Tovaxin press release

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Questions

Postby IHaveMS-com » Fri Jan 20, 2006 7:12 pm

Hi to all,

I have spent the afternoon getting some information that I didn’t have. I will start with the last comments that I saw this morning and work my way up. I don’t type very fast and there are a few questions and comments that I want to answer.

I did go to my exercise class and I hope that all MSers try to do some sort of exercise. When I started Tovaxin, my parents wheeled me down to Houston. I could still walk short distances, but not through a large airport. I had given up going out to the mall because of my staggered gait. I would have people come up to me and accuse me of being drunk. I still have a noticeable stagger, but it is not as bad and I can walk for a fairly long distance.

For the month of October 2005, I was the spotlight member at the wellness center that I go to. If you read the comments about me on my website, you would see that many of the things I do require people on both sides to prevent me from falling over. I am the only disabled person in the group, and I think they are determined to make me whole again. When I am in Houston for a checkup, I must promise to call at class time and let them know of any improvements I have had since my last visit. Today, for the first time, with a person on each side, I was trying to do heel-toe walking. They know this is something that the doctor makes me do and they are determined to see me improve. I will work at it, but it will be a while before I will be doing it without spotters.

My tremor has decreased to the point that I now wear tie shoes and a zipper coat. My parents bought me some 500-piece puzzles and some connects building blocks, suitable for ages 4 and up or someone with a tremor. I have been building things like the Doozers on Fraggle Rock. A show that I watched when I was a kid.

The entry from June 11, 2005 was the last entry that Dad has made. At that point he felt that his increased involvement with the company and my website had become a conflict of interest. From the current questions and reaction, he was correct, and it was a good decision for him to no longer participate. There was almost a two-month gap in entries and I was getting lots of email through the site asking if I was okay. So on August 1, 2005, my brother and I took over the site on the condition that my brothers became the narrators.

I am 16 months older than my twin brothers and we have always done lots of things together. All a long, most of the observation had been made by Tom. He was the one that first pointed out that I looked a little stiff coming down the stairs. That lead to my being diagnosed with MS. Up until 6/11/05, my father would take everyone’s observation and write my timeline. He was the narrator, even though the observations were made primarily by Tom. Dad’s observations were generally ones made in Houston, or ones from a parent’s point of view.

My father started a web company in 1996. He has since turned that over to Tom and Rob, but everything still remains in his name. It would be a lot of unnecessary work to reassign ownership of several hundred domains. New domains that my brothers register are still in my father’s name and probably always will be. The only domain that he still is actively involved with is http://www.TotallyFreeMath.com. He is currently loading 4 more books and all of the student and teacher resource materials for anyone to use for free, hence the name. The home page indicates why he is doing that. His email address is on the site, but if NHE checked to see who the registrant is, I don’t think you will find one. I only point that out because it is easy to cloak whom the registrant is if your intent was to fabricate a story and deceive the reader.

In the study that I am in, there are 15 people. I think that was discussed in the press release about the data presented at the International MS conference, but I didn’t look back at the article. A common comment that I see is why didn’t we hear from the other people in the study. Since I am new to all of this, and several years ago I did search the Internet to try to find personal account of people in FDA studies, I assume most people don’t share their experiences. Some may post on a blog, but that is hard to find unless you visit lots of blogs and read everything that is posted. I have only had 2 emails from each of the other participants. I would have thought that they would want to constantly be comparing notes with me. They didn’t even ask if I knew of anyone else in the study.

The website that flipflopper cited http://www.crystalra.com/pdf/PFTR-OB_EIO_11-21-05.pdf has a 60 page summary about the company. I have not read it, but I assume it contains any details about the company that you might be interested in. This was written before the Chinese deal, so that will not be in there.
I agree that it is too early for everyone to think that this is a cure. The study that I am in has had some very promising results. I have had no attacks in over 2 years, but the people in the Tysabri studies had some promising results only to see the drug pulled. If I had not gotten in the Tovaxin study, our second choice was Compath. That drug has recently been pulled from clinical trials.

