biojax blog 1

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This is Google's cache of http://biojaxusa.blogspot.com/2015_03_01_archive.html . It is a snapshot of the page as it appeared on 26 Mar 2015 02:47:07 GMT. The current page could have c Tip: To quickly find your search term on this page, press Ctrl+F or F (Mac) and use the find bar. Wednesday, March 25, 2015 Feasibly A Few Weeks Away A Remarkable Treatment For Ischemic Stroke March 25, 2015 3:40 PM ET About: Athersys, Inc. (ATHX), Includes: CUR, PFE, STEM, MBLTY, OSIR, ROG.VX, CMXI, CYTX Note: This article covers a stock trading at less than $4 per share and/or with less than a $300 million market cap. Please be aware of the risks. Introduction Athersys, Inc. (NASDAQ: ATHX) is currently engaged in a phase II, double blind, placebocontrolled study to examine the safety and potential effectiveness of the adult stem cell investigational product, MultiStem, in adults who've suffered a moderate to moderately severe ischemic stroke. According to the American Heart Association, eightyseven percent of all strokes are ischemic. What Is Ischemia\Ischemic The healthy brain requires a constant delivery of oxygen and nutrient rich blood to each one of its approximately 100 billion neurons. Accomplishing this, and thus ensuring normal brain function, blood travels across multiple blood vessels to every part of the brain. Some blood vessels, however, become blocked with blood clots or\and cholesterol plaque, leaving discrete brain areas transiently disconnected from their blood supply. The resulting lack of oxygen and nutrients in these areas is known as ischemia. Neurons in ischemic areas starve rapidly and rapidly stop functioning. Ischemic strokes are caused by a blood clot in an artery in the brain. Treatment options currently available for this type of stroke are timesensitive, which makes recognition of stroke symptoms and rapid access to medical care critical. Currently tissue Plasminogen Activator (tPA) is the standard of care for stroke and it being a time sensitive treatment makes rapid access to medical care critical. Unfortunately in the real world patients often arrive at medical facilities after the option for tPA use has expired. This is often the case even when a patient has rapid access to medical facilities. It's estimated that less than 5 percent of IS victims currently receive treatment with tPA. See: Ischemic stroke statistics One European clinical trial argues a patient may still benefit from tPA up to 4 1/2 hours after a stroke. Even if this is true, the window to treat stroke with tPA is very narrow. See: Stroke Treatment window Widens MultiStem could help stroke victims by offering a wider treatment window. The aim is to help prevent large scale damage to the brain after a stroke and to facilitate healing and the prevention of long term damage. The focus is not on clot removal as is the case with tPA. The consequences without treatment are disabilities that will vary depending on stroke location and severity. Patients will often suffer physical disabilities such as partial loss of motricity or hemiplegia, sensory loss, language disorders, aphasia, visual disorders, and even memory loss. Level of recovery will vary from patient to patient. Starting a rapid rehabilitation program is key to recovery. Results from Animal Models Allogeneic stem cells, the type used in MultiStem have been used to aid in ischemic stroke recovery in animal (rat) models. The findings from the research by the University of Texas Health Science Center at Houston were especially interesting in that all the treated rats showed great recovery, achieving nearnormal results following treatment. In this model the stem cells were injected thirty minutes after an induced ischemic stroke. The same study also used a control group that was injected with saline solution. According to the study, results were astounding. Only one day after the stem cell treatment all rats showed some functional improvement. Two weeks later, the treated rats had almost recovered back to their prestroke state. What is intriguing is that the improvement happened despite the fact that the transplanted stem cells didn't seem to migrate to the damaged brain. No changes were noticed in the control group, strongly indicating that the recovery in the other group was the result of the stem cell treatment. Additional animal studies have shown improvements in brain function, and healing of stroke victims through mechanisms involving the spleen. Below are illustrations showing the effect of the transplantation of human multipotent adult progenitor cells (hMAPCs) vs. human mesenchymal cells (hMSCs). Biojax Microcap Why Invest i RNAi techn investment The BIZ focus For example; focus. This st investor to ge thus reap grea over the map proper due dil With any infor use their own and not this b investment ch Articles on th posted on oth They are just Dissenting op on this blog c blog allows di try and give a comments or force deeper d Here at the B Shorting runs this is an inve dilutive to the unethical if fo About the B The Biotech Investor Villia Silicon Inves Investors hu Biotech For Bioscience T The Life Scie Maxim Grou NIH Nation ScienceBas MDExpress Adam Feuer Helpful link 0 Mehr Nächster Blog»

