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>Anyone have a good feel for how SAB and scientific collaborators *truly* impact a biotech's development?<
I've sat in on a relatively large number of advisory boards and can tell you that--within cost constraints--the advisors have a major, and often dominant, role in the design and interpretation of sponsored clinical trials. Just my experience.
J
ASCO GI
Perhaps the most remarkable thing I saw were the FOLFIRI/bevacizumab results--75% RR in first line therapy. This is compared with 45% response in patients who receive bevacizumab in combination with IFL.
Sanofi representatives have, for a while now, really been emphasizing how oxaliplatin in combination with bevacizumab is a superior regimen compared with irinotecan plus bevacizumab. REALLY a disingenuous comparison because they were using the data from the Goldberg study which compared FOLFIRI (eg, infused 5-FU) with IFL (bolus 5-FU)--in fact, the bolus 5-FU plus oxaliplatin regimen was discontinued for toxicity, but they never say anything about that.
John
INSM--DrBio
All I can report is what I saw. INSM was listed in a table in the presentation as having an IGF-1R targeted therapy. Ellis did not go into details on the drug. I assume that protein BP3 is not targeted to the receptor, so all I can assume is that he was referring to something preclinical? I am as interested as you in finding out what he was talking about. Time to harass the company?
John
>There was a talk about the future of targeted therapies, focused on IGF-1R and Src. Insmed fans will be happy to know they got a mention. Ellis (the presenter) cautioned that there is a high degree of homology between the insulin receptor and IGF-1R, so although agents targeting IGF-1R have very impressive efficacy, there are going to be the obvious problems. Seemed very excited about Src-targeted therapies. Ariad and Targegan, along with a couple big-caps I can't remember, are developing Src-targeted treatments
May I ask why Insmed would have gotten a mention at the meeting? They have a Protein BP3 the reverses the pro cancer tendency of igf-1. Is that the product that was mentioned?<
>>There was an oral presentation on the correlation between PFS, TTP, RR and OS. The data (shown as measure: Spearman's correlation coefficient--P value): PFS: 0.71--p=0.00001; TTP: 0.32--p=0.059; RR: 0.54--p=0.00001.<
How can the numbers for PFS and TTP differ by that much? PFS and TTP are almost the same thing. Please double check those numbers! T.i.a.
<<
These numbers are correct. Once the abstracts go online, you can check for yourself--#226, Tang et al. The poor P-value can't be attributed to a small sample size; of the 75 arms used in the study, 40 reported PFS and 35 reported TTP.
Note that there are small differences in P values between what was presented and the oral presentation.
John
>Breaking News on Targeted Therapies in Colorectal Cancer From the ASCO-GI Conference: An Expert Interview With Bruce Giantonio, MD<
Which part of this was "breaking news"
ASCO GI
Some interesting stuff here, nothing particular earth shattering.
I spoke with two serious KOLs (anyone who knows CRC would know their names) regarding nimotuzumab, neither had heard of it--including one who did a presentation on EGFR inhibitors. This particular KOL also said that rash correlated with response. Discussed the nimo data, they said they'd look into it.
Other interesting stuff: lots of pharmacogenomics data--particularly on the UGT1A1 polymorphism that influences neutropenia with irinotecan. One of the presenters said that it's a little more nuanced than 1) you have the mutation 2) you get neutropenia. More data will appear at regular ASCO.
Anyone know of a good small-cap that focuses on developing genetic tests? An area I haven't ventured in to at all. From what it sounds like, pharmacogenomics is going to be huge in a couple years--individualizing treatment.
Here's one for all of you obsessed with the relationship between surrogate measures and OS. There was an oral presentation on the correlation between PFS, TTP, RR and OS. The data (shown as measure: Spearman's correlation coefficient--P value): PFS: 0.71--p=0.00001; TTP: 0.32--p=0.059; RR: 0.54--p=0.00001. So it appears both PFS and RR predict OS. At least in CRC trials.
