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Bapineuzumab Phase III Information Now Up at Clinicaltrials.gov
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: Felicia

According to Elan's Webpage, they are running the BAP trials along with Wyeth, so I think it's very relative to the topic to know that they are being secretive about it. It doesn't necessarily mean that anything is wrong with the trial, it's just information so that caregivers can make informed decisions about the trial and the companies running them.
Internal Administrator
Posted: Saturday, January 7, 2012 11:17 AM
Joined: 1/14/2015
Posts: 40463


Originally posted by: Ger

Information on two upcoming Bapineuzumab Phase 3 Clinical Trials is now published. Recruitment has not begun.
Link: http://clinicaltrials.gov/ct2/results?term=aab-001


Contact: Study Coordinator 1-888-MEMORY
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: maebee

Deb,
I put Bapineuzumab into "news.google.com" and got this report, from 9/9/08:
http://www.troyrecord.com/site/news.cfm?newsid=20113313&BRD=1170&PAG=461&dept_id=7021&rfi=6
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: Traude

Erin, I'm so sorry to hear this. It must be such a blow after all you went through to get your dad into the study. He is the second person I heard of who has been withdrawn from this study.
It is certainly making me nervous as we approach the date for the second infusion.
I will keep you posted on our progress.
The best to you and your dad.
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: Traude

Ann, my husband gets his second infusion this month. So far no change but I'm hoping we will notice something positive after the next one. No adverse effects which is good in itself.
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: JAB

Erin, I'm sure you're deeply disappointed. Elan is being super careful after the earlier problems.

They're getting ready to recruit for GammaGard. Since that's already FDA-approved for other diseases, many of the safety issues have already been addressed. Perhaps your father could qualify for that...
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: maebee

Awesome, Deb!
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: tkb

Ger:

This no. is not correct. Memory has 6 didgits not 7. The correct no is 1-877-687-8839.

ELND005 is also recruiting here is the link:

http://clinicaltrials.gov/ct2/show/NCT00568776?term=alzheimer%27s
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: bob54

Erin:

I am so sorry to hear this as well. Your family is in my prayers.
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: scs

Erin;

When Tom was denied from this study due to a small arachnoid cyst, I thought my world had ended. Can only imagine the depth of your disappointment.

Please have hope and look at the other studies available. Tom, with his cyst, was just accepted for screening, (not accepted, not counting my chickens yet) for the RAGE study. Also look at the IVIG (Gammagard) study.

We need hope to survive. Take care, Sandy
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: ForGranny

Here is another article regarding the Lawsuit against Elan. These two statements were especially upsetting to me:
1. "Elan issued materially false and misleading statements regarding the Phase II clinical results of the Company's investigational treatment for Alzheimer's disease, bapineuzumab."
2. "Specifically, Elan failed to disclose unfavorable results from the bapineuzumab trial in a June 17, 2008 press release regarding the study, misrepresenting the safety and efficacy of the drug to investors and analysts.
--------------------------------------------
http://biz.yahoo.com/pz/081113/154697.html
Scott+Scott LLP Files Class Action Lawsuit Against Elan Corporation, plc On Behalf of Investors -- ELN
Thursday November 13, 6:37 pm ET

NEW YORK, Nov. 13, 2008 (GLOBE NEWSWIRE) -- On November 13, 2008, Scott+Scott LLP filed a class action lawsuit against Elan Corporation, plc (``Elan'' or the ''Company'') (NYSE:ELN - News) and certain officers and directors of the Company in the U.S. District Court for the Southern District of New York. The action is on behalf of those purchasing American Depository Receipts (``ADRs'') of Elan during the period beginning June 17, 2008 through July 29, 2008, inclusive (the ``Class Period''), for violations of the Securities Exchange Act of 1934.
If you purchased ADRs of Elan during the Class Period and wish to serve as a lead plaintiff in the action, you must move the Court no later than December 14, 2008. Any member of the investor class may move the Court to serve as lead plaintiff through counsel of its choice, or may choose to do nothing and remain an absent class member. If you wish to discuss this action or have questions concerning this notice or your rights, please contact Scott+Scott (scottlaw@scott-scott.com, (800) 404-7770, (860) 537-5537 or visit the Scott+Scott website, http://www.scott-scott.com) for more information. There is no cost or fee to you.
ADVERTISEMENT

