Opexa (OPXA) Surges on FDA Fast-Track Designation.

A board to discuss Tcelna as a treatment for Multiple Sclerosis

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Postby Lyon » Fri Nov 11, 2011 5:06 pm

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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby Vikingquest » Sat Nov 12, 2011 3:42 am

Thanks, that's very interesting. I still think that you can err on the side that she probably would have had some more symptoms over the last 3-4 years if she hadn't had Tovaxin. Those are strange requirements for a trial, and suggest that they were trying to finish with above realistic results maybe? Who knows, but this has made my confidence grow. I would invest in Opexa if I had spare cash to hand, as I think that Tovaxin has a good shot of going all the way, although it might be 10 years until it's available for RRMS as a first line treatment.

Do you think that, hypothetically, if you were a multi-millionaire, that you could approach Opexa and ask them to give you Tovaxin if you paid for it?
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Postby Lyon » Sat Nov 12, 2011 6:08 am

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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby Lars » Tue Nov 15, 2011 1:58 pm

Bob,
Maybe I was alone in the Tovaxin trial when they pulled the plug? Maybe I was also alone in trying to get some, any information over the last 3 years? Maybe I am also alone in not understanding how anything can be fast tracked when the trial Phases were not completed? I'm sorry but I feel that being a volunteer for a drug trial should warrant a touch more concern and respect. Oh, I was also excluded from participating in any more trials as a result of my participation in the Tovaxin trial. I went through the same (nearly 18 months) as everyone else, had ONE open label visit followed by a dismissal call and NO further contact. I was not willing to sit around, possibly forever waiting for Opexa to bless us all with their comeback. I hope this all turns out great for everyone but sorry, I'm still pissed!
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby Liberation » Sat Jan 28, 2012 3:54 am

Any news on the fast track designation? How much would it shorten its entrance to the market? Does anyone know if it might be good for ppms or only for RRMS and SPMS?
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby Lyon » Sat Jan 28, 2012 7:29 am

Liberation wrote:Any news on the fast track designation? How much would it shorten its entrance to the market? Does anyone know if it might be good for ppms or only for RRMS and SPMS?
Good questions but Opexa's financial situation is the most immediate limiting factor and it's impossible to tell when or if it will resolve. Secondly this is a situation which phase I and II haven't shown safety problems but still requires further research and clinical trial time and now throw in it being fast tracked.....there are just too many variable factors to make a "how long" guess.

Earlier there were interesting reasons to think that Tovaxin had some effacacy on SPMS and PPMS, partially because Tim Wesner's neuro evidently felt that he had progressed to SPMS but that all remains to be determined as does whether or not Tovaxin even offers anything to people with RRMS.

Before putting too much interest into Tovaxin keep in mind that at last count the necessary mrtc's could only be isolated from the blood of about 50% of people with MS to make Tovaxin for them although the company had hoped to eventually get that number up to about 95%.

http://www.fda.gov/forconsumers/byaudie ... 128291.htm

Fast Track

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases.

Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious diseases. However, diseases such as epilepsy, depression and diabetes are also considered to be serious diseases.

Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy.

Any drug being developed to treat or prevent a disease with no current therapy obviously is directed at an unmet need. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as:

Showing superior effectiveness
Avoiding serious side effects of an available treatment
Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
Decreasing a clinically significant toxicity of an accepted treatment

A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written correspondence from FDA about such things as the design of the proposed clinical trials
Eligibility for Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit
Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA, and
Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status.

In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within
sixty days based on whether the drug fills an unmet medical need in a serious disease.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby Liberation » Sun Jan 29, 2012 2:27 am

Thanks, Lyon. Yes, it is true that the financials of the companies put a limitation on their ability to move forward. I am afraid that it is quite prevelant in this economic environment all over the world.
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby NHE » Sun Jan 29, 2012 2:51 am

Liberation wrote:Thanks, Lyon. Yes, it is true that the financials of the companies put a limitation on their ability to move forward. I am afraid that it is quite prevelant in this economic environment all over the world.


Opexa's stock has been trading under $1 for about the last month. Unless something happens soon, I suspect that they will receive a warning from the SEC that they could be delisted from NASDAQ. Without promissing news regarding Tovaxin, the company may revert to doing another reverse split on its stock. This scenario certainly would not bode well for the company's financial situation.

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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby Liberation » Sun Jan 29, 2012 4:03 am

NHE wrote:
Liberation wrote:Thanks, Lyon. Yes, it is true that the financials of the companies put a limitation on their ability to move forward. I am afraid that it is quite prevelant in this economic environment all over the world.


Opexa's stock has been trading under $1 for about the last month. Unless something happens soon, I suspect that they will receive a warning from the SEC that they could be delisted from NASDAQ. Without promissing news regarding Tovaxin, the company may revert to doing another reverse split on its stock. This scenario certainly would not bode well for the company's financial situation.

NHE


Probably, there is much more to the story than we know. From the outside, it seems like a company with a potential blockbuster drug and they are close to the final steps, but no one buys their stocks. Big pharmas and funds who keep distance from buying in must know more about it.
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby NHE » Sun Jan 29, 2012 7:14 pm

Liberation wrote:Probably, there is much more to the story than we know. From the outside, it seems like a company with a potential blockbuster drug and they are close to the final steps, but no one buys their stocks. Big pharmas and funds who keep distance from buying in must know more about it.


Novartis bought part of Opexa's stem cell program back in Aug 2009. I don't know what's happened with it since.

http://www.fiercebiotech.com/story/nova ... 2009-08-07

http://www.reuters.com/article/2009/08/ ... 2920090807


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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby wootes06 » Tue Jan 31, 2012 4:14 pm

A larger phase IIb study was conducted by Dr. Ed Fox. This data compared two groups of MS patients. One group got Tovaxin and the second group got a placebo. These patients were followed for one year. While the Tovaxin group did better than the placebo group, the overall difference did not reach statistical significance. An open label extension study was then terminated

http://www.bellaireneurology.com/multip ... vaxin.html

I think this is why you are not seeing any interest in Tovaxin.
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby Lyon » Tue Jan 31, 2012 6:52 pm

wootes06 wrote: I think this is why you are not seeing any interest in Tovaxin.
There's a lot more to it than that but that sure doesn't help things in this shaky world economy.
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby Lars » Wed Nov 28, 2012 9:52 am

Long time my friends. I check in every now and then to see if Opexa has done anything and I am generally disappointed with the news. I see so many other therapies moving forward at an alarming and hopeful rate. I cant help but think the science is now outdated and considerably behind the pack. Maybe I am missing something?? I participated in the Anti-Lingo trial without much to show for it other than the onset of a faster paced disease progression (unrelated to the trial I hope). Finally gave in to Tysabri but apparently developed antibodies to it. Options seem to be getting slimmer.....Rituxan next. Boy, this road never seems to get easier. I have missed conversing with you all and hope things are going well for you all. Keep up the good fight.
Peace,
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby NHE » Wed Nov 28, 2012 11:20 pm

Hi Lars,
It's good to hear from you. I was wondering what you think of Opexa's new trial for SPMS? There's a study site not far from where I'm located.

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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby Lars » Thu Nov 29, 2012 8:58 am

NHE,
I have dropped out of the Opexa loop. In fact, I cant seem to figure out what they are doing. I havent seen any of the data from their trials. I does however seem that they are riding the slowest horse in the race. I know how informed you are so I hope that leads to the right decision. Be well my friend.
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