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  • 4/8/2015 TheBiojaxInvestingZone:March2015

    http://webcache.googleusercontent.com/search?q=cache:gWB0KdfQPPMJ:biojaxusa.blogspot.com/2015_03_01_archive.html+&cd=1&hl=en&ct=clnk&gl=ch 1/5

    ThisisGoogle'scacheofhttp://biojaxusa.blogspot.com/2015_03_01_archive.html.Itisasnapshotofthepageasitappearedon26Mar201502:47:07GMT.Thecurrentpagecouldhavechangedinthemeantime.Tip:Toquicklyfindyoursearchtermonthispage,pressCtrl+ForF(Mac)andusethefindbar.

    Wednesday,March25,2015

    FeasiblyAFewWeeksAwayARemarkableTreatmentForIschemicStroke

    March25,20153:40PMETAbout:Athersys,Inc.(ATHX),Includes:CUR,PFE,STEM,MBLTY,OSIR,ROG.VX,CMXI,CYTX

    Note:Thisarticlecoversastocktradingatlessthan$4pershareand/orwithlessthana$300millionmarketcap.Pleasebeawareoftherisks.

    Introduction

    Athersys,Inc.(NASDAQ:ATHX)iscurrentlyengagedinaphaseII,doubleblind,placebocontrolledstudytoexaminethesafetyandpotentialeffectivenessoftheadultstemcellinvestigationalproduct,MultiStem,inadultswho'vesufferedamoderatetomoderatelysevereischemicstroke.AccordingtotheAmericanHeartAssociation,eightysevenpercentofallstrokesareischemic.

    WhatIsIschemia\Ischemic

    Thehealthybrainrequiresaconstantdeliveryofoxygenandnutrientrichbloodtoeachoneofitsapproximately100billionneurons.Accomplishingthis,andthusensuringnormalbrainfunction,bloodtravelsacrossmultiplebloodvesselstoeverypartofthebrain.Somebloodvessels,however,becomeblockedwithbloodclotsor\andcholesterolplaque,leavingdiscretebrainareastransientlydisconnectedfromtheirbloodsupply.Theresultinglackofoxygenandnutrientsintheseareasisknownasischemia.Neuronsinischemicareasstarverapidlyandrapidlystopfunctioning.

    Ischemicstrokesarecausedbyabloodclotinanarteryinthebrain.Treatmentoptionscurrentlyavailableforthistypeofstrokearetimesensitive,whichmakesrecognitionofstrokesymptomsandrapidaccesstomedicalcarecritical.

    CurrentlytissuePlasminogenActivator(tPA)isthestandardofcareforstrokeanditbeingatimesensitivetreatmentmakesrapidaccesstomedicalcarecritical.UnfortunatelyintherealworldpatientsoftenarriveatmedicalfacilitiesaftertheoptionfortPAusehasexpired.Thisisoftenthecaseevenwhenapatienthasrapidaccesstomedicalfacilities.It'sestimatedthatlessthan5percentofISvictimscurrentlyreceivetreatmentwithtPA.See:Ischemicstrokestatistics

    OneEuropeanclinicaltrialarguesapatientmaystillbenefitfromtPAupto41/2hoursafterastroke.Evenifthisistrue,thewindowtotreatstrokewithtPAisverynarrow.See:StrokeTreatmentwindowWidens

    MultiStemcouldhelpstrokevictimsbyofferingawidertreatmentwindow.Theaimistohelppreventlargescaledamagetothebrainafterastrokeandtofacilitatehealingandthepreventionoflongtermdamage.ThefocusisnotonclotremovalasisthecasewithtPA.

