Industry Update: Latest developments in stem cell research and regenerative medicine

Abstract

Regenerative MedicineVol. 4, No. 4 News & ViewsFree AccessIndustry Update: Latest developments in stem cell research and regenerative medicineDusko IlicDusko IlicStemLifeLine, Inc., 1300 Industrial Rd. #13, San Carlos, CA 94070, USA. ; www.stemlifeline.com Search for more papers by this authorEmail the corresponding author at dilic@stemlifeline.comPublished Online:6 Jul 2009https://doi.org/10.2217/rme.09.27AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail Going Global▪ BrazilTo evaluate the effect of autogenous undifferentiated stem cell infusion for the treatment of patients with chronic spinal cord injury on somatosensory evoked potentials (SSEPs), a public tertiary hospital in Sao Paulo, Brazil, conducted a prospective, nonrandomized clinical series trial [1]. A total of 39 consecutive patients with diagnosed complete cervical and thoracic spinal cord injury for at least 2 years and with no cortical response in the SSEP study of the lower limbs were included in the trial. The trial patients underwent peripheral blood stem cell mobilization and collection. The stem cell concentrate was cryopreserved and reinfused through arteriography into the donor patient. The patients were followed up for 2.5 years and submitted to SSEP studies to evaluate the improvement in SSEPs after undifferentiated cell infusion. A total of 26 (66.7%) patients showed recovery of somatosensory evoked response to peripheral stimuli after 2.5 years of follow-up.▪ ChinaChina announced a plan to build a large base to develop stem cell medical technology. The base will be in Taizhou, an area of Jiangsu with many medical and pharmaceutical businesses, will cover 20,000 m2 and will include a clinic. It was not announced when the project will be completed.It has also been announced that China’s National Centre for International Research in Stem Cells (NCIR) will work together with The Scottish Centre for Regenerative Medicine (SCRM) at Edinburgh University after signing an agreement in Beijing. This collaboration will see the development of technologies, standards and programs in all areas of regenerative medicine.▪ IndiaCryo-Save Group (www.cryo-savegroup.com), The Netherlands-based stem cell company with a large Indian presence, plans to increase the number of stem cell donors in the country by opening more representative offices. The company expects that this would increase the number of clients and extend reach beyond the current five cities; Delhi, Mumbai, Pune, Ahmedabad and Bangalore. Cryo-Save Group plans to invest US$2.65 million in its Bangalore-based subsidiary for over 3 years. By the end of the year, Cryo-Save plans to open three additional centers, one of which will be in Kolkata, and expand into other South Asian countries by the end of 2010. Cryo-Save Group is one of Europe’s largest adult stem cell storage banks, with more than 100,000 samples stored. The company, established in 2000, is headquartered in The Netherlands and owns or has access to operating laboratory and storage facilities in Belgium, Germany and Dubai. Cryo-Save’s services are available in 38 countries across three continents (Europe, Asia and Africa). In India, Cryo-Save currently charges Rs75,000 ($1500) per person to save a child’s umbilical cord blood and stem cells. This includes collection, processing and storing the cells for approximately 21 years.LifeCell International (www.lifecellinternational.com), India’s first cord blood bank, launched its R&D center for various stem cell technologies. The facility will focus on increasing the gamut of stem cell banking by developing processes for the isolation, processing and preservation of other stem cell-rich tissues in the body. The R&D facility, spread across 280 m2, includes a clean room for harvesting and storage of human somatic stem cells and state-of-the-art equipment for molecular biological analysis of stem cells and their derivatives. A Kumar, Chief Scientific Officer of LifeCell International, will lead the operation with a team of 15 scientific and medical professionals.▪ RussiaA register of donor cells taken from the umbilical cords of newborn babies is planned in St Petersburg. This will consist of 10,000 samples and will take 3–4 years to develop. The cost of developing the register for Russia’s northwest region will amount to $15–20 million, and the entire country will be able to use the register.