More on Tovaxin and Phase IIb Clinical Trials

I’m just going to take it straight from Opexa’s press release that I found today on MarketWatch about the “upcoming Phase IIb clinical trial using Opexa’s T-cell therapy in patients with Secondary Progressive Multiple Sclerosis (SPMS).”

We’ve written about Opexa before because they seem to understand that NOT killing the patient is the best way to try and treat Multiple Sclerosis.

Everything below is taken directly from MarketWatch

PRESS RELEASE

April 19, 2012, 8:30 a.m. EDT

Opexa to Hold Preliminary Investigator’s Meeting for MS Trial at American Academy of Neurology Annual Meeting

Dr. Mark Freedman and other Members of Opexa’s SAB to introduce SPMS clinical trial to prospective trial physicians

THE WOODLANDS, Texas, Apr 19, 2012 (BUSINESS WIRE) — Opexa Therapeutics, Inc. OPXA -0.24% , a biotechnology company developing Tovaxin(R), a novel T-cell therapy for multiple sclerosis (MS), announced today that the Company will be holding a preliminary meeting with prospective clinical trial investigators at the 64th Annual American Academy of Neurology (AAN) Meeting in New Orleans on April 24, 2012. The purpose of this meeting will be to discuss the upcoming Phase IIb clinical trial using Opexa’s T-cell therapy in patients with Secondary Progressive Multiple Sclerosis (SPMS).

“We are honored to introduce our next clinical trial to a group of invited neurologists at this year’s AAN meeting in New Orleans,” commented Neil K. Warma, President and Chief Executive Officer of Opexa. “The meeting will be an opportunity to discuss with select clinicians and their study coordinators potential participation in the SPMS clinical trial as well as present the final protocol for the trial including the design, structure and patient selection criteria. This is an exciting time for Opexa, neurologists and SPMS patients as this study will provide an innovative opportunity for treatment in an area where currently there are very few treatment options. The annual AAN meeting is an excellent forum for the MS community to discuss and present new therapies that could have an important impact on the treatment of MS. We are pleased that Tovaxin is generating a great deal of enthusiasm among physicians, key opinion leaders and patients in the lead up to this meeting and are equally pleased to be advancing our clinical plans for Tovaxin.”

Mark Freedman, M.D., director of the Multiple Sclerosis Research Unit at the Ottawa Hospital and member of Opexa’s Scientific Advisory Board, commented, “I am pleased to contribute my expertise to Opexa with their design and planning of this Phase IIb study. Opexa is now in the process of selecting clinical trial investigators and finalizing the remaining steps in order to conduct a study of optimal quality. I am pleased to facilitate the introduction of the Phase IIb study to prospective clinical trial investigators at this year’s AAN meeting. Patients with SPMS have few treatment options and Tovaxin’s safety profile certainly justifies investigation of this therapy in the challenging SPMS patient population.”

The proposed Phase IIb clinical trial will be a randomized, double-blind, placebo-controlled study of Opexa’s T-cell therapy in SPMS patients with evidence of disease progression without associated relapses. The study, to be initiated once the necessary resources are secured, is expected to treat approximately 180 patients in up to 30 sites in the United States and Canada with annual courses of treatment for two years.

About Opexa

Opexa Therapeutics, Inc. is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as multiple sclerosis (MS). The Company’s leading T-cell therapy, a personalized cellular immunotherapy treatment, is in clinical development targeting both Secondary Progressive and Relapsing Remitting MS. Opexa’s T-cell therapy is derived from T-cells isolated from peripheral blood, expanded ex vivo and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin and, thereby, reduces the risk of relapse over time.

For more information, visit the Company’s website at http://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 which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “expects,” “believes,” “anticipates,” “estimates,” “may,” “could,” “intends,” and similar expressions are intended to identify forward-looking statements. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding the development of the Company’s product candidate, Tovaxin, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: our capital position, the ability of the Company to enter into and benefit from a partnering arrangement for the Company’s product candidate, Tovaxin, on reasonably satisfactory terms (if at all), our dependence (if partnered) on the resources and abilities of any partner for the further development of Tovaxin, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of developing a marketable product, our ability to raise additional capital to continue our treatment development programs and to undertake and complete any further clinical studies for Tovaxin, the success of our clinical trials, the efficacy of Tovaxin for any particular indication, such as Relapsing Remitting MS or Secondary Progressive MS, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights (including for Tovaxin), the risk of litigation regarding our intellectual property rights, the success of third party development and commercialization efforts with respect to products covered by intellectual property rights that the Company may license or transfer, our limited manufacturing capabilities, our dependence on third-party manufacturers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date made. We assume no obligation or undertaking to update any forward-looking statements to reflect any changes in expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. You should, however, review additional disclosures we make in our reports filed with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2011.