There was a talk about the future of targeted therapies, focused on IGF-1R and Src. Insmed fans will be happy to know they got a mention. Ellis (the presenter) cautioned that there is a high degree of homology between the insulin receptor and IGF-1R, so although agents targeting IGF-1R have very impressive efficacy, there are going to be the obvious problems. Seemed very excited about Src-targeted therapies. Ariad and Targegan, along with a couple big-caps I can't remember, are developing Src-targeted treatments.
Couple of other things--FOLFOX has equivalent efficacy and safety in older and younger patients; a study of xaliprodin, which was intended to show that the drug reduced neuropathy in patients recieving oxaliplatin, showed less-than-impressive results. A new regimen called FOLFOXIRI (you can guess what's in this one) showed very impressive results at the cost of some added toxicity, as one might expect. Presenter made the point that this regimen exposes patients to all 3 cytotoxic agents up front, which he seems to think is good. I prefer the idea of reserving something for second-line.
A huge analysis showed really impressive results for chemoprevention. High-risk patients (those witth family history of CRC, FAP, HNPCC, APCI1307K) engaging in what the presenter called "healthy" behaviors--taking low-dose aspirin, statins, exercise, and 5 servings of veggies per day were at only 16% increased risk for CRC compared with healty controls.
Grothey gave a talk on how to sequence therapies. Nothing new at all, although he did mention that patients who receive all agents have the best performance.
That's it for exciting news. Not much new. I, however, am in a very good mood because I got an upgrade to first class and a corner room with a view of the Brooklyn Bridge!
John
HEPH
UPDATE 1-Hollis-Eden up 19 pct on nuclear preparedness talk
Fri Jan 27, 2006 08:20 PM ET
(Adds company comments, closing stock price, byline)
By Deena Beasley
LOS ANGELES, Jan 27 (Reuters) - Shares of Hollis-Eden Pharmaceuticals Inc. (HEPH.O: Quote, Profile, Research) rose 19 percent on Friday ahead of a segment on U.S. nuclear preparedness set to run Sunday on news magazine program "60 Minutes."
"You can see a preview on the CBS Web site .... I'm sure that has something to do with the stock today," said Ronald Opel, an analyst at Moors & Cabot.
Shares of the San Diego-based company rose 99 cents to close at $6.27 on Nasdaq.
Hollis-Eden has been considered a top contender to supply the U.S. Department of Health and Human Services with a drug for acute radiation sickness under the $5.6 billion Project Bioshield established after the Sept. 11, 2001 attacks to build up the national drug stockpile in the event of a terrorist attack or other disaster.
"There seems to be some confusion with how Bioshield is being implemented and how the congressmen who passed it would like it to be implemented," said Richard Hollis, chairman and chief executive at Hollis-Eden.
Word from HHS last year that it would seek to buy just 100,000 doses of a radiation sickness drug, rather than the 10 million some analysts had expected, sparked a sharp sell-off of Hollis-Eden shares.
"Now that we are past (Hurricanes) Katrina and Wilma and bird flu, the focus is back on a potential nuclear event," Opel said.
He cited renewed worries of nuclear weapons capability in Iran, recent threats from Osama Bin Laden, as well as comments from French President Jacques Chirac on his willingness to use nuclear weapons for the media attention.
The "60 Minutes" report quotes Lee Hamilton, vice chairman of the 9/11 Commission, as saying, "We know it is possible to have a nuclear attack very soon and we must not go about business as usual."
Radiation damages the bone marrow, which produces infection-fighting white blood cells, platelets that help blood to clot, and oxygen-carrying red blood cells. The result is lethal infections and hemorrhaging.
Hollis-Eden's experimental drug Neumune -- so far tested only in monkeys -- is designed to protect components of bone marrow, enabling the body to recuperate over several weeks after radiation exposure.
The company is also talking with the U.S. Department of Defense regarding a potential separate procurement for Neumune for use by the military.
