Tovaxin update from Opexa

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Re: Thanks Bob!

Postby JanethePain » Thu Oct 04, 2007 6:28 am

notasperfectasyou wrote:Thanks Bob!

I sure hope this works out for her. I've been interested in Tovaxin for a good while.

Are you still up for me drafting you for president this coming election?

Ken


I'll second that motion... as long as I can be the Vice President. Not necessarily second-in-command... you know, the Prez in charge of vice. Ah, memories. 8O :lol:
Jane the Pain
User avatar
JanethePain
Family Elder
 
Posts: 223
Joined: Wed Jun 13, 2007 2:00 pm
Location: Historical Glendale, OH: Home of the Squirrrels

Advertisement

Re: Thanks Bob!

Postby Lyon » Thu Oct 04, 2007 7:48 am

JanethePain wrote: I'll second that motion... as long as I can be the Vice President. Not necessarily second-in-command... you know, the Prez in charge of vice. Ah, memories. 8O :lol:
Gosh, if THAT is the way it's supposed to work, the politicians have had it mixed up so far in my lifetime! In my time it seems it's been the Presidents who have been in charge of vice!

On the other hand, I don't remember hearing anything TOO terrible about Eisenhower, Carter and Regan so maybe I'm not giving them enough credit.

Don't worry Jane. Because you're my buddy, when I get to be President you have your choice between the President of Vice or Secretary of the Offense.

As President, no one needs to worry about me becoming a nuisance. I'm planning on spending most of my time practicing for the annual grits eating contest http://tinyurl.com/3ae9k9 and having the pilots of Air Force One keep me at zero gravity so that I don't feel so fat!

Bob
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 2:00 pm

Re: Thanks Bob!

Postby hmtucker » Fri Oct 05, 2007 9:36 am

Politics and Presidents aside, here is some info from the Opexa site about an upcoming presentation by Opexa. The extent that they will discuss the Tovaxin IIb trial is not clear.

<shortened url>

October 05, 2007 12:42 PM Eastern Daylight Time
Opexa Therapeutics to Present at the BIO Investor Forum 2007
BIO InvestorForum 2007

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, today announced that David McWilliams, Chief Executive Officer, will present at the BIO Investor Forum 2007 on Thursday, October 11, 2007 at 1:00 p.m. (4:00 p.m. ET) at the Palace Hotel in San Francisco, CA. Mr. McWilliams will provide an overview of the Company and an update on its clinical development programs.

Interested parties can access a live audio webcast and slide presentation by visiting the Investor Relations section of the Company’s website www.opexatherapeutics.com. An archived version of the webcast will be available on the website for 30 days following the presentation.

About Opexa Therapeutics

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, 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.
User avatar
hmtucker
Family Elder
 
Posts: 100
Joined: Tue Nov 28, 2006 3:00 pm
Location: Versailles, Kentucky

Postby Lyon » Fri Oct 05, 2007 1:20 pm

Thanks Mike, obviously I don't check the Opexa website nearly often enough. I'm glad others do :)

It seems the presentation is going to be geared towards convincing potential investors, but it should be interesting anyway.

Bob
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 2:00 pm

Postby IHaveMS-com » Tue Mar 11, 2008 6:26 am

Press Release Source: Opexa Therapeutics, Inc.

Opexa Therapeutics Announces Completion of Mid Study Descriptive Analysis on
Phase IIb Trial of Tovaxin(R) for Treatment of Multiple Sclerosis
Tuesday March 11, 7:00 am ET


Data Safety Monitoring Board Recommends Continuing Trial as Scheduled


THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA
<http://finance.yahoo.com/q?s=opxa&d=t> - News
<http://finance.yahoo.com/q/h?s=opxa> ) today announced that the independent
Data Safety Monitoring Board (DSMB) of its ongoing 150-patient Phase IIb
safety and efficacy study (TERMS) of Tovaxin in multiple sclerosis
recommended that the trial be continued as scheduled.

Opexa's Data Safety Monitoring Board is an independent group of multiple
sclerosis experts which is responsible for monitoring the ongoing safety and
conduct of the study. At each DSMB meeting, the board may recommend
continuing the trial unmodified, continue the trial with modifications or
discontinue the trial.


The DSMB meeting reviewed 28-week data for approximately 50% of the patients
in the study. The DSMB noted in their report very few dropouts and that the
study appears to be proceeding well. In addition, the report indicated that
baseline MRI data is consistent with the assumptions used in the design of
the study. Edward Fox, M.D., Ph.D. commented, "As the lead investigator of
the TERMS trial, I continue to anticipate the conclusion of this
experimental protocol, which has been designed to evaluate the efficacy,
tolerability, and safety of Tovaxin in the treatment of patients in the
early stages of Multiple Sclerosis."