I am glad that Brownsfan is not ready to dismiss how I have done. Since he works in finance, I assume he would agree that no “qualified” investor or fund would read my website and invest because I was doing okay. They have scientists that analyze the company’s product and make informed decisions. If Tovaxin gets fast-tracked, it might be out in 2009, but more likely in 2010. The company has no snake oil to sell you and unless one of your friends runs a biotech fund, no one reading this post could possibly invest in the company.

I am excited about what Tovaxin has done for me, but that could change tomorrow. I must admit that that excitement has made me get a little carried away in spreading the word. I am going to retire from posting after I answer your questions.

On August 30, 2005 my father was appointed to the board of directors of PharmaFrontiers. http://www.pharmafrontiers.net/board.php His bio outlines how I got in the study and his involvement to that point.
Terry Wesner
Mr. Wesner is a biostatistician and a [Chi Beta Phi] graduate of The University of Memphis with degrees in biology, mathematics, and statistics. His first position after graduate school was an appointment to the Faculty of Harvard School of Medicine as Director of Research for the National Diabetes Association. While a Faculty member at Harvard School of Medicine, Mr. Wesner researched gestational diabetics. Since then he has been a Professor of Mathematics and Statistics, published a successful series of 30 college level mathematics textbooks with McGraw-Hill Publishers, and currently is CEO and Owner of Bernard J. Klein Publishing and GetMath Educational Software. Mr. Wesner brings a unique perspective to the Board as one of the Founding Investors in Opexa Pharmaceuticals, a wholly owned subsidiary of PharmaFrontiers. Following a 16-month search of the journals, he chose Dr. Zhang's T-cell based therapeutic and technology platform as the experimental treatment for his son's Multiple Sclerosis. After having his son qualified by Dr. Zhang for the next FDA trial, he participated in the startup funding of a company to commercially develop Dr. Zhang's targeted T-cell elimination platform for autoimmune diseases. He also has been elected to the National Council of The Text and Academic Authors Association, his company has formed a partnership with World Vision to bring free educational materials to needy schools throughout the United States, served as Chair of his community's planning commission, founded and is now Vice-Chair of his community's building authority, serves on The Advisory Board for The Ann Arbor Academy a school for children with learning disabilities, and volunteers for various other community and civic organizations.

It was pointed out that my parents control 540,000 shares of company stock. I called Dad to find out what that meant. Currently they own approximately 210,000 shares out of 20,500,000 shares that have been issued, or about 1%. Some of the original investments in the company carried warrants. That is the ability to buy more shares at a fixed price. Next month, 10,500,000 warrants will expire. Some of those are my folks, and they will expire because the fixed share price is $2.00. Since the stock is currently selling at approximately 60 cents, these will not get exercised. In October another set of warrants priced at $2.90 probably will also expire. There is a third set priced at $5.00 four years from now. Those may or may not be in the money. If my parent exercised all of these warrants paying approximately $900,000, they would have 540,000 shares out of approximately 47,000,000 shares.

At my father’s insistence, I will be adding to my website the fact that he is on the board of directors and put a link to his bio. I should have this on the site by the end of the month. Sooner if my brothers are not too busy. I am saddened by the fact that I may have upset some people. MS is a terrible disease and you don’t need any up and down expectations of a new drug in the pipeline.

It looks like I have covered the questions that were raised earlier, but every answer generates two more questions. I will check back in.

Best regards, Tim
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Postby ljm » Sat Jan 21, 2006 3:15 pm

Just to point out (in case its not obvious) The Crystal Research Report is, of course, paid for and prepared in conjunction with PharmaFrontiers. Its not unusual for companies, especially small cap, to pay for analyst type of coverage, but its not reassuring, nor is their 50/1 reverse stock split, bottoming share price etc.

