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ISSN 1746-075110.2217/RME.11.4 © 2011 Future Medicine Ltd 145Regen. Med. (2011) 6(2), 145–156

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� Collaborations, partnerships & alliancesCo-development agreement: Shrink & EV GroupShrink Nanotechnologies, Inc., CA, USA (www.shrinknano.com), a nanotechno­logy company developing products and licensing opportunities in the solar energy industry, medical diagnostics and sensors and biotechnology research and develop­ment tools businesses, has entered into a multiyear development and manufac­turing agreement with EV Group, head­quartered in Austria (www.evgroup.com), a leader in the nano­imprint lithography process development and equipment manufacturing. The mutually exclusive, 2­year agreement calls for EV Group and Shrink to develop and manufacture Shrink’s structured substrates for its StemDisc™ stem cell and cell­culturing platform. StemDisc is designed to improve embryoid body formation of stem cells, a prerequisite in the study of many stem cell characteristics.

Collaboration agreement: DiaMedica & Sanford ProjectDiaMedica Inc., MB, Canada (www.diamedica.com) commenced its collabo­ration with The Sanford Project, SD, USA (www.sanfordproject.com) in Type 1 dia­betes research. The Sanford Project is one of the initiatives established after Denny Sanford’s US$400 million gift to Sanford Health in 2007. The Project aims to cure Type 1 diabetes through the development

of b­cell regeneration. DiaMedica has shown the ability of its compound DM­99 to protect and increase b­cells, making it a strong b­cell regeneration candidate. DiaMedica also announced the in vivo validation of DM­199, its next­generation recombinant version of DM­99.

Collaboration agreement: Plasticell & Sigma-AldrichPlasticell, UK (www.plasticell.co.uk), a biotechnology company specializing in the use of innovative high­throughput techno logies in stem cell research, has announced the signing of a collabora­tion agreement with Sigma­Aldrich, MO, USA (www.sigmaaldrich.com). In the collaboration, Sigma­Aldrich will use its CompoZr® Zinc Finger Nuclease Technology to engineer various human stem cell lines that enable tracking of differentiation to specif ic mature cell types via fluorescent reporters, integrated directly into developmentally expressed genes. The technology enables highly eff icient, precisely targeted knock­in of reporters, resulting in more reliable reporter systems than conventional trans­genic methods, which integrate report­ers randomly throughout the genome. Plasticell will use these cell lines in its CombiCult™ high­throughput screening system to develop novel stem cell differ­entiation protocols. Under the agreement, Plasticell will own the resulting protocols for high efficiency, directed differentia­tion of stem cells, with Sigma­Aldrich

Industry UpdateLatest developments in stem cell research and regenerative medicine

Latest developments in the field of stem cell research and regenerative medi-cine compiled from publicly available information and press releases from non-academic institutions from November 1st, 2010 until December 31st, 2010.

Business Development

Dusko Ilic, MD, PhDEmbryonic Stem Cell Laboratories, Guy’s Assisted Conception Unit, Division of Women’s Health, King’s College London School of Medicine, UK dusko.ilic@kcl.ac.uk

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marketing the reporter stem cell lines. Cells and media may be commercial­ized together in kits, while reporter cell lines can be linked to specific CombiCult screens, for optimized differentiation of human embryonic stem cells (hESCs) or induced pluripotent stem cells.

Collaboration agreement: Plasticell & USBPlasticell, UK (www.plasticell.co.uk), a biotechnology company specializing in the use of innovative high­throughput technologies in stem cell research, has announced the signing of a collabora­tion agreement with the biopharmaceuti­cal company UCB from Belgium (www.ucb.com). Under the terms of the agree­ment, UCB will supply Plasticell with drug compound libraries with known biological targets. Plasticell will screen these using its proprietary CombiCult technology to discover new cell signal­ing pathways involved in stem cell bio­logy, including tissue regeneration. UCB, headquartered in Brussels, Belgium, is a global biopharma company with a team of over 8000 employees, a strong market presence in more than 40 countries, over US$4 (€3.1) billion in revenue in 2009 and numerous strategic partnerships across the industry.

Distribution agreement: BioTime & CIRMBioTime, Inc. CA, USA (www.biotimeinc.com) has entered into an agreement with the California Institute for Regenerative Medicine (CIRM; www.cirm.ca.gov) to make five clinical­grade hESC lines available to California­based research­ers [1]. CIRM is the stem cell agency cre­ated when California voters supported a US$3 billion funding measure for stem cell­related research and clinical trans­lation. Under the agreement, BioTime will initially provide research­grade cell lines, and within 1 year, BioTime will also make available current good manufactur­ing practice (cGMP)­grade cell lines along with certain documentation and complete DNA sequence information. The parties

anticipate that the use of the cGMP­grade cell lines may streamline the translation of basic science to human therapies. Should the users of the cell lines and BioTime eventually sign definitive license agree­ments for commercial use of the cell lines, BioTime will receive a royalty on net sales. The first material transfer agreement was signed with the University of California (CA, USA) system. By 21 October, 2010, CIRM had approved more than 180 grants totaling more than US$540 million for projects being conducted in the University of California system.

Distribution agreement: ThermoGenesis & NanshanThermoGenesis Corp., CA, USA (www.thermogenesis.com) has signed a distribu­tion agreement covering China and Hong Kong for its products used to prepare cell concentrates, including stem cells, from bone marrow, at the point­of­care and in the laboratory. The 4­year agreement is with the Nanshan Memorial Medical Institute (www.nsmmi.com), a regen­erative medicine company in China and Hong Kong that distributes medical products and has operated multiple, large healthcare facilities, including hospitals, stem cell banks and research centers. Under the agreement, Nanshan will have exclusive distribution rights for the com­pany’s Res­Q™ 60 BMC System and the MXP MarrowXpress™ products.

Distribution & licensing agreement: Amedica/US Spine & BioDlogicsAmedica/US Spine, UT, USA (www.amedicacorp.com), a spine and recon­structive implant and instrument man­ufacturer focused on unique silicon nitride technologies, recently completed a distribution/licensing agreement with US­based BioDlogics (www.biodlogics.com) that will clearly expand its pre sence in the growing spine and orthopedic bio­technology arena. Amedica/US Spine will distribute stem cell products indi­cated for spinal fusion, adhesion barrier and nerve protection. BioDlogics procures and processes human cellular and tissue­based products/allografts derived from the amniotic tissue of healthy, prescreened live donors through scheduled cesarean births.

