of my well informed chat group collegues had heard the results were stronger than most expected.
This reinforces the point about doing the best DD you can, and if you really feel the company is on solid ground then hang tough with it.
Early stage biotech, especially if financed on a shoe string is a very risky business.
Good Luck
Bob
TAT0002
From Esammee's transcript of Lazard presentation this line made me think:
>>So what we have done is discovered from a traditional Chinese medicine extract a single entity, small molecule telomerase activator that's extremely specific and potent in upregulating telomerase activity in telomerase competent cells.<<
>>Telomerase competent cells !!<<
The concern of telomerase activation is if all the cells of the body would have their telomeres extended by an activator, increasing the possibility of creating cancers from cells with enough DNA mutations to only need TA to become cancerous.
Even this is somewhat remote due to the fact a Telomerase activator would be given for a limited time, whereas cancer cells have Telomerase turned on continuously. However like Micro says it wuld give them more throws of the dice to achieve a self sustaining cancer phenotype. OKarma has said however they have NEVER seen this in animal studies to date.
I suspect Telomerase Competent Cells refers to Adult Stem Cells that currently express some level of Telomerase, but as I understand Adult Stem Cells like CD8 T cells they do not produce enough to maintain telomere length in balance, but over time the telomeres erode to the point of senescence. Tissue types like skin that use adult stem cells to replace rapidly turning over cells with age loose youthful appearance and in the case of skin it wrinkles and becomes fragile and healing becomes more difficult. I suspect it is these Adult Stem Cells that are the target of TAT0002, giving their telomerase output a boost enough to extend their shortened Telomeres.
If this is the case TAT0002 has the potential to restore a more youthful phenotype to all aged tissue that rely on adult stem cells for maintainance. I remember a TV presentation with Tom OKarma where they showed cells that had their Telomeres extended due to TA have regained a youthful appearance and behaviour compared to the control group of sibling cells.
When Tom OKarma referred to TAT002 having the potential equal to GRN163L he maybe wasn't kidding. A simple pill on a regular schedule restoring the function of aged tissues from Skin to Liver would be an incredible product
Bob
>>both licensed them to our telomerase target for their vaccine approach which is adenovirus<<
Thanks Esammee, this is specific concerning a license from Geron that allows Merck to use their adenovirus to target Telomerase. There would be revenue if it is successful.
Bob
Esammee
I agree that Merck's adenovirus platform is a vaccine because it activates the immune system.
I'm just thinking the language of the agreement is not explicite that this method of activating the immune system against Telomerase positive cells requires Geron's permission.
It is times like this I wish Cancerfoe or Tantoguy would help out. I recall Tantoguy was very informative about Geron's Onc Virus, describing how it worked in great detail before there was much public dislcosure.
Since the new Yahoo format came into play there has been a falling off of worthwhile posts IMHO, even though we are probably at the beginning of the most interesting of times for Geron.
Bob
Thanks RM
Your description of the two "virus" approaches is helpful.
I rather prefer the CEGE Onc Virus for its direct attack without having to involve the immune system.
Still not clear if Geron would receive any financial return with the Merck adenoviruse.
Bob
Thanks
Still sounds like Merck's adenovirus platform targeting Telomerase without mention of potential benefit to Geron.
Nice to see someone is pursuing the virus approach.
Have a good Thanksgiving, I know I'm giving thanks that the reign of Bush the II is coming rapidly to an end.
Bob
Esammee
Thanks for continuation of transcript.
This line was interesting
>>Merck plans to file their IND on both their plasmid and virus in prostate cancer in the first quarter of next year,<<
I didn't recall reading of any agreement by Geron to let Merck target Telomerase with an Onc Virus.
CEGE has a non exclusive right to do so so it is allowable, but I just thought this was new.
The preliminary in-vivo trials by CEGE were impressive and I've been disappointed by the lack of obvious progress in that direction. I've always thought the trifecta of complimentary Telomerase targeted approaches of Inhibitor, Vaccine and Virus would offer a blizzard of punches to cancer and I was looking forward to the virus joining the fight.
With Merck's deep pockets it could move pretty quickly. However without an announced agreement it isn't clear if the virus being constructed would bring revenue to Geron.
Bob
Interesting telomere/telomerase article
http://www.sciencedaily.com/releases/2006/11/061116131631.htm
Thanks RM
Should be well worth listening to.
Geron does not bring up the subject of GRNVAC1 as much as it used to.
I'm inclined to agree with CRISCLUB in his speculation that something may be in the works with MRK.
Bob
From your transcript
>>Q Thanks. Finally, I may have missed this in the beginning from your prepared remarks but can you give us an update on, on the vaccine program and what's happening there.