According to the complaint, during the Class Period, Elan issued materially false and misleading statements regarding the Phase II clinical results of the Company's investigational treatment for Alzheimer's disease, bapineuzumab. As a result of defendants' false statements and omissions during the Class Period, Elan ADRs traded at artificially inflated prices.
Specifically, Elan failed to disclose unfavorable results from the bapineuzumab trial in a June 17, 2008 press release regarding the study, misrepresenting the safety and efficacy of the drug to investors and analysts. As a result of the press release, Elan ADRs surged upward nearly 11% in one day. However, when the detailed Phase II results were finally disclosed, the Company's prior representations on the safety and efficacy of bapineuzumab were shown to be overblown. On that day, the price of Elan's ADRs plunged from $33.75 to $19.63.
Scott+Scott has significant experience in prosecuting major securities, antitrust and employee retirement plan actions throughout the United States. The firm represents pension funds, foundations, individuals and other entities worldwide.
-------------------------------------
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: Norbert

I find this discussion of Elans behavior to be very on topic.

It is very similar to behavior seen last year when the previous supposed wonder drug, Alzhemed, failed tests and the company attempted to find a way to spin the results.

Thanks everyone for the information from a variety of sources.
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: Felicia

Hi Erin,

Sorry about your Dad. All that trouble and preparation you had to make just to get him ready.

It's also very sad that he has had such a quick decline...any bladder infections or anything like that? I hope it's something simple like that.

You all are in my prayers.

Felicia
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: Felicia

Hi Ira,

Very interesting article. It took me a few tries to find it so I hope you don't mind me putting up the link:
http://www.thestreet.com/story/10416074/1/feuersteins-biotech-stock-mailbag.html

Also, thank you for putting up the link on the enbrel spreadsheets. I have a feeling the new drug isn't getting these kind of results and maybe that's why they don't want us to spread the news about Enbrel. But, if BAP and Enbrel could work well together, that would be terrific!

So far, no bad side effects or problems reported with everyone I've ever communicated with who is receiving the Enbrel Treatments.

We had a nice Mother's Day here, a bit much for Mom, but she did fine. She smiled, ate, and talked with the family...and enjoyed watching her two great-grandson's run around the house.

Thanks, Felicia
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: Traude

I just re-read the consent forms we signed to participate in this trial. It states that if you experience a bad side effect from the study drug your doctor may ask you to have a lumbar punture. I will ask for further clarification of this at our next infusion. It was certainly not stressed at the time of the assessment.
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: AnnMW

I'm so sorry, Erin. I pray that there will be an answer for your father as well as all others. Please keep us updated.

Ann
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: eoneill

I wish I had something positive to say, but we were just dismissed from the study. My father was to receive his second infusion last week and instead we did the exit interview. Apparently the Elan folks reviewed his initial MRI which showed an area of infarct less than 1cm. Any infarct 1cm. or less qualifies for the study. After the review, his initial infarct measured 1.5cm. I don't quite understand how this error in measurement occurred. We are ok with it as he is a carrier of the gene and his MMSE score has declined 4 points since the initial screening back in July. Good luck to those of you in the study.
Erin
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: maebee

If you go to this page:
http://news.google.com/news?hl=en&tab=in&ned=us&q=bapineuzumab&btnG=Search+News

At the bottom is a link where you can sign up for email alerts for the latest news on bapineuzumab.
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: Moms_Buddy

I have NO IDEA what the corporate inside information means or has to do with the trials and I would be willing to bet that folks do not find that length and level of corporate chatter at all helpful in making their decisions!! TOO MUCH INFORMATION is merely a tool that some folks use to confuse and misdirect others away from a thread.

Once again, why don't we TRY to stay ON TOPIC which was:
informing people that some Phase 3 BAP trials are planned but not yet recruiting? Is that too much to ask?
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: vend95

Interesting article from The Street.Com regarding secretcy at Elan's Annual Meeting:


1.) Elan did not permit a couple stock analyst's in their annual meeting claiming that the room was full even though the room was half empty. Analyst does not have a buy rating on Elan stock.