The BioDfactor liquid product is derived from human amnion living tissue and is cryopreserved to provide viable tis­sue for clinical use. The BioDfence allo­graft is a sterile structural tissue derived from human amniotic tissue that forms a physical barrier between the dura and surrounding soft tissue or paraspinal mus­cles to reduce fibroblast infiltration into the epidural space where postoperative scar tissue normally forms. This reduces epidural fibrosis at the surgical site. The allograft also acts as a structural barrier to preserve the plane between the dura and the surrounding soft tissue to reduce the tethering of adhesions to the dura or nerve roots. Amedica/US Spine markets a com­plete suite of biologic products, including human amniotic stem cells, injectable 100% demineralized bone matrix, allo­graft bone, hydroxyapatite and b­trical­cium phosphate synthetic bone. Both BioDfence and BioDfactor are processed and packaged at a US FDA­registered tis­sue bank in accordance with current good tissue practice standards.

Joint venture: Fibrocell & Hefei MeifuFibrocell Science, Inc., PA, USA (www.fibrocellscience.com), a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, has signed an agreement to establish a joint venture with Hefei Meifu Bio­Tech Limited Co., Hefei, China, for develop­ing and marketing autologous fibroblast therapies in Asia, excluding Japan. The joint venture will be called Fibrocell Science Asia Co. Ltd. Under the terms of the agreement, Fibrocell will provide access to its intellectual property, clini­cal data and manufacturing processes. Hefei Meifu will be responsible for all costs associated with construction and operation of a manufacturing facil­ity in Hefei and commercialization, as well as all ongoing operational, research and develop ment expenses. Fibrocell Science’s lead therapy, azficel­T, is an investigational autologous cell therapy. In the Fibrocell Science patented proc­ess, a patient’s own natural fibroblasts are extracted, multiplied and re­injected as personalized therapy to regenerate skin.

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Azficel­T is currently under review by the FDA for the treatment of moderate to severe nasolabial fold wrinkles. Also, the company recently submitted a clinical study report to the FDA for a Phase II/III trial of azficel­T in acne scarring.

Licensing agreement: Audax Medical & Brown UniversityMedical device startup Audax Medical Inc., MA, USA (www.audaxmed.com) has gained exclusive rights from Brown University, RI, USA (www.brown.edu) for Arxis™, a biomaterial intended to help regenerate diseased bone and cartilage. The company has also secured a deal for clinical development support from Brown University. The Arxis biomaterial is made of organic nanomolecules and is designed to have growth agents added to it to aid in its regenerative properties. Terms of the licensing deal were not released.

Licensing agreement: NeoStem & Shijiazhuang Third HospitalNeoStem, NY, USA (www.neostem.com) announced an agreement with Shijiazhuang Third Hospital in the pro­vincial capital of Hebei Province, China, to offer orthopedic applications based on NeoStem’s licensed technology.

Marketing agreement: BioTime Asia & GenextBioTime Asia, Ltd. (www.biotimeasia.com), a subsidiary of BioTime, Inc., CA, USA (www.biotimeinc.com), announced an agreement with Shanghai Genext Medical Technology Co. Ltd., China (www.genext.com.cn) to sell ACTCellerate™ cell lines to the medi­cal and biological research communi­ties in China, Taiwan, Hong Kong and Macau. In addition to a wide array of human cell types, Genext will market cell culture media customized for each line. The marketing agreement includes provi­sions for an initial stocking inventory and annual milestones to maintain exclusiv­ity. ACTCellerate is a novel technology invented by BioTime scientists that allows the expansion of over 140 highly purified primitive human embryonic progenitor cells from hESCs or induced pluripo­tent stem cells. These cells have potential

applications in basic biological and medi­cal research, use in screening for novel pharmaceuticals and cell­based therapies.

Memorandum of understanding: Advanced Cell Technology & Roslin CellsAdvanced Cell Technology, Inc., MA, USA (www.advancedcell.com) has entered into a memorandum of understanding with Roslin Cells Ltd., Scotland, UK (www.roslincells.com), in which the two companies contemplate a definitive col­laboration agreement in the near future. They will work together to establish a bank of cGMP­grade hESC lines using Advanced Cell Technology’s proprietary ‘single­blastomere’ technique for deriv­ing hESC lines without damage to the embryo. The collaboration contemplates that the hESC lines will be created and stored using protocols that meet the regulatory standards of the European Medicines Agency (www.emea.europa.eu) as well as the FDA (www.fda.gov). Roslin Cells will be responsible for main­taining the banked hESC lines, which will be made available for both research and commercial purposes.

Strategic alliance: Cephalon & MesoblastCephalon Inc., PA, USA (www.cephalon.com) and Australia­based Mesoblast Ltd. (www.mesoblast.com) entered into a stra­tegic alliance to develop and commercial­ize adult stem cell therapeutic products for degenerative conditions of the heart and CNS. Under the terms of the deal, Cephalon will make a US$130 mil­lion upfront payment to Mesoblast and regulatory milestone payments of up to US$1.7 billion. In return, Cephalon gets exclusive worldwide rights to com­mercialize specif ic products based on Mesoblast’s proprietary adult stem cell technology platform. Conditions targeted under the partnership include congestive heart failure, acute myocardial infarc­tion, Parkinson’s disease and Alzheimer’s disease. The alliance also extends to products for augmenting hematopoi­etic stem cell transplantation in cancer patients. Cephalon will also make an equity investment of US$220 million to purchase a 19.99% stake in Mesoblast.

The price represents a 45% premium to the last 30 days’ volume­weighted aver­age price for Mesoblast shares. Cephalon has entered into a standstill agreement to limit its investment to 19.99% of Mesoblast common stock for the next 12 months.

� Launching new products & servicesHamilton ThorneHamilton Thorne Ltd., MA USA (www.hamiltonthorne.com), a leading provider of advanced laser systems for the regen­erative medicine and stem cell research markets, launched its new Stiletto™ laser system. The Stiletto laser system has broad applications for research with a variety of cells, allowing the company to enter new research markets, including develop mental and advanced cell biology. The Stiletto laser is a novel technology that can automate the manual and tedi­ous process of separating and removing unwanted cells. The Stiletto laser system has the ability to sweep aside cells from the beam of the laser without burning or cauterizing, but also has the capacity to destroy unwanted cell colonies. The Stiletto laser utilizes a novel approach to cell manipulation, for which Hamilton Thorne has applied for patent protec­tion. The Stiletto laser system combines a proprietary laser and objective, control­ler software, and an automated stage, allowing researchers to perform high­speed scoring and separation of stem cell colonies.

International Stem Cell CorporationInternational Stem Cell Corporation, CA USA (www.internationalstemcell.com) launched its line of topical skin care products by the company’s wholly owned subsidiary, Lifeline Skin Care™ (www.lifelineskincare.com). Containing extracts from human ‘parthenogenetic’ stem cells, the products were formulated by a team of International Stem Cell Corporation’s research scientists in collaboration with cosmetic formulation experts. The patent

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pending serums, which come in separate formulations for day and night time use, have been safety tested by independ­ent laboratories. The Lifeline Skin Care serums was the encapsulation of the partheno genetic stem cell extracts into nanospheres protected the proteins, and substantially enhanced the effectiveness of the serums.

