Opexa Completes Patient Enrollment in Phase IIb

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Opexa Completes Patient Enrollment in Phase IIb

Postby IHaveMS-com » Thu May 17, 2007 6:23 pm

http://www.genengnews.com/news/bnitem.aspx?name=17568660
Opexa Therapeutics Completes Patient Enrollment in Phase IIb Trial of Tovaxin(TM) for Treatment of Multiple Sclerosis
May 17 2007, 7:00 AM EST
Business Wire


Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, today announced the completion of patient enrollment in a 150-patient Phase IIb safety and efficacy study (TERMS). The trial design is a U.S. multicenter, randomized, double-blind, placebo-controlled study of subcutaneous Tovaxin(TM) in subjects with Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis (RRMS).

Patients participating in the study, which is being conducted under Opexa's U.S. Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA), will receive 52 weeks of treatment and will undergo safety and efficacy assessments using primary criterion of gadolinium-enhancing lesions and secondary criterion of annualized relapse rate. The Company will collect descriptive analysis data on the first 75 subjects to reach 6 months evaluable later this year. This trial was specifically designed, with the assistance of well-known multiple sclerosis experts, to address three important objectives: to rigorously assess the safety and efficacy of Tovaxin, to maintain a robust clinical effect for the full study, and to provide a scientific and clinical database for advancement to Phase III.

David McWilliams, president and chief executive officer of Opexa Therapeutics, stated, "Full enrollment in this Phase IIb study is an important milestone in the commercialization of Tovaxin. With this milestone achieved, we now look forward to reporting a descriptive analysis in the fourth quarter of 2007 and the full data results in the second half of 2008." McWilliams continued, "I am convinced that the ability to rapidly enroll this study across 35 U.S. centers reflects the high level of interest by multiple sclerosis patients in new safe and effective treatments."

Edward Fox, MD, PhD and lead principal investigator for the Phase IIb study, commented, "If the results of this study can replicate the safety and effectiveness demonstrated in earlier studies, I believe Tovaxin could be an important advance in treating patients with MS. I'm pleased that the positive response from physicians and their MS patients across the country has resulted in the rapid enrollment of this study."

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(TM). The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in treated patients.

About TERMS

The Tovaxin Phase IIb clinical study will include 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.

All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin under an open-label protocol. The open-label study is being planned under a different protocol that will be submitted to the FDA.

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(TM), 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.

Safe Harbor Statement

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, 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.
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 3:00 pm

Advertisement

an epiphany

Postby IHaveMS-com » Sun May 20, 2007 10:26 am

This is just a thought.

Since the IIb trial is already closed, people who might want to be in the phase III trail should be contacting their local site and Shannon to get on a list to be contacted when the phase III trial enrollment starts.

You probably will get a response that they are not currently enrolling patients in a phase III trail for Tovaxin, but I am sure they will keep interested patients name on file.

Every time you see a new press release about the current trial, I would send another "I am interested in participating in the Phase III trial" email.
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 3:00 pm

Postby Lyon » Sun May 20, 2007 12:40 pm

Hi Tim,
Does Opexa already know how many registrants they are going to be accepting for the phase III?
Bob
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 3:00 pm

Postby IHaveMS-com » Sun May 20, 2007 3:44 pm

Hi Bob,

It will be much less than the typical drug studies. If you triple the current study, 450 to 500 would be a good estimate. I think it could go as high as 700. It probably will be a double blind placebo study. The larger the number of participants the smaller the percentage of placebo recipients.
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 3:00 pm

Postby Lyon » Sun May 20, 2007 7:19 pm

Very interesting! Thanks Tim!
Bob
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 3:00 pm

Postby sh8un » Sun May 20, 2007 8:41 pm

OPEXA THERAPEUTICS (NASD: OPXA) "Up 23.40% on Thursday"

Detailed Quote: http://www.otcpicks.com/quotes/OPXA.php

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(TM), 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.

OPXA News:

May 17 - Opexa Therapeutics Completes Patient Enrollment in Phase IIb Trial of Tovaxin(TM) for Treatment of Multiple Sclerosis

Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, recently announced the completion of patient enrollment in a 150-patient Phase IIb safety and efficacy study (TERMS). The trial design is a U.S. multicenter, randomized, double-blind, placebo-controlled study of subcutaneous Tovaxin in subjects with Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis (RRMS).

Patients participating in the study, which is being conducted under Opexa's U.S. Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA), will receive 52 weeks of treatment and will undergo safety and efficacy assessments using primary criterion of gadolinium-enhancing lesions and secondary criterion of annualized relapse rate. The Company will collect descriptive analysis data on the first 75 subjects to reach 6 months evaluable later this year. This trial was specifically designed, with the assistance of well-known multiple sclerosis experts, to address three important objectives: to rigorously assess the safety and efficacy of Tovaxin, to maintain a robust clinical effect for the full study, and to provide a scientific and clinical database for advancement to Phase III.

David McWilliams, president and chief executive officer of Opexa Therapeutics, stated, "Full enrollment in this Phase IIb study is an important milestone in the commercialization of Tovaxin. With this milestone achieved, we now look forward to reporting a descriptive analysis in the fourth quarter of 2007 and the full data results in the second half of 2008." McWilliams continued, "I am convinced that the ability to rapidly enroll this study across 35 U.S. centers reflects the high level of interest by multiple sclerosis patients in new safe and effective treatments."

Edward Fox, MD, PhD and lead principal investigator for the Phase IIb study, commented, "If the results of this study can replicate the safety and effectiveness demonstrated in earlier studies, I believe Tovaxin could be an important advance in treating patients with MS. I'm pleased that the positive response from physicians and their MS patients across the country has resulted in the rapid enrollment of this study."


http://boston.stockgroup.com/sn_newsrel ... id=8573584
sh8un
Family Elder
 
Posts: 303
Joined: Wed May 03, 2006 3:00 pm
Location: Calgary, AB, Canada

Re: an epiphany

Postby JanethePain » Thu Jun 14, 2007 10:12 am

IHaveMS-com wrote:This is just a thought.

Since the IIb trial is already closed, people who might want to be in the phase III trail should be contacting their local site and Shannon to get on a list to be contacted when the phase III trial enrollment starts.

You probably will get a response that they are not currently enrolling patients in a phase III trail for Tovaxin, but I am sure they will keep interested patients name on file.

Every time you see a new press release about the current trial, I would send another "I am interested in participating in the Phase III trial" email.


I'm curious about inclusion/exclusion criteria for the next round. So many people who couldn't manage the "walking" portion of the baseline visit for II-b are hoping the next phase will recruit patients with higher levels of disbality.

If that's the case, I know of two who are ready to camp out at their neuros' offices so they can fill out the paperwork. Yesterday... if you get my drift!
Jane the Pain
User avatar
JanethePain
Family Elder
 
Posts: 222
Joined: Wed Jun 13, 2007 3:00 pm
Location: Historical Glendale, OH: Home of the Squirrrels

Postby IHaveMS-com » Thu Jun 14, 2007 10:24 am

Hi Jane,

Quote fro Jane
I'm curious about inclusion/exclusion criteria for the next round.


The current IIb protocol was written so that Opexa would be able to transition into Phase III without much red tape. The age and EDSS range were increased after the IIb study was started, so nothing is ever set in cement.
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 3:00 pm


Return to Tcelna (Tovaxin)

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users