2.) Elan requested an invitation to a private stock analyst consulting conference with an AD expert, which is only open to the firms clients.

3.) The Elan annual meeting did not have any Question Answer session, which is normal for annual meetings.

4.) Related note, Bob Ruffolo,head of Drug Research at Wyeth, announced his retirement, April 30. He is only 58 years old. Bob was the top R&D guy, responsible for Bapineuzumab.

Here is the entire article:



The Street.Com Feuerstein's Biotech-Stock Mailbag


Before I get to your email, an Elan (ELN - Cramer's Take - #HYPERLINK "http://www.stockpickr.com/thestreet-symbol/ELN/"Stockpickr) update: I didn't attend Elan's investor meeting Wednesday in Boston. I wanted to go, but I was denied an invitation. Elan told me the room was too small to accommodate everyone who wanted to be there.

Funny, but several people in attendance at the event told me afterward that the room was half full. There were plenty of seats available.

One New York hedge fund analyst who also requested an invite in advance but was turned down nevertheless showed up at the conference center hoping Elan would let him sit in on the meeting. No way, the Elan officials told him, asking him to leave.

Having nowhere else to go, the analyst decided to sit in the lobby of the conference center building and listen to the Webcast of the Elan meeting on his laptop. After a few minutes, a police car pulled up and a Boston cop approached, telling him he needed to leave the building immediately. (There's a great picture of the cop confronting the analyst, snapped by another Elan meeting attendee, that has made the rounds of Wall Street.)
Caroline Stewart is an analyst for Piper Jaffrey. She has a neutral rating on Elan, in part because she says she's not sure that bapineuzumab, Elan's experimental Alzheimer's drug, is going to actually work. She, too, ran into trouble snagging an Elan invite.

A month or so ago, Stewart was planning to conduct a consulting call with an Alzheimer's expert for her clients, in part to discuss bapineuzumab. Elan wanted to listen to the call live, but Stewart explained that it was a call for Piper Jaffrey clients only. The company, however, was free to listen to the replay.


Stewart says that Elan insisted on listening to her consulting call live, and if not, she wouldn't be allowed to attend the company's analyst meeting. Stewart explained again that Piper rules forbade Elan from listening to her consulting call live. She also got angry, and asked Elan whether it was legal for the company to exclude her from attending a meeting where other analysts were invited.
Elan backed down and allowed Stewart to attend.
"The whole experience makes you wonder what they're trying to hide," she says, adding that she suspects her neutral rating on the stock had something to do with Elan's attitude. "They do some good science at Elan, but their behavior is bad."
More Elan meeting weirdness: No question-and-answer session? That's right, Elan didn't take any questions from the attendees after they wrapped up the presentations.
"The meeting was a total waste of time," says Stewart. "Why did Elan hold an investor and analyst meeting but then not allow any of us to ask questions?"
I've asked Elan to comment on why it seems like only "friends" were invited to its investor meeting. I haven't heard back. If and when I do, I'll let you know.
On a related note: Bob Ruffolo, head of drug research at Wyeth (WYE - Cramer's Take - #HYPERLINK "http://www.stockpickr.com/thestreet-symbol/WYE/"Stockpickr), announced his retirement April 30. He is 58 and was at Wyeth for about eight years.
As the top R&D guy at Wyeth, Ruffolo, naturally, was responsible for Wyeth's work on bapineuzumab, which is being conducted jointly with Elan.

Why would Ruffolo retire now, with key bapineuzumab data from the phase II study coming out in a couple of months, or even sooner? (He also sold a lot of Wyeth stock immediately after Wyeth and Elan announced in May 2007 that bapineuzumab was moving into phase III studies.) The timing of his retirement sure seems strange.
Now, before I get to your mail, a housekeeping item: I'm going on vacation, so the Biotech Mailbag will go on hiatus for the next two weeks. I'll miss you all. Well, maybe not so much since I'll be in Italy. But I will return in time, rested and ready, for the big ASCO cancer meeting. And eager to write more Mailbags, of course.
Hey, any recent travelers to Rome and Tuscany out there? If you are, and have some tips on things not to miss (great food, wine and gelato, especially), send me an email, please.
Speaking of ASCO, if you missed it earlier this week, check out my research abstract planner, Asco Abstract Preview. This should help prepare you for Thursday, when ASCO releases abstracts online. My colleague at TheStreet.com, Elizabeth Trotta, will be working to bring you all the news. I'll try to comment as well, probably while sitting in a Roman café sipping espresso. (Does it sound like I'm looking forward to this vacation?)
Onward to your email.