DR. OKARMA: Yeah. Sure. And, and I – thank you. I didn't mention that. Imminently our IND will be submitted to the agency for a hematologic malignancy and at your conference, Ren, I'll unveil what that plan is,<<
When Tom refers to Ron's "conference" he is refering to the one on Nov 7-8.
So on that date we will be hearing more about the GRNVAC1 IND and its target.
No mention of a webcast, but hope for at least a PR.
Thanks for transcript Esammee
Bob
Esammmee
Thanks in advance for the transcript. I've always found them extremely useful.
It was such a long conference call I thought you would be justified in passing on creating one.
I contacted Investor Relations to ask if they made transcripts available for their conference calls and the reply was no.
This is a bit surprising because they should realize any potential investor would find a written document more convincing than the synopsis reports they release from time to time.
Thanks again. Looking forward to a good read.
Bob
Onc Virus.
CEGE needs to get going.
This looks pretty good.
>>This combination therapy regimen induced complete tumor regression and generated antitumor immunity in 75% of tumor-bearing mice.<<
>>Cell, Tumor, and Stem Cell Biology
Low-Dose Etoposide Enhances Telomerase-Dependent Adenovirus-Mediated Cytosine Deaminase Gene Therapy through Augmentation of Adenoviral Infection and Transgene Expression in a Syngeneic Bladder Tumor Model
Gia-Shing Shieh1,5, Ai-Li Shiau1,2, Yi-Te Yo2, Pey-Ru Lin2, Chao-Ching Chang3, Tzong-Shin Tzai4 and Chao-Liang Wu1,3
1 Institute of Clinical Medicine and Departments of 2 Microbiology and Immunology, 3 Biochemistry and Molecular Biology, and 4 Urology, National Cheng Kung University Medical College, Tainan, Taiwan; and 5 Tainan Hospital, Department of Health, Executive Yuan, Taiwan
Requests for reprints: Chao-Liang Wu, Department of Biochemistry and Molecular Biology, National Cheng Kung University Medical College, 1 Dashiue Road, Tainan 70101, Taiwan. Phone: 886-6-2353535, ext. 5536; Fax: 886-6-2741694; E-mail: wumolbio@mail.ncku.edu.tw or Tzong-Shin Tzai, Department of Urology, National Cheng Kung University Medical College, Tainan 70101, Taiwan. Phone: 886-6-2353535, ext. 5253; Fax: 886-6-2383678; E-mail: TTS777@mail.ncku.edu.tw.
The human telomerase reverse transcriptase (hTERT) promoter can selectively drive transgene expression in many telomerase-positive human cancer cells. Here we evaluated combination therapy of adenoviral vector Ad-hTERT-CD encoding E. coli cytosine deaminase (CD) driven by the hTERT promoter and low-dose etoposide (0.1 µg/mL) for treating bladder cancer. Ad-hTERT-CD conferred sensitivity to 5-fluorocytosine (5-FC) in bladder cancer cells, which could be enhanced by etoposide treatment, but not in normal cells. Such effect was correlated with up-regulation of hypoxia-inducible factor (HIF)-1 expression. By contrast, etoposide activated p53 and down-regulated hTERT promoter activity in normal cells. Etoposide also increased adenoviral infection via enhancement of coxsackie-adenovirus receptor expression on bladder cancer and normal cells. Combination index analysis revealed that combined therapy of Ad-hTERT-CD (109 plaque-forming units)/5-FC (200 mg/kg) with etoposide (2 mg/kg) synergistically suppressed tumor growth and prolonged survival in mice bearing syngeneic MBT-2 bladder tumors. This combination therapy regimen induced complete tumor regression and generated antitumor immunity in 75% of tumor-bearing mice. Furthermore, increased infiltrating CD4+ and CD8+ T cells and necrosis within tumors were found in mice receiving combination therapy of Ad-hTERT-CD and etoposide compared with those treated with either treatment alone. Thus, the potential high therapeutic index of the combination therapy may be an appealing therapeutic intervention for bladder cancer. Furthermore, because a majority of human tumors exhibit high telomerase activity, adenovirus-mediated CD gene therapy driven by the hTERT promoter in combination with low-dose etoposide may be applicable to a broad spectrum of cancers. (Cancer Res 2006; 66(20): 9957-66)<<
Cancer Stem Cells in bone marrow of breast cancer patinets.