▪ United Arab EmiratesThe British mega-brand Virgin has launched a stem cell bank in Qatar. Although Virgin is only storing umbilical-cord blood stem cells, Qatar’s scientists are also open to working with the more controversial human embryonic stem cells (hESCs).Business Development▪ Collaborations, partnerships & alliancesCodevelopment agreement: ArunA & Open BiosystemsArunA Biomedical, Inc., from GA, USA (www.arunabiomedical.com) has codeveloped a validated kit to produce induced pluripotent stem cells (iPSCs) with Open Biosystems (AL, USA), now part of Thermo Fisher (www.thermo.com/openbiosystems). They launched the complete and fully validated iPSC kits, containing all the tools and reagents necessary to generate patient- and disease-specific cell lines for use in research applications. The innovative viPS™ product offerings include two kit formats and additional supplemental kits designed exclusively by the companies.Codevelopment agreement: Fate Therapeutics & StemgentFate Therapeutics from CA, USA (www.fatetherapeutics.com), and Stemgent from MA, USA (www.stemgent.com), joined forces to offer new developments in iPSC technology for research purposes. The joint effort could provide Fate with a new source of money to develop drugs based on the same technology. The so-called Catalyst program, formed by the two companies, is focused on making available technology from the labs of S Ding at the Scripps Research Institute in CA, USA, and R Jaenisch at the Whitehead Institute in MA, USA, which grows out of those researchers’ work on iPSC (Jaenisch and Ding are founders of Fate, and Ding is also a founder of Stemgent). In exchange for undisclosed payments to be shared by Fate and Stemgent, the Catalyst program intends to provide large pharmaceutical companies, big biotech firms and academic labs with access to the Jaenisch and Ding work. The idea behind Catalyst is for paying members to use the iPSC technologies from Jaenisch and Ding’s labs to test the toxicity of drugs or perform other research. The cells the companies will make available to outside scientists include those made by Ding [2] and Jaenisch [3].Codevelopment agreement: MultiCell & MaximMultiCell Technologies, Inc. from RI, USA (www.multicelltech.com) has entered into a cooperative research and development agreement with Maxim Biotech, Inc. from MD, USA (www.maximbio.com) to develop products for the study of liver stem cells and liver cancer. MultiCell owns exclusive rights to two issued US patents (6,872,389 and 6,129,911), one US patent application (US 2006/0019387A1), and several corresponding issued and pending foreign patents and patent applications related to the isolation and differentiation of liver stem cells. The role of liver stem cells in the carcinogenic process has recently led to a new hypothesis that hepatocellular carcinoma arises by maturation arrest of liver stem cells. The cooperative research and development agreement with Maxim Biotech, Inc. will initially focus on the development of a family of life science research reagent tool kits, which can be used to isolate liver stem cells and help to elucidate their gene functions and encoded proteins. MultiCell plans to further leverage this research effort involving liver stem cells to identify therapeutic targets, and diagnostic and prognostic markers of liver cancer. MultiCell will also seek to develop and patent therapeutic product opportunities, specifically targeting the treatment of primary liver cancer and intrahepatic bile duct cancer.Collaboration agreement: iZumi & Kyoto UniversityiZumi Bio, Inc. from CA, USA (www.izumibio.com), and Kyoto University’s Center for iPS Cell Research and Application (CiRA; www.icems.kyoto-u.ac.jp/cira/e) announced a collaboration to promote the basic research, development and application of iPSC technology with the goal of advancing drug discovery and enabling cell-based therapies. Through the collaboration, iZumi and CiRA will exchange part of their representative human iPSC lines derived by various methods. The two organizations also will conduct comparison and characterization studies independently but will share their results to determine which methods produce the most appropriate iPSC lines for drug screening and development, and those most suitable for cell-based therapy. iZumi and CiRA offer the capability to take skin cells from a diseased patient with known genotypic and phenotypic information and reprogram the cells to behave similarly to hESCs, respectively. iZumi is initially focusing on three neurological disorders: Parkinson’s disease, spinal muscular atrophy and amyotrophic lateral sclerosis. Former Vice President Al Gore, a partner with venture capital firm Kleiner Perkins Caufield and Byers, which is backing iZumi, enthusiastically greeted the collaboration agreement between iZumi and CiRA.Collaboration agreement: Pfizer & University College LondonPfizer Regenerative Medicine (www.pfizer-regenerativemedicine.com) has entered into a collaboration and license agreement with University College London (UCL; www.ucl.ac.uk) focused on gaining better understanding into how to develop stem cell-based therapies for certain ophthalmic conditions. The collaboration will examine how hESCs differentiate into retinal pigment epithelium, with the goal of developing stem cell-based therapies primarily for wet and dry macular degeneration. Under the terms of the agreement, Pfizer will