THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing Tcelna, a novel T-cell therapy for multiple sclerosis (MS), today announced the initiation of a Phase IIb clinical trial of Tcelna in patients with Secondary Progressive Multiple Sclerosis (SPMS). Several patients have already been enrolled in the study and enrollment is expected to increase rapidly as additional sites begin screening and enrolling patients in the coming weeks. Tcelna is the first ever personalized T-cell therapy for MS patients and has received Fast Track Designation from the United States Food and Drug Administration (FDA) for the treatment of SPMS. The therapy is specifically tailored to each patients individual disease profile and has demonstrated superior safety and encouraging indications of efficacy in previous clinical studies in MS that included the treatment of SPMS patients. There is currently only one FDA-approved treatment for SPMS but safety warnings have severely restricted its use.
While a positive trial outcome will certainly be good news for SPMS patients, it is also not difficult to envision that it could position Tcelna as a promising treatment for the larger RRMS patient population as well.
The newly initiated trial, named Abili-T, is a randomized, double-blind, placebo-controlled clinical study in SPMS patients who demonstrate evidence of disease progression without associated relapses. The trial is expected to enroll 180 patients at approximately 30 leading clinical sites in the U.S. and Canada with each patient receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. The study will assess a number of clinical endpoints to evaluate the efficacy and safety of Tcelna in patients with SPMS. The primary efficacy outcome of the trial is the percentage of brain volume change (atrophy) at 24 months. Study investigators will also measure several important secondary outcomes commonly associated with MS including disease progression as measured by the Expanded Disability Status Scale (EDSS), annualized relapse rate (ARR) and changes in disability as measured by EDSS and the Multiple Sclerosis Functional Composite (MSFC).
In multiple previously conducted clinical trials for the treatment of patients with MS, Tcelna has demonstrated one of the safest side effect profiles of any marketed or development-stage MS therapy, as well as encouraging efficacy signals indicating Opexas therapy may have the potential to be both safe and effective for the treatment of both SPMS and RRMS patients. In Phase I/II studies involving SPMS patients treated with Tcelna (n=36), 80 percent of the patients treated with Tcelna showed no evidence of disease progression at 24 months (a 50% improvement, with respect to patients showing evidence of disease progression, over historical controls). Following two years of treatment, a subset of these patients (n=10) reported no worsening of their physical or psychological condition. Additionally, in 21 years of cumulative follow up in the same SPMS patients treated with Tcelna, the annualized relapse rate for this same subset of patients was reduced significantly compared to baseline and only one patient experienced a relapse during this time.
To witness the initiation of this clinical study following the extensive preparations that were required is a tremendous testament to the dedication and talent of the entire Opexa team. We believe this is a critical milestone for not just our Company, but for all of those SPMS patients who desperately need and deserve a better, safer and more effective treatment option, said Neil K. Warma, President and Chief Executive Officer of Opexa. We return to the clinic with an enhanced manufacturing process, an optimized clinical development strategy, Fast Track designation from the FDA and the belief that Tcelna is the most promising MS treatment in development today.
The initiation of this trial follows a number of key enhancements to the Tcelna clinical development program. First, Opexa has optimized its Chemistry, Manufacturing and Control (CMC) process for the therapy in order to improve efficiency, reduce overall costs and bring it further in line with commercial stage requirements. Following completion of these manufacturing and logistical enhancements, the Company submitted an updated CMC application which has been fully reviewed by the FDA. In addition, the Company has modified its clinical development strategy for Tcelna to focus current efforts on the SPMS patient population in order to address the severe lack of treatment options currently available or in development for these patients. Finally, to reflect its work in optimizing the overall manufacturing process and clinical development strategy for the program, Opexas lead product candidate, formerly known as Tovaxin, has been rebranded as Tcelna.
It is very gratifying to see Opexas novel T-cell therapy return to the clinic and I am excited to be part of the ongoing investigation of a potential MS treatment that possesses such an impressive early safety profile. This is an exceedingly important study for the entire MS community as it will go a long way toward demonstrating how effective the therapy may be for the most in need and underserved progressive MS patient population, stated Mark Freedman, M.D., director of the Multiple Sclerosis Research Unit at the Ottawa Hospital, member of Opexa's Scientific Advisory Board, and an investigator for the Abili-T trial. While a positive trial outcome will certainly be good news for SPMS patients, it is also not difficult to envision that it could position Tcelna as a promising treatment for the larger RRMS patient population as well.
The initiation of this clinical trial is a very important milestone in the area of MS research, particularly in light of the significant need for new and effective treatments for these patients, commented Hans-Peter Hartung, M.D., chairman of the department of neurology at Heinrich-Heine University, Dusseldorf and member of Opexa's Scientific Advisory Board. As a personalized immunotherapy, Tcelnas unique mechanism strongly differentiates it from other development stage MS treatments. This combined with a safety profile that is unmatched by other MS therapies currently available or in development positions Tcelna as a potentially very interesting therapy for a large, underserved patient population. Currently, there is no satisfactory treatment available for SPMS patients.
While its current clinical trial targets SPMS patients, Opexa also intends to continue the development of Tcelna as a treatment for RRMS patients. Opexa has successfully completed End of Phase II meetings with the FDA and believes it is positioned to initiate Phase III pivotal trials in RRMS patients. Importantly, the results of the ongoing Abili-T trial should further enhance the Companys future efforts in the RRMS indication. The primary focus at present, however, is the ongoing Phase IIb SPMS Abili-T trial and on securing the necessary capital required for the completion of that trial.
About SPMS
Go here to read the rest:
Opexa Initiates Late Stage Clinical Study of Tcelna in Patients with Secondary Progressive Multiple Sclerosis (SPMS)
- Rally for Multiple Sclerosis Treatment Funding - May 7th, 2011 [May 7th, 2011]
- Breakthrough Multiple Sclerosis Treatment? - May 8th, 2011 [May 8th, 2011]
- Multiple Sclerosis Treatment - Mayo Clinic - May 11th, 2011 [May 11th, 2011]
- Tracy Macchia: Controversial MS Treatment - May 14th, 2011 [May 14th, 2011]
- What is Multiple Sclerosis - May 19th, 2011 [May 19th, 2011]
- MS Multiple Sclerosis treatment testimonial from Sanoviv Medical Institute - May 20th, 2011 [May 20th, 2011]
- Patient with progressive ms(paraplegia) Fmr treatment 1/4 - May 22nd, 2011 [May 22nd, 2011]
- New Jersey Multiple Sclerosis Treatment with Chiropractic Care - May 23rd, 2011 [May 23rd, 2011]
- MS Cure - Progression - June 2nd, 2011 [June 2nd, 2011]
- CCSVI UK Multiple Sclerosis Liberation Treatment - June 2nd, 2011 [June 2nd, 2011]
- Stem Cell Therapy MS: Sam Harrell and The Superbowl - June 3rd, 2011 [June 3rd, 2011]
- Holly Huber on Recovery: Stem Cell Therapy for Multiple Sclerosis Community Outreach Dallas, TX 2011 - June 8th, 2011 [June 8th, 2011]
- MS treatment sees early success - June 9th, 2011 [June 9th, 2011]
- CCSVI Possible cure for Multiple sclerosis - June 10th, 2011 [June 10th, 2011]
- MS Cure - Introduction to stem cell bone marrow transplant in Australia - June 11th, 2011 [June 11th, 2011]
- (Multiple Sclerosis Cure) Change Your Thinking? (Multiple Sclerosis Cure) - June 12th, 2011 [June 12th, 2011]
- Essiac cancer treatment herbal tincture, Ms Caisse...from The Secrets of Eden - June 12th, 2011 [June 12th, 2011]
- MS walking treatment breakthrough - June 14th, 2011 [June 14th, 2011]
- multiple sclerosis natural treatment | Kathy Canada Testimonial - June 18th, 2011 [June 18th, 2011]
- CCSVI Surgery India - Liberation Procedure Multiple Sclerosis Treatment in India - June 29th, 2011 [June 29th, 2011]
- XCell-Center MS CCSVI Liberation Angioplasty Treatment Results E.Schuurman 18_01_11 - July 1st, 2011 [July 1st, 2011]
- MS Cure - 7PM Project Carmel Turner MS Stem Cell Treatment - July 9th, 2011 [July 9th, 2011]
- MS Update! Tysabri or Gilenya? - July 10th, 2011 [July 10th, 2011]
- What causes BSE, CJD - July 15th, 2011 [July 15th, 2011]
- Kath Bartlett, MS, LAc Balance Method Acupuncture - July 16th, 2011 [July 16th, 2011]
- MS Cure - 730 report ben leahy carmel turner ms stem cell treatment - July 17th, 2011 [July 17th, 2011]
- CCSVI LIberation Treatment Tokuda - July 18th, 2011 [July 18th, 2011]
- FOX News Interview on the O'Reilly Factor - Treatment of Women in Islam - July 18th, 2011 [July 18th, 2011]
- CCSVI treatment bloopers holy crap - July 18th, 2011 [July 18th, 2011]
- Tarah's CCSVI Venoplasty. Dr McGuckin Explaining procedure findings - July 19th, 2011 [July 19th, 2011]
- Cancer Cure: The One-Minute Cure For Cancer, MS - July 24th, 2011 [July 24th, 2011]
- Not Ready to Cheer CCSVI Trials - July 29th, 2011 [July 29th, 2011]
- New Oral Treatment for MS - July 30th, 2011 [July 30th, 2011]
- 27/07/2011 - MS patients seek controversial treatment - August 1st, 2011 [August 1st, 2011]
- MS Cure - 11 I am still walking - August 5th, 2011 [August 5th, 2011]
- Upcoming Treatments for MS - Pt 1 -MSRA Public Lecture - Dr Suzanne Hodgkinson - August 10th, 2011 [August 10th, 2011]
- Stem Cells for MS Community Outreach: Patient Judi Lecoq - Dallas, TX 2011 - August 18th, 2011 [August 18th, 2011]
- Stem Cell Treatment for Multiple Sclerosis - Community Outreach, San Diego: David Oliver - August 19th, 2011 [August 19th, 2011]
- New Study Tests Possible Treatment for MS - August 25th, 2011 [August 25th, 2011]
- Professor Dimitrios Karussis: Treating MS - August 26th, 2011 [August 26th, 2011]
- walking with MS before CCSVI treatment.wmv - August 27th, 2011 [August 27th, 2011]
- Suzy Cohen Discusses The Liberation Treatment for MS - September 14th, 2011 [September 14th, 2011]
- Multiple Sclerosis MS People - Amazing New Treatment - September 15th, 2011 [September 15th, 2011]
- Multiple Sclerosis Alternative Treatment - September 17th, 2011 [September 17th, 2011]
- CLEAR scoliosis treatment, Dr. Culpepper (MS) - September 22nd, 2011 [September 22nd, 2011]
- Liberation treatment for MS - September 23rd, 2011 [September 23rd, 2011]
- 44b - My Lyme disease and rheumatoid arthritis journey - Miraculous CCSVI treatment for MS sufferers - September 24th, 2011 [September 24th, 2011]
- A Closer Look at Gilenya - The First Oral Treatment for MS - September 28th, 2011 [September 28th, 2011]
- Unequal Treatment Drives Disability Rights Movement - September 28th, 2011 [September 28th, 2011]
- Multiple Sclerosis - The Nebraska Medical Center - September 29th, 2011 [September 29th, 2011]
- Testimonial for CCSVI Treatment Excel Heart Center Mexico -- Tanya Reay - September 30th, 2011 [September 30th, 2011]
- Current thinking on what causes MS - Pt 1 - MSRA Public Lecture -Prof Graeme Stewart - October 2nd, 2011 [October 2nd, 2011]
- Current and emerging therapies in MS - Part 02 (How do these treatments work?) - October 2nd, 2011 [October 2nd, 2011]
- MS Richard Humphries before and after treatment for Multiple Sclerosis with stem cells - October 3rd, 2011 [October 3rd, 2011]
- Matthew - CCSVI and his Liberation Treatment - October 8th, 2011 [October 8th, 2011]
- Multiple Sclerosis - Myelin Repair - Video - October 14th, 2011 [October 14th, 2011]
- MS Auto Immune vs CCSVI Treatment Simple Pictures by Berukoff - Video - October 23rd, 2011 [October 23rd, 2011]
- New Promising Treatment for Those Living with Multiple Sclerosis - Video - October 29th, 2011 [October 29th, 2011]
- Stem cells to treat MS - Pt 2 - MSRA Public Lecture - A/Prof Richard Burt - Video - October 30th, 2011 [October 30th, 2011]
- New hope for treating multiple sclerosis - Video - October 31st, 2011 [October 31st, 2011]
- CCSVI Multiple sclerosis Breakthrough/cure - Video - October 31st, 2011 [October 31st, 2011]
- Inhuman Treatment of Wheelchair bound Multiple Sclerosis Patient in Canadian Care Home - Video - November 9th, 2011 [November 9th, 2011]
- MS treatment movie Cells4health.mp4 - Video - November 10th, 2011 [November 10th, 2011]
- Racing to the Cure for MS: Myelin Repair Foundation Celebrates MS Awareness Week - Video - November 12th, 2011 [November 12th, 2011]
- [Symptoms of Multiple Sclerosis] - Video - November 12th, 2011 [November 12th, 2011]
- Multiple Sclerosis Treated with Adult Stem Cells - Video - November 13th, 2011 [November 13th, 2011]
- Stem cells to treat MS - Pt 1 - MSRA Public Lecture - A/Prof Richard Burt - Video - November 16th, 2011 [November 16th, 2011]
- Multiple Sclerosis A Natural Treatment - Video - November 16th, 2011 [November 16th, 2011]
- My MS and Stem Cell Treatment - Video - November 16th, 2011 [November 16th, 2011]
- CCSVI Liberation News Reports - Video - November 20th, 2011 [November 20th, 2011]
- Stem Cells for MS Community Outreach: Patient Sam Harrell - Dallas, TX 2011 - Video - November 21st, 2011 [November 21st, 2011]
- Arthur S13 E2-1 - The Silent Treatment - Video - November 27th, 2011 [November 27th, 2011]
- Holly Huber on Recovery: Stem Cell Therapy for Multiple Sclerosis Community Outreach San Diego CA - Video - December 3rd, 2011 [December 3rd, 2011]
- CCSVI - Video - December 3rd, 2011 [December 3rd, 2011]
- My Sister's Experience with Liberation Treatment for Multiple Sclerosis PART 2/2 - Video - December 5th, 2011 [December 5th, 2011]
- Multiple Sclerosis -- Treatment LDN story - Video - December 7th, 2011 [December 7th, 2011]
- ABC News - Multiple Sclerosis effectively treated by a new acoustic medical device. - Video - December 9th, 2011 [December 9th, 2011]
- MS Patient After Stem Cell Therapy - Video - December 10th, 2011 [December 10th, 2011]
- Multiple Sclerosis - Video - December 12th, 2011 [December 12th, 2011]
- Journey of Connective Tissue, Autoimmune disease, steroid treatment updates. - Video - December 22nd, 2011 [December 22nd, 2011]