Its over

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby HEC » Tue Nov 25, 2008 8:18 am

Yep, Opexa file an 8-K yesterday confirming it, but I haven't seen a press release yet. Here's a link to read the whole 8-k, duplicative of a previous post from yesterday, but the reality hit home for me after seeing the actual filing. The company I work for was publically traded up until a few months ago (thank goodness we went private when we did with this economy), and I know it's a big damn deal to file an 8-k with bad news like this.

http://www.sec.gov/Archives/edgar/data/ ... 839581.htm

You can also find this filing on Opexa's site in the Investors section under SEC filings.

Once everyone figures out what treatment plan they intend to take, I think we should start a new thread. I was thinking we could do our own informal study to track our progress. In theory, we all have a lot in common, so it could be particularly beneficial to compare notes. I will know which drug I'm taking by next Tuesday and will report back to the group.
User avatar
HEC
Getting to Know You...
 
Posts: 13
Joined: Sun Oct 12, 2008 2:00 pm
Location: Seattle

Advertisement

Postby hmtucker » Tue Nov 25, 2008 8:24 am

Morning folks,

I just received my call that it's over as well. I go in next Thursday to discuss what my options are but it will almost certainly be limited to the CRABs or Tysabri because we are not eligible to jump ship to the Campath study.

Bummer!

Mike
User avatar
hmtucker
Family Elder
 
Posts: 100
Joined: Tue Nov 28, 2006 3:00 pm
Location: Versailles, Kentucky

Postby JanethePain » Tue Nov 25, 2008 8:30 am

Lars wrote:Hi All, Wow, this was shitty breakfast news. I have NOT gotten the call. I suppose it's stupid to ask "are you sure"? Lars


I think the mentality behind the Martian Protocol is still hanging around. A few minutes ago, I got the "one-week-past-jabs" follow-up call from the nurse practitioner (most often, the REAL brains behind a neuro practice) and she'd heard only a whisper--NOTHING from Opexa about what to do about paperwork or anything. She's severely pissed off--as the jabber-in-chief, she's seen some VERY positive results in this study.

Two things here, folks:

1) I was awake most of the night trying to absorb this ridiculous news (ridiculous because a yea-nay decision based exclusively on money is among the worst kind). Eventually, I calmed down enough to remember ::: drum roll, please::: Our Very Own Av8rGrl who was primarily responsible for getting Tysabri back on the market. And what a logistics organizer she is!

We're not in a position to bother the FDA at this point, but we sure ARE in the cat-bird seats when it comes to getting in touch with various pharmaceuticals. And that gang at the Myelin Repair Foundation who, if memory serves me fairly well, HAD expressed interest in our gunk... I think at the end of second quarter last year? I would list Teva, Bayer and Biogen among the big boys we should think about because...

2) My dear nurse practitioner told me that one of the reasons Avonex is still available in the "mix-it-yourself" formula is because an Ohio Avonex patient had some sort of rare reaction to the pre-mix and raised some major cane with Biogen.

These two examples (Av8rgrl and the Avonex-Ohio-Gal) are PROOF that one person CAN make a huge difference in things.

Therefore, I not-so-humbly suggest we do the following:

1) ask the moderators of this website if they'll keep this section opened for us indefinitely
2) if they can't, get ourselves a mailer of these "usual suspects" so we can communicate via e-mail
3) decompress during this holiday
4) get back here on Monday morning and start bouncing around ideas for annoying the Myelin Repair Foundation and the Big Boy Pharmas to acquire Opexa and our gunk and get us back on track asap!

Whatch'all think?
Jane the Pain
User avatar
JanethePain
Family Elder
 
Posts: 223
Joined: Wed Jun 13, 2007 2:00 pm
Location: Historical Glendale, OH: Home of the Squirrrels

Postby HEC » Tue Nov 25, 2008 8:32 am

Count me in!
User avatar
HEC
Getting to Know You...
 
Posts: 13
Joined: Sun Oct 12, 2008 2:00 pm
Location: Seattle

Postby Lars » Tue Nov 25, 2008 10:48 am

JTP and All,
After spending nearly 2 years hanging out with you all, shutting it off like a light switch seems strange. I would love to hear what everyone chooses to do from this day forward. Personally, I am still not willing to go down the CRAB road and will try to find some way to wait it out for the Revimmune or Campath option. I hope the Tovaxin site can hang around for a while. Maybe the name can be changed to Tovaxin POW/MIA's
Well wishes to you all and thanks for all the help thus far.
Lars
Lars
Family Elder
 
Posts: 433
Joined: Wed Mar 21, 2007 3:00 pm
Location: Durango, Co

Postby TWG » Tue Nov 25, 2008 11:25 am

Who knows, maybe Opexa will find a financial partner and start phase III. We may be the first on the list if this happens. I suggest this forum be kept alive for that possibility. Also, I can keep up on the treatment choices all have made.
Diagnosed with MS in Feb. 14 2000! Was a Tovaxin guinea pig.
User avatar
TWG
Family Elder
 