provide funding to UCL to enable research into the development of stem cell-based therapies for macular degeneration as well as other retinal diseases. Pfizer is granted exclusive worldwide rights to develop and commercialize a retinal pigment epithelium stem cell-based therapeutic in the ophthalmology field. After the completion of preclinical safety studies, Pfizer will have the option to conduct clinical trials to determine efficacy of treatment and commercialize any resulting product.Licensing agreement: Advanced Cell Technology & CHAAdvanced Cell Technology, Inc. from MA, USA (www.advancedcell.com) and a Seoul, South Korea-based stem cell company, CHA Bio & Diostech Co., Ltd (www.chabio.co.kr), have entered into a licensing agreement under which Advanced Cell will license its retinal pigment epithelium technology, for the treatment of diseases of the eye, to CHA Bio for development and commercialization exclusively in South Korea. Advanced Cell Technology is eligible to receive up to a total of US$1.9 million in fees based upon the parties achieving certain milestones, including Advanced Cell Technology making an Investigational New Drug (IND) submission to the US FDA to commence clinical trials in humans using the technology, which Advanced Cell Technology currently plans to do during the second half of 2009. The company received an up-front fee under the license and expects to receive the balance of the fees over the next 12 months. Under the terms of the agreement, CHA Bio will incur all of the costs associated with retinal pigment epithelium clinical trials in South Korea. The arrangement is part of continuing cooperation and collaboration between the two companies, including a recent joint venture regarding hemangioblast technology, known as Stem Cell & Regenerative Medicine International.Marketing agreement: ArunA & NeuromicsArunA Biomedical, Inc. from GA, USA (www.arunabiomedical.com) has entered an agreement with Neuromics, Inc. of MN, USA (www.neuromics.com), giving Neuromics the right to nonexclusively market and sell the ArunA hN2™ Human Neural Cells and Neural Culture Medium to support applications in neurological research. ArunA has an exclusive worldwide license to develop and commercialize neural cells derived from hESCs, and hN2 is a second-generation product from this technology.Service agreement: NeoStem & Progenitor Cell TherapyNeoStem, Inc. from NY, USA (www.neostem.com), will be moving its commercial adult stem cell processing and storage operations and utilizing exclusively Progenitor Cell Therapy, LLC of NJ, USA (www.progenitorcelltherapy.com), an international provider of current good manufacturing practice (cGMP) cell therapy manufacturing and storage. Progenitor Cell Therapy is a client-based cell therapy services company that supports the development and commercialization of cellular therapies by providing cGMP-compliant services for preclinical and clinical development, manufacturing and eventual commercialization of cellular therapies for clients throughout the world. This relationship will allow NeoStem to utilize the highest cGMP standard within the industry and associate itself further with clinicians, scientists and business executives with significant accomplishments in both the general field of healthcare and specifically within the field of cell-based therapeutics. NeoStem and Progenitor Cell Therapy believe that cGMP-compliant adult stem cell blood banking will be essential for the use of these stem cells in many of the more complex future therapies presently being developed.▪ Launching new products & servicesInvitrogenInvitrogen (www.invitrogen.com), a division of Life Technologies, CA, USA (www.lifetech.com), launched GIBCO® OpTmizer™ T-cell Expansion SFM, a next-generation serum-free media (SFM) for culturing and expanding human T cells that does not require the addition of serum to achieve optimal, cost-efficient results. OpTmizer SFM is also xeno-free, meaning that it does not contain material of nonhuman origin, which further enhances its safety, while decreasing variability of results from lot to lot. It is currently available in Research Use Only grade. This product is manufactured under cGMP regulations, and comes with an FDA Drug Master File to support regulatory filings. OpTmizer SFM expands Invitrogen’s portfolio of solutions for immunology research, which includes AIM V®, the only FDA 510(k)-cleared commercial T-cell medium for human ex vivo tissue and cell culture processing applications, in addition to an extensive selection of serum- and xeno-free products.National Marrow Donor ProgramThe National Marrow Donor Program, a nonprofit organization from MN, USA (www.nmdp.org), dedicated to creating an opportunity for all patients to receive the bone marrow or umbilical cord blood transplant that they need, when they need it, launched a new website: Be The Match™ (www.bethematch.org). The site provides general information on The National