    Theconsequenceswithouttreatmentaredisabilitiesthatwillvarydependingonstrokelocationandseverity.Patientswilloftensufferphysicaldisabilitiessuchaspartiallossofmotricityorhemiplegia,sensoryloss,languagedisorders,aphasia,visualdisorders,andevenmemoryloss.Levelofrecoverywillvaryfrompatienttopatient.Startingarapidrehabilitationprogramiskeytorecovery.

    ResultsfromAnimalModels

    Allogeneicstemcells,thetypeusedinMultiStemhavebeenusedtoaidinischemicstrokerecoveryinanimal(rat)models.ThefindingsfromtheresearchbytheUniversityofTexasHealthScienceCenteratHoustonwereespeciallyinterestinginthatallthetreatedratsshowedgreatrecovery,achievingnearnormalresultsfollowingtreatment.Inthismodelthestemcellswereinjectedthirtyminutesafteraninducedischemicstroke.Thesamestudyalsousedacontrolgroupthatwasinjectedwithsalinesolution.Accordingtothestudy,resultswereastounding.Onlyonedayafterthestemcelltreatmentallratsshowedsomefunctionalimprovement.Twoweekslater,thetreatedratshadalmostrecoveredbacktotheirprestrokestate.Whatisintriguingisthattheimprovementhappeneddespitethefactthatthetransplantedstemcellsdidn'tseemtomigratetothedamagedbrain.

    Nochangeswerenoticedinthecontrolgroup,stronglyindicatingthattherecoveryintheothergroupwastheresultofthestemcelltreatment.Additionalanimalstudieshaveshownimprovementsinbrainfunction,andhealingofstrokevictimsthroughmechanismsinvolvingthespleen.

    Belowareillustrationsshowingtheeffectofthetransplantationofhumanmultipotentadultprogenitorcells(hMAPCs)vs.humanmesenchymalcells(hMSCs).

    BiojaxMicrocap

    WhyInvestinArrwheadResearch

    RNAitechnologyisstillanaffordableinvestment

    TheBIZfocusesononesingleinvestmentatatime.ForexampleAthersysisthecurrentinvestmentfocus.Thisstrategygivesthetimerequiredforaninvestortogettoknow\learntheinvestmentandthusreapgreaterreturns.Chasingmomentumalloverthemapisbelievedtoruncountertotheuseofproperduediligence.

    Withanyinformationsourceinvestorsareadvisedtousetheirownduediligence.Theindividualinvestorandnotthisblogisresponsibleforhis/herinvestmentchoice.

    Articlesonthisblogaren'tdifferentthanopinionpostedonotherinternetvenuesormessageboards.Theyarejustthatopinion.

    Dissentingopinioninregardstostocksmentionedonthisblogcanmakeyourinvestmentrisky.Thisblogallowsdissentingcommentstoarticlesandwilltryandgiveanaccurateresponsetodissentingcommentsorquestions.Dissentingopinionscanforcedeeperduediligencepractice.

    HereattheBIZthereisnoloveforshorting.Shortingrunscountertoinvestinginabusinessandthisisaninvestingblog.Shortingbynatureisdilutivetothesharecountofanystockandunethicaliffornootherreasonthanthat.

    AbouttheBiotechInvestingZone(BIZ)

    TheBiotechInvestor

    InvestorVilliage

    SiliconInvestor

    Investorshub

    BiotechForums(otherthanYahoo)

    BioscienceTechnology

    TheLifeSciencesReport

    MaximGroup

    NIHNationalInstitutesofHealth

    ScienceBasedMedicine

    MDExpress

    AdamFeuerstein'sBiotechBlog

    Helpfullinks

    0 Mehr NchsterBlog

  • 4/8/2015 TheBiojaxInvestingZone:March2015

    http://webcache.googleusercontent.com/search?q=cache:gWB0KdfQPPMJ:biojaxusa.blogspot.com/2015_03_01_archive.html+&cd=1&hl=en&ct=clnk&gl=ch 2/5

    TheillustrationsshowtheclinicalsuperiorityofthehMAPCsusedinMultiStemovertheMesoblastLimited(MBLTY)hMSCs.ThecurrentMultiStemischemicstrokephaseIItrialusesanIVinfusionasthemethodofdeliveryvs.transplantation,thisisconsideredavastimprovement.