Ira

Enbrel for AD Patient Spreadsheet:
http://spreadsheets.google.com/pub?key=pXy1TUb9QGEh5I0Jh6Qk7HQ
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: tkb

Inge:

The question is your husband in the Elan or Wythe study? The Wythe study (in Europe) may be halted- NOT the Elan study. Do not worry about this.
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: Felicia

Just about everything posted on this board is based on our own experiences. Be sure to read the words as careful as possible. jdm did say possible, not that is was definite that you may need a bone marrow test.

Most everyone is here looking out for a loved one, and we do the best we can in explaining things. Hmmmm...I just went back on this post and added "just about" at the first paragraph, and "most" at the beginning of my next paragraph. I was also given great advice to add "In my opinion" when I am speaking my mind!
It's hard when we're not face to face, In my opinion! Smiler

Take care, Felicia Smiler
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: Moms_Buddy

Ira, this clipping does NOT pertain to the Bapineuzumab trials (mentioned as an aside in the last two paragraphs) AND, if you read the article, states that the VACCINE trials which were suspended, have now been resumed.

Again, could we PLEASE stay ON TOPIC?!!
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: Ger

Moms_Buddy The sites for the Bapineuzumab Phase III Trials are recruiting. clinicaltrials.gov
when page opens, type bapineuzumab in the search space top right of screen. Up will come various Bapineuzumab trials and within them, you will be able to click open the various locations recruiting across the United States
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: CR55

New study about this drug Bapineuzumab:


Alzheimer's drug hits two forms of toxic protein

"A small brain imaging study last year showed bapineuzumab was able to shrink solid clumps of beta amyloid in the brain by 25 percent in 28 patients. [ID:nLDE61P171]

But several recent studies in mice and rats suggest that the much smaller floating, or soluble, pieces of beta amyloid found in cerebrospinal fluid - the clear, watery substance that bathes the brain and spinal cord -- are the real bad actors in Alzheimer's disease.

That has raised questions about whether bapineuzumab -- an engineered immune-system molecule called a monoclonal antibody -- is targeting the wrong thing. [ID:nN1296061]

To study this, researchers at J&J did a series of studies in mice and cells. They suggested that the drug not only binds to soluble beta amyloid, but also may neutralize some of the protein's ability to harm brain cells."


http://www.reuters.com/article...e=companyNews&rpc=43
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: DebZ

OK - anybody have anything recent on Bapineuzumab? A local neurologist is doing one of the Phase III trials (18 months I believe) and am wondering if it would be worth bringing my bro here from Nevada to participate??
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: tiggermom

My husband has been accepted into the trial and will have his first infusion next week. My understanding is that he will have one of three doses or the placebo. I don't know anything about a possible bone marrow sampling, but we were given the choice to participate in the optional add-on study using the lumbar puncture - which he declined. I'll be interested in talking to others in the study as it progresses.
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: AnnMW

My husband received his first infusion on Friday......He has also agreed to the sub studies.......So far, so good.

Would love to hear of anyone else who is in this study.
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: vend95

Per Reuters :Elan suspended this study in April due to a patient being hospitalized with skin lesions that a lead researcher suspected was a case of vasculitis, an inflammation of blood vessels.


http://www.reuters.com/article/marketsNews/idUSN1112586220080611

Elan says trial of Alzheimer's vaccine restarted
Wed Jun 11, 2008 1:07pm EDT
By Ransdell Pierson

NEW YORK, June 11 (Reuters) - Elan Corp's (ELN.I: Quote, Profile, Research)(ELN.N: Quote, Profile, Research) mid-stage trial of a vaccine to treat Alzheimer's disease has resumed following a six-week suspension prompted by safety concerns, Chief Executive Kelly Martin said on Wednesday.