Marrow Donor Program, the Be The Match RegistrySM and Be The Match FoundationSM. This site answers the most frequently asked questions of donors, patients and medical professionals, and provides medical information on diseases treatable by marrow or umbilical cord blood transplantation. Since 1987, the National Marrow Donor Program has provided more than 35,000 unrelated transplants. Today, the National Marrow Donor Program facilitates more than 4300 transplants a year.Stem Cell TechnologiesStemCell Technologies, Inc. from BC, Canada (www.stemcell.com), released MesenCult®-ACF Medium, the first defined, animal component-free (ACF) and serum-free medium for culturing human mesenchymal stem cells. MesenCult-ACF Medium supports long-term growth of mesenchymal stem cells with retention of multilineage differentiation potential. In addition, mesenchymal stem cells cultured in MesenCult-ACF Medium expand faster and show a significant reduction in hematopoietic cell contamination at early passages compared with serum-containing media.Vitro DiagnosticsVitro Diagnostics, Inc. from CO, USA (www.vitrodiag.com), dba Vitro Biopharma, announced the introduction of ‘Tools for Stem Cell and Drug Development™’ at the recently held Society of Toxicology meeting in Baltimore, MD, USA. These products are designed to support stem cell and cancer research specifically targeting mesenchymal stem cells and iPSCs.VitrolifeVitrolife from Göteborg, Sweden (www.vitrolife.com) is establishing a sales office in Japan and in Beijing, China, in line with the strategy of operating under its own management in key markets. These markets for in vitro fertilization are among the largest in the world in terms of the number of treatments, and they are rapidly growing.▪ AdvancementsBioLife SolutionsBioLife Solutions, Inc. from WA, USA (www.biolifesolutions.com), a developer and marketer of proprietary cGMP hypothermic storage and cryopreservation media products for cells, tissue and organs, announced that an independent comparison of the company’s CryoStor preformulated serum- and protein-free biopreservation media against traditional in-house formulated culture media/serum/dimethyl sulfoxide showed that CryoStor offers a significant cryopreservation process improvement and better cellular outcomes [4]. Compared with media/serum/dimethyl sulfoxide, CryoStor enabled enhanced post-thaw cell membrane integrity and a full recovery of metabolic activity and differentiation capacity within 24 h after thawing. The experiments were conducted by research teams at the Fraunhofer IBMT in St. Ingbert/Sulzbach, Germany and IBET/ITQB-UNL in Oeiras, Portugal.InvitrogenScientists from Invitrogen generated platform hESC lines that allow efficient targeting at a predetermined genomic location using phiC31 integrase to target a plasmid to a pseudo attP site in the cellular genome [5]. The integration site was mapped and the chromosomal location evaluated for its potential to be transcriptionally active in differentiated cells. The target plasmid carried a wild-type R4 attB site that acts as a target for further integration of expression constructs. They engineered two hESC lines, BG01V and H9, to contain the target and showed that genetic elements such as promoter–reporter pairs can be inserted at the target efficiently and specifically. The retargeting construct has been adapted for complex element assembly using Multisite Gateway technology. Retargeted clones show sustained expression and appropriate regulation of the transgenes over long-term culture, upon random differentiation, and directed induction into neural lineages. The system represents a method to rapidly assemble complex plasmid-based assay systems, controllably insert them into the hESC genome and have them actively express in undifferentiated as well as in differentiated cells.Clinical Trials▪ Aastrom BiosciencesThe FDA informed Aastrom from MI, USA (www.aastrom.com) that it had completed its review of the company’s response to the issue cited in the FDA clinical hold letter and that the clinical hold had been lifted; therefore, the IMPACT-DCM clinical trial evaluating the use of cardiac repair cells (CRCs), a mixture of stem and progenitor cells derived from a patient’s own bone marrow, for the treatment of dilated cardiomyopathy, could resume. To date, nine of 40 patients have been enrolled in the IMPACT-DCM trial at the first three sites: The Methodist DeBakey Heart & Vascular Center (TX, USA), Baylor University Medical Center (TX, USA) and The University of Utah School of Medicine (UT, USA). In addition, the fourth site, the Cleveland Clinic Heart and Vascular Institute in OH, USA, was recently initiated and trained for participation in the trial. Activation of the fifth clinical site is underway. IMPACT-DCM is the first clinical trial in the USA to evaluate the surgical delivery of autologous cells directly into the human heart muscle for the treatment of congestive heart