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Pfizer
Does anyone who follows Pfizer know what happened to their CCR2 program that they inlicensed from Incyte for >$800M in potential fees and milestones, plus royalties?
It has been >1.5 years since the deal, but as far as I know Pfizer has put nothing in the clinic - despite the fact that Incyte had multiple P2a trials ongoing at the time of the inlicensing, and several other P2 trials were scheduled.
Since the upfront fee was rather small, there is always the chance that Pfizer inlicensed Incyte's CCR2 program only to protect their own by burying it.
micro
Over 23,000 Trofile Assays have been performed since 2004 in Monogram's CLIA certified laboratory. Trofile is the only diagnostic proven in clinical studies to identify whether patients are CCR5-tropic and has been used in all clinical trials of CCR5 antagonists to date.
I hadn't read this post before speculating about the possibility of Pfizer shutting down the CCR5 inhibition competition by making their Monogram deal exclusive. But it is obviously supportive.
micro
[Analysts’ sales projections for Celsentri (a.k.a. maraviroc) are modest because it is assumed that the drug will be given only after other (safer) options have been exhausted.]
Yeah, but if somebody comes up with an orally bioavailable dual CCR5/CXCR4 inhibitor, that could be a first-line HIV blockbuster.
I don't understand why that should be particularly difficult. There are many CCR5 inhibitors in development and there are at a few CXCR4 inhibitors out there as well ...
AnorMED, recently acquired by Genzyme, has some CXCR4 inhibitors in late stage clinical trials, though they have had more luck using them to mobilize stem cells than as an anti-HIV therapy.
micro
MRGM makes a diagnostic to determine if an HIV patient has the kind of HIV that is amenable to treatment with a CCR5 entry inhibitor such as PFE’s maraviroc.
In other words Monogram's (MRGM's) diagnostic determines whether a patient's HIV is CCR5 tropic, CXCR4 tropic, or both. If it is only CXCR4 tropic, there is no point in administering a CCR5 inhibitor such as maraviroc. Therefore the FDA is likely to require such a test before a patient is treated with a CCR5 inhibitor.
But given that Monogram has done a deal with Pfizer regarding that diagnostic, an obvious question arises. Can Pfizer block off competition in the very active CCR5 inhibitor space through Monogram's assay? Or put another way, does Monogram have strong enough IP to have a monopoly on HIV tropism assays?
At this point I believe the Pfizer/Monogram deal is still non-exclusive. But Pfizer has an equity state in Monogram. Could their deal be made exclusive, potentially shutting out all other CCR5 inhibitor competition?
My guess is Monogram's IP isn't that strong and even it is, the resulting potential political firestorm would likely prevent Pfizer and Monogram from making that move.
But I have wondered ...
Anybody have any further thoughts/info on this issue?
micro
How long after the live presentations do the webcast replays become free?
90 days
The webcasts are actually pretty cool. You have on-demand access to most of the talks including the big ones and including slides - within 24 hours of the presentation. Despite missing out on the Q&A (when there is a Q&A), I think it is better than being there.
micro
ASCO - Virtual Annual Meeting
Doesn't seem as if my link worked.
Try ...
http://www.asco.org/portal/site/ASCO/menuitem.56bbfed7341ace64e7cba5b4320041a0/?vgnextoid=ab08201eb6...
or find the ASCO annual meeting page.
Click on "Products and Resources".
Click on "Virtual Meeting".
Click on "Pricing Structure".
I'd be happy to pay for an Attendee's Virtual Meeting Subscription.
micro
ASCO Virtual Meeting Subscriptions Now Available
The price for non-ASCO members has been raised from $125 to $175 ...
http://www.asco.org/portal/site/ASCO/menuitem.5d1b4bae73a9104ce277e89a320041a0/?vgnextoid=57ec9d57df...
Is anyone interested in 'sharing' a subscription? I am assuming/expecting/hoping that will not cause any technical problems, e.g. that more than one person can log in on different computers at the same time to watch sessions - but I can *not* guarantee that. Last year I purchased my own subscription.
If anyone is interested, please email me at microcapfun@yahoo.com.
micro
CEGE, warrants (delayed response)
Jon: You said
Actual proceeds are really the 60 MM less about 10 MM for the warrant value (5 year warrants probably worth 4-5 per warrant but I do not see details on strike price and I don't have my B-S application on this computer) divided by 10.8.