SOURCE: Opexa Therapeutics, Inc.

        Neil K. Warma
        Opexa Therapeutics, Inc.
        President & CEO
        281-775-0600
        nwarma@opexatherapeutics.com
        or
        Institutional Investors:
        Carney Noensie
        Burns McClellan
        212-213-0006
        cnoensie@burnsmc.com

Copyright Business Wire 2012

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CCSVI and Multiple Sclerosis

As promised, this Foundation will be starting our own CCSVI section. It is theorized that MS may indeed be a vascular disease and that the resulting destruction of myelin comes from iron deposits in the brain (due to lack of blood flow) which triggers the autoimmune response. However, we’ve been a bit slow in fact-gathering, but there are so many valuable sources of information already on the web, so we are going to start with a compendium of those sites.

This Is MS Forums has many sections on research and discussion of CCSVI. Start here with their CCSVI Research section. They’ve done a good job at finding links to scholarly research.

The Reformed Multiple Sclerosis Society was started much like this Foundation because of one’s spouse fight for another’s treatment. Mr. Steven Simonyi-Gindele began the Society after his wife, Ruth, who suffers from Multiple Sclerosis, had the treatment for CCSVI.

Wheelchair Kamikaze, Marc, has written extensively on the procedure. Start here with his posting about CCSVI and his own experiences with it. It’s well-written and extremely informative. I urge you all to read his posting.

On Facebook, you can find the CCSVI in Multiple Sclerosis page. The comments from MS sufferers who have had the procedure are insightful and a good way to get in touch with someone you can talk to who has gone through the venoplasty.

Direct-MS dot com (DIRECT-MS, short forDIet REsearch into the Cause and Treatment of Multiple Sclerosis) has an information section on CCSVI. They are a Canadian group begun by families affected by MS and are now channeling most of their donation money into CCSVI research.

Finally on the list, a site begun by MS patients, is Venous Multiple Sclerosis Hypothesis | CCSVI and the goal is to gather all information about CCSVI. From their About Us page:

Who are we?

We are MS patients who want to give the research of the CCSVI hypothesis a chance simply by informing about it.

This project was founded 22 July 2009 and announced 6 Aug 2009.

If you want to contact us please use our contact form.

Independence

csvi-ms.net is an unbiased information platform for everyone interested in multiple sclerosis.

This web site is not sponsored and does not show ads. We work in our spare time on this web site and pay our expenses ourselves.

Multiple Sclerosis studies, especially about CCSVI, need to be done without ties to Big Pharma

A new article in the Annals of Neurology has made its way across various blogs and discussions about Multiple Sclerosis around the internet. It’s about CCSVI. And when we saw this article’s head line here, “Cerebrospinal Drainage Not Tied to Multiple Sclerosis,” along with the disclaimer:

Several of the researchers on this study disclosed financial relationships with pharmaceutical companies, including Pfizer, Sanofi-Aventis, and Merck-Serono.

Our first reaction was that any study that is to be done (especially one involving a treatment that could potentially make MS drugs a thing of the past)  the authors need to be free of any ties to pharmaceutical companies. The authors are:

1. Claudio Baracchini MD
2. Paola Perini MD
3. Massimiliano Calabrese MD
4. Francesco Causin MD
5. Francesca Rinaldi MD
6. Paolo Gallo MD, PhD

Here are the full conflicts of interest from the article:

C.B. has received compensation for being a board member, expert testimony, payment for development of educational presentations including service on speakers’ bureaus, and has had travel/accommodations expenses covered or reimbursed by Pfizer, Guidotti, Sanofi-Aventis, Novartis.