PX’TherapeuticsPX’Therapeutics SA, France (www.px­therapeutics.com), formerly known as Protein’eXpert, opened an additional cGMP production facility dedicated to mammalian cell culture. The French regulatory authority (www.afssaps.fr) has authorized manufacturing operations including the production of biotechno­logy products, immunology products and extracted products from animal or human origin. This new facility will allow cell banking as well as small­scale production and release of protein batches intended for preclinical/clinical use and niche market (orphan disease, cell therapy).

ReinnervateReinnervate, UK (www.reinnervate.com), a life sciences company driving the adoption of routine 3D cell culture, launched Alvetex®, its breakthrough 3D cell culture technology. Alvetex is a unique material that provides a robust and inert scaffold for cells to grow and form complex 3D cell structures in the laboratory, mimicking the normal growth and formation of tissues in the body. Reinnervate has extensively tested and validated Alvetex with a large number of cell types, including liver, skin, cancer and stem cells, all of which have impor­tant applications in basic research into cell development, disease modelling and drug safety screening. The first Alvetex format to be launched is a 12­well plate designed as an off­the­shelf, sterile­packed, ready­to­use product, and will be available via international life science product distributors. Alvetex, seen as a white membrane at the bottom of each well, has a highly porous architecture that

is specifically tailored for 3D cell culture and is compatible with a large number of well­known cellular and molecular assay techniques. Over the next 12–18 months, the company plans to introduce Alvetex products in a range of standard multiwell plates including those suitable for high­throughput drug screening, and unique well inserts that enable long­term 3D cell culture over several weeks. Alvetex will allow researchers in academia and the pharmaceutical and related industries to construct different 3D cell culture mod­els to meet their specific research needs. Alvetex is manufactured by Reinnervate at its facility at NETPark, near Sedgefield, UK, and assembled for distribution and sale by Classic Industries Europe at its cGMP production facility.

The Automation PartnershipThe Automation Partnership, UK (www.automationpartnership.com) announced a new 12­well version of Real Architecture for 3D Tissue (RAFT)™, its innovative system for generating reproducible, 3D collagen tissue models. The simple­to­use RAFT system consists of a worksta­tion, consumables and reagents to cre­ate consistent 3D tissue models in less than 1 h. The 12­well and 24­well plate options give scientists the flexibility to produce a range of 3D tissues including multicellular models, barrier models and air–liquid interface cultures. The con­structs generated can be used for a wide range of cell­based assays or regenerative medicine applications. The RAFT pro­cess has the unique ability of encapsulat­ing viable cells in a natural 3D tissue­strength collagen environment without the use of crosslinking agents. As the cells are captured during the 1 h process, there is no requirement for extensive culture periods to allow the cells to infiltrate the 3D matrix, in some cases saving 2 weeks or more.

TransparentJapanese company Transparent Inc. (www.transparent.co.jp) has developed a more advanced medium for Cell­able (www.cell­able.com), a human hepato­cyte array kit that has the potential to reduce drug development costs and time­to­market for pharmaceutical companies.

Transparent first introduced Cell­able in the USA a year ago. The new medium enables frozen human primary hepato­cytes to maintain metabolite activity at a significantly higher level. Using the previous version of Cell­able’s medium, CYP3A enzyme activity in a platable lot of frozen human primary hepatocytes demonstrated that the ratio in cell suspen­sion dropped to 1–2% on the seventh day. However, the new medium improves the ratio to 10–40%. Uridine diphosphate­glucuronosyltransferase enzyme activity has also shown the same type of improve­ment. These factors indicate that Cell­able can create an in vivo environment. The Cell­able array enables the formation of 3D structures from human liver cells that mimic liver tissue and can sustain func­tions for 4 weeks or more. The product allows researchers to evaluate multiple liver functions using one test plate.

� AdvancementsAnchor TherapeuticsAnchor Therapeutics, MA, USA (www.anchortx.com) has identified and charac­terized a pepducin­based allosteric agonist that targets CXCR4, a chemokine G pro­tein­coupled receptor (GPCR) found on hematopoietic stem cells and other bone marrow­derived cells [2]. Pepducins are composed of a peptide coupled to a lipid tether – the amino acid sequence of the pepducin is derived from one of the intra­cellular loops of a target GPCR. This publication represents the first account of an in vivo active pepducin agonist and demonstrates the promise for pepducin technology as a novel approach to tar­get therapeutically important GPCRs. The study describes a unique approach to the development of GPCR­targeted therapeutics using Anchor’s proprietary pepducin technology. A small pepducin library was created using reverse engi­neering based on the natural sequences of the intracellular loops of CXCR4. In vitro screening resulted in the iden­tification of several pepducins with ago­nist activity. The paper details one of the most potent of these agonist compounds (ATI­2341), which induced receptor­ and G ­protein­dependent signaling in CXCR4­expressing cells and was shown to be active in vivo. When administered

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Industry Update –

� AastromAastrom Biosciences, Inc., MI, USA (www.aastrom.com), a developer of expanded autologous cellular therapies for the treatment of severe cardiovascular diseases, announced that an interim ana­lysis of all 86 patients enrolled in the com­pany’s Phase IIb RESTORE­CLI clinical trial shows that the study achieved both its primary safety end point and primary efficacy end point of time to first occur­rence of treatment failure. The findings related to time to first occurrence of treatment failure were statistically sig­nificant (p = 0.0132). Further analyses show a clinically meaningful reduc­tion of 56% in treatment failure events. The RESTORE­CLI trial is the largest fully controlled cell­therapy study ever conducted in critical limb ischemia.

This interim ana lysis includes results from all 86 patients who were randomized and enrolled in the trial, 72 of whom were eligible for treatment and have completed at least 6 months of follow­up and 62 of whom completed 12 months of follow­up. Analysis of the data for amputation­free survival, a secondary measure that the study was not powered to demonstrate, showed a clinically meaningful reduc­tion in event rates of 24%, but did not show statistical significance (p = 0.5541). Importantly, ana lysis of the data between the interim results shows similar treat­ment. Additional information about this clinical trial can also be found at www.clinicaltrials.gov (ID: NCT00468000).

� Cardio3 BioSciencesThe Belgian biotechnology company Cardio3 BioSciences (www.c3bs.com) announced positive 6­month results, including significant functional and clinical benefit, from the Phase II clinical trial of its

development program C­Cure®, designed as a novel stem cell therapy for heart failure based on breakthrough technology.

A total of 45 patients with severe heart failure of ischemic origin participated in the C­Cure multicenter Clinical Trial in Belgium, Serbia and Switzerland, and were randomized to optimal standard of care (control group; n = 24) or optimal standard of care plus C­Cure treatment (treatment group; n = 21). The primary objective of this trial was to assess the safety and feasi­bility of C­Cure, a stem cell product can­didate derived from the patient’s own bone marrow and guided to cardiac lineage cells.

