News from Opexa

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News from Opexa

Postby hmtucker » Tue Jul 22, 2008 5:40 am

Opexa Conducts Additional Analysis on Phase I/II Extension Study with Tovaxin(R) for Multiple Sclerosis

As of 9:30 AM ET 7/22/08
Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company leading in the development of cell therapies for multiple sclerosis (MS) and diabetes, has completed an internal assessment of data from its Phase I/II two year extension study with Tovaxin in patients with MS. While confirming the favorable safety and efficacy profile of Tovaxin, further analysis also confirms both the benefit of consecutive annual treatments with Tovaxin and the advantage of tailoring each vaccination to the patient's changing disease profile.
The extension study evaluated 22 intent-to-treat patients that had enrolled in two Phase I/II open-label clinical studies with Tovaxin. 13 patients were enrolled with Relapse Remitting Multiple Sclerosis (RRMS) and 9 with Secondary Progressive Multiple Sclerosis (SPMS). After the first annual course of treatment the company conducted an analysis of each patient's specific disease profile and myelin peptide epitope profile using Opexa's proprietary Epitope Analysis Assay (EAA). The analysis showed that 19 of the 22 patients (86%) had undergone an epitope shift, or change in disease pattern since the original course of treatment. Based on the epitope analysis, Opexa manufactured a new and specific vaccine for each of these patients for their second course of treatment. This enabled Opexa to tailor each vaccine to the individual's current disease profile, thereby maximizing the effect.
The treatment regimen of five subcutaneous injections per year for each of the two years with two different vaccines tailored to each patient's disease profile produced promising results. Pooled data from the RRMS and SPMS patients showed that, as a group, 73% remained relapse free after two years and 86% demonstrated no worsening of disease (27% of these showed sustained improvement). Additionally, there was an overall decrease in the Annualized Relapse Rate (ARR) of 82% (from 1.38 to 0.21 relapses/patient/year). Each of these endpoints was compared to the patient's own baseline reading, taken prior to enrollment in the trials.
A further analysis of several effectiveness parameters showed that Tovaxin effectively decreased the number of circulating Myelin Reactive T-Cells (MRTCs) but did not cause any detectable reduction in the general lymphocyte populations. The lack of generalized immune suppression observed at this stage of development is one important aspect that distinguishes the safety of Tovaxin from certain marketed drugs. Side effects observed over the two year treatment period have been limited to moderate injection site reactions. There have been no serious adverse events related to treatment.
"The results from this extension study support our clinical strategy for Tovaxin of annual treatments tailored to each patient's clinical disease state," commented Dr. Jim Williams, Opexa's Chief Operating Officer. "And although the safety and efficacy data from the two year Tovaxin studies are based on a limited MS patient sample across two open-label clinical studies, comparing the annualized relapse rates of the RRMS patient population treated with Tovaxin at 0.2, places this treatment at the lower end of documented relapse rates of the major marketed drugs which range from 0.2-0.9. We believe Tovaxin's safety profile and a treatment regimen of five subcutaneous injections per year will also position the therapy favorably from a patient compliance perspective," added Dr. Williams.
The company is currently completing a larger Phase IIb study in 150 patients in a multi-center, randomized, double blind, and placebo-controlled study in patients with RRMS or Clinically Isolated Syndrome (CIS). The company expects to announce top line results in September 2008.
About Tovaxin
Tovaxin is an autologous attenuated whole T-cell vaccine manufactured by specifically selecting 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.
Treatment with Tovaxin results in a decrease in the number of pathogenic T-cells by anti-idiotypic mechanisms and restores the immune regulatory network by anti-ergotypic immune responses. Although Tovaxin administration results in the depletion and regulation of pathogenic T-cells, there is no generalized immune suppression.
About Opexa
Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as multiple sclerosis, rheumatoid arthritis 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 multiple sclerosis 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.