That contract would likely be for 1 million to 2 million courses of the drug, Opel said.
"I understand that there is movement in those talks," the analyst said.
Richard Hollis said the company hopes to have a final order from the DOD sometime in the first half of this year.
He said the HHS order "is not addressing the mass casualty scenario of a nuclear event in a major city. It is really addressing a few lucky people who would find their way to a hospital."
CRME
Forget it...just a new price target from Versant. C$18 which equals US$15.66
CRME
Interesting how CRME gained 4.2% in the last half hour of trading. Moderate volume day, but most of the volume was skewed toward the last hour of today's session.
Insights? If this jump isn't just noise, it can only be due to 1) takeover or 2) FDA filing for the IV formulation. Can't think of any other events--we know that the phase 2a results for the oral drug aren't due until March.
I had many thrilling meetings today at ASCO GI...but no real news.
Masterlongevity,
I'm at ASCO GI. Just arrived in my hotel room and am arranging my schedule for Saturday. There's a press conference Saturday morning at 7:30 am. All of the CRC stuff--I'm here strictly for CRC--is happening on Saturday; I'll be at non-ASCO meetings all day tomorrow.
Will report on Sunday afternoon, when I get home, unless there is something really exciting. They have wireless in the conference area, so you might get an extemporaneous report.
Oh, and I'm going to try to corner my favorite advisor to my favorite biotech and ask him some questions.... He's going to be at a small meeting with me tomorrow.
And now I shall raid the minibar.
John
Valuation model
Not sure if this has been discussed here before.
http://www.biogeneticventures.com/art9.html
YMI
Article is from April 2005, unable to access online--if anyone has it, you know where to send it!
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_...
I'm covering this meeting (and the main ASCO, and a few European meetings) to create a series of continuing medical education pieces on new developments in colorectal cancer. I'm not there for any particular sponsor or product.
ASCO GI
I'm leaving for the meeting tomorrow. No idea if I will have time, but any requests? I know I will be at the Hecht panitumumab presentation, at least.
John
Reyataz?
REX
Anyone? Any comments? See my previous post. Don't make me make up my mind all by myself
John
YMI
Dew, this should answer your question. The F-X filing is routine.
http://www.sec.gov/about/forms/formf-x.pdf
John
OT: Thomas
Where are you in SE Asia? I'm going to be working for a month in Beijing and HK in either April or May.
John
REX
Any opinions? Current market cap $70 million with 2 ongoing phase IIIs in ovarian cancer (complete Q1 07) plus 2 additional drugs in the pipeline. Has several platform technologies. Their main drug is partnered ex-Europe with a relatively poor royalty rate (8%-12%).
Seems very cheap for the pipeline. Not much cash on hand but they have a very low burn rate.
Haven't done much research yet other than listening to the R&R webcast. Does this represent deep value or is it crap? Hoping someone who owns or has already analyzed can save me some time. Considering this for later in the year; I think it's dead money until maybe Q4.
J
OT: Praveen
ESLR did well today. Looking for additional alternative power investments. I'd like to buy one wind and one nuclear; however, the only thing I can find for wind is ZOLT, which supplies carbon fiber to windmill makers. Unfortunately up 12% today. As far as nuclear, I can only find crazy Canadian miners. Any suggestions?
...sorry all, promise to terminate this thread soon.
John
OT: First non-biotech investment
Made my first non-biotech investment since I purchased AMR calls at the beginning of 2005.
ESLR--they make solar panels. Figured if oil is going to $100, it should be a good investment.
Wish me luck. With the exception of my AMR calls last year, I've always gotten killed in non-biotech stocks.
John
YMI
>From what I have read Epirubicin is a little more active and has a better profile then Dox<
Actually, on a mg-for-mg basis, dox is more active than epirubicin. Epirubicin has a better safety profile, so doctors can give more of it. Essentially achieving the same effect.