Beyond meeting the safety objective as assessed by an independent safety board, the trial revealed that 6 months after receiving C­Cure, patients in the treat­ment group showed significant improve­ments in a number of measures of their heart function.

Patients receiving the trial drug C­Cure saw an 18.1% increase in left ventricu­lar ejection fraction over baseline at the 6­month follow­up point, as measured by ECG, while the mean left ventricular ejection fraction increased only by 3.6% in patients enrolled in the control group. This difference in left ventricular ejection fraction between the C­Cure treated and control patients was highly significant (p < 0.0001). The trial also generated data that suggest favorable remodeling of heart muscle and improved heart muscle perform­ance in the treatment versus control group. Signs of functional improvement were sup­ported by improved fitness, shown by a sig­nificant mean difference in the 6­min walk­ing distance test between the treatment and control groups. In terms of feasibility, the bone marrow of 70% of the attempted 30 patients was successfully processed into C­Cure. The company is targeting further

increasing this successful rate to 80% in its Phase III clinical program. Additional information about this clinical trial can also be found at www.clinicaltrials.gov (ID: NCT00810238).

� CytherisCytheris SA, headquartered in France and with a US subsidiary in Maryland (www.cytheris.com), is a clinical­stage biopharmaceutical company focused on research and development of new thera­pies for immune modulation. Cytheris announced interim results from a Phase I clinical trial of its investigational new drug (IND) candidate, recombinant human IL­7 (CYT107), in the treatment of post­transplant patients with T­cell­depleted bone marrow or peripheral blood stem cell transplants. Preliminary assessment of the immunological effects of CYT107 in eight evaluable patients demonstrated a median increase in CD4 T cells exhib­iting a naive or central memory pheno­type of 69% over baseline, and a median increase in CD8 T cells exhibiting a naive or effector memory phenotype of 94% over baseline. The study is being conducted at Memorial Sloan­Kettering Cancer Center, NY, USA (www.mskcc.org). Additional information about this clinical trial can also be found at www.clinicaltrials.gov (ID: NCT00684008). CYT107 is a criti­cal immune modulator for immune T­cell recovery and enhancement.

� CytoriAdipose tissue­derived regenerative cells obtained using the Celution® System demonstrated a statistically significant improvement in cardiac functional capacity at 18 months in Cytori’s, CA, USA (www.cytori.com) PRECISE trial for chronic myocardial ischemia. New data from

locally, the compound induced dose­dependent recruitment of neutrophils and, when administered systemically,

ATI­2341 mobilized bone marrow­derived neutrophils and hematopoietic progenitor cells into circulation.

Clinical Trials

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outcome of these treatments has led to this Phase II trial in military personnel with burn scars. The work is funded by a signifi­cant agreement from the US Department of Defense (www.defense.gov) and the clini­cal trial is scheduled to begin at Pittsburgh University Hospital, PA, USA in 2011, in partnership with the McGowan Institute for Regenerative Medicine.

In addition to the US trial, a grant from the UK Technology Strategy Board (www.innovateuk.org) has been awarded to Intercytex in collaboration with Lt COL Steve Jeffery, a consultant plastic surgeon, to develop a clinical trial application to exam­ine VAVELTA in scar patients in the UK. The intention is to begin this trial at Queen Elizabeth Hospital, UK, later in 2011.

As well as developing treatments for burn and trauma scars, Intercytex is also planning to evaluate VAVELTA in patients with a rare genetic skin disorder called dys­trophic epidermolysis bullosa. In dystrophic epi dermolysis bullosa the skin and internal body linings blister at the slightest impact, causing painful open wounds. This devas­tating and often fatal disease affects approx­imately 1000 patients in the UK alone. The clinical trial is expected to start in London at the end of the year and is funded jointly by The Technology Strategy Board and the patient charity DebRA (www.debra.org.uk).

� ReNeuronUK­based ReNeuron (www.reneuron.com) announced that, following a positive inde­pendent safety review of progress of the first patient treated in the Pilot Investigation of Stem Cells in Stroke (PISCES) clinical trial of ReNeuron’s ReN001 stem cell therapy for stroke, the clinical trial will now progress to treatment of the remainder of the first patient cohort. The PISCES study is the world’s first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients. ReNeuron is the first company to have received regulatory approval for any stem cell­based clinical trial in the UK. The first patient in the PISCES trial was treated at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board and was safely discharged 2 days after the straight­forward neurosurgical procedure used to administer the ReN001 cells. In line with

the clinical trial protocol, an independent Data Safety Monitoring Board met yester­day to review the status of the patient at 28 days post­treatment and, based on this review, has determined that the study can progress to treatment of the remainder of the first dose cohort of three patients. In this Phase I trial, ReNeuron’s ReN001 stem cell therapy is being administered to stroke patients who have been left disabled by an ischemic stroke, the most common form of the condition. The PISCES trial is designed primarily to test the safety pro­file of ReN001 in ischemic stroke patients at a range of cell doses, but a number of efficacy measures will also be evaluated over the course of the trial. Additional information about this clinical trial can also be found at www.clinicaltrials.gov (ID: NCT01151124).

� SANUWAVESANUWAVE Health, Inc. GA, USA (www.sanuwave.com), an emerging medi­cal technology company focused on the development and commercialization of noninvasive, biological response activat­ing devices in regenerative medicine, announced positive top­line results from the company’s pivotal Phase III, Investigational Device Exemption clinical trial comparing dermaPACE™ to sham control (nonac­tive treatment), when both are combined with the current standard of care for the treatment of diabetic foot ulcers. PACE, defined as pulsed acoustic cellular expres­sion, delivers high­energy acoustic pressure waves to produce compressive and tensile stresses on cells and tissue structures to promote angiogenic and positive inflam­matory responses and quickly initiate the healing cascade. This results in revasculari­zation and microcirculatory improvement, including the production of angiogenic growth factors, enhanced new blood ves­sel formation (angiogenesis), and the sub­sequent regeneration of tissue, such as skin, musculoskeletal and vascular structures. PACE treatment triggers the initiation of an accelerated inflammatory response, speeding wounds into proliferation phases of healing, and subsequently returns a chronic condition to an acute condition to help the body’s own healing response to re­initiate. The design of this 206­patient, randomized, double­blind, parallel­group,

this trial were presented at the American Heart Association Scientific Sessions 2010 in Chicago, IL, USA. The trial demonstrated the following outcomes in no­option chronic ischemic heart disease patients:

� The statistically significant improvement in maximum oxygen consumption in the cell­treated group compared with the control group, first demonstrated at 6 months, is sustained at 18 months;

� The statistically significant improvement in patients’ ability to perform physical activity, as measured by metabolic equiv­alents, in the cell treated group compared with the control group is sustained from 6 to 18 months;

� The procedure, which includes with­drawing fat tissue, separating out the regenerative cells using Cytori’s Celution System and reinjecting the cells into the patient’s heart, and was previously found to be safe and feasible, had no safety con­cerns emerge during the 18­month observation period.