SOURCE: Opexa Therapeutics, Inc.
Opexa Therapeutics, Inc., The Woodlands
Lynne Hohlfeld, 281-719-3421
lhohlfeld@opexatherapeutics.com
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Postby TWG » Wed Aug 13, 2008 6:15 am

Opexa Therapeutics Completes $3 Million Financing
Funding to Support Ongoing Clinical Development of Tovaxin(R)

Last update: 7:30 a.m. EDT Aug. 13, 2008
THE WOODLANDS, Texas, Aug 13, 2008 (BUSINESS WIRE) -- Opexa Therapeutics, Inc. (OPXA:
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OPXA 1.71, 0.00, 0.0%) , a company developing novel cell therapies for multiple sclerosis, today announced the completion of a private placement financing with total gross proceeds of approximately $3.0 million. Opexa will use the proceeds from the financing to support the ongoing clinical development of Tovaxin, the company's novel treatment for multiple sclerosis. Top-line data from the company's Tovaxin Phase IIb clinical trial (TERMS) are expected to be presented in September 2008. New institutional investors Lehman Brothers and Diker Management, LLC joined existing shareholders, directors and officers to complete the financing.
"The financial support of new institutional investors, as well as our current investors and board, in advance of the results from our Tovaxin Phase IIb clinical study demonstrates an important vote of confidence for Opexa," said Neil K. Warma, president and chief executive officer of Opexa.
Under the terms of the financing, Opexa received approximately $3.0 million in proceeds from the sale of 2,003,874 shares of its common stock and warrants to purchase an additional 2,003,874 shares of Opexa's common stock. The purchase price paid by non-affiliate investors was $1.48 for each unit and $1.655 per unit for affiliate investors. The warrants expire in four years, are first exercisable after six months of the closing of the transaction, and are exercisable at $1.78 per share. No commissions or fees to placement agents were paid in connection with the transaction.
As part of the financing, Opexa appointed David E. Jorden to the company's board of directors. Mr. Jorden is presently a vice president in the Private Wealth Management group at Morgan Stanley. He has previously served as vice president and chief financial officer at Genometrix, Inc., principal with Fayez Sarofim & Co., and a private investor.
None of the shares of common stock, the warrants or the common stock issuable upon exercise of the warrants have been registered under the Securities Act of 1933, as amended (the "1933 Act") or any state securities laws. Unless so registered, such securities may not be offered or sold in the United States absent an exemption from, or in a transaction not subject to, the registration requirements of the 1933 Act and any applicable state securities laws. This announcement is neither an offer to sell nor a solicitation of an offer to buy any of these securities.
About Tovaxin
Tovaxin is an individualized T-cell therapeutic vaccine that consists of attenuated patient-specific myelin-reactive T-cells (MRTCs) against peptides of proteins from Myelin basic protein (MBP), Myelin oligodendrocyte glycoprotein (MOG) and Proteolipid protein (PLP) or combinations thereof. Recently announced two-year follow up data from Phase I/II clinical studies of 22 patients showed 73% of patients on Tovaxin remained relapse free after two years with 86% experiencing no disease progression. Tovaxin is manufactured in Opexa's in-house cGMP facility.
About Opexa
Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as multiple sclerosis, rheumatoid arthritis 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 multiple sclerosis is in Phase IIb trials. The Company holds the 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 preclinical development for diabetes mellitus. For more information visit the Opexa Therapeutics website at www.opexatherapeutics.com.
Cautionary Statement Relating to Forward - Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995
This press release contains "forward-looking statements," including statements about Opexa Therapeutics' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics' ability to obtain additional funding, develop its stem cell technologies, obtain FDA approval for its therapeutic products, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics' actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE: Opexa Therapeutics, Inc.

Opexa Therapeutics, Inc.
Lynne Hohlfeld, 281-719-3421
lhohlfeld@opexatherapeutics.com
or
Vida Communication
Stephanie Diaz, 415-675-7400 (investors)
sdiaz@vidacommunication.com
Tim Brons, 415-675-7400 (media)
tbrons@vidacommunication.com


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Diagnosed with MS in Feb. 14 2000! Was a Tovaxin guinea pig.
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Postby mrhodes40 » Wed Aug 13, 2008 8:25 am

I have not ben following the Tovaxin story closely at all: I know it depletes the MRTC's and that these are not present in all people. I know who Tim is and have read his story some years ago.

My MS clinic was doing a study on tovaxin 3 years ago and my doctor offered that they were finding the vast majority of people did not have the MRTC's, which he found curious. I also did not fit the criteria for the study so it was not offered to me. It has largely been out of my mind as a possibility since then.

BUT I see that this report mentions some people with SPMS, which I have recently been diagnosed as having.

Does Tovaxin expect to be available for both RRMS and SPMS? Are they looking only at people with SPMS who also have marked inflammation and superimposed relapses? Is there anyone with an active interest in Tovaxin who knows anything about how the drug may apply to SPMS?