On the other hand. I have to say I was kind of troubled that one of the posts questioned the posts because the used terminology that, if I understand correctly, seemed too literate for a guy who "couldn't use his own zipper". Ouch. I'm hoping that was just exasperation.
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Postby Author » Sat Jan 21, 2006 10:57 pm

ljm-

Please provide your authority regading the 50 to 1 reverse split. I have seen no mention of it.

James
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Re: Tovaxin Press Release

Postby NHE » Sun Jan 22, 2006 3:25 am

Author wrote:Please provide your authority regading the 50 to 1 reverse split. I have seen no mention of it.

The 1:50 split occurred around April 13 of 2004. You can look up the PFTR stock on CNN Money.

NHE
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Postby Author » Sun Jan 22, 2006 7:30 pm

Thank you. I thought the reference was to a recent R/S. [/quote]
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Postby Baumer » Thu Jan 26, 2006 3:53 pm

The company has no snake oil to sell you and unless one of your friends runs a biotech fund, no one reading this post could possibly invest in the company.



I wouldn't agree with this statement. I bought 800 shares through my online trading account a few months ago. Hopefully it won't be a total waste of money...:(
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Postby mrhodes40 » Sat Sep 09, 2006 11:21 am

Edit this is in response to the last post on the first page:
I'm so gald you posted this link Dignan. As I read this thread I thought to myself whatever happened to the historical placebo group? I was pleased you added it as if you read my thought! Thanks

The value of placebo blinded trials is in question anyway.

According to this citation I've posted before,

The double-blind in danger: untoward consequences of informed consent.

Brownell KD, Stunkard AJ.

Patients and physicians correctly identified medication assignments in 70% of the cases in a double-blind trial of an appetite suppressant. The breach of the double-blind design may have had therapeutic consequences; correct identification was associated with favorable outcome. These findings suggest that requirements for describing the side effects of medications to patients before they give informed consent may help them guess which medication they receive and thus may influence the integrity of double-blind studies and the results of controlled trials.


If blinded trials do not have integrity, then why are we pretending this kind of sacrifice on the part of placebo participants is necessary? marie

but now having read this whole thread which I did not realize was there (Doh!)and realizing my post is totally out of sync, I say a couple of things
Bromley Shame on you! We'll see more about how this works down the road, you are not protecting anyone by attacking people with nasty comments like that! You don't see many folks doing abx posting here either because of your tendency to submarine people this way. MS is no excuse for being rude.

Tim, thanks for your story and yes you should disclose. It is important. Thanks for addressing these concerns in an open mined way.

but tying in to the abstract I put in here, Tim's tiny trial was an open trial so everyone had a placebo type of reaction along with any "real" improvements they had. However, the positive material about Tovaxin on the net which has had me almost salivating several times in anticipation of the "cure" I seemed to be hearing of, will bias people in the later trials so that if they can discern whether or not they got the drug (see abstract above) they will anticipate the same kind of improvements. As you see early in this thread, we've got people all from everywhere thinking of ways to wrangle themselves into the trial Why? becasue they already think it'll work.

marie
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Postby CureOrBust » Sat Sep 09, 2006 6:05 pm

mrhodes40 wrote:will bias people in the later trials so that if they can discern whether or not they got the drug (see abstract above) they will anticipate the same kind of improvements.

I have yet to read of any noticeable side effects of tovaxin? Have I missed something? So, hopefully those on placeabo or on the drug will not know either way. However, i would not be surprised if the placebo arm AND the actual treatment arm would have a high baseline caused by the buildup of expectations, and hence placebo effect. But they will cancel each other out. Hopefully, the doctors have a good poker face...
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Postby mrhodes40 » Sun Sep 10, 2006 8:13 am

Yes you are right, if there are no side effects and good poker faces it should be a good trial with high numbers on both sides: one good reason to keep placebo arms and not move to the historical placebo. If it's double blinded so both the patient and the doctor giving the drug do not know what they are getting then it should be good. I am looking forward to this one as an option-a shot twice a year is much better than what is available now. But everyone will try to figure it out, from the nurse giving it, to the doctor, to the patient. It's impossible not to.