Adipose tissue­derived regenerative cell­treated patients had a lower cardiac mortal­ity rate compared with the control. At an average follow­up of 28 months, two out of six placebo patients died of cardiac causes whereas one of 21 died from cardiac causes in the cell­treated group. There were two patient deaths from noncardiac causes in the cell­treated group. Based on this new information, Cytori will directly seek EU regulatory approval of this treatment for no­option chronic ischemia patients. The com­pany intends to file necessary submissions in early 2011. Additional information about this clinical trial can also be found at www.clinicaltrials.gov (ID: NCT00426868).

� IntercytexIntercytex Ltd., UK (www.intercytex.com), relaunched as a private enter­prise, announced that their lead product ICX­RHY (VAVELTA®) would be evalu­ated by the US military in the treatment of injured soldiers. VAVELTA has already been used in a small number of patients suffering from scar contractures and the

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Industry Update –

sham­controlled, multicenter (22 sites in the US and two in Europe), 26­week clini­cal trial was intended to quantify the effec­tiveness of four 20 min, noninvasive pro­cedures with dermaPACE, delivered over a 2­week period. By 12 weeks, the average percentage reduction in the size of the target ulcer in patients treated with dermaPACE was 56%, compared with only 7% in the patients randomized to receive sham. A consistently greater proportion of patients randomized to receive sham experienced

continued worsening as evidenced by an increase in the size of the ulcer from base­line, compared with patients randomized to receive dermaPACE treatment. Patients treated with dermaPACE were twice as likely to achieve 90–100% wound closure within 12 weeks of their initial dermaPACE treatment compared with patients rand­omized to receive sham. Importantly, there were no serious adverse events associated with dermaPACE treatment reported dur­ing the course of the study, and no issues

regarding the tolerability of the treatment. Of the patients who achieved complete wound closure at 12 weeks, the recurrence rate was only 4.5% in the dermaPACE group compared with 20% in the patients treated with sham. Additional information about this clinical trial can also be found at www.clinicaltrials.gov (ID: NCT00536744).

Regulations, Approvals & Acquisitions

(www.allcells.com), a provider of human primary cells and related services for the life science industry. The license enables AllCells to engage in the operation of a tis­sue bank in accordance with Division 2, Chapter 4.1 of the Health and Safety Code.

AthersysAthersys, Inc., OH, USA (www.athersys.com) announced that the FDA has authorized commencement of a Phase II clinical trial evaluating the safety and efficacy of administration of MultiStem®, Athersys’ allogeneic investigational cell therapy product, for the potential treat­ment of ulcerative colitis. This Phase II clinical trial is expected to begin enroll­ing patients before the end of 2010 and is part of a collaboration between Athersys and Pfizer that the companies formed in December 2009 to develop MultiStem for the treatment of inflammatory bowel disease. The Phase II study will be a rand­omized, double­blind, placebo­controlled, multicenter study to investigate the safety and efficacy of MultiStem in subjects with moderate­to­severe ulcerative colitis. The trial is designed to include approximately 126 patients. Patients participating in the study will receive multiple doses of either MultiStem or placebo, administered over 8 weeks. Clinical efficacy end points will be examined through week 16 with follow­up of patients for 12 months. The study will be conducted at clinical centers in

North America and Europe. Additional information about this clinical trial can also be found at www.clinicaltrials.gov (ID: NCT01240915). This is the fourth clinical study of MultiStem authorized by the FDA and the first in the autoimmune disease area.

NeuralstemFDA has approved Neuralstem’s, MD, USA (www.neuralstem.com) IND appli­cation to initiate a Phase Ia safety trial to test NSI­189, its first small molecule compound, in major depression. NSI­189 is a proprietary new chemical entity dis­covered by Neuralstem that stimulates new neuron growth in the hippo campus, an area of the brain that is believed to be involved in depression and other dis­eases, such as Alzheimer’s disease. In mice, NSI­189 stimulated neurogenesis of the hippo campus and also increased its overall volume. Additionally, NSI­189 stimulated neurogenesis of human hippocampus­derived neural stem cells in vitro. Therefore, NSI­189 may reverse the human hippocampal atrophy seen in major depression and schizophrenia. This program has received significant support from both the Defense Advanced Research Projects Agency (www.darpa.mil) and the NIH. This Phase Ia trial will test a sin­gle dose of NSI­189 in healthy patients. If the safety end points are met, the trial will commence to the Ib phase, testing the

� Green lightAdvanced Cell TechnologyAdvanced Cell Technology, Inc., MA, USA (www.advancedcell.com) announced that the FDA has cleared the company’s IND application to immediately initiate a Phase I/II multicenter clinical trial using retinal cells derived from hESCs to treat patients with Stargardt’s macular dystro­phy, one of the most common forms of juvenile macular degeneration in the world. The decision removes the clinical hold that the FDA had placed on the trial. The Phase I/II trial will be a prospective, open­label study that is designed to determine the safety and tolerability of the hESC­derived retinal pigment epithelial cells following subretinal transplantation to patients with advanced Stargardt’s macular dystrophy. A total of 12 patients will be enrolled in the study at multiple clinical sites. Earlier last year the FDA also granted orphan drug des­ignation for the company’s hESC­derived retinal pigment epithelial cells. As a result, the company is eligible to receive a number of benefits, including tax credits, access to grant funding for clinical trials such as this one, accelerated FDA approval and allow­ance for marketing exclusivity after drug approval for a period of as long as 7 years.

AllCellsThe State of California Health and Human Services Agency has granted a Tissue Bank License to AllCells, LLC, CA, USA

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California Stem CellCalifornia Stem Cell, Inc., CA, USA (www.californiastemcell.com) has filed an IND application with the FDA for approval to commence a Phase I safety study on a jointly developed stem cell­derived motor neuron transplantation therapy for spinal muscular atrophy (SMA) type I. SMA is the leading genetic cause of death of infants. It is a disorder that results from a chronic deficiency in the production of the survival of motor neuron protein, which is essential to the proper functioning of the motor neurons in the spinal cord. SMA is typically marked by the deterio­ration of the muscles that control crawl­ing, walking, swallowing and breathing. Approximately 1 in every 6000 babies born is affected. One in 40 people, or approxi­mately 7.5 million in the USA, are genetic carriers. SMA type I, the most severe form of the disease, progresses very rapidly and is often fatal in the affected infants. To date, there are no treatments for this disease.