TIA!
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Postby JanethePain » Wed Aug 13, 2008 11:11 am

mrhodes40 wrote:I have not ben following the Tovaxin story closely at all: I know it depletes the MRTC's and that these are not present in all people. I know who Tim is and have read his story some years ago.

My MS clinic was doing a study on tovaxin 3 years ago and my doctor offered that they were finding the vast majority of people did not have the MRTC's, which he found curious. I also did not fit the criteria for the study so it was not offered to me. It has largely been out of my mind as a possibility since then.

BUT I see that this report mentions some people with SPMS, which I have recently been diagnosed as having.

Does Tovaxin expect to be available for both RRMS and SPMS? Are they looking only at people with SPMS who also have marked inflammation and superimposed relapses? Is there anyone with an active interest in Tovaxin who knows anything about how the drug may apply to SPMS?

TIA!
marie


Hiya, Marie! :D Good news for you--in the last few years, Opexa has found a lot more ways of coaxing MRTCs out of a blood sample than was previously expected. They've also learned a lot about "masking (some antibiotics and definitely steroid usage)" and have lots of tips for making sure you're "clear" when it comes to blood draws so you contribute "gunk" for vaccine.

Another piece of good news for you--Phase III of this shindig will involve SPMS. So reserve your seat soon so you can be one of the next kids on the block to have some. :D

Drop in on us often, okay? I've really been in "whine mode" for too long a time and newcomers stopping in and dropping a line makes me want to reform.

At least for a little while. :lol:
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Postby mrhodes40 » Wed Aug 13, 2008 3:16 pm

Well JTP I never heard you whine and I won't believe a word of it so there you go.

Thnaks for giving me the quickie, "no need to read the whole forum to find out" download, I appreciate it! I am really glad to hear it.

Frankly the derth of options for the SPMS patient is depressing, I'm gald these guys are doing it for us as well.

Thanks!
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Postby JanethePain » Fri Aug 15, 2008 5:58 am

mrhodes40 wrote:Well JTP I never heard you whine and I won't believe a word of it so there you go.

Thnaks for giving me the quickie, "no need to read the whole forum to find out" download, I appreciate it! I am really glad to hear it.

Frankly the derth of options for the SPMS patient is depressing, I'm gald these guys are doing it for us as well.

Thanks!
marie


I'm sure we'll be cussing and discussing all the skinny on Phase III as we learn about it. As soon as I get the info that Phase III is off and running (recruiting, that is... :lol: ), I'll be zapping off e-mails to a couple of people (at least!!) that didn't qualify for II but almost assuredly WILL in the next batch.

I'll be glad when you can join us. :) "The more, the merrier" for sure--but let's face it--this IS the best treatment option, hands down.
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Postby av8rgirl » Fri Aug 15, 2008 9:38 am

Welcome! Ditto what JTP writes! She's got it all down pat...LOL! :D
“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford
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Postby mrhodes40 » Fri Aug 15, 2008 1:33 pm

Hey, thanks! I will not qualify for any trials, I have RA too so I can't go off all supppressive therapies and can't take a chance on placebo. I will need to wait for the final tah-dah to get mine...I hope it goes well
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Postby Lyon » Sat Aug 16, 2008 4:27 am

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Last edited by Lyon on Sun Nov 27, 2011 1:37 pm, edited 1 time in total.
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Postby mrhodes40 » Sat Aug 16, 2008 6:18 am

Hi Bob,
Thanks! You are right that tovaxin is not likely to help RA and other approaches might.

I already sent MRI's to JH and Dr Kerr said I do not qualify for reviummune as I have no inflammation and no enhancement at all, and they already know it does not help people with that situation. I was bummed because potentially the RA could have been stopped/rebooted with that as well.

I am considering rituxan, it depletes b cells, but I may not qualify for that as you have to have failed several first tier approaches and no one recognizes copaxone as an RA approach!

I am not willing to go on several other kinds of RA drugs to see how I do with no idea of what impact they might have on MS (rituxan has been tried and it helps).

I did methotrexate for a year, and that seemed very bad for my MS, that was by far my worst year and it was definitely the start of my progressive phase, though that was not actually dignosed until last month. MTX depletes folic acid (that's how it works), and I thought that was the likely mechanism for the worsening of the MS.

One of the RA drugs an anti TNF had an increase in MS diagnoses in patient population who took it, so those people started out with RA and ended up with MS and RA. I do not need that drug for sure, whatever the mechanism for increasing MS incidence.