David McWilliams, president and chief executive officer of Opexa
Therapeutics, stated, "I am pleased by the steady progress of the trial and
the recommendation of the DSMB. We have delivered all Tovaxin doses to
patients in the study and now look forward to presenting 52-week topline
results of the TERMS Phase IIb study in September. McWilliams continued,
"with this report, we are aggressively moving forward with our regulatory
plans and furthering our discussion with potential strategic development
partners."


About TERMS Descriptive Analysis


The descriptive analysis provided to the DSMB included clinical laboratory
results, adverse events, vital signs and physical examination data as well
as the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI
scans, the cumulative number of new gadolinium-enhancing lesions, the change
in T2-weighted lesion volume, and annualized relapse rates. Disease
progression, as measured by changes in disability scores using the
industry-standard Kurtzke Expanded Disability Status Scale (EDSS) along with
other select qualitative/quantitative MS-specific instruments, was also
assessed.


About TERMS


The Tovaxin Phase IIb clinical study includes 150 patients in a multicenter,
randomized, double blind, placebo-controlled trial designed primarily to
evaluate the efficacy, safety and tolerability of the Tovaxin T-Cell
vaccination with clinically isolated syndrome (CIS) and relapsing-remitting
MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50
will receive placebo. The study is designed as a two-arm, 52-week,
parallel-group study, whereby patients will be given five subcutaneous
injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at
the end of the 52-week study to assess the safety and efficacy of Tovaxin.
The primary efficacy variable is the cumulative number of
gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week
28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative
number of new gadolinium-enhancing lesions at Weeks 28-52, the change in
T2-weighted lesion volume, and the annualized relapse rate.


About T-cell Vaccination


For a T-cell vaccine to be effective, it should be able to induce T-cell
cytotoxic and/or regulatory immune responses against the pathogenic T-cells.
Studies of T-cell vaccine have indicated that T-cell vaccination with
peripheral blood-derived autologous myelin-peptide selected T-cells in
multiple sclerosis patients resulted in the in vivo induction of CD8+
cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The
induction of anti-idiotypic cytotoxic CD8+ effector T-cells and
anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a
therapeutically effective dual mechanism of protection to patients treated
with Tovaxin. The observed regulatory immune responses have been shown to
collectively correlate with clinical improvement in some patients treated in
earlier clinical studies.


About Opexa Therapeutics


Opexa Therapeutics develops and commercializes cell therapies to treat
autoimmune diseases such as MS, 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,
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 <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," 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.



Contact:
Opexa Therapeutics, Inc.

Lynne Hohlfeld, 281-719-3421

lhohlfeld@opexatherapeutics.com
Best regards, Tim

In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.
User avatar
IHaveMS-com
Family Elder
 
Posts: 213
Joined: Tue Jun 07, 2005 2:00 pm

Postby Lyon » Tue Mar 11, 2008 7:10 am

.
Last edited by Lyon on Mon Nov 28, 2011 7:57 pm, edited 1 time in total.
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 2:00 pm

Postby hmtucker » Tue Mar 11, 2008 8:52 am

IHaveMS-com wrote:We have delivered all Tovaxin doses to patients in the study and now look forward to presenting 52-week topline results of the TERMS Phase IIb study in September. McWilliams continued, "with this report, we are aggressively moving forward with our regulatory plans and furthering our discussion with potential strategic development partners."


Interesting couple of sentences there. Confirmation that the IIb results will be released in September and they are looking for "development partners." There is a lot riding on the September release both for us lab rats and Opexa as a business. Moving on to a phase III study is going to be VERY expensive and it sounds like they are looking for partnership or buyout to help with the cost.

Interesting times indeed,
Mike
User avatar
hmtucker
Family Elder
 
Posts: 100
Joined: Tue Nov 28, 2006 3:00 pm
Location: Versailles, Kentucky

Postby schnittke » Sat Mar 22, 2008 6:49 am

This sounds a bit worrisome.

Opexa Therapeutics Announces Retirement of CEO David McWilliams
Friday March 21, 2008 9:00 am ET
Search Underway for Successor
THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA - News), a company leading in the development and commercialization of personalized cell therapies, today announced that David B. McWilliams, President and Chief Executive Officer, has notified the Company of his intention to retire following the naming of his successor. Scott B. Seaman, Chairman of the Company’s Nominations Committee, stated, “All of the directors would like to thank David for his valuable contributions to the Company and for his generous commitment to continue to provide leadership during the search and transition period. We are also pleased that David will continue to serve on the Board of Directors and be part of advancing both our platforms, especially as we approach completion of the Tovaxin® Phase IIb trial.”
User avatar
schnittke
Family Member
 
Posts: 27
Joined: Sun Jan 06, 2008 3:00 pm

Postby rainer » Sat Mar 22, 2008 12:40 pm

Noticed their stock took a big hit too.
User avatar
rainer
Family Elder
 
Posts: 367
Joined: Thu Jan 17, 2008 3:00 pm

Previous

Return to Tcelna (Tovaxin)

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users


Contact us | Terms of Service

cron