I said:
No. The warrants haven't been exercised yet, so they didn't bring in any extra cash.
You replied:
Wrong in terms of calculations by both of us.
I said nothing wrong. Actual proceeds means cash, and cash received by Cell Genesys was not reduced one cent because they gave out warrants to grease the deal. In fact they will get more cash if the warrants are exercised, but that's down the road.
Valuing the transaction by considering the effective cost of the warrants may be a worthwhile activity, but it does not change the proceeds received by Cell Genesys.
Regards,
micro
Vertex, HCV, IF-alpha, HGSI
I think McHutchison’s comments are good spin, but spin nonetheless.
Let me turn this issue around and ask what would happen if VX-950 were not able to shorten the SoC in HCV to 24 weeks?
Answer: it would be one of the biggest flameouts in biotech history.
Of course Telaprevir is also showing signs of increasing the SVR rate (in combination with standard therapy), which is probably more important than reducing the time of treatment.
Will the IF-alpha companies be able to raise their prices significantly if the duration of treatment goes down??? What do people think?
I think Human Genome Sciences has the best chance in that regard, because Albuferon isn't yet on the market and so hasn't yet been priced. Also it will be given every two weeks rather than every week, so it can be argued to be a superior product compared to the Pegasys and Peg-Intron. With the nasty side effects of IF-alpha, that may allow them to charge significantly more per course of therapy and thus compensate for the shorter time per course.
But clearly this issue (shorter course of therapy) is increasing the risk for HGS, and I think that can be seen in the stock price over the past few months.
http://finance.yahoo.com/charts#chart3:symbol=hgsi;range=6m;compare=^ixic;indicator=split+volume;cha...
micro
My definition , and one that probably approximates the one the FDA has been using , would be that "reasonably likely" means there is maybe a one in ten chance that the benefit does not exist. Thus , one would approve ten drugs for such dire indications , using these criteria , knowing that one of them would eventually prove to be useless.
That sounds very good, but the problem is that after the approval, there may never be another opportunity to find out whether the approved drug is providing benefit or not. Imagine a situation where drug A is tested against placebo in an indication with no approved therapies - such as metastatic HCC - and is approved on the basis of the 1 in 10 rule you suggested.
Now no patient will be willing to be placed in a drug A versus placebo trial, which would be considered immoral anyway. Yet doubts remain about drug A's efficacy.
A couple years later drug B is tested against drug A (the standard of care) in a non-inferiority trial (perhaps with the thought in mind that maybe drug A may provide no real hurdle) and drug B is found to be non-inferior. The FDA has no choice but to approve drug B as well.
History repeats with drug C and drug D ...
Before long you have a slew of drugs approved for metastastic liver cancer and a ~10% probability that NONE of them are any more efficacious than water.
A bit farfetched I admit - maybe more than a bit - yet the hypothetical scenario may illustrate the pitfalls of allowing the FDA to approve drugs with too low a hurdle.
micro
CEGE
The approval of Provenge will mean they will get no enrollment in the US except in VITAL-2.
Actually, this might accelerate US enrollment:
Additional follow-up of the 22 patients who received the dose that is comparable to that being employed in the company's ongoing Phase 3 program indicates that the median survival is 35.0 months.
http://biz.yahoo.com/prnews/070403/sftu047.html?.v=89
You and I know how uninformative and inconclusive that single-arm Phase 2 result with 18 patients is (4 withdrew), but some patients as well as some investors may jump for the dream that they will live much longer on GVAX than Provenge ...
... but Sherwin has confused PR with strategy and hurt his company perceptibly. If he was smart, given Petrylak's retrospective data on Provenge followed by Taxotere, he should have CEGE focusing hard on VITAL-2.
There has never been a clinical trial looking at GVAX + Taxotere, so I consider Vital-2 more of a crap shoot than Vital-1. But there is some good preclinical data and heck - sometimes crap shoots pay off.
micro
>>
>These advances using adult and other forms of stem cells are exciting. Some have even produced effective therapies and treatments for disease -- all without the destruction of human life. <
Does anyone know what examples he is talking about?
Or is this simple "disassembling" to the public, since the public is generally naive?