These issues are not a simple take this drug, get that good result kind of thing. One has to look 8O really well ahead of time.

That having been said, tovaxin is so targeted these other issues are not going to come up even with time it seems to me.
thanks for the input Bob, I appreciate it.
marie
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Postby rainer » Sat Aug 16, 2008 11:09 am

You might be interested in this study if you are considering ritux.

http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=265
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Postby mrhodes40 » Sat Aug 16, 2008 11:42 am

Thanks Rainer!

I really do appreciate it :D
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Postby av8rgirl » Sun Aug 17, 2008 4:30 pm

mrhodes40 wrote:Hi Bob,
Thanks! You are right that tovaxin is not likely to help RA and other approaches might.

I already sent MRI's to JH and Dr Kerr said I do not qualify for reviummune as I have no inflammation and no enhancement at all, and they already know it does not help people with that situation. I was bummed because potentially the RA could have been stopped/rebooted with that as well.

I am considering rituxan, it depletes b cells, but I may not qualify for that as you have to have failed several first tier approaches and no one recognizes copaxone as an RA approach!

I am not willing to go on several other kinds of RA drugs to see how I do with no idea of what impact they might have on MS (rituxan has been tried and it helps).

I did methotrexate for a year, and that seemed very bad for my MS, that was by far my worst year and it was definitely the start of my progressive phase, though that was not actually dignosed until last month. MTX depletes folic acid (that's how it works), and I thought that was the likely mechanism for the worsening of the MS.

One of the RA drugs an anti TNF had an increase in MS diagnoses in patient population who took it, so those people started out with RA and ended up with MS and RA. I do not need that drug for sure, whatever the mechanism for increasing MS incidence.

These issues are not a simple take this drug, get that good result kind of thing. One has to look 8O really well ahead of time.

That having been said, tovaxin is so targeted these other issues are not going to come up even with time it seems to me.
thanks for the input Bob, I appreciate it.
marie


I was on MTX and Betaseron for a year with Folic Acid supplements. Yes it does deplete folic acid but also platelets.

The combination didn't work for me as it really lowered my WBC and I was sick the entire year I was on it. I did shots, not pills, once a week. I tried, but it just didn't work. I've tried so many different things to break the 3-4 exacerbation a year cycle I've been on since I was dx'd in 2001 and so far, this has been the first thing that's worked!

Good luck. I hope you find something that works for both RA and MS!
“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford
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Postby mrhodes40 » Mon Aug 18, 2008 8:03 am

Av8grl
Gee I am glad to know you! I don't know any other MSers who tried MTX, though there must be some.

I wish I had never done the MTX at all. It is one of those things supposed to be good for MS and RA, but the folic acid angle makes me wonder now in hindsight about b12 and the need for that along with folic acid for neural integrity.

It's one thing to think you are hampering immunity to quell autoimmunity, another to deplete something important to neural function.

I'll say it again tovaxin is so targeted it seems likely it will be a really safe thing, none f these other worries down the road.
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Postby av8rgirl » Thu Aug 21, 2008 12:20 pm

mrhodes40 wrote:Av8grl
Gee I am glad to know you! I don't know any other MSers who tried MTX, though there must be some.

I wish I had never done the MTX at all. It is one of those things supposed to be good for MS and RA, but the folic acid angle makes me wonder now in hindsight about b12 and the need for that along with folic acid for neural integrity.

It's one thing to think you are hampering immunity to quell autoimmunity, another to deplete something important to neural function.

I'll say it again tovaxin is so targeted it seems likely it will be a really safe thing, none f these other worries down the road.
marie


There are quite a few who do MTX for MS. Most do the oral, but I did the shots. I have a lot of stomach upset issues to the RA decided to bypass the stomach and have me do the shots.

I do have B12 deficiency which was also dx'd shortly after the MS dx. I take B12 shots monthly unless the blood tests show lower than 345.

I also have Reynaud's. Just one autoimmune disorder after another! My dad had RA most of his life but so far I haven't had any signs of that and no one else in the family either. I am the only one with MS out of a whole lot of kids and grandkids and cousins, etc.

Yeah, MTX is pretty strong stuff, that's why I opted not to try any other chemo for tx MS...I am happy with Tovaxin so far (that is if I am getting the real stuff). Should know soon enough!
“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford
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