� AcquisitionsCryo-Save & Cryo Center Bulgaria ADCryo­Save, headquartered in The Netherlands (www.cryo­save.com), paid US$2 (€1.5) million in cash and 100,000 shares, worth nearly US$660,000 (€500,000), for Tissue Bank Cryo Center Bulgaria AD, Bulgaria’s leading private stem cell bank.

Medtronic & OsteotechMoving to expand its biologics product offerings, Medtronic, Inc., headquartered in MN, USA (www.medtronic.com), has completed the acquisition of Osteotech, NJ, USA (www.osteotech.com), follow­ing payment of US$6.50 per share in cash for each share of Osteotech’s stock, with a total transaction value of approximately US$123 million. Osteotech is a leader in the growing field of biologic products for regenerative healing, and its acquisition, combined with Medtronic’s portfolio, will provide surgeons with an expansive range of bone­generating and biologic therapies.

Mesoblast & AngioblastAustralian regenerative medicine com­pany Mesoblast Limited (www.mesoblast.com), announced that the required period

for any antitrust objection under the US Hart–Scott–Rodino antitrust improve­ment Act 1976 in respect of its acquisi­tion of Angioblast Systems Inc. NY, USA (www.angioblast.com) has expired. On completion of the acquisition, the enlarged Mesoblast Group will have on issue approximately 250 million shares and at today’s share price, a market capitalization approaching US$748 (AU$750) million. Under the Hart–Scott–Rodino Act, given the size of the transaction, both entities involved in the merger, acquisition or con­solidation were required to file notifica­tions to the US antitrust authorities and to observe the statutory waiting period before going ahead with the transaction. The parties are now able to proceed with finalization of all merger conditions.

� Capital market & financesAcceleronAcceleron Pharma, Inc., MA, USA (www.acceleronpharma.com), a biopharma­ceutical company developing novel therapeutics that modulate the growth of cells and tissues including muscle, bone, fat, red blood cells and the vascu­lature, has been awarded grants for five projects under The Patient Protection and Affordable Care Act of 2010 Qualifying Therapeutic Discovery Project (QTDP) program. Included as part of the Patient Protection and Affordable Care Act of 2010, the QTDP program provided a tax credit to encourage investments in new therapies to prevent, diagnose, and treat acute and chronic diseases. Companies that cannot currently use a tax credit were allowed to apply for a cash grant in lieu of a tax credit. To be eligible for the program, the companies must not have more than 250 employees and the projects must show reasonable potential to: result in new therapies to treat areas of unmet medical need, or prevent, detect, or treat chronic or acute disease and conditions; reduce long­term healthcare costs in the USA; or significantly advance the goal of curing cancer within a 30­year period. In addition, preference was given to projects that showed the greatest potential to create and sustain (directly or indirectly) high­quality, high­paying jobs in the USA, and advance US competitiveness in the fields of life, biological and medical sciences.

safety of escalating doses of daily admin­istration for 28 days in depressed patients. The entire Phase I trial is expected to be approximately 1 year in duration.

StemCellsStemCells Inc., CA, USA (www.stemcellinc.com) was authorized by Swiss regulators to begin the world’s first trial to assess the effectiveness and safety of its human neural stem­cell product for treating chronic spinal cord injuries. Shares were up 3.4% at US$1.21 in recent premarket trading. The trial in Zurich will include 12 patients with chest level injuries and varying degrees of paralysis 3–12 months after their injuries. It is set to begin in early 2011.

� PendingAdvanced Cell TechnologyAdvanced Cell Technology, Inc., MA, USA (www.advancedcell.com) has filed an IND application with the FDA to ini­tiate a Phase I/II multicenter study using hESC­derived retinal pigment epithelial cells to treat patients with dry age­related macular degeneration. This disease report­edly afflicts more than 30 million peo­ple worldwide, including an estimated 13–15 million Americans. Approximately 10% of people aged 66–74 years will have findings of macular degeneration, and this prevalence increases to 30% in patients aged 75–85 years of age.

Advanced Cell Technology has also filed for orphan drug designation with the European Medicines Agency for its hESC­derived retinal pigment epithelial cells for use in treatment of Stargardt’s macu­lar dystrophy, also known as Stargardt’s disease. Orphan drug designation may provide Advanced Cell Technology with several advantages, including 10 years of marketing exclusivity for hESC­derived retinal pigment epithelial cells upon market authorization for the indication, financial incentives such as fee reductions or waivers, free scientific advice during the drug development process and access to a centralized review process for all 27 member states.

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Projects were selected jointly by the US Treasury Department (www.treasury.gov) and the Department of Health and Human Services (www.hhs.gov).

Advanced Cell TechnologyAdvanced Cell Technology, Inc., MA, USA (www.advancedcell.com) has received an US$977,917 grant under the QTPD pro­gram. The grant was related to four of the company’s projects: the blasto mere pro­gram, the myoblast program, the retinal pigment epithelium program for Stargardt’s disease and the iPS cell program. The grants were for US$244,479.25 each. To learn more about the QTDP program see the section on Acceleron above.

Furthermore, the company has strengthened its balance sheet through the elimination of approximately US$3 mil­lion in debt within November 2010. The conversion of senior and sub ordinated debentures to equity has reduced the company’s outstanding convertible deben­tures to approximately US$890,000. Since September 2009, Advanced Cell has eliminated approximately US$33 million in indebtedness.

AgentaAgenta Biotechnologies, Inc., AL, USA (www.agentabio.com), a private bio­technology company, has received a US$1.1 million grant from the NIH and National Institute of Dental and Craniofacial Research for the further development of a biologically activated membrane to improve soft tissue healing associated with oral surgery. This grant is funded through the Small Business Innovative Research program of the NIH and it is the second such award received by Agenta.

Angioblast SystemsAngioblast Systems, NY, USA (www.angioblast.com) has been awarded US $1.2 million in grants under the QTDP program for each of the five projects that were eligible for funding.

BioTimeBioTime, Inc. CA, USA (www.biotimeinc.com) has been awarded three grants tota­ling approximately US$733,000 under the QTDP program. To learn more about

the QTDP program see the section on Acceleron above. The grants awarded to BioTime were for the maximum amount allowed for three of the company’s pro­grams: orthopedic product development, the ACTCellerate™ platform and the company’s ReCyte™ program.

Furthermore, BioTime announced that in the last 18 months it has received cumu­lative total proceeds of US$24,174,733 from exercises of warrants that expired on 1 November, 2010. A remaining 24,976 common share purchase warrants expired unexercised. BioTime now has approxi­mately US$32 million of cash on hand on a consolidated basis. BioTime plans to use the capital raised through the warrant exercises to strengthen its working capital reserves for the expansion of its stem cell product development, including product development being undertaken at its sub­sidiaries, Embryome Sciences, Inc. (www.embryome.com), OncoCyte Corporation (w w w.oncocy te.com), OrthoCyte Corporation (www.orthocytecorp.com), BioTime Asia, Ltd. (www.biotimeasia.com) and ES Cell International Pte Ltd. (www.escellinternational.com), each focused on individual medical applications of stem cell technology.