J
David:
>Dew attacks me here and at the Yahoo board because he knows it is a win-win for him. He gets to score easy points because he's smart enough to realize I cannot respond fully. If he's wrong there and I do respond fully, then he still wins because publishing our research on a free message board (a) pisses off my paying customers and damages my business; and (b) it appears on the free message board he has a personal interest in making successful.
It's a common ploy in this business, but those outside it may not realize that's the subtext here. Hopefully now you do.<
I’m sorry, but this just sounds paranoid. Kind of like my manipulation fantasies.
Terry:
>I think you know, David, I have posted many times that your newsletter is the only one I subscribed to in oh, maybe, 30 years or so and I unhesitatingly recommend the research to anyone. I find most other newsletters I have read worse than useless.<
Me too. Even though I am quite well versed in the industry—I work in it, after all—I just shelled out for a subscription. Although I only agree with about half of what is said, I find David and his team come up with many things I haven’t thought about. The cost is trivial in the context of my portfolio.
PGS:
>So what does it matter if I choose to make a public fool of myself of my own free will, especially if I'm looking to learn as a result of the ensuing critical debate?<
Amen.
That was sarcasm.
I'd appreciate it if someone could answer my questions.
Re: buy and hold--I consider myself a buy-and-hold investor, but I am perfectly willing to take profits or sell a loser before it becomes a substantial loss, even if the tax implications are not positive. Any other strategy in biotech is crazy. In my opinion, of course.
AVN Timeline
I'm trying to put together a reasonable timeline for AVN--can anyone help? Not just Neurodex--include all products. A quality read me first would be nice.
Tried downloading the JP Morgan presentation and ended up with some dude babbling about oil. The website is not particularly informative--and it is extremely difficult to navigate. I keep having to re-register, I get error messages--big pain in the butt.
Here's what I have, but it is out of date:
Resubmission of Neurodex Year-end 05 (didn't happen)
Initiate phase II study of AVP13358 in asthma (didn't see a press release)
IND filing for MIF/ApoA1 compounds (huh? Assume this is the AZ compound)
Potential FDA approval of Neurodex in PBA (don't think so)
Phase III results of Neurodex in diabetic neuropathy (I have my doubts given they can't seem to hit any of their targets)
What about the phase I trial of the AZ-partnered compound? I see that it started but they don't give any sort of timeline.
Please note that I am not being critical. I'm interested, just trying to figure out when would be the best time to invest to avoid dead money.
I did some work for AVN on PBA during the Yakatan era. Got to sit next to the great man himself during an ad board. It's been a long time, and I've completely lost touch with the data since then.
Building my grand plan for '06 today.
J
Timeline
I'm trying to put together a reasonable timeline for AVN--can anyone help? Not just Neurodex--include all products. A quality read me first would be nice.
Tried downloading the JP Morgan presentation and ended up with some dude babbling about oil. The website is not particularly informative.
Here's what I have, but it is out of date:
Resubmission of Neurodex Year-end 05 (didn't happen)
Initiate phase II study of AVP13358 in asthma (didn't see a press release)
IND filing for MIF/ApoA1 compounds (huh?)
Potential FDA approval of Neurodex in PBA (don't think so)
Phase III results of Neurodex in diabetic neuropathy (I have my doubts given they can't seem to hit any of their targets)
What about the phase I trial of the AZ-partnered compound? I see that it started but they don't give any sort of timeline.
Please note that I am not being critical. I'm interested, just trying to figure out when would be the best time to invest to avoid dead money.
I did some work for AVN on PBA during the Yakatan era. Got to sit next to the great man himself during an ad board. It's been a long time, and I've completely lost touch with the data since then.
J
GNT
Nice find, I admit it. Reviewed the corporate presentation and various data; seems the porcine mucosal ssDNA works, although I am still puzzled about the MOA. Near as I can tell, it coats the endothelium and maybe the charge keeps RBCs from sticking?