"Last week dosing was restarted," Martin told analysts and money managers at the Goldman Sachs annual Global Healthcare Conference in Dana Point, California. He said the study, which had been suspended in mid-April, was "back on track."

The vaccine, called ACC-001, stimulates the immune system to block production of A-beta peptide, a component of the amyloid-protein plaque which forms tangles in the brain that are the chief suspected cause of Alzheimer's.

The suspension allowed Elan and partner Wyeth (WYE.N: Quote, Profile, Research) to examine a potentially serious side effect suffered by one patient in the mid-stage trial. The patient was hospitalized with skin lesions that a lead researcher suspected was a case of vasculitis, an inflammation of blood vessels.

Later on Wednesday, Elan spokesman Andrew Lewis said the trial was resumed after diagnostic tests failed to confirm vasculitis.

Elan and Wyeth are also co-developing another Alzheimer's drug, an antibody called bapineuzumab (AAB-001) that is farther along in testing and widely considered the most promising product in development against the degenerative brain disease.

Bapineuzumab, a humanized monoclonal antibody which directly attacks A-beta-peptide, has potential to become one of the world's biggest selling drugs if it slows down progression of Alzheimer's and is approved by regulators, according to many industry analysts

Ira
vend95@yahoo.com
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: tkb

Sometimes I am amazed at the incorrect information given out on these message boards. A bone marrow is not required to participate in this study! I've have posted a link to the clinical trail data base. Please read the inclusion/exclusion to see if your loved one qualifies. Elan is also doing another study of an oral drug ELND-005. This is a smaller phase II study. In the BAP trial there are several different "sub" studies including a CFS one, however participating in this is not required. Our research nurse told us they turn away several due to health issues. They are being selective. The ELND-005 should be easier to get into.

http://www.clinicaltrials.gov/ct2/results?term=&recr=&type=&cond=alzheimers&intr=&spons=
elan&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&rcv_s=&rcv_e=&lup_s=&lup_e=

The facts is that no one survives this disease-for me it was worth enrolling my husband. Oh yeah for the record so far so good.
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: FPS

Some data emerged this week which seems to show positive test results for a special subgroup in the Phase II study -- the subgroup being those who do not carry the ApoE4 gene.

I just read this thread (which thankfully is not that long) and noticed conversations pertaining to public practices of Elan. There's a very interesting article -- written in lay terms -- about Elan's release of BAP data at:

http://www.thestreet.com/s/biotech-review-elans-alzheimers-drug/newsanalysis/biotech/10421811.html?puc=googlen&cm_ven=GOOGLEN&cm_cat=FREE&cm_ite=NA

The inference is that the data might be skewed to force a positive spin on the results for public consumption. More information will be made at the ICAD conference at the end of July.
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: DebZ

Thank you both for your replies. I'm not too big on the bone marrow testing - don't think I want to put my bro through it. I also don't like the idea of it being an 18 month study, particularly if he may be getting the placebo.
Maebee - I checked out that news article and much to my surprise it's from a newspaper in the next city over from me (Troy, I'm in Albany) and the neurologist whom they quote is the doctor I would be taking my bro to!!
I guess a bit more research on this drug is in order for me.
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: Moms_Buddy

Please correct me if I am mistaken, but isn't this topic about Bapineuzumab trials? Not ELND005 or alleged secrecy at Elan's Annual Meeting or Enbrel spreadsheets?

Could we PLEASE stay ON TOPIC?

I had no trouble locating the trials and the email contacts for the ones not yet recruiting...
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: skericheri

The following is a duplicate of a post that I put on the other BAP thread

Just came across a video and story that stated that the European BAP tests had been temporarily halted to allow time to check out potential health problems. Below are the links:

video
http://www.youtube.com/watch?v=HTHbHCLDo94

story
http://www.smartmoney.com/breaking-news/on/?storyN-20081022-000732-1033&afl=yahoo
Anonymous
Posted: Saturday, January 7, 2012 11:17 AM
Originally posted by: Moms_Buddy

Thanks for the update, Ger. Smiler

I wish the name was a little shorter for that drug... I can never remember it and call it Beelzebub in my head... ;P This is gonna be a copy/paste job for sure!!
 
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