smokes, I never really thought you were the former founder and former
member of the BOD of ADVR -- Bill Bregman. I have to tell you, it feel
really weird having you post on ADVR Stock Message Board. You really
have got to be walking on eggs - each and every time - you make a post
on here. Did you not sign a Confidentiality Agreement during your time
with ADVR? I know you mentioned your "right" to have Freedom
of Speech and do as you will since you are not RETIRED. But, the fact
is, YOU STILL OWN A CONSIDERABLE AMOUNT OF ADVR SHARES - whether they be
in your name of in the name of other family members.
What is YOUR purpose of posting on this rather insane message board? I'm not sure I can come up with a legitimate answer --- I'M STILL IN SHOCK FROM YOUR REVELATION!!!!
P.S. I haven't had a chance to read any of the messages posted last night after your Revelation Post -- I still catching up on here!
AVI BioPharma Presents Additional Data on West Nile Virus Clinical Trial
At International Antiviral Conference
Tuesday May 4, 6:45 am ET
First Report of an Antisense Drug Crossing the Blood-Brain Barrier
PORTLAND, Ore.--(BUSINESS WIRE)--May 4, 2004-- AVI BioPharma, Inc. (Nasdaq:AVII - News), today announced that data from its Phase I/II West Nile virus (WNV) clinical trial with its proprietary NEUGENE® antisense drug AVI-4020 showed presence of the drug in cerebrospinal fluid (CSF) of patients treated with AVI-4020. This represents the first report of an antisense drug crossing the blood-brain barrier in a clinical study. The data were presented at the 17th International Conference on Antiviral Research by Patrick L. Iversen, Ph.D., senior vice president of research and development at AVI.
The Phase I/II West Nile virus clinical study was conducted in fall 2003, enrolling 10 patients, nine of whom received AVI-4020 and one of whom received a placebo. The trial was conducted in Colorado at the Boulder Community Medical Center, and was designed to evaluate the safety of AVI-4020. As previously reported by AVI, the study met its primary endpoint, as no safety concerns pertaining to the drug were identified during the trial.
Pharmacokinetic (PK) data from the study showed that the plasma elimination half-life of this third-generation antisense drug was four to five hours. Approximately 24 hours after the last dose of the drug was administered, a spinal tap was done to collect CSF for PK analysis. When the CSF samples were analyzed, all of the patients who received the drug intravenously had drug in the CSF. The mean concentration of the antisense drug was 8.1 nanograms per milliliter (ng/ml) or approximately 1 nanoMolar (nM).
"In addition to the safety results seen in this study, we now have the first evidence of an antisense drug crossing the blood-brain barrier as measured by concentrations in the cerebrospinal fluid of treated patients," Iversen said. "These results open up numerous avenues for development of our NEUGENE compounds in neurological indications, and we plan on further exploring this significant potential in diseases with neurological implications."
"AVI-4020 is a unique drug with the potential to treat West Nile virus, a disease with no existing treatment options," said Nelson Gantz, M.D., chief of Infectious Diseases at the Boulder Community Hospital and an investigator in the study. "In this initial small study, the compound was well tolerated, with no reported drug-related serious adverse events. The results presented show the drug can enter the central nervous system, which appears consistent with the improvement noted in the condition of the patients, and which is an important element in treating viruses, such as West Nile, that may cause brain inflammation. Based on the results to date and the need for new treatments against emerging viruses such as West Nile, AVI-4020 merits further study."
is finishing out his contract, (12/31/04). Friedland was the only one
who knew how to make the drug and he's been gone for 2.5 years. Do you
really think Hirschman holds the magic key?
If you would move your butt and visit Hawkins and Epstein in Yonkers, you would take back every word you have said here. Very peculiar that you don't let one post slip by while claiming not to own any stock. What's your agenda Yanks?
(Voluntary Disclosure: Position- Long; ST Rating- Strong Buy)
All,This is from the YAHOO BB...NICE!!...Aven1
From: "draydel" Add to Address Book
Date: Tue, 04 May 2004 13:36:49 -0000
Subject: [Advanced Viral is Reticulose] ADVR will be presnting at an Investor's Conference in NY
On June 5
Nice to see efforts by the company to get their investment story out.
(Voluntary Disclosure: Position- Long; ST Rating- Strong Buy; LT Rating- Strong Buy)
the Sunday meeting.
There didn't seem to be much said about the upcoming completion of the Israeli Trial. Back in Nov of 2003 the management seemed to do back-flips over the good pre-lim results. Now la-de-dah?