    TransplantationofhMAPCsandhMSCsisassociatedwithareducedlossofbraintissue,suggestinganeuroprotectiveeffect.*IntheimagePBS=phosphatebufferedsaline

    Below:GlialscarinhibitoryeffectafterhMSCsandhMAPCstransplantation.

    Source:TherapeuticeffectsofhMAPCandhMSCtransplantation

    Alsosee:MAPCvsMSC

    ArealisticneedtodevelopMultiStemforstrokeexists

    StatisticsfromtheU.S.CentersforDiseaseControlandPreventionindicatethatstrokeisaleadingcauseofseriousdisabilityandthethirdleadingcauseofmortalityintheU.S.andglobally.Annually,thereareapproximately795,000strokevictimsintheU.S.and15millionglobally(87%ischemicstrokes).Withanincreasinglyobeseandagingpopulation,theclinicalneedandcommercialopportunityisexpectedtoincreasedramaticallyinyearsahead.

    Recentprogresstowardthedevelopmentofsaferandmoreeffectivetreatmentsforischemicstrokehasbeendisappointing.Despitethefactthatstrokeisaleadingcauseofseriousdisabilityandthirdleadingcauseofdeath,therehasbeenlittleprogresstowardthedevelopmentoftreatmentsthatimprovetheprognosisforstrokevictims.TheonlyFDAapproveddrugcurrentlyavailableforischemicstrokeistheanticlottingfactor,tPAmentionedabove,whichmustbeadministeredtothepatientwithinthreetofourhoursoftheonsetofthestrokealsomentionedabove.AdministrationoftPAbeyondthistimeframeisnotrecommended,sinceitcancausebleedinginthebrainorevendeath.

    AthersysCEOGilVanBokkelenhashadsomepositivecommentsaheadoftheIStrialdatareleasevswhathewassayingaheadoftheulcerativecolitis(UC)trail.ForthosethatrecallpriortotheUCdatareleaseGillikedtomentionMultiStemwouldnotbeeffectiveineachtreatmentareabeingtested.Moreover,GilwouldononevideooccasionjumpoffthetopicoftheUCtrialaltogetherandstarttalkingabouttheIStrailinstead.ThiswasbeforetheUCdatawasevenreleased.GilseemstotakemoreprideinwhathemayviewasacomingsuccessstoryinthecaseoftheIStrail(alogicalassumption).TheseareGil'srecentcommentsstemmingfromtheFebruary10,2015BIOCEOConferenceatthe21minutemark"Weareveryoptimisticaboutthisstudy"(ischemicstroke)."Wethinkit'sgoingtobesuccessfulforalotofreasons...weexpectthatwithinthenextcouplemonthswearegoingtohavethe(ischemicstroke)datasubstantiatethat".Gil'snotbeenknownfor"upselling"AthersysafterheseemstohavetakenittoheartwhathappenedtothecompaniespubliclytradedstockaftertheUCdatawasreleased.SomeinvestorslikelybelievethesenewpositivecommentsweremadeafterGilsawinitialblindedandrawdataanalysisinregardstotheIStrialfromatleastasiteortwothathelpedconductthetrial.Isthisthecase?Nobodyknowsforsure,however,it'sarguablyafairassumptionandonethatmaybesharedbyacompanyinJapanandmaybethereasonthisrecentnewstookplace:AthersysLandsJapanPartnerforStrokeTherapy.

    MultiStemhasthepotentialtoaddressthelackofavailabletreatments.Further,MultiStemmaybecomeabestinclasscelltherapy.ThisisbasedonthehMAPCsabilitytodelivertherapeuticbenefitthroughmultiplemechanismsofaction,itsabilitytobedelivered"offtheshelf"likeapharmaceuticalproductanditsconsistentsafetyprofile.MultiStemappearscapableofdeliveringatherapeuticbenefitinmultipleways,suchasthroughtheproductionoffactorsthat:

    ProtectdamagedorinjuredneuronsReduceinflammationcommoninischemicinjuryPromotenewbloodvesselformationAugmenttissuerepairandhealing

    OneadvantageMultiStemhasoveradultstemcellsharvestedfromthepatientlikethoseusedbyCytoriTherapeutