Navigation Links
Opexa Presents Tovaxin Research at Federation of Clinical,Immunology Societies Annual Meeting

THE WOODLANDS, Texas--(BUSINESS WIRE)--Jun 11, 2007 - Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, made a poster presentation at the 2007 Annual Meeting of the Federation of Clinical Immunology Societies (FOCIS) in San Diego June 7-11 at the Sheraton San Diego Hotel & Marina. The poster, entitled "Identifying New Immunodominant Myelin Peptides in Relapsing Remitting Multiple Sclerosis Patients" was presented on Sunday, June 10.

The presentation covered laboratory and clinical data from the Company's proprietary T-cell vaccination technology for the treatment of multiple sclerosis. Key highlights of research detailed in the poster presentation include:

-- Data accumulated from over 173 assays (using a T-cell Epitope Analysis Assay (EAA)) have allowed Opexa to identify several myelin protein peptides from myelin basic protein (MBP), myelin proteolipid protein (PLP) and myelin oligodendrocyte glycoprotein (MOG) as being immunodominant, including some peptides never before reported, and others as being non-reactive,

-- The EAA can be utilized to screen additional or combinations of peptides that have biological significance and;

-- These results have permitted Opexa to optimize the number of myelin peptides across the lengths of MBP, PLP and MOG in the screening assay for Tovaxin(TM) vaccine production to qualify subjects for Opexa's current 150-patient Phase IIb safety and efficacy clinical trial (TERMS).

"These findings mark an important development for Tovaxin, which is a patient-specific autologous T-cell vaccine, because it helps us qualify subjects for our current clinical trial and improves production of the vaccine. The EAA is an important assay for further refinement of the T-cell vaccination technology, which is truly personalized, to make the therapy as efficacious as possible for each patient," said Jim Williams, PhD, chief operating officer.

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 o ne-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 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(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 rev ise 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
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
Bruce Voss, 310-691-7100
bvoss@lhai.com


'"/>




Related medicine technology :

1. Opexa Advances Monocyte Derived Islet Technology to Proof of Principle in stz-induced NOD/SCID Mice
2. Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Extension Trial with Tovaxin for Multiple Sclerosis
3. Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Dose Escalation Trial with Tovaxin for Multiple Sclerosis
4. Inspiration Biopharmaceuticals Presents Data From Hemophilia Program at International Society On Thrombosis and Haemostasis (ISTH) Annual Meeting
5. European Society for Medical Oncology (ESMO) Presents Data from the Clinical Trial of MediGenes Cancer-Killing Virus in Press Conference
6. Cytogen Presents Phase 1 Data Showing Promising Antitumor Activity and Safety Profile of Quadramet at International Myeloma Workshop
7. SemBioSys Presents Positive Insulin Data at the American Diabetes Association Conference
8. Tranzyme Pharma Presents Initial Phase IIa Data for its Novel Ghrelin Agonist, TZP-101, in Patients with Diabetic Gastroparesis
9. Novagali Pharma Presents at AACO the Results of its Pivotal Phase III Clinical Trial of Vekacia in Children Suffering From Vernal Keratoconjunctivitis
10. BioLife Solutions Presents Data on CryoStor at International Society for Cellular Therapy Annual Meeting
11. Genaera Presents Preclinical Data on Trodusquemine (MSI-1436) for the Treatment of Obesity at the American Diabetes Association 67th Scientific Session
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... 24, 2016  Consumers have taken a more ... placed more emphasis on patient outcomes. ... in the pharmaceutical industry have evolved beyond just ... companies are focusing on becoming more patient-oriented across ... and services that improve health. ...
(Date:6/24/2016)... 24, 2016   Bay Area Lyme Foundation ... Dean Center for Tick Borne Illness , Harvard ... MIT Hacking Medicine, University of California, Berkeley, and ... the five finalists of Lyme Innovation , ... than 100 scientists, clinicians, researchers, entrepreneurs, and investors ...
(Date:6/24/2016)... The Academy of Managed Care Pharmacy (AMCP) ... would allow biopharmaceutical companies to more easily share health ... and coverage decisions, a move that addresses the growing ... The recommendations address restrictions in the sharing of ... label, a prohibition that hinders decision makers from accessing ...
Breaking Medicine Technology:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... PawPaws ... a new product that was developed to enhance the health of felines. The formula ... , The two main herbs in the PawPaws Cat Kidney Support Supplement ...
(Date:6/25/2016)... ... , ... The temporary closing of Bruton Memorial Library on June 21 due to a possible ... often overlooked aspect of head lice: the parasite’s ability to live away from a human ... but a necessary one in the event that lice have simply gotten out of control. ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health ... of their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards ... at the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out ... family verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers ... would throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... ... , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business ... to $12 an hour by 2020 and then adjusting it yearly to increase at the ... minimum wage, assure the wage floor does not erode again, and make future increases more ...
Breaking Medicine News(10 mins):