<<
Adult stem cells are proving useful in many indications beyond cancer. One of the most fascinating to me personally is in certain autoimmune diseases, where it appears that killing off the bone marrow and starting over with a transplant (similar to what is done in many leukemia patients) often 'reboots' the immune system and provides a potentially permanent cure to the autoimmune disease. Also allogeneic mesenchymal cell injections appear to cure many cases of graft-versus-host disease.
What is often lost in the ASC vs ESC arguments is the fact that nobody is planning to carry out regenerative or other therapies by injecting ESC's directly. Rather one differentiates ESCs into ASCs or even progenitor cells and injects those. So there is really very little difference in principle between ASC and ESC therapies. But ESCs provide the potential for scaling, GMP and off-the-shelf treatments. Perhaps the analogy should be to making high quality micro or nanoscale devices by the millions very cheaply or one at a time ad hoc.
Human ESCs were first cultured less than a decade ago whereas human ASCs have been studied for something like half a century. No surprise except to the right wingers that ASCs are 'ahead' in terms of therapeutic applications. But ASCs are forging a path through which ESCs will clearly follow.
What I have never understood is how so many right wingers can get emotional about 'killing' a spherical ball of ~100 cells the size of the head of a pin, none of which are nerve cells, brain cells, etc. To me, that ball of cells is much further removed from a living, breathing human than is a living, breathing cow. Yet I bet 98% of those right wingers don't feel the slightest twinge of remorse in killing cows in order to eat their flesh ...
micro
Cell Genesys (late response)
Actual proceeds are really the 60 MM less about 10 MM for the warrant value (5 year warrants probably worth 4-5 per warrant but I do not see details on strike price and I don't have my B-S application on this computer) divided by 10.8.
No. The warrants haven't been exercised yet, so they didn't bring in any extra cash.
micro
>> The individual, allogenic version of this vaccine has cleared circulating prostate cancer cells in patients’ blood, extended PSADT to 100 months <<
Hi, rm. Hate to be picky, but as you know that Geron/Duke study didn't go on for anything close to 100 months. So what you really want to say is that in a small number of patients (~10), PSA was seen to more or less stabilize for a few weeks after treatment with a dendritic cell vaccine using telomerase as an antigen. Without booster shots it then started rapidly back up. With booster shots of the above-mentioned vaccine there is some evidence (in ~3 patients) that PSA can again be brought under control for some unknown period of time.
How's that?
The main message is that the telomerase vaccine is at a quite early stage (and headed back to Phase 1 after some manufacturing changes), and the idea of making it off-the-shelf from ESCs rather than leukophoresis is wayyyyyyyyyyyyyy early.
micro
>> Several companies have tried to develop CCR5 inhibitors, but with limited success. In 2005, GlaxoSmithKline discontinued its CCR5 blocker aplaviroc after people taking the drug suffered liver problems, and Schering–Plough's development of vicriviroc, once on track with maraviroc, has slowed owing to concerns about the risk of cancer in those taking the drug.
"Maraviroc seems to be the best in class, in terms of safety profile and activity," says John Mellors, Chief of Infectious Diseases at the University of Pittsburgh, USA (who has no financial ties to Pfizer). <<
There are a LOT of other CCR5 inhibitors in development. One worth keeping an eye on is Incyte's INCB9471. Very early stage, but besides knocking down viral load by 2.1 logs in a small 14 day study, the half-life is 60 hours vs 16 hours for maraviroc, which may well provide advantages as regards dosing, combinations with other therapies, and 'forgiveness' to patients who occasionally miss taking their medicine - which apparently happens a lot more often that one might think.
micro
>> The message that #44280 is in reply to is in #msg-18469811 <<
Well that clears up that ... I think.
micro
O/T Deleted posts and banned nerds
>>
Posted by: DewDiligence
In reply to: A deleted message Date:4/4/2007 8:45:56 AM
Post #of 44797
>amgn/abgx the lies<
We’re not talking about small lies, IMO. The question now is: will the FDA pull Vectibix if the second-line trial with chemo fails?
<<
I am confused. Why is there a reply to a deleted message? Why was the message deleted?
I noticed somewhere that nerdseeksblond was banned from either this board or InvestorsHub in general. I remember seeing some savvy posts from him elsewhere. Was a brunette responsible for this ban?
Inquiring minds want to know.
Thanks,
InvestorsHub Newbie
Erbitux, safety issues
If this one of the SOC's, then it appears that new and safer drugs need to be brought to market as these side effects are terrible and the safety profile imho is suspect at best...once again imho only.
