Opexa Therapeutics Receives European Patent Notification for T-Cell Vaccine

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, today announced that it has received notification under Rule 51(4) from the Examining Division of the European Patent Office (EPO) that the EPO intends to issue a patent for “Autologous T Cell Vaccine Materials and Method.” The European patent application is related to a unique method-specific approach for generating a T-cell vaccine that attacks what is believed to be the underlying cause of multiple sclerosis (MS). Rule 51(4) EPC notification is equivalent to a “Notice of Allowance” by the United States Patent and Trademark Office. It is expected that the patent will be granted within the next six months.

David McWilliams, president and chief executive officer of Opexa Therapeutics, commented, “This is an important step in advancing our intellectual property strategy for Tovaxin®, T-cell vaccine for the treatment of MS. Europe represents a significant market as we move forward with our clinical development of Tovaxin and we are pleased that our method has been recognized as being unique.”

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 treated patients. Tovaxin is currently in a Phase IIb clinical trial. Patients treated in Opexa’s Phase I/II open-label studies have experienced an approximately 90% average reduction in annualized relapse rate, minimal side effects and observed improvement in average disability (EDSS) scores.

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.

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.

Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Extension Trial with Tovaxin(TM) for Multiple Sclerosis

Jun 21 2007, 9:19 AM EST

Business Wire

Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, today announced positive top-line data in an open-label Phase I/II extension clinical trial of the investigational T-cell vaccine, Tovaxin(TM), for multiple sclerosis (MS). In this one-year, 8-subject extension clinical trial of relapsing remitting (RRMS) and secondary progressive (SPMS) subjects, Tovaxin therapy was shown to be safe and effective. The "per-protocol" analysis of Tovaxin therapy achieved a 92% reduction in annualized relapse rate (ARR) in subjects who received two treatment doses of 30 - 45 x 10(6) attenuated T-cells eight weeks apart and were monitored for an additional 44 weeks. Subjects in the extension study had previously been treated an average of 5.2+/-1.8 (1, 8; median 5.4) years earlier at Baylor College of Medicine under the direction of Jingwu Zhang, M.D., Ph.D with a T-cell vaccine developed from myelin basic protein (MBP) reactive T-cells. The safety profile revealed only injection site mild reactions and no severe adverse reactions related to T-cell vaccination.

Both Phase I/II clinical studies have demonstrated that T-cell vaccination depletes myelin reactive T-cells in peripheral blood. In the extension study patient population, the myelin reactive T-cell frequencies were reduced by 84% and 72% at 6 and 12 months on study, respectively. Reductions in myelin reactive T-cell frequencies in the dose escalation study were 76.7% and 64.8% at 6 and 12 months on study, respectively.

All subjects currently are enrolled in a retreatment extension study to collect longitudinal safety and effectiveness data.

Effectiveness data for the 13 RRMS subjects across the two Phase I/II trials showed an 80% reduction in ARR. The Expanded Disability Scoring Scale (EDSS) for the RRMS subjects for a 0.5 point effect was improved, unchanged and worsened by 64.3%, 21.4% and 14.3%, respectively. The EDSS for a 0.5 point sustained (no change over 3 months) effect was improved, unchanged and worsened by 42.9%, 42.9% and 14.2%, respectively. The EDSS for a 1.0 sustained effect was improved, unchanged and worsened by 28.6%, 57.1% and 14.3%, respectively.

Brian Loftus, M.D. of Bellaire Neurology, the Principal Investigator of these Tovaxin studies, commented, "This data, combined with prior data presented on myelin reactive T-cell frequencies and ARR reductions, laid the ground work for the placebo-controlled Tovaxin IIb clinical trial (TERMS). We have shown that myelin reactive T-cells can be identified and used to produce T-cell vaccine which effectively induces the depletion of an individual's autoreactive T-cells and results in positive clinical outcomes. I anticipate Tovaxin will usher in the age of personalized therapy for MS."

David McWilliams, president and chief executive officer of Opexa, said, "We are particularly encouraged by the data from this extension trial which indicates that subjects previously treated with T-cell vaccine can be safely and effectively retreated with Tovaxin. This outcome is important to our planned extension trial for subjects currently enrolled in our TERMS trial following the one year core study time period." In addition, the effectiveness data in RRMS subjects across the two Phase I/II trials indicate strongly positive outcomes in both ARR and EDSS improvements following Tovaxin therapy."