M.C. has been a member of the board of Merk-Serono, Sanofi-Aventis, and Bayer-Shering; a consultant for Merk-Serono and Sanofi-Aventis; given expert testimony for Biogen-Dompé Italy and Bayer-Shering; received honoraria from Merk-Serono, Sanofi-Aventis, and Bayer-Shering; and had travel/accommodations expenses covered or reimbursed by Biogen-Dompé Italy, Merk-Serono, Sanofi-Aventis, and Bayer-Shering.

P.G. has been a member of the board of Novartis, Biogen-Elan, Merk-Serono, Sanofi-Aventis, and Bayer-Shering; has been a consultant for Biogen-Elan, Sanofi-Aventis, and Bayer-Shering; has given expert testimony for Biogen-Dompé Italy, Sanofi-Aventis, and Merk-Serono; has received honoraria from Novartis Farma, Biogen-Elan, Sanofi-Aventis, Merk-Serono, and Bayer-Shering; and has had travel/accommodations expenses covered or reimbursed by University of Padova, Novartis Farma, Sanofi-Aventis, Biogen-Dompé Italy, Merk-Serono, and Bayer-Shering.

P.P. has received honoraria from Biogen-Dompé Italy, Sanofi-Aventis, and Merk-Serono; and has had travel/accommodations expenses covered or reimbursed by Sanofi-Aventis, Biogen-Dompé Italy, and Merk-Serono.

All of the above pharmaceuticals make Multiple Sclerosis drugs and have a large stake in those drugs. They cost a lot of money. See more about how much money here, here and here. And here as well.

This Foundation is not going to go into the details of the findings of the study. That is best left to experts in this field.

And as we find discussions on this study, we will post them here like the one at the MS blog on About.com. I threw in my two cents as well.

This Foundation just wants to point out the conflicts of interest to demonstrate that studies like these need to be done by those free and clear of the ties as shown above, like being members of the board of Pfizer, Sanofi and Merck. Seriously.

Much more information about CCSVI at The Reformed Multiple Sclerosis Society.

An introduction to CCSVI thanks to the Reformed Multiple Sclerosis Society

I first heard of the Reformed Multiple Sclerosis Society from this New York Times article back in June of last year.

The Reformed MS Society started much in the same way this Foundation started with one spouse fighting for the rights and treatments for another.

Mr. Steven Simonyi-Gindele began the Society after his wife, Ruth, who suffers from Multiple Sclerosis, had the treatment for CCSVI. It is theorized that MS may indeed be a vascular disease and that the resulting destruction of myelin comes from iron deposits in the brain (due to lack of blood flow) which triggers the autoimmune response.

CCSVI, or chronic cerebrospinal venous insufficiency, is treated with balloon angioplasty and stenting of the blocked veins.

The Reformed Multiple Sclerosis Society is your best source for information regarding the treatment for CCSVI. They are not beholden to donations from pharmaceutical companies. We will also start to keep our own section on CCSVI and update with information as it becomes available. I spoke with Elizabeth of the Reformed MS Society back in November of last year. They are a wonderful and accessible organization and if you have any questions, they will try and answer them. Their office number is 604-639-4405.

More about CCSVI here. And Wheelchair Kamikazee‘s articles on his own trials with CCSVI treatment. From Marc’s blog which reinforces the theory that MS may be a vascular disease:

In short, the procedure was a “successful failure,” in that we successfully determined that I do have significant abnormalities in the vascular system associated with my central nervous system (a very important discovery), but those abnormalities unfortunately could not be remedied during the procedure.

And with the pharmaceutical companies regurgitating cancer drug after cancer drug as the “newest therapy” in their MS arsenal–reformulated and slapped with a higher price tag–it’s time for some real research into the disease and not research into how more money can be made from the disease, year-after-year with no end in sight.

The kind of Multiple Sclerosis research that should be well funded in this country, but isn’t.

José Antonio Lozano, Borja Calvo and Iñaki Inza, in the Computer Faculty of the UPV/EHU.

I found this article yesterday about some very important research that you may have never heard about. It is being done by the University of the Basque Country (UPV/EHU) located within Spain.

Before I get into trouble with the people of the Basque region, please know that pinpointing your location within Spain is just recognizable for those unfamiliar with the country, region or your really good food.