My feeling is that as regards AEs, in practice it doesn't matter much whether a therapy is highly targeted or not, for the simple reason that the sponsors simply crank up the dosage until they can't crank it up any more. Rare exceptions are where complete inhibition of all the targets occurs before the DLT is reached. But with 'dirty' drugs which hit several targets with various efficiencies, that just ain't gonna happen.
micro
>>CEGE - Last I heard it went from summer 2007 to 2H-2007 to Q3-2007. It just depends on how fast they can buy enrollment overseas.<<
Hi, David. Their original target was 3Q06, and it's been slipping from there. I'm guessing they will finish enrolling around the end of this year.
micro
>>This does not disprove that it is GMCSF that is the active agent via generating general immune upreg.<<
A week ago there was a discussion as to whether the Provenge-generated immune response is mainly generated by GM-CSF rather than PAP.
This reminds me of some MDX-010 results that people here may be familiar with. In a small number of HRPC patients, MDX-010 + CEGE's GVAX gave rather remarkable results.
Of the six patients treated in the two highest dose groups, antitumor activity has been observed in five
patients, including prostate-specific antigen (PSA) declines of greater than 50%
that were maintained in four of these patients for at least six months, with the
longest response ongoing at more than 12 months. Moreover, clinical evidence of
antitumor activity has been observed in three of these five PSA responders,
including improvement of multiple lesions on bone scan, resolution of abdominal
lymph node disease by CT scan, and improvement in pain due to bone metastases,
respectively.
http://www.medarex.com/cgi-local/item.pl/20070222-966145
GVAX consists of irradiated tumor cells, genetically modified to express GM-CSF.
Less noted were some results which came out at the same time in the same general patient population, involving MDX-010 + GM-CSF:
The current study examines whether combining systemic GM-CSF to CTLA-4 blockade can augment immune and/or clinical responses in HRPC patients. Methods: In a phase I trial of patients with metastatic HRPC, sequential cohorts of 3-6 patients received GM-CSF (sargramostim, Berlex) 250 mg/m2/d SC on days 1-14 of a 28-day cycle with escalating doses (0.5, 1.5 or 3 mg/kg) of ipilimumab (MDX-010), a fully human anti-CTLA antibody (Medarex/BMS), given IV on day 1 of each cycle x 4 cycles. Patients were monitored for toxicity as well as for T cell activation. PSA and radiographic tests were performed at baseline and through therapy to evaluate for clinical response. Results: 18 patients were accrued. Ipilimumab-related dose-limiting toxicity was limited to one patient with grade 3 rash at the 3 mg/kg priming dose level. Seven patients had <50% declines in their serum PSA levels. A dose response relationship was seen between ipilimumab dose and activation of both CD4 and CD8 T cells in the blood.
http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb6...
I have wondered whether the striking MDX-010 + GVAX results were largely due to the MDX-010 + GM-CSF 'component', and the discussion from a week ago regarding the origin of the Provenge-generated immune response caused a little bell to go off in my head.
What do people think about the 'added value' of GVAX over GM-CSF, and PAP over PAP + GM-CSF?
micro
>>I don’t know how far along CEGE is in their phase-3 enrollment, but microcapfun probably does.<<
Sorry - was on vacation for a while and am now digging out. Cell Genesys does not give enrollment numbers. They say when they think they will complete enrollment, and then when that date comes near, they push it ahead 6-12 months and start over.
Right now they are saying they will finish enrolling by this summer. The trial began ~ July 2004.
I'm referring to their first P3 trial, Vital-1, which is GVAX vs taxotere. They haven't even given an estimate for Vital-2, which is GVAX + taxotere vs taxotere.
micro
>>Provenge arm 26.3 months
placebo crossovers 23.9 months
placebo noncrossovers 19.3 months<<
Not sure in this case, but don't noncrossovers often do worse than crossovers in trials because at the time they were allowed to crossover they were ... (i) dead or (ii) in very bad shape or (iii) simply not fighting as hard as the crossovers for a few extra months of life?
micro
Thanks for the comments re GRN163L. I didn't see any discussion of hepatic tox in their preclinical papers, but may have missed it. At sufficiently high doses, animals die from 163L, but that could be simply from the electric charge on the oligos.
