Opexa Cancels Tovaxin Clinical Trial
 

Opexa filed a form 8K with the SEC today to cancel the open label clinical trial for Tovaxin. We have all been receiving phone calls today letting us know that due to lack of funding the clinical trial is over.

Guess it's back to square one for me and about 100 others....:(

http://biz.yahoo.com/e/081124/opxa8-k.html

How disappointing! :(

I don't even know what I am going to do at this point. The rug has just been pulled out from under me...all of us. We sort of saw it coming, but figured something would happen and funding would come. But guess not. It goes to show you what the press can do to a small pharma company.

So Sorry, Cheryl. I hope something positive comes up for you.

Want some of my LDN?

IHow disappointing! I am so sorry to hear this. I know we were all so hopeful that it would be the one. I just want to say thank you for your participation, and hope you can figure out your next step.

That's probably my next step...not sure what I am going to do. It was being discussed before this clinical trial came open and I qualified for it.

Just have to talk to my neuro...have a call in to her for tomorrow.

You're just so awesome for taking part in this trial and putting so much into it. I'm sorry it ended. :(

:hug::hug::hug:

:(

It's not "drug", so does it even need FDA approval to be marketed?

So, it just fades away as an option?

:(

Cherie

I am so sorry to hear that FG :(:hug:

Yes it does require FDA approval. It's a vaccine, a blood product, and thus FDA approval is required. Clinical trials are required. They have applied for a patent and who knows, if they get more funding, they could reapply and get approval to continue the Phase III open label trial.

i'm sorry about this cheryl.
i hope you and your dr will come up with another option that helps you.

Sorry to hear this. I hope your neuro is open to the LDN theory. Jim's doctor is investigating it as we speak. He has some neuro friends in Cali he's talking to.

Now that just sucks.:mad:

I hope that something else comes your way fast.:hug:

-Vic

Wow. That just stinks they had to stop the trial. My neuro offered to get me enrolled in it. I just wasn't ready to take on all that was required for it. So I have followed your posts hoping this would offer more hope than we have seen with the others.

Cheryl, I hope they find something for you soon. :hug:

Awwww, (((Cheryl))), how disappointing for you. And all of us who were following your Tovaxin trial. I'm so sorry. :(

But at least now you can take drugs to relieve your cold symptoms, etc. I know you've really struggled with illness during this trial.

:hug::hug::hug:

I'm sorry to hear this too, Cheryl. Hope your neuro's agreeable to the LDN.

Im sorry Cheryl.:( :hug::hug:

Thanks everyone. It's going to be interesting for all of us. Especially those who were in the trial and not receiving the vaccine and who have just started the open label and have received at least two doses. I feel bad for everyone.

It's sad when a company is $200k short and these mismanaged big companies are getting bailout money....:o

Who knows the real story...anyway....I've got to stay positive. I've had too much negative in my life in the past couple of weeks.

I know my reaction is unreasonable, but I was chilled and angered by the tone of the report that was filed.

I guess that it's focus had to be on costs and fiscal intentions, but if they could speak to the issue of severance and continuing benefits, why could they not address the realities faced by the 100 or so MS patients who have done so much to get their product this far, only to be dumped.

At least offer a word of recognition, of thanks, to the human "lab rats" they used.

Sorry for my grumble Cheryl, and even sorrier about your news.

:hug:

That's because Form 8K is only about fiscal issues. It's an SEC filing. But thanks for the thought. :D

We are all receiving phone calls from site coordinators who are compassionate and caring. At least I didn't have to talk to the one who has been following me who cannot answer any questions!!! That was the big plus!!!

There is some recent good news about the trial to date though, so maybe they will eventually be able to turn things around:

"Opexa Therapeutics, Inc. announced additional positive data from the company's Phase IIb TERMS clinical trial (Tovaxin(R) for Early Relapsing Multiple Sclerosis).

The latest analysis focused on a prospective group of patients (n=50) with an annualized relapse rate (ARR) of greater than 1 at study entry which is comparable to ARR baselines of patients in previous Tovaxin studies. These findings demonstrate a statistically significant improvement in disability as measured by the Expanded Disability Status Scale (EDSS) (p=0.045) for patients treated with Tovaxin as compared to those receiving placebo. In this group, 28.1 percent of patients treated with Tovaxin showed an improvement in EDSS as compared to only 5.6 percent in the placebo group.

Additionally, there was an 88 percent reduction in the level of brain atrophy and a more than 20 percent reduction in the number of gadolinium (Gd) lesions progressing to black holes in the Tovaxin group, which may suggest a beneficial neuroprotective effect. Overall, the analysis shows that patients treated with Tovaxin demonstrated a benefit across all clinical and magnetic resonance imaging (MRI) endpoints (primary, secondary and tertiary) in this patient population.