Okay, on to the research. The University’s computer researchers, specifically the Intelligent Systems Team (working with the use and application of algorithms), are working with BioDonostia to find the genetic markers for Multiple Sclerosis.

Finding the genetic markers would give researchers the ability to find a cure for MS and also, possibly, a host of other autoimmune diseases. Finding a cure does not sit too well with companies who make millions (or as Mr. Termeer of Genzyme has postulated, billions) from just maintaining the disease.

Algorithms can even help to better understand certain diseases, as well as to find biomarkers related to their diagnosis and prognosis. This is one of the key functions of bioinformatics. In fact, four members of the Intelligent Systems Team (José Antonio Lozano, who is the director of the team, and Borja Calvo, Iñaki Inza and Rubén Armañanzas, the latter currently at the Polytechnic University of Madrid), are working closely with researchers from Biodonostia, the first health research body within the Autonomous Community of the Basque

Who or what is BioDonostia?

The BioDonostia Institute was founded in December 2008 by the Osakidetza’s (Basque Public Health System) Management Board and the Basque Foundation for Health Innovation and Research (BIOEF), Board of Trustees, focusing on fostering biomedical research. Its headquarters are in the Donostia Hospital, located on the Paseo Dr. Beguiristain in Donostia-San Sebastian.

Based on the tools developed by the Bioinformatics engineers at the University of the Country of Basque, BioDonostia is using the tools for medical research. It’s a cooperative research system where the objective isn’t a higher stock price, but actually working out a solution to our most basic human problems.

They have worked together on studies linked to Parkinson’s, frontotemporal dementia and muscular dystrophy. Nevertheless, as Mr Inza explained, “at present the most visible fruit of our work is with multiple sclerosis. We have published an article in an international journal (in the US Public Library of Science, PLoS ONE, in 2009) and there is a patent pending between Osakidetza (the Basque National Health Service) and the UPV/EHU”.

Mr Inza stated that “whoever finds the biomarkers for multiple sclerosis will receive a Nobel Prize”, to underline the difficulty of the challenge. But at least they believe that are taking steps in the right direction. In the words of Mr Borja Calvo, the Biodonostia researchers suspect that some of the molecules known as micro RNA could be linked to multiple sclerosis, or act as biomarkers, which is why they have taken samples and analysed their levels of expression. This was when bioinformatics came into play: “They generated these data, they passed them on to us and we aimed to construct a classificatory model which, introducing levels of expression into it, was able to predict if there was a disease or not, or the state thereof”. The results were quite good: “The models predicted the disease quite well and, on this basis, a series of validation phases has been initiated”.

I just wanted to highlight the fact that this research is taking place–but not in this country where we have a lot of money being thrown at Multiple Sclerosis: a lot of fundraisers, a lot of 501(c)(3)’s raising millions to fund research but also to fund salaries, rent on high priced real estate, brochures touting their work, and the other expenses with running a high profile foundation.

See the Susan G. Komen Foundation and their work blocking the Patients Bill of Rights in 1999, 2000 and 2001, which certainly runs counter to their work to help women suffering from breast cancer, as a prime example of high profile foundations working for themselves and not for their original charity-driven mission.

Could it be that money isn’t given to fund research to find a cure when so money is to be made from not finding a cure?

My understanding of finding the genetic marker for any disease would be, as Mr. Inza puts it above, worthy of a Nobel Prize. The rest of the article is here, and I urge you to read it. It is incredibly interesting, especially for you nerdy people out there like me, how these researchers are converting the genes into numbers and then using a DNA chip (which fits in your hand) to store the information. Your genome on a chip!

Now research that used to take decades on a single gene can be sorted out much more quickly. With the use of the chip, a researcher can begin to look at the genetic make-up of someone with Multiple Sclerosis and compare that DNA with someone without the disease and see where the genetic differences may lie. We hope they succeed quickly.

“When the DNA from a sample of a person’s body is inserted behind the chip, each gene goes to its allotted slot, as it were”, stated Mr Inza. Then images of colours, partitioned into these slots, are obtained. These colours represent “levels of intensity and are proportional to the level of expression of each one of these genes. These are translated into numbers”. José Antonio Lozano adds, “The numbers express a level of fluorescence, the intensity of the signal.” With these numbers, computer models enter the scene.