Then, if I recall, it was said that the new Dr.H was sorting through all the docs one by one. What about the old Dr.H is he lending his full support? Does he even go to the office daily? What about the expensive computer? Any help? I just get this vision of someone sitting at a desk burning the mid-night oil going through box after box of papers looking for something, anything.
Always more questions than answers. That favors traders.
(Voluntary Disclosure: Position- Long)
asked that question, her reply was that there are two drugs on the
market now for that indication and it is unlikely the FDA would fast
track another one. She is looking to fast track."
The two Tx refered to for HPV are Aldara & Condylox. We have discussed many times here that the efficacy rate of Aldara hovers around 40%. If the results that are touted in the patent ADVR for HPV (which has since been granted) are to be believed, with efficacy rates of nearly 100%.....this would be a clear improvement to the currently marketed products. Couple this with the often cited low manufacturing cost of AVR118....and, a strong argument could be presented to the FDA for fast track status for this indication.....
BTW.....There are currently at least 3 marketed products for HIV Wasting Syndrome, with several trials for other currently marketed products underway.....
I have said it before & will say it again.....touts of "FAST TRACK STATUS" from management at this juncture has more to do with hyping the shareholders than it has to do with science presentable to the FDA.....
poppop53: The LiarRarBoston has over 1600 posts here and claims to have
no position in ADVR also yet he makes a career out of bashing this stock
and others. It's no wonder LiarRar can't earn a living. He has no time
left to explore that avenue.
BTW, that p53 at the end of your screen name is a hot topic. A protein that may be crucial for the development of many forms of cancer. Very interesting.
Of course 53 could be just your age, or anything else for that matter. I'm just trying to make a point here how everyone can see and read things differently.
Unfortunately, this used to be an informative Board. Now it's taken over by a bashing group of frustrated wannabees. Every now and then the decent shareholders, like you are, voice opinions and are taken seriously by others.
Best of luck to you. Anyone here since 1986 deserves respect.
you for a most articulate reply. You are so right this board has been
taken over my some stange people and its a shame.I wish all the
shareholders good luck and hope this board could return to serious
- - - - -
View Replies »
Dr. Hawkin' stated intention is to file a new IND with the FDA in 2-3
months. The goal is to get a fast-track application with the FDA. The
specific disease for which the drug will be used in these trials was not
specified by her.
Apparently, the Phase 2 topical HPV trials on the previously FDA-approved IND will not be done, despite Phase 1 having been successfully completed. The reason given is that this cannot be fast-tracked, and there are other effective drugs out there for the topical treatment of genital warts.
It is still not known if all 30 patients in Israel are enrolled or when those AIDS cachexia trials will be concluded. Hawkins has been hush-hush on this, as she has about the upcoming ASCO presentation. One would assume that if the trials were completed, something would have been said about it in Florida. I presume therefore that they are still continuing and that the 30 patients are not yet completed. If the ASCO presentation next month relates to this study, we will know then.
It is not known if the application of the drug Dr. Hawkins will go for is AIDS cachexia, cancer cachexia or something altogether different. Perhaps even she doesn't quite know yet. However, the only real patient efficacy data in a controlled clinical trial that the company has available to show the FDA is on the AIDS cachexia patients in the Israeli trial. The previous study in AIDS proper carried out in Barbados showed that the drug was marginal at best in fighting the virus directly. In the age of the new effective anti-AIDS HAART drugs, this use of AVR118 would never be fast-tracked by the FDA.
Of course, there could be other options open. Anecdotally, and in patents, the drug has also been touted for diseases as diverse as lymphoma, basal cell carcinoma, boosting red blood cell production, rheumatoid arthritis, multiple sclerosis and canine distemper (a panacea for all ills, it seems). However, in the absence of hard data in proper clinical trials, other than just anecdotal snippets in the patents and patent applications, the FDA may not buy into these applications of the drug. It appears that trials in AIDS or cancer patients who are terminal would be most likely fast-tracked by the FDA.
The name of the game (as it is often played) is that the conference can
be as big for you as you want to make it. With the proper spin and hype
on the science, and all the anciliary press hoopla one can garner with
one's PR firm, anything is possible.
Companies are not "invited" to make specific presentations at ASCO. The members of the American Society of Clinical Oncology (ASCO) are all sent notices (by e-mail or mail) and asked to contribute papers for the annual conference. A member of ASCO (presumably Dr. D'Olimpio) probably sent in an abstract from Advanced Viral, which is what is being presented. A large percentage of contributed abstracts are actually accepted for presentation. I don't believe for a moment(as some here delude themselves) that ASCO pleaded with ADVR with a specific invitation to present its data.
