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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....:(

Quote:

Form 8-K for OPEXA THERAPEUTICS, INC. 24-Nov-2008
Costs Associated with Exit or Disposal Activities

Item 2.05. Costs Associated with Exit or Disposal Activities On November 21, 2008, the board of directors of Opexa Therapeutics (the "Company") approved a restructuring plan to terminate the one-year open label extension of the TERMS Phase IIb Clinical Trial of Tovaxin� therapy for multiple sclerosis (OLTERMS). The trial was enrolled with patients that had previously completed one year in the TERMS, Tovaxin Phase IIb multi-center, randomized, double blind, placebo-controlled trial. The Company is terminating OLTERMS in order to focus all of its financial resources on completing clinical data analysis, future clinical trial planning and seeking a development partner for Tovaxin. As a result of these circumstances, the Company will immediately reduce its staff of 29 to approximately 10 people. Personnel-related restructuring charges of approximately $120,000 are expected to be incurred in the fourth quarter of 2008. Employees directly affected by the restructuring plan will be provided with severance payments and continuation of benefits. The Company is exploring its strategic alternatives, including a clinical development partnership, merger with or acquisition by another company, further restructuring of the Company, or sale of the Company's assets and liquidation of the Company.
The personnel-related restructuring charges that the Company expects to incur are subject to a number of assumptions and actual results may differ. The Company may also incur other material charges not currently contemplated due to the events that may occur as a result of, or associated with, the restructuring plan.
This Form 8-K contains forward-looking statements that are based on our management's current expectations, but actual results may differ materially due to various factors. There are significant risks and uncertainties in our operations including the lack of available capital and uncertainty regarding the restructuring costs. For additional information about the factors that affect our business, please see the company's latest Form 10-K filed March 18, 2008. The Company undertakes no duty to update forward-looking statements.

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.

Quote:

Originally Posted by SallyC (Post 413838)

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

Want some of my LDN?

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:

Quote:

Originally Posted by lady_express_44 (Post 413902)

:(

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

So, it just fades away as an option?

:(

Cherie

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.