Posts: 102
Joined: Sun Jul 08, 2007 2:00 pm

BLAST FROM THE PAST

Postby notasperfectasyou » Tue Nov 25, 2008 12:10 pm

Here's a Blast from the Past:

September 03, 2008 07:30 AM Eastern Time
Opexa Therapeutics and Myelin Repair Foundation Partner on Novel Multiple Sclerosis Research Program
Collaboration to Identify Therapeutically Relevant Biomarkers and Offer Key Insight for Further Clinical Development of Tovaxin®

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as multiple sclerosis (MS) and diabetes, today announced the establishment of a novel MS research partnership with the Myelin Repair Foundation, Inc. (MRF). As part of this collaboration, Opexa and the MRF will work to identify therapeutically relevant biomarkers in MS that may provide important insight to support the continued development of Tovaxin®, Opexa’s T-cell vaccine currently in Phase IIb clinical testing in MS patients. In addition, biomarkers identified as part of the research program may also assist in guiding the discovery and development of novel diagnostics and treatments for MS.

Under terms of its collaboration with Opexa, the MRF will receive and analyze patient samples and clinical data from Opexa’s Phase IIb clinical study with Tovaxin to identify biomarkers related to safety and efficacy of the therapy in MS patients. As part of this analysis, the MRF will leverage its network of leading MS researchers, as well as its proprietary biochemical and biological assays which are designed for the discovery and characterization of novel biomarkers that may have clinical use in diagnosing and/or treating MS.

“Through our collaboration with Opexa and our analysis of patient samples from the Tovaxin Phase IIb study, we hope to discover novel therapeutic, diagnostic and surrogate biomarker targets of components and pathways involved in the destruction, repair and re-myelination of axons in the central nervous system,” said Russell Bromley, chief operating officer of the MRF. “Research has shown that MS attacks individual patients differently. Accordingly, we expect that clinical samples from this study, in which T-cell vaccines were tailored for each subject, will help us better understand how we can identify specific myelin repair therapeutic targets to assist in the rapid development and commercialization of personalized MS treatments.”

The collaboration will be jointly managed by research and development experts from Opexa and the MRF. Under terms of the agreement, each party will own all program intellectual property that is conceived of solely by its representatives. Intellectual property that is conceived of collaboratively will be jointly owned by both Opexa and the MRF with Opexa retaining the option to negotiate an exclusive license for any of the collaboration’s joint intellectual property or that which is solely owned by the MRF.

The MRF is a non-profit medical research foundation dedicated to accelerating basic medical research into myelin repair treatments aimed at dramatically improving the lives of people suffering from MS. The group’s innovative Accelerated Research Collaboration™ (ARC) model involves the establishment of collaborations with a number of leading MS researchers at prestigious institutions who agree to work jointly to develop and conduct experiments that will lead to targeted myelin repair discoveries. To date, the MRF has entered into collaborations with researchers at Stanford University, Northwestern University, University of Chicago and Case Western Reserve University.

“Organizations such as the MRF are critical to the discovery and development of safe and effective MS therapies, and data generated from the MRF’s analysis of the patient samples from our Phase IIb Tovaxin study will provide valuable insight into the treatment of the disease,” stated Jim Williams, Ph.D., chief operating officer of Opexa. “Together with the MRF, we have the potential to uncover breakthroughs in an area of important medical research, discover additional promising MS therapies for development under Opexa’s T-cell platform, and gain invaluable data to guide the appropriate design of future clinical trials with Tovaxin to support future regulatory filings for the biologic.”

Opexa is currently evaluating Tovaxin in 150 patients in a multi-center, randomized, double-blind, placebo-controlled Phase IIb clinical trial in patients suffering from Relapsing-Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS). The company expects to announce top-line results from the Phase IIb study in September 2008.

About Tovaxin

Tovaxin is an autologous attenuated whole T-cell vaccine manufactured by specifically selecting Myelin Reactive T-Cells (MRTCs) from a patient’s blood and expanding them ex-vivo to a therapeutic dose. In this way, the vaccine is tailored to each patient’s disease state. The reintroduction of the attenuated T-cells via subcutaneous inoculation induces an immune response against the MRTCs, thereby triggering the immune system to attack the pathogenic T-cells in the body.

Opexa recently announced two-year follow-up data from its Phase I/II clinical studies. Data from 22 patients demonstrated that 73 percent of patients on Tovaxin remained relapse free after two years with 86 percent experiencing no disease progression. Tovaxin is manufactured in Opexa’s in-house cGMP facility.

About Opexa Therapeutics

Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as multiple sclerosis (MS) and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company's lead product is Tovaxin, a T-cell therapy for MS which is in Phase IIb trials. The Company holds an exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte-derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in the preclinical stages of the development of insulin-producing monocyte-derived islets as a replacement therapy for diabetes mellitus. For more information visit the Opexa Therapeutics website at www.opexatherapeutics.com.