failure associated with dilated cardiomyopathy in both ischemic and nonischemic patients. The randomized, controlled, prospective, open-label, Phase II study seeks to enroll 20 patients with ischemic DCM and 20 patients with nonischemic DCM at five clinical sites in the USA. Participants must have a left ventricular ejection fraction of 30% or less (60–75% is typical for a healthy person) and meet certain other eligibility criteria. All patients in each group will receive standard medical care and 75% of the patients will be treated with CRCs through direct injection into the heart muscle during minimally invasive open-heart surgery. While the primary objective of this study is to assess the safety of CRCs in patients with dilated cardiomyopathy, efficacy measures, including left ventricular ejection fraction and other cardiac function parameters, as well as heart failure stage, will be monitored. Patients will be followed for 12 months post-treatment.▪ Cardio3 BioSciencesCardio3 BioSciences from Mont-Saint-Guibert, Belgium (www.c3bs.com) has treated its first patient with its cell-based treatment C-Cure soon after it had obtained US$9.5 million in a successful Series B fundraising round from a range of new and existing investors. The patient, who was treated at the Cardiovascular Center of Aalst (Aalst, Belgium) is participating in a Phase II/III clinical study to assess this cell therapy in patients with heart failure. C-Cure is an autologous product that is produced by taking a patient’s own bone marrow cells and, through a proprietary culturing technology, gives rise to ‘cardiopoietic’ cells that can regenerate damaged heart muscle. The randomized, prospective, multicenter trial is designed to evaluate the safety and efficacy of C-Cure beyond optimal clinical care in patients with heart failure. Patients will be randomized to C-Cure in addition to optimal standard therapy versus optimal standard therapy alone. The trial is also designed to evaluate the socioeconomic implications of therapy.▪ Cytograft Tissue EngineeringCytograft Tissue Engineering from CA, USA (www.cytograft.com), has developed a proprietary technology to build living vascular grafts exclusively from the patient’s own cells [6]. Ten patients with end-stage renal disease, who had been receiving hemodialysis through an access graft that had a high probability of failure, and had had at least one previous access failure, were enrolled from centers in Argentina and Poland between September 2004 and April 2007. Completely autologous tissue-engineered vascular grafts were grown in culture supplemented with bovine serum, implanted as arteriovenous shunts, and assessed for both mechanical stability during the safety phase (0–3 months) and effectiveness after hemodialysis was started. Three grafts failed within the safety phase, which is consistent with failure rates expected for this high-risk patient population. One patient was withdrawn from the study owing to severe gastrointestinal bleeding shortly before implantation, and another died of unrelated causes during the safety period with a patent graft. The remaining five patients had grafts functioning for hemodialysis 6–20 months after implantation, and a total of 68 patient-months of patency. In these five patients, only one intervention (surgical correction) was needed to maintain secondary patency. Overall, primary patency was maintained in seven (78%) of the remaining nine patients 1 month after implantation and five (60%) of the remaining eight patients 6 months after implantation. The proportion of primary patency in this high-risk cohort approached Dialysis Outcomes Quality Initiative objectives (76% of patients 3 months after implantation) for arteriovenous fistulas, averaged across all patient populations.▪ DaVinci BiosciencesDaVinci Biosciences from CA, USA (www.dvbiosciences.com), in collaboration with Luis Vernaza Hospital in Ecuador, published study results demonstrating the safety and feasibility of its acute and chronic spinal cord injury treatment platform [7]. The study demonstrates that administering adult autologous bone marrow-derived stem cells via multiple routes is feasible, safe and, most importantly, improves the quality of life for both acute and chronic spinal cord injury patients. The study documents 2-year follow-up on the first eight of 52 patients (four acute and four chronic) who were administered autologous bone marrow-derived stem cells using a multiple route delivery technique. The study demonstrated no adverse effects such as tumor formation, increased pain and/or deterioration of function following administration of autologous bone marrow-derived stem cells. Using sequential MRIs, the follow-up demonstrated noticeable morphological changes within the spinal cord after administration of autologous bone marrow-derived stem cells. Participating spinal cord injury patients experienced varying degrees of improvement in their quality of life, such as increased bladder control and regained mobility and sensation.