BioTime also announced that it plans to distribute new common share purchase warrants to the holders of BioTime common shares. Under the plan, shareholders will receive one warrant for every eight shares held. Each warrant will entitle the holder to purchase one common share for US$12.00 per share. The warrants will expire 4 years after the date of issue. BioTime’s Board of Directors has not yet set a record date for determining shareholders entitled to receive the warrants. The warrants will be freely tradable, and BioTime plans to apply to list the warrants on the NYSE Amex. The potential US$72 million of proceeds from the exercise of the warrants may be used by BioTime and its subsidiaries to finance the growth and expansion of their current research and development programs, as well as in any new programs that may be instituted in the future.

BrainStormBrainStorm Cell Therapeutics Inc. (www.brainstorm­cell.com) received notice from Israel’s Office of the Chief Scientist of its

commitment to match expenditures on the company’s NurOwn™ adult stem cell therapy program with a total grant of approximately US$750,000 (NIS 2.8 mil­lion). The NurOwn technology processes adult human mesenchymal stem cells that are present in bone marrow and are capa­ble of self­renewal as well as differentiation into many other cell types. The research team is among the first to have success­fully achieved the in vitro differentiation of adult bone marrow cells (animal and human) into astrocyte­like cells capable of releasing neurotrophic factors, includ­ing glial­derived neurotrophic factor. The ability to induce differentiation into astro­cyte­like cells along with intra muscular or intrathecal (or other) delivery makes NurOwn technology highly attractive for treating neurodegenerative diseases as well as spinal cord injury.

CapricorCapricor, Inc. CA, USA (www.capricor.com) announced its most recent capital infusion of nearly US$2 million from Broadview Ventures and private individual investors. The funds will be used toward the development of US clinical trials for cardiac therapies based on Capricor’s pro­prietary mix of stem cells derived from cardiac tissue, which aim to regenerate damaged areas of the heart and improve heart function.

CardiumCardium Therapeutics, CA, USA (www.cardiumthx.com) was awarded a cash grant of approximately US$245,000 under the QTDP program to further its Generx® clinical development program. To learn more about the QTDP program see a section on Acceleron above. Generx® (alferminogene tadenovec, Ad5FGF­4) is a DNA­based angiogenic growth fac­tor therapeutic being developed for the potential treatment of patients with advanced coronary artery disease. Generx is designed to stimulate the growth of supplemental collateral blood vessels in the heart in order to enhance myocardial perfusion in patients who have insufficient

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each of the projects. To learn more about the QTDP program see the section on Acceleron above.

Geron also closed public offering of 17,391,305 shares of its common stock, as well as 2,608,695 additional shares of its common stock pursuant to the full exercise of the overallotment option granted to the underwriters. The public offering price was US$5.00 per share and the total net proceeds to Geron from the public offering are approxi­mately US$93.5 million, after deducting underwriting discounts and commissions and estimated offering expenses. Geron intends to use the net proceeds from the offering for research and development, including clinical trials for its prod­uct candidates, clinical develop ment of product candidates it has in­licensed and other general corporate purposes. Geron has sold all of the shares in the offering. J.P. Morgan Securities LLC and Lazard Capital Markets LLC were acting as joint book­running managers of the offering.

HistogenHistogen, Inc., CA, USA (www.histogen.com) successfully completed its Series A f inancing at US$10 million. Among other private investors, Secure Medical, Leonard Lavin, Lordship Ventures and Angus Mitchell brought the round to a close. This successful completion follows the announcement of initial Series A financing in May 2008. Simultaneously, Histogen opens its Series B f inanc­ing, which has been approved up to US$23 million. Angus Mitchell opened the Series B and Histogen has already received further commitments toward that round. The company is scheduled to begin a Phase I/II clinical trial of its hair­stimulating complex in Singapore in Spring 2011, and hopes to also begin a clinical study of its soluble human extracellular matrix for the treatment of carcino matosis, a rapidly progressing and debilitating cancer, mid­year.

International Stem Cell CorporationInternational Stem Cell Corporation, CA, USA (www.internationalstemcell.com) had entered into an agreement with Aspire Capital Fund, LLC, IL, USA

(www.aspirecapital.com) to provide, at the company’s sole option, up to US$25 mil­lion of equity capital over the next 3 years. As part of this transaction, Aspire pur­chased, upon execution of the agreement, 333,333 shares of International Stem Cell Corporation’s common stock at a price of US$1.50 per share, a 7% premium over the last closing price of US$1.40 per share. Pricing of future sales under the agreement will be determined each time the company elects to sell shares to Aspire by a formula that is based on the actual sale prices of the company’s stock over the 12 days preceding each sale to Aspire. Thus, the company will control the timing and amount of any sales of its common stock to Aspire, and will always know at the time it gives a notice of sale what the cost of that round of financing will be. Aspire has no right to require any sales by the company, but is obligated to make purchases as the company directs in accordance with the purchase agree­ment, and the company has the right to terminate the agreement at any time. The agreement does not restrict other financ­ings by the company. A more detailed description of the transaction agreements with Aspire is set forth in the Company’s report on Form 8­K, filed with the US Securities and Exchange Commission (www.sec.gov).

InVivoInVivo Therapeutics, MA, USA (www.invivotherapeutics.com), a company focused on the development of techno­logies for the treatment of spinal cord injuries, has been awarded US$244,000 in grant funding as part of the QTDP pro­gram. Proceeds from the grant will be used to support ongoing research and develop­ment costs associated with InVivo’s lead product candidate, a novel biocompatible polymer scaffolding device designed for implantation into a lesion to treat acute open­wound spinal cord injury. To learn more about the QTDP program see a section on Acceleron above.

InVivo Therapeutics has also success­fully closed a private placement offering of 13 million units of its securities for total gross proceeds of US$13 million. The company had announced on 27 October 2010 that it completed a placement of

blood flow due to atherosclerotic plaque build­up in the coronary arteries. Generx has progressed through four randomized, placebo­controlled clinical studies at over 100 medical centers in the USA and Western Europe that have enrolled over 650 patients.

Cytori & AstellasCytori Therapeutics, CA, USA (www.cytori.com) and Japan’s number two drugmaker Astellas Pharma Inc. (www.astellas.com) have entered into a strategic equity agreement to evaluate the potential of adipose­derived stem and regenerative cells for the treatment of serious illnesses for which there is no fundamental treat­ment. Astellas will purchase approxi­mately 1.43 million unregistered shares of Cytori common stock at US$7.00 per share for net proceeds to Cytori of US$10 million. As part of the agreement, Cytori granted Astellas the following additional rights:

� 2 year right of first refusal for a world­wide research, development and/or commercialization partnership using Cytori’s products and technologies in the treatment of liver disease;

� Nonvoting observer seat on Cytori’s board of directors;

� Participation in a newly formed scientific advisory board.