Blessings
marie
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Postby sh8un » Sun Sep 10, 2006 9:36 am

mrhodes40 wrote:But everyone will try to figure it out, from the nurse giving it, to the doctor, to the patient. It's impossible not to.


As a Nurse, I have to say that I never tried to figure out if I was giving the drug or not. There is usually too much to do and not enough time for that kind of stuff. I never knew what I was giving in double blind studies. just knew the adverse side effects which don't happen in everyone anyway. There is also an ethical side to this. I personally, and I think a lot of other nurses, would not go out of thier way to try and figure out what they are giving because I hope, and know, that nurses realize that the patient has more to gain form us not knowing. I am sure that this could be said about the Dr.s too. In a hospital, the pharmacy prepares the drugs and we have no idea what is in it. I don't even think that unrses or Dr. could find out even if they wanted to.
NN
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Postby Loobie » Tue Sep 12, 2006 9:37 am

Hello group. Wow, lot's of talk about investing in this forum labelled drug pipeline! I know I will be purchasing Opexa in the near future as I am embarking on the Phase IIb of Tovaxin (I bought Biogen when I went on Avonex). I think it helps me feel better about the whole thing if I have a financial stake in it. I had to go off of Interferons (specifically Avonex) due to rapidly worsening side effects after three years on it. I am really looking forward to it and hope to be able to keep a log on my progress as well. There is a 33% chance I will get placebo, but after 1 year everyone in the study gets the drug since it is useless to anyone but oneself.

I just wanted to introduce myself as a new participant of the trial for Tovaxin. Take care all

Lew
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Postby gkalman » Tue Sep 12, 2006 11:51 am

In many studies, there are three arms.
1) All placebo
2) All trial drug
3) 50/50 placebo and trial
The last one is often a dead giveaway. Imagine getting a reaction every other time as a rule. Or if you have to disolve powder in liquid, and it disolves easier every other time, etc.
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Postby mrhodes40 » Tue Sep 12, 2006 3:38 pm

Hi NN! I am an RN also. Of course people try to maintain ethical blindenss and do not make any effort to go around the system but frankly can you imagine being in the copaxone trial? would it have been any effort at all to figure it out? It would not take you too long to "know" that patient 0405 and patient 0406 both have no reaction what so ever to the injections while the others have marked swollen sites that you are dutifully measuring and making notes on. This was my point merely: blind is not exactly blind, and I offered a reference to support this in spite of the fact people make ethical efforts to remain so. :?

marie
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Postby sh8un » Tue Sep 12, 2006 9:52 pm

Marie...I totally agree with you. I mean, if the person is having the side effects thery are to have on the drug, then it may be clear that they are on the drug. However, I was trying to say that we, RNs and DR.s don't go out of our way to find out. Some drugs being tested that I was involved in did not have any real side effects...so I really had no idea and neither did the patient. Like antibiotics...sure there are side effets for them but most ppl tolerate them just fine.
By the way...don't you think way too many nurses end up with autoimmune diseases? Just from my own experiences i have noticed that...there is something to talk about. :roll:
Another thing I would like to ask you...earlier it was said that the placebo had Albumin in it. Do you think that it is possible Albumin would also give some of those flue like symptoms? I was not sure about this.
NN
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Postby CureOrBust » Wed Sep 13, 2006 3:18 am

Loobie wrote:I just wanted to introduce myself as a new participant of the trial for Tovaxin.

Welcome, there has been a lot of excitement about tovaxin here, and a lot of concern that there has only been one personal vocal viewpoint on the whole web. I am sure a lot of people (including me) will appreciate your posts.
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