▪ Eli LillyResearchers at the University of Rochester Medical Center in NY, USA (www.rochester.edu), gave teriparatide, a drug for the treatment of osteoporosis marketed under the brand name Forteo® and manufactured by Eli Lilly, headquartered in IN, USA (www.lilly.com), to 145 people who had bone fractures that had not healed, many for 6 months or more. They found that 93% of patients showed significant healing and pain control after 8–12 weeks. The researchers found that teriparatide speeds the healing of fractures by changing the behavior and number of cartilage and bone stem cells involved in the healing process, cutting healing time by more than half. Based on the findings, the US NIH is funding a clinical trial of the drug in fractures. The study will include men and postmenopausal women older than 50 years who have what is known as a low-energy pelvic fracture and who are admitted to the emergency department of Strong Memorial Hospital in Rochester, NY, USA. Participants in the study will be given either teriparatide or a placebo and will be followed for 16 weeks to measure fracture healing in a number of ways, including pain levels, microscopic bone growth determined through CT scans and functional testing of bone strength. If clinical trials prove that the drug speeds bone healing, it could prove especially important for older adults, who suffer the majority of slow-healing broken bones.▪ Living Cell TechnologiesLiving Cell Technologies Ltd, based in Sydney, Australia, and Auckland, New Zealand (www.lctglobal.com), reported insulin independence in a patient with insulin-dependent Type 1 diabetes who received DIABECELL®, its encapsulated insulin-producing porcine cells, as part of an ongoing Phase I/IIa clinical trial. The patient is a 37-year-old woman who was on daily insulin injections for 15 years and now maintains good blood glucose control without insulin injections. Live porcine cells in intact capsules have been biopsied from the site of implants in the abdomen and porcine insulin was detected in the patient’s blood.▪ MesoblastMesoblast Ltd, from Melbourne, Australia, (www.mesoblast.com), has received approval at Melbourne’s Epworth Hospital to start a Phase II trial of its stem cell therapy product for fusion of the cervical spine. The trial will compare the safety and effectiveness of Mesoblast’s product, NeoFuse, against a fusion procedure using the patient’s own hipbone.▪ Opexa TherapeuticsOpexa Therapeutics, Inc., from TX, USA (www.opexatherapeutics.com), has published data from its Phase I/II dose-escalation study [8]. This small, dose-finding study of Tovaxin®, T-cell vaccine in development for multiple sclerosis (MS), enrolled patients with relapsing–remitting MS or secondary progressive MS who had failed or were intolerant of currently approved MS therapies. The study was designed to find a safe and effective Tovaxin dose. Tovaxin immunization resulted in rapid depletion of circulating myelin-reactive T cells (MRTCs), with an observed dose–response effect. A safe and effective dose was identified for further clinical trials, associated with reductions in MRTCs ranging from 92% at week 5 to 65% at week 52. Clinically, using the per-protocol criteria for MS relapses, a statistically significant reduction in relapse rate (85%, p < 0.05) was seen among the ten evaluable patients, and a 63% reduction was demonstrated in the modified intent-to-treat population. The MRI lesions were stable and there was an improving trend in disability as measured by the expanded disability status scale and patients’ physical score as measured by the Multiple Sclerosis Impact Scale (MSIS-29), following the second injection. The mid-dose was selected for further clinical development studies owing to the rapid depletion of peripheral blood MRTCs and a trend towards an improvement in clinical outcomes following immunization. The most common vaccine-associated adverse events were injection-site reactions, all of which were mild and resolved rapidly. The vaccine was prepared by using two peptides from each of three myelin proteins: myelin basic protein, myelin oligodendrocyte glycoprotein and proteolipid protein. The peptides were used to identify and expand patient-specific myelin-reactive T cells for vaccine preparation. Vaccine was administered at four scheduled intervals over 20 weeks, with immunologic, clinical and MRI follow-up to 52 weeks.Tovaxin is an individualized cellular immunotherapy treatment in Phase IIb clinical development for multiple sclerosis. Tovaxin is derived from T cells isolated from peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T cells known to attack myelin and, thereby, reduces the risk of relapse over time. Opexa completed the 150-patient landmark Tovaxin for Early Relapsing Multiple Sclerosis (TERMS) Phase IIb clinical study in late 2008, which was one of the first clinical studie