As per this agreement, Cytori and Astellas will further explore a collabora­tion for an advanced regenerative drug techno logy. The premium equity purchase will further support Cytori’s ongoing clinical and commercial activities.

GeronGeron Corporation, CA, USA (www.geron.com) has been awarded US$1.2 mil­lion in grants under the QTDP pro­gram. The maximum grant amount was awarded to each of the five Geron programs that were eligible for QTDP funding and included oncology and hESC projects. The funds will be used to continue therapeutic development of

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10.5 million units of such securities. The additional 2.5 million units sold sub­sequently enabled the company to reach the maximum overallotment for the offer­ing. Spencer Trask Ventures, Inc. served as placement agent for the financing and financial advisor to the company. Each unit sold in the private placement consists of one share of common stock of InVivo and one warrant, with each warrant enti­tling the holder to purchase one share of common stock for a 5­year period at an exercise price of US$1.40 per share. Warrants issued to investors in the private placement, if exercised or called, would yield additional total gross proceeds of US$18.2 million.

NanotopeNanotope, Inc., IL, USA (www.nanotope.com), a portfolio company of Arrowhead Research Corporation, CA, USA (www.arrowheadresearch.com), has been awarded cash grants totaling US$245,000 under the QTDP program. The QTDP grants will help fund Nanotope’s regen­erative compounds that promote healing for spinal cord and other tissues. To learn more about the QTDP program see the section on Acceleron above.

PervasisPervasis Therapeutics, Inc., MA, USA (www.pervasistx.com) has been awarded over US$920,000 in grants through the QTDP for the following four programs:

� Development of PVS­10200 for periph­eral artery disease (US$244,479.25);

� Development of Vascugel® to sustain arteriovenous access for hemodialysis (US$244,479.25);

� Development of tissue­engineered endothelial cell therapy to supplement ortho pedic procedures (US$244,479.25);

� Development of tissue­engineered endothelial cell therapy for brain and prostate cancer (US$191,420.94).

A Phase I/II study is currently under­way in France to evaluate PVS­10200, an IND under development by Pervasis to prevent restenosis in patients with peripheral arterial disease who undergo an angio plasty and stent procedure in the

superficial femoral artery. The company’s most advanced program, Vascugel, has demonstrated proof of concept and safety in two Phase II trials in patients under­going arteriovenous access procedures for hemodialysis. Earlier this year, Pervasis announced that it had reached an agree­ment with the FDA for its Phase III clinical trial of Vascugel under the FDA’s special protocol assessment procedure. Through this procedure, FDA formalized its agree­ment that the design of the Phase III trial was acceptable to support a regulatory submission seeking new drug approval.

RegenecinRegenicin, Inc. (www.regenicin.com), a biotechnology company specializing in the development of regenerative cell therapies to restore the health of dam­aged tissues and organs, changed its ticker symbol on the Over The Counter Bulletin Board (www.otcbb.com), US securities market, from ‘WDST’ to ‘RGIN.OB’ effective at the opening of the market on 10 November, 2010. Regenicin secured proceeds of US$467,550.25 and, in addi­tion, the company converted US$500,000 of debt into equity.

Regenicin is playing a critical role in the development of the therapeutic candidate PermaDerm™, a technology that uses the patient’s own skin cells to generate living, tissue­engineered skin for the treatment of severe burns. A small harvested section of the patient’s own skin can be grown to graft an area 100­times its size in as little as 30 days.

The US Department of Defense (www.defense.gov) awarded more than US$18 million in funding to a unit of Lonza Group, Ltd for the development and commercialization of PermaDerm for the treatment of severe burns among US troops and civilians. Regenicin has an agreement with Lonza pursuant to which Regenicin has been charged to obtain FDA approval for the commercial sale of PermaDerm. The funding will assist Regenicin and Lonza in advancing the clinical trials to be conducted in connection with the FDA approval process.

Regenicin, Inc. received its Central Contractor Registration (CCR) from the US Government. The registration quali­fies Regenicin to receive funding from the

Federal Government through contracts, grants, cooperative agreements and other forms of federal assistance. The CCR is the primary registrant database for the US Federal Government. A CCR is required prior to being awarded a contract with any federal government agency. The CCR also serves as a search engine for contracting officers and a link to current procurement opportunities.

RepRegenRepRegenTM Ltd, UK (www.repregen.com), the ‘smart biomaterials’ com­pany, has raised US$1.6 (£1.03) million. Existing investor Imperial Innovations (www.imperialinnovations.co.uk) led the financing, which also included Longbow Capital (www.longbow.co.uk) and other investors. Proceeds will be used to further the product development pipeline, includ­ing regulatory approvals, commercializa­tion programs and preparation for relevant postmarket clinical studies.

RepRegen is an emerging medical device company using patent­pending repair and regeneration technology in two platforms designed to mend and regrow tissue in vivo. The first platform is focused on bone and other ‘hard’ tis­sue, whereas the second platform is focused on muscle and other ‘soft’ tissue. Through the recent CE marking approval RepRegen is now commercializing the first product of its hard tissue repair and regeneration platform – StronBone™ bone graft substitute bioactive glass with strontium. StronBone is targeted for orthopedic (trauma and spine) and craniomaxillofacial applications.

StemCellsAnnouncement that StemCells Inc., CA, USA (www.stemcellsinc.com) intends to begin clinical trials in Switzerland on a treatment for chronic spinal cord injury patients increased shares by 9%. Shares of StemCells increased 9 cents to US$1.11. The stock has traded between US$0.75 and 1.58 over the last year. The company said the stem cell study will focus on HuCNS­SC’s impact on patients who have

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totaling US$488,950 under the QTDP program. To learn more about the QTDP program see a section on Acceleron above.

Financial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the sub-ject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

References1 Crook JM, Peura TT, Kravets L et al.:

The generation of six clinical­grade human embryonic stem cell lines. Cell Stem Cell 1(5), 490–494 (2007).

2 Tchernychev B, Ren Y, Sachdev P et al.: Discovery of a CXCR4 agonist pepducin that mobilizes bone marrow hematopoietic cells. Proc. Natl Acad. Sci. USA 107(51), 22255–22259 (2010).

been injured for 3–12 months and they are awaiting approval from Swissmedic (www.swissmedic.ch), the Swiss regulatory agency, to start studies.

StemCyteStemCyte, Inc., an umbilical cord blood bank from CA, USA (www.stemcyte.com), has been awarded two cash grants