I've been in almost as long as you. Sounds and feels like a prison sentence at times. I think I remember you from the Silicone Investor board. I wonder if you know anything recent of Old Jake Justus. There was a rumor at one time that he died but I think that was denied. On good days he would have a few and then croon on his telephone hotline. I received his newsletter and actually spoke to him a few times. He seemed to be an intelligent gentleman as well as a character. Please let me know if you have any news of him.
Good Luck to all
you I don't believe ASCO begs anyone for data, but I do believe there
would have to be some type of acceptance or approval process in place.
ASCO would likely have a finite number of abstracts they can
accept/approve, so I guess the next question would be how many
submittals are actually made. ADVR could still be in the elite part of
the class if say only 50% of 10,000 submittals were accepted. I'm only
guessing, but isn't that what we're all doing?
hey you're another old timer from the ADVR Silicon Investor board. Those
were the good old days of fun without the bash.
Please don't leave us. We need you guys here.
justus a golden name out of the past.I heard he died a few years ago as
did john holmes. Do you rember john he had this stock rockin and had he
lived we would have seen more than the1.95 high. i had very cheap
warrants because of him.jake was something else a real down home
southern character who loved a few adult beverages while he talked up
advl. we have a pornographic klown and schoolboys who carry on like
idiots boy has this board come down.I never got involved with the
silicone investor board so im innocent of all charges there. nice
hearing from you and if i can be of any help to you you can always catch
me on mxdy or cirt. regards mark
- - - - -
the ASCO abstract for the June 2004 meeting had to be submitted by a
December 2003 deadline, it could only have contained data for the first
fifteen patients that were completed at that time.
Emma's name and replace it with Shalom Hirschman's in terms of what HIS
focus was back in 1996.
It was to redo the scientific data so that an IND could be filed with the FDA. We were JUST as excited in the focus he had and had announced - and following his IND focus we had a coup,e of poster sessions etc etc.
We all expected great things for the PPS and so on and so on.
So now we have Emma, instead of SZH, the hype remains the same with the same expectations.
In the end, as Sal has said...what is was old is new again.
I'm not sure why anything coming this summer will make much of a difference, much like we expected - but were disappointed - when the last IND and the poster sessions and the microbiology presentations were made.
Maybe I'm stupid, but can you say deja' vu??
is it that you have an unending string of disputes here.
Are you not satisfied with just the present ones?
Must you start over again with each new poster??
You are turning into a bore, Barry - really!
Justus still walks the face of the earth."
Yes, the last rumor was just that.
Istael gov. allowed 30 patients for this study. 23 patients were used.
the results will be with 23 patients which will give very satisfactory
statistical results. this study is on AIDS. The ASCO is for Cancer..
Lets keep things straight.
made this forum the absolute disgrace that it is and baited us daily to
respond in kind as they got rid of the best posters."
You and son were (and continue to be) just as responsible for the smell here on this board - don't discount your own responsibility for the disgrace here.
study is on AIDS. The ASCO is for Cancer.. Lets keep things
So, Bill, are you saying then that the presentation at ASCO is NOT about the HIV Israeli tests but about "something else?"
I also thought it weird that everyone assumes the HIV tests in Israel are the ones that are going to be presented - but knew the ASCO is a cancer seminar/meeting, which represented to me a dichotomy!
Wow now that is interesting.
04 May 2004, 10:01 PM EDT Msg. 151498 of 151500
(Msg. is a reply to by None.)
The Istael gov. allowed 30 patients for this study. 23 patients were used. the results will be with 23 patients which will give very satisfactory statistical results. this study is on AIDS. The ASCO is for Cancer.. Lets keep things straight.
Reading that statement means to me you know that only 23 patients were used. "... 23 patients were used. the results will be with 23 patients..." Were used? Game over, were used!!! From what I know I would have thought the Trial was still in progress.
From the 10K "...Out of 30 total
patients contemplated under the protocol for this study, 23 patients are enrolled, 22 of whom have completed the full course of treatment of AVR118, and one is continuing to receive treatments of AVR118, as required under the study..."
also later in the filing,
"...The completion of the study is dependent upon the availability of patients meeting the prescribed protocol and the ability of the hospitals to meet the requirements of the protocol..."
So if I read what you have wrote to be fact ADVR will not meet the protocol but will use results of an incomplete study using data from the 23 patients instead of the 30 patients described in the protocol.
Now I am not a research scientist but I hope I can follow what is written up to this point. But I don't know the answer to these two questions.
1) How valid will the results be if the protocol is not met?
2) How do you know, as you wrote, "..the results will be with 23 patients..."? Seems like we should all have known that at the same time. I assume I missed the written information.