About the Myelin Repair Foundation

The Myelin Repair Foundation (MRF) - http://www.myelinrepair.org - is a Northern California-based not-for-profit research foundation created to provide a collaborative environment in which leading research scientists at multiple universities, and experienced business executives, can work together to execute a five-year research plan – with milestones, parallel experiments, collaboration, and, most important, a constant focus on developing effective treatments for multiple sclerosis. Many believe MRF’s Accelerated Research Collaboration model could change the way in which all medical research is conducted.


This therapy is not likely to be considered for investment unless someone like MRF does something substantial. I don't know, I can only speculate that this partnership was set up for the specific reason of carrying on the ideas. Early September is recent enough to think that management saw the need for a backup plan. I therefore suspect, more importantly, that MRF will become the depository of the research OPXA did. Of course, I doubt MRF has any idea about this right now, these things usually take months to sort out. Ken
User avatar
notasperfectasyou
Family Elder
 
Posts: 774
Joined: Thu Feb 09, 2006 3:00 pm
Location: Northern Virginia

Postby ssmme » Tue Nov 25, 2008 12:13 pm

Like all the rest of you, I got the official call. Mine came in this morning. I have an appointment next week to discuss my treatment options post Tovaxin. I do not plan on (ever) taking a CRAB and my doctor knows how I feel about it. It'll be an interesting visit. I'll keep you guys posted on my next venture.
I did get four doses of the real thing during OLTERMS and should have had the 5th dose in January. Who knows, maybe a major Christmas present (ie. cash infusion) will show up for Opexa and we'll all get to finish out our extension year. I wish we could pay for the "production" of the vaccines ourselves even though we couldn't pay for the vaccine itself since it would be illegal to buy something not FDA approved. I hope this forum stays open for a while longer since we still have more things to learn about this potential therapy.
Marcia
User avatar
ssmme
Family Elder
 
Posts: 355
Joined: Sat Sep 22, 2007 2:00 pm
Location: Lexington, KY

Postby Lyon » Tue Nov 25, 2008 2:42 pm

oo
Last edited by Lyon on Sun May 08, 2011 6:12 pm, edited 1 time in total.
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 2:00 pm

Postby Lars » Tue Nov 25, 2008 4:29 pm

Bob,
Where does Dignan keep that list? By the way, it is really hard not to be angry at Opexa at this point, I was on placebo which means less than 2 months ago I could have qualified for the Campath trial. It is beyond my ability to believe that Opexa had no knowledge of this eventuality at that point. I did my part and so did everyone else, some honesty and integrity was expected in return. Now that that rant is over, I'm not absolutely sure I am disqualified for the Campath trial. I did the interview today and I am awaiting a call from the Grand Poobah. Yes, I did tell them I had 2 Tovaxin injections, we'll see. If Opexa had the wherewith-all to be more forthright and tell me 4 days ago it would only have been one.
P.S. By the way, on that injection visit last Friday I was forbidden to take Prednisone for an upcoming sinus surgery unless I withdrew for the mandatory month, I was going to do it without it. Are you kidding me?????
Looking Forward,
Lars
Lars
Family Elder
 
Posts: 433
Joined: Wed Mar 21, 2007 3:00 pm
Location: Durango, Co

Postby Lyon » Tue Nov 25, 2008 4:45 pm

oo
Last edited by Lyon on Sun May 08, 2011 6:13 pm, edited 1 time in total.
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 2:00 pm

Postby Lars » Tue Nov 25, 2008 4:56 pm

Bob,
Thanks for the quick response, by the way how the hell do you always respond so quickly? Telepathy, bells going of when your name is typed on the keypad or ? Either way, thanks. I would love to talk to you sometime about the now real eventuality of the Revimmune vs.Campath choice, hmmmmmmm! Campaths trial comparison arm is Rebif, not so sure about my willingness in that arena.
Peace,
Lars
Lars
Family Elder
 
Posts: 433
Joined: Wed Mar 21, 2007 3:00 pm
Location: Durango, Co

Postby Lyon » Tue Nov 25, 2008 5:22 pm

oo
Last edited by Lyon on Sun May 08, 2011 6:13 pm, edited 1 time in total.
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 2:00 pm

Postby av8rgirl » Wed Nov 26, 2008 7:43 am

Good luck to everyone. I hope we all do stay in touch.

As for me, I am starting 3 days of IVSM this morning!

Not sure where I am going from here. I have failed the CRABS and cannot take Ty. So, not sure what's next for me.

Guess I have to sit down and have a very long talk with my Neuro after I finish the IVSM. I just need to feel better first.

Happy Thanksgiving everyone.
“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford
User avatar
av8rgirl
Family Elder
 
Posts: 216
Joined: Thu Apr 03, 2008 2:00 pm

Postby TWG » Thu Nov 27, 2008 11:39 am

Happy Thanksgiving!! I know it's a bummer about the OTERMS, but my thought are with the approx. 19 who got axed from Opexa before this holiday season.........
Diagnosed with MS in Feb. 14 2000! Was a Tovaxin guinea pig.
User avatar
TWG
Family Elder
 
Posts: 102
Joined: Sun Jul 08, 2007 2:00 pm

PreviousNext

Return to Tcelna (Tovaxin)

Who is online

Users browsing this forum: No registered users


Contact us | Terms of Service