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. As of May 17, 2007, Opexa announced the completion of patient enrollment in a 150-patient Phase IIb safety and efficacy study (TERMS). 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.

The TERMS study is being conducted at 36 U.S. sites to evaluate the safety and effectiveness of Tovaxin. The TERMS study is registered on the U.S. National Institutes of Health-sponsored website, www.clinicaltrials.gov, where pharmaceutical companies are required to register trials for medicines that will treat serious or life-threatening diseases or conditions. For more information, visit the TERMS website at www.tovaxin.com.

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 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 a Phase IIb trial. 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.

Opexa Therapeutics Completes Patient Enrollment in Phase IIb Trial of Tovaxin™ for Treatment of Multiple Sclerosis

THE WOODLANDS, Texas--(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™ 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™. 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.

Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Dose Escalation Trial with TovaxinTM for Multiple Sclerosis

Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Dose Escalation Trial with TovaxinTM for Multiple Sclerosis

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company involved in the development and commercialization of cell therapies, today announced positive top-line data in an open-label Phase I/II dose escalation clinical trial of the investigational T-cell vaccine, Tovaxin™, for multiple sclerosis. In this one-year, 10-subject dose escalation clinical trial, Tovaxin therapy was shown to be safe and effective. The “per-protocol” analysis of Tovaxin therapy achieved a 90% reduction (p = 0.0039) in annualized relapse rate (ARR) in subjects who received one of the three dosage levels; the doses were 6 – 9 x 106, 30 – 45 x 106 or 60 – 90 x 106 attenuated T-cells. Subjects in the study received subcutaneous injections of Tovaxin over a period of 20 weeks (0, 4, 12 and 20 weeks) and were monitored for an additional 32 weeks.

The safety profile for all dosage levels revealed no severe adverse reactions related to T-cell vaccination. With increasing dosage, an increase in mild injection site reactions was observed and these resolved within 48 hours.

All subjects currently are enrolled in an extension study to collect longitudinal safety and effectiveness data.

David McWilliams, president and chief executive officer of Opexa, commented, “We are particularly encouraged by the data from this dose escalation trial. While all three dosage levels were safe and effective, the group treated with the 30 – 45 x 106 T-cell dose achieved a 100% reduction in ARR. The currently enrolling Tovaxin IIb clinical trial is being conducted with the 30 – 45 x 106 T-cell dose.”

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. As of March 19, 2007, Opexa reported that more than 110 patients have been enrolled in the TERMS clinical trial and the Company expects enrollment to be complete by mid 2007.

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.

The TERMS study is being conducted at 36 U.S. sites to evaluate the safety and effectiveness of Tovaxin It is registered on the U.S. National Institutes of Health-sponsored website, www.clinicaltrials.gov, where pharmaceutical companies are required to register trials for medicines that will treat serious or life-threatening diseases or conditions. For more information, visit the TERMS website at www.tovaxin.com.

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 treated patients.

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.

Editor's Note:

In first and fourth paragraphs of this release, T-cell dosage levels include the figure 10(6), which should be read as ten to the sixth power.

Opexa Therapeutics to Be Featured in Live MN1.com Interview

Mar 19 2007, 6:30 AM EST

Business Wire

Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, announced that its chief executive officer, David McWilliams, will be featured in a live Market News First interview on Tuesday, March 20, 2007 at 9:30 am Central Time. The interview can be heard live on Market News First's website at www.mn1.com.

The interview will also be available in a podcast which can be downloaded from the Market News First website within 48 hours of the interview.

Mr. McWilliams will discuss the Company's ongoing clinical trials for its novel therapeutic, Tovaxin(TM), for multiple sclerosis as well as the innovative therapies the Company is developing to treat rheumatoid arthritis and diabetes.

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.

About MN1.com

Market News First is an online, market news provider that brings investors current news on the market. Market News First is the only online, live radio web site that brings real market news to investors and features live interaction with companies from the Bulletin Board to NYSE.

Through daily, live interviews, we bring you up to date on all the established companies and inform the investors of the newest opportunities within the market. Market News First offers one-on-one interviews with the presidents and CFOs of companies to deliver answers to the questions that investors may ask and provides them insight into the companies' present condition and future plans.

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.