Think you're right that this represents a "deep value." However, I am not in a rush to buy it--as far as I can see, there are no major milestones over the next few months that would strongly influence PPS.
Considering this for later in the year.
Thanks again!
John
INSM will make you smarter too
NEW YORK (Reuters Health) - Children who are short for their age may perform more poorly on tests of intelligence than their taller peers, a new study suggests. The findings, say researchers, imply that some environmental factors may negatively affect both early childhood height and mental development.
What those factors are is uncertain, but a stressful home life is one possibility, according to Dr. Scott Montgomery of the Karolinska Institute in Stockholm, Sweden, the study's lead author.
"Childhood stress can slow growth significantly," he told Reuters Health, pointing to evidence that children's growth can be impaired when parents divorce or frequently argue. Research suggests that long-term stress can affect the body's production of growth hormone -- and, therefore, a child's height.
Similarly, Montgomery explained, stress can influence the development of brain regions involved in memory and learning.
Of course, short stature need not signal any underlying problem. Some children are simply shorter than average, particularly if their parents are not tall. "Some children are shorter for genetic reasons," Montgomery said, "and this will not influence their intelligence."
His team's study, published in the Archives of Disease in Childhood, included more than 1,400 British children born in 1970. Each child's height was recorded at the ages of 22 months and 5 years, and all completed a standard test of mental acuity at the age of 10.
The researchers found that shorter height at age 5 was associated with poorer test performance at age 10 -- regardless of factors such as birth weight and family income.
The implication, according to Montgomery, is that slower childhood growth is somehow associated with "lower intelligence." Poor nutrition is a potential reason, he noted, but among healthy children in a developed country like the UK, stress may be a more important factor.
"A happy childhood is likely to enhance both physical growth and intellectual growth," Montgomery said.
GNT
I may be speaking out of turn because I haven't looked at the data yet, but this strikes me as a particularly bizarre MOA.
>Defibrotide is a single-stranded DNA that protects the vascular endothelial cells, particularly those of small vessels, from damage and activation. After binding to endothelial cells, Defibrotide decreases cell adhesion and pro-coagulant activity of activated endothelial cells, and increases the fibrinolytic potential of endothelial cells. Defibrotide's effects are predominately local within the vascular bed, and there is no significant effect on systemic coagulation. Its beneficial pharmacological effects are due to its anti-thrombotic, anti-inflammatory and anti-ischemic properties.<
Is this just plain ol' ssDNA? Is it a particular sequence? Or perhaps a specific percentage mix of the various bases? Does it have a tertiary structure that allows it to actually activate/inactivate something, or does it passively coat and protect? What protects it from exo- and endonucleases? Naked ssDNA would be chewed apart ASAP if injected. Given that DNA is negatively charged, and the surface charge of RBCs changes with age and disease state, in some cases it might be actively repelled.
Anyway...
One positive: ultra-cheap to make.
John
GTCB
Yes, I agree with you that a negative decision might come in January, whereas a positive would most likely come in February.
I tried to establish 50% of my position today, ended up only getting a little less than half filled (at $1.73). I will buy the remainder on January 27.
John
YMI
I think there are others on this board who may be more qualified to answer your questions than me, but if you e-mail me I'd be happy to forward you all of the information and discussions that have taken place off the board.
John
GTCB
After long, long deliberation, finally decided to buy some GTCB. That's me sitting at $1.72.
John
YMI
Any guesses as to why YMI is getting killed?
Market Cap
Could someone fill me in on the real market cap for AVN. Yahoo has it listed at $1.9B. Assume it is more like $500M?
J
Scientists discover most fertile Irish male
...and I thought he was io_io.
DUBLIN (Reuters) - Scientists in Ireland may have found the country's most fertile male, with more than 3 million men worldwide among his offspring.
The scientists, from Trinity College Dublin, have discovered that as many as one in twelve Irish men could be descended from Niall of the Nine Hostages, a 5th-century warlord who was head of the most powerful dynasty in ancient Ireland.