Appears to support hypothysis of Cancer Stem Cells being the source of metastises.
http://www.newswise.com/articles/view/524105/
Chris:
The quote from the article is
>>Geron chief executive Tom Okarma declared that his Menlo Park, Calif., company planned to begin clinical trials using embryonic stem cells to treat acute spinal cord injury within the year. Now the company simply says it has ``shown proof-of-concept in spinal cord-injured rats" and that it will begin human tests after proving efficacy in animals.<<
Notice the reporter is quoting Tom's ``shown proof-of-concept in spinal cord-injured rats" but is not directly quoting him when she adds >>that it will begin human tests after proving efficacy in animals.<<
There is nothing new in what she says. But it is spun in a way that makes Tom appear to be leaving the date of starting human tests possibly far in the future.
We all know Geron has a history of missing deadlines. Considering all the obstacles, many political, thrown in its path it's making excellent progress.
You and I and a lot of others have been very very patient because we believe the company is heading in the right direction but really wish we'd get some solid results.
Bob
Todays New York Times article by Lawrence Altman on Lasker prize to Blackburn and Greider.
This line from the article bugs me:
"In animal experiments, researchers are testing chemicals that thwart telomerase as a potential strategy for fighting cancer in humans."
This line would be correct if it said instead:
> After an eight year search Geron Corporation (GERN) the company which owns the patent rights to Telomerase has discovered and refined a Telomerase Inhibitor drug GRN163L for treating cancer that entered Phase I human clinical trials in 2005. If successful this drug has the potential to treat all forms of cancer, since Telomerase is needed by all types of cancer to progress. The first results of this clinical trial are expected to be released in December of this year.<
I sent a complaint to the Times using the above language. Stating out of date information as fact does us no good.
Bob
"The regulatory pathway is quite straight forward. It is no different for this cell type as it is for other cells and we remain optomistic that we'll be in the clinic in 07"
Tom OKarama quote concerning oligodendrocytes from presentation around 6/14/06.
Since these cells are derived from one of the Bush blessed stem cell lines the FDA may not put up political barriers like they did with Plan B and very possibly the unreasonable delay of approving meat for consumption of the offspring of cloned farm animals.
We waited through a lot of delay before GRN163L entered the clinic. Maybe we've almost waited enough for oligodendrocytes.
Bob
Jim. Your description of your relationship with Geron is very much like mine, even to Geron being your one never let it go investment.
I first looked at Geron for the their immortilizing of somatic cells be then got excited about the cancer programs.
I am looking forward to getting some information this December on how GRN163L is doing, and I suspect the slow pace of initiating the Phase II on GRNVAC1 is to give time for Merck to syncronize their plans and to decide if they want to partner with Geron on the trials.
As for Australia over New Zealand my preference is Portobello near Dunedin looking north over Otago Harbour.
http://www.nzarchaeology.org/aerial/large/21890050.JPG
Bob
Jim
I've been sitting on the dock for 9 years and hoping this is the year the good ship Geron comes over the horizon to take me away to New Zealand.
Bob
From the Post article
>>"telomerase activators" that may help prolong the lives of HIV-fighting cells that use the protein CD8.<<
Too bad author doesn't know that the CD8's are immune system cells and not proteins.
It would help if the reporters reviewed their science based articles with scientists before publishing.
Bob
Political gunpowder if the Democrats sre smart
http://msnbc.msn.com/id/14079538/site/newsweek/
>>deny them the most effective therapies because of politics.<<
It's worse than just politics as usual. It is based upon a religious belief that is held to be more important than the expressed desires of about 75% of the population.
Just like Hezbolla holding the mojority of Lebanese hostage because of their religious beliefs.
Both irrational and backward.
November can't come soon enough for me.
Bob
>>The stem cell IND data submittal is supposed to be 1Q 2007.<<
In the link you included Dr OKarma says if things remain on schedule he expected to submit an IND in the fourth quarter of 2006.
Where have you heard differently?
Bpb
>>growing in the laboratory human embryonic stem cells that have been derived from the female<<
How did he derive these cells?? That's what the Korean claimed to do using cloning.
I have a hard time buying this.
Bob
Aureas:
>>I think we have all seen how the FDA has been co-opted on drugs that have some distaste to the RR, i.e. the morning after pill, RU486, and even more unbelievably the HPV vaccine.<<
You can add the unexplained delay of FDA approval of cloned animals for consumption. It was a long time ago an FDA panel of experts recommended its approval. The only credible delay I can see is political with the "C" word being the trigger to get the RR's tail in a knot although it has nothing to do with human cloning. Maybe just a general offense against "god's" plan for the universe.
Bob
Hi everyone.
The new Yahoo format does not work for me.
I'll be watching this one and the old one for a while to decide which one I'll stay with.
Bob