...

http://www.msrc.co.uk/index.cfm?fuse...ow&pageid=1312 "

I agree with your point about the disadvantages of being a small company though, vs. the financial backing, experience, and resources of the large pharma's. :(

Cherie

From what I understand, there are many of us who did well on Tovaxin. I can attest to the fact that I personally did very well. I think just the ARR decline from 4 relapses prior to Tovaxin to 1 during the trial is significant.

If one were to factor in the $$ savings for the 3 less exacerbations per year, that alone is enough to get anyone's attention. That's 3 less IVSM infusions, 2 weeks x 3 for each infusion of time lost working (when you are self employed that's significant), let alone all the other collateral costs for medical care, medications, etc., that go along with an exacerbation.

The only thing that I have failed to notice any change in is fatigue. But that could be due to many things - B12 deficiency, stress, heat, working too much, stress, taking on a new business, stress. Did I mention stress? :(

I think Opexa marketing or press people could have done a better job of focusing on those of us who did well on the drug instead of allowing the press to focus on the one part of the data that was so insignficant that it ended up being a runaway train. :mad:

Just my thoughts....for what they are worth now...zip. :rolleyes:

Just got back from the birth of my new grandbaby and saw this. :hug: FG, that sucks.

Here's to finding something else. Let's see what you and your neuro come up with.

In the meantime, "Here's mud in your eye!"

Congrats on the new grand daughter! :hug:

Right now we're doing 3 days of IVSM to get me out of this damn flare...then we go from here!

IVSM for Thanksgiving anyone!!

Wow, that is super crappy news. Sorry to hear about this :(

Oh...CG a new baby...goo, goo...oh....I forgot...FG.....:eek:

You know what really burns me about this whole thing?

How am I going to get you to come over to this side of the world to see poor old Taffy?:(

:hug:

Guess I will be driving to Boise someday!

Bribe me with mints...:D

You know I will come over there to see you! I came over there before the trial! :hug:

Oh Cheryl, I am SO saddened to read this (especially on the heels of my posting about my good experience).

I cannot imagine the anger, frustration, fear, etc. that must be going on for you right now. It downright sucks.

Okay, I was more poignant the FIRST time that I wrote this post before my internet crashed....and of course, I can't remember what I wrote! Sorry.

I don't really have words to express my sadness and sorrow for what has happened. I hope you can find an equally positive or better treatment experience soon!!

If you need anything....I'm an email away.

~Keri

Thanks Keri. It is a disappointment but hey! Life goes on...

;)

Once I get through this 3 day IVSM, I will be a little more positive about what's next...

Cheryl,

I'm so sorry to hear about Tovaxin. I just saw my neuro on November 25 and he mentioned that he had been running a Tovaxin trial but was no longer involved - didn't mention the rest. :(

Now you know the rest of the story...sad but true.

:(

Sorry to be late coming in here Cheryl, but wanted you to know that I sympathize with you. After going through so much of the trial so faithfully and enduring other physical problems, I can't imagine your frustration. Guess it's the same old problem going around these days.......money, money, money. Hope you feel better soon and be sure to keep LDN in mind.....it's cheap, cheap, cheap......and really seems to be slowing progression down, at least for me. Good luck!! :)

Please forgive me for being late coming into this thread FG, but I've been a bit pre-occupied this week because my DH is in hospital.

I'm sorry to read that the trial has been cancelled through lack of funding, especially as you say you were doing well on the vaccine. That really is the pits when it's just mere money standing in the way of either a cure, or something that can alleviate the debilitating symptoms of MS.

As one ex-lab rat to another..... I thank you for giving it a try. No drugs would be available today if people like us didn't put ourselves through the wringer for the benefit of others.

Incase anyone is interested.... the drug trials for me were the interferons.... way back in the late 1970's / early 1980's, and those trials led to the ABC drugs that we now have on the market.

Thanks! I am just finishing 3 days of IVSM so will be having a follow up appt with my neuro soon to discuss future treatment...not sure what will be in the wind for me...

Us lab rats have to stick together! :hug:

You've had a lot on your plate later so no need to apologize!!! Not sure what is going to happen with the drug company but time will tell!

Thanks for your volunteer time as a lab rat as well! Fun times, huh?

Dangling a bag of mints....I wonder if we can get that Princess to come up here again sometime?

Dangling a BOX of mints....:D

Hi Cheryl, I've been super busy and out of the country over the holidays so I just read your report. What really crappy news!!! :( and :mad:
That is just such a plain old bummer. Thanks though for being a lab rat for everyone--I know this whole trial has been ups and downs. Take care of yourself on the IVSM--hopefully you are feeling better soon.
:hug: :hug: :hug: :hug:

Thanks Natalie.

Doing the bruised body feeling right now after the 'roids...drinking lots of fluids but hey! I can hold a pencil again...there are ++'s to everything! :D

Sorry to read about this. I can't really think of anything brilliant or hopeful to say right now, but I do hope things look up for you soon.

Grabs mints and runs :eek:

I sure hope she meant this princess :D

Sorry about the hide yak FG but she started it

ha ha ha! What other "princess eats mints?"