This came out today (someone may have already posted it):
>>28/03/2007 - Antisense drug developers received a boost today with the news that Isis Pharmaceuticals' cholesterol lowering drug is showing good results in clinical trials.<<
>>Isis also said the drug was well tolerated, with "no liver chemistry findings that would suggest risk of drug-induced liver injury," and, "no evidence of clinically significant drug interactions or side effects such as central nervous system, muscle, or renal toxicity."<<
http://www.drugresearcher.com/news/ng.asp?n=75306-isis-genta-antisense-methylgene
micro
Would you expect hepatic toxicity as the DLT for GRN163L?
http://www.geron.com/showpage.asp?code=prodcati
GRN163L does not function as antisense, but the backbone of the molecule is an oligo.
micro
>>I’m hereby calling for a halt to threads about whether statins are harmful. This has been debated here ad nauseam and I see little likelihood that further posts will cover new ground.<<
O.K. by me. (Hadn't read your post until after my last one on the subject.)
micro
>>try and get out a little and speak with some real people, objectively, like I do and then come back and not quote some pharmaceutical companies study or propoganda ...
If you think that statins are that safe, put it in your water there mr microcapfunnyman, and leave my friends and relatives out of your Statins are the greatest thing since Greta Garbot ...<<
I don't know your particular history regarding this issue, Preciouslife. Maybe you or someone you know had a problem which was attributed to statin use, and of course I can not prove otherwise. I meant no personal harm or animosity with my comments.
But when it comes to making decisions about drugs, I try to leave anecdotes at the door. (I'm sure we both know a lot of cases where drugs gave rise to impressive results in the first few patients, only to fail miserably after statistics took hold.) There have been hundreds if not thousands of statin studies, not all done by Big Pharma, and even if they were, the truth tends to come out eventually no matter how hard Big Pharma tries to keep it bottled up. Look at Vioxx.
If I stumble onto that meta-analysis paper again, I'll post it, because I think it was an academic study and looked at some very large number of studies involving >70,000 people. No statistical evidence of increased muscle pain or weakness or any other problems associated with statins - except liver-related in a small fraction of statin users. <1% I think.
That's the sort of information I can't get by chatting with a few friends at work about whether they use statins and in what ways they feel differently since they starting using them ...
The comment about putting it in the water was said pretty much tongue-in-cheek. I apologize if it upset you. Most cases of liver problems can be done away with simply by switching statin types and dosages, so putting only one type of statin in the water doesn't really make sense.
Especially if you drink quite a lot of water, like me.
Hey look - I'm sure you know more about the molecular interactions of statins than I, but from all the statin studies I've seen in the literature, statins are the closest thing to a wonder drug since aspirin, and I'll keep taking them until I see clinical evidence to the contrary or my LDL drops into the single digits.
All the best,
micro
P.S. Please don't call me "mr microcapfunnyman". It hurts my feelings.
>>The powerful biomedical lobby got its wish. Between 1998 and 2003, Congress doubled the NIH budget, upping it from $13 billion to a staggering $26 billion. Since then, it has risen even further, to $28 billion.<<
For comparison, the National Science Foundation gets $5.6B. The NSF funds ...
math
physics
chemistry
engineering
nanotechnology
biology
earth
environment
computing
astronomy
polar science
education
materials science
Basically everything science related.
The NIH is incredibly rich.
micro
>>his treatment has remitted the nhl
but also has caused interstitial pneumonitis
he is now on a vent with 100% oxygen for 10days
with no success
if anyone knows of any other suggestions
please speak up
<<
Just want to echo a previous comment about perhaps finding someone good at weaning people off respirators. I had an experience where docs said a loved one would be gone 5 minutes after unplugging the respirator, but it took 16 hours even with heavy sedatives, flat on her back, no fluids, etc. Probably she could have been weaned off the respirator and had another year after recent diagnosis of lung cancer, but the doc said they couldn't get her off the respirator and I stupidly believed him. People sometimes have much greater reserves than expected, but the longer on the respirator the worse the prognosis. They must be weaned off.
Don't know what I'm talking about, actually. Find another doc for a 2nd opinion. Good luck.
micro
>>The most common side effect is muscle pain and weakness<<
I lost the reference, but a paper just came out which did a meta-study of ~100,000 people and found that there was no significant increase in muscle pain or weakness from statins. The only negative signal came from liver damage in a small fraction of people.