His genetic legacy is almost as impressive as Genghis Khan, the Mongol emperor who conquered most of Asia in the 13th century and has nearly 16 million descendants, said Dan Bradley, who supervised the research.
"It's another link between profligacy and power," Bradley told Reuters. "We're the first generation on the planet where if you're successful you don't (always) have more children."
The research was carried out by PhD student Laoise Moore, at the Smurfit Institute of Genetics at Trinity. Moore, testing the Y chromosome which is passed on from fathers to sons, examined DNA samples from 800 males across Ireland.
The results -- which have been published in the American Journal of Human Genetics -- showed the highest concentration of related males in northwest Ireland, where one in five males had the same Y chromosome.
Bradley said the results reminded the team of a similar study in central Asia, where scientists found 8 percent of men with the same Y chromosome. Subsequent studies found they shared the same chromosome as the dynasty linked to Genghis Khan.
GENGHIS KHAN EFFECT
"It made us wonder if there could be some sort of Genghis Khan effect in Ireland and the best candidate for it was Niall," Bradley said.
His team then consulted with genealogical experts who provided them with a contemporary list of people with surnames that are genealogically linked to the last known relative of the "Ui Neill" dynasty, which literally means descendants of Niall.
The results showed the new group had the same chromosome as those in the original sample, proving a link between them and the Niall descendents.
"The frequency (of the Y chromosome) was significantly higher in that genealogical group than any other group we tested," said Bradley, whose surname is also linked to the medieval warlord. Other modern surnames tracing their ancestry to Niall include Gallagher, Boyle, O'Donnell and O'Doherty.
For added proof, the scientists used special techniques to age the Y chromosome, according to how many mutations had occurred in the genetic material over time. The number of mutations was found to be in accordance with chromosomes that would date back to the last known living relative of Niall.
Niall reportedly had 12 sons, many of whom became powerful Irish kings themselves. But because he lived in the 5th century, there have been doubts the king -- who is said to have brought the country's patron saint, Patrick, to Ireland -- even existed.
"Before I would have said that characters like Niall were almost mythological, like King Arthur, but this actually puts flesh on the bones," Bradley said.
When international databases were checked, the chromosome also turned up in roughly 2 percent of all male New Yorkers.
Re: Antibody names
Strangely enough, I was looking whether there was an IUPAC-like mechanism for antibody naming a week or so ago and got side tracked. Thank you!
Does anyone know how the prefixes are determined? I can see no pattern, and it doesn't look like they are chosen for ease of pronounciation.
J
Dan,
Thanks for your considered response.
>What's your problem with e-Trade? They handle my MTBF (Metabolic Pharma-AUS ) buys pretty good.<
Although they told me they accept on-line buys of international stocks, I've had to call them...and sit on hold...yesterday, about 20 minutes.
I'm also irritated that they took away the percent return graph.
>Too many guys have posted trade histories of a series of 100 share sales, followed by buying when stop sells appear.<
That's sort of what I'm talking about. Who buys and sells 100-share blocks of a $3.50 stock?
Anyway, I'm not overly concerned; I just looked at E-Trade's level 2 screen and was mystified. I need to stay away from stuff like that--it's too easy to get hypnotized.
J
Two off-topic questions:
Hope someone here is willing to answer:
1) What are your thoughts regarding deliberate manipulation of stock prices? The reason I ask is I have recently been watching YMI closely, and it almost looks like someone is deliberately trying to manipulate the stock--both up and down.
2) Anyone have a recommendation for a good discount broker that permits easy buying/selling of international stocks on their exchanges? E-Trade is hell. Also, anyone know who has the lowest margin rates?
John
io_io,
Of course I looked at their material before buying--more later.
John
Ahem...DND.TO
Up 52% this morning. Io_Io, thank you--bought 20,000 shares yesterday afternoon. Now I owe you a drink.
John