Balance that with a huge number of positive signals (see previous post) and statins are a no-brainer. I REQUESTED a statin 10 years ago and have been on them ever since even though my HDL and LDL are well within the normal range and would probably stay there from diet and exercise alone. Get my liver function checked once a year; never had any problem.
Those claims of muscle pain and weakness are probably from middle-aged couch potatoes who can't understand why they don't seem to be able to lift fridges anymore like they could in high school ...
micro
Statins just keep getting better.
Just from the last 24 hours ...
>>This epidemiologic study reports that men who currently used statin drugs had half the risk of advanced CaP and less than half the risk of metastatic or fatal CaP compared to men who did not currently use statins.<<
http://www.newswise.com/articles/view/528284/?sc=rsmn
>>DALLAS, March 22 -- When diet and exercise fail to lower cholesterol in children with high-risk lipid abnormalities, statins should be first-line drug therapy, declared the American Heart Association in a new scientific statement.<<
http://www.medpagetoday.com/Cardiology/Dyslipidemia/tb/5299
>>Lipitor (atorvastatin) As A Treatment For Spinal Cord Injuries Following Trauma<<
http://www.medicalnewstoday.com/medicalnews.php?newsid=65760
Studies indicate statins reduce the risk of heart disease, certain cancers, Alzheimer's, stroke, they lower CRP ...
PUT IT IN THE FRICKEN WATER!!!
You'd probably have a net savings of lives even with the small amount of liver damage.
(Give everybody yearly liver function tests and let those with liver problems drink bottled water!!)
;o)
micro
Dynepo
>> was surprised when I saw your post on the discount. I remember back in the TKT days, Michael Astrue gave the impression a discount would be modest and it had some potential selling advantages the main being lack of evidence of pure red cell aplasia (though since it was rare hard to know for sure). If this still holds that and the price discount seems to be placing Shire in a strong position. FYI I think Dynepo was valued at about 450 million (if the TKT acquisition fell through that is what they would have paid for Dynepo alone). I believe their is a royalty still to be paid on Dynepo sales.<<
Cell Genesys no longer is due a royalty, though it is possible they will get a milestone associated with commercialization. Cell Genesys traded in future milestones for cash a while ago. Is someone else due a milestone??
I believe Dynepo is discounted because Amgen's EPO is longer lasting and there is also a cheaper generic EPO on the market or soon to be on the market.
(I think that's right, but I don't follow EPO closely.)
micro
>>Micro I meant CGRB, Cougar Bioscience<<
Oh. I'm not familiar with them, but the results of their early HRPC study do sound impressive.
micro
>>Microcapfun, I respect your evaluation technique, what do you think of Medarex.Also look at crgr, there results in Prostate cancer look stunning.Thank in Advance.<<
Thanks for the flattery. I eat it up.
I only follow a small number of bio/pharma companies. Any more and there is insufficient time for sleeping and going to the bathroom. So I only know Medarex at a voyeur level and I don't know what crgr is.
I think Medarex is a great company with a s___load of shots on goal. In particular, MDX-010 has the potential to be a big hit, and used in combination with most cancer vaccines. But I couldn't tell you if the market cap is high or low because that takes a LOT more work - which I haven't done for Medarex.
Sorry,
micro
>>microcap,
Your name says it all.<<
Actually it's a remnant of a much earlier time. I don't invest much in microcaps anymore, but I kept the name.
>>What effect did 911 have on bio's...none. But it upset the maco.<<
9/11 made it harder for biotechs to raise funds which reduced the purchase of biotools, the number of R&D programs, future drug pipelines ... There were the fears that government funding to biotech and Medicare might be diverted to war, that biotech facilities might be targets of terrorism. There were lots of connections in reality or in people's minds. You can call that "the macro". Doesn't matter what you call it. The correlation coefficients may be smaller between biotech and the rest of the economy (including subprime lenders), but they certainly are there.
That's my only point.
micro
>>Slowing it down ought to be doable, but I’m pessimistic about the possibility of halting it. Aging is (IMO) just another name for an increase in entropy; hence, trying to halt it is tantamount to stopping entropy in its tracks. Good luck with that!<<
The 2nd law of thermodynamics does not imply the necessity of aging because living organisms aren't isolated systems.
This is the same mistake the creationists make when attempting to argue that evolution violates the 2nd law of thermodynamics (with the claim that evolution predicts movement toward more organized systems).
micro
>>Just wanted to know what you guys thought about the DNDN AC members in this list:
http://www.fda.gov/ohrms/dockets/ac/07/waivers/2007-4291-w-00-index.htm
Care to share how you think each will vote?<<
Interesting. Dranoff is one of the key scientists working with Dendreon competitor Cell Genesys, but he got a conflict-of-interest waiver. I bet Dendreon isn't too happy about that.
http://www.fda.gov/ohrms/dockets/ac/07/waivers/2007-4291-w-01-Dranoff-208.pdf
micro
I followed Maxygen for several years before giving up on them. They started with a great technology and some great scientists. But megalomaniac CEO Howard really trashed the company, in too many ways to mention here. Almost all the good scientists left over the years (some of whom I have talked to) and the only reason the company hasn't totally crashed is because the raised a lot of money in their IPO and by selling off parts of the business, and also because the technology was good enough to generate a few interesting molecules. But I wouldn't invest in any company with Howard as CEO. He talks the talk, but doesn't walk the walk.
micro
>>What does sub-prime lending have to do with biotech? <<
It is amazing how almost everything gets linked. For example oil prices and the cost of eggs.
When oil prices go up it encourages more ethanol to be made from corn ... which increases the price of corn ... which increases the cost of feeding chickens ... which increases the price of eggs.
And that's not a minor correlation, either.
I guess the sub-prime lending fiasco could make it more expensive for biotechs to raise funds and carry debt. Also the sort of people who have been the recipients of sub-prime mortgages often don't have health insurance. They may be less able to afford to pay cash for drugs.
I'm sure there are other more important connections that I can't think of. As I said, in today's world, everything is connected to everything. But I've found a good hedge to almost anything is military and security stocks. It goes against my morals, but it has helped me survive with a portfolio which is all tech and biotech. E.g. a luggage-scanning security stock I owned on 9/11 went from the 3's to 50 within a couple years (buyout by GE at 50).
micro
>>Can lengthening telomeres make a good cosmetic?
I rather doubt it, but here’s a company who wants
you to think it can.<<
My first reaction to seeing the Geron PR this morning was to let out a "have they sunk so low as to deal in cosmetics and nutraceuticals?" moan. My 2nd reaction was to think that it could be more serious than that.
When telomerase is activated in completely normal somatic cells, you don't get cancer and the cell goes through more population doublings before reaching senescence. BUT ... consider a cell which has been around the block a few times, has p53 disabled, Ras/Raf/Mek/Erk etc. on hyperdrive ... and is only missing the activation of telomerase to become a tumor cell - hell ... a tumor STEM cell. Maybe this cell has senesced and is quietly minding its own business ... And suddenly is has telomerase temporarily activated and gets to roll the dice a few more times to see if it can activate telomerase permanently.
Come on ... snake eyes!
In small animals, telomerase activation has given rise to an increased number of cancers in some experiments.
So one might worry quite a lot about a telomerase activating nutritional supplement on the market (mixed in with ginko biloba, warts from St. John, etc.) that has never been tested in humans.
On the other hand, the Geron CEO has claimed that in early experiments, their particular small molecule telomerase activator has activity only in cells which are not "pre-malignant".
I have no idea what mechanism could give rise to that. Is it possible?
I suspect that Geron's deal is arranged so that if Asia Biotech Corp's nutraceutical gives a lot of people cancer, Geron will be indemnified or otherwise off the legal hook.
Now if it doesn't give anyone cancer, I'll probably be interested in taking it! Experiments have shown, in particular, that T cells are more potent if they have longer telomeres ...
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STRANGER THAN TRUTH!
>>But if you check out the latest CC again, you'll notice that they hedge their plan going forward and sneak in something about how they're going to judge the submission route depending on how the data turn out.<<
They are 100% positive that they are going to start and finish filing for registration by the end of this year but ...
They claim they haven't seen any of the *unblinded* P3 data yet, they say they won't start analyzing the P3 data until sometime in Q2, and they say they won't know what submission route they'll take until they see the data ...
Huh?
And what happens if even after all that slicing and dicing in P2 their P3 data sucks no matter how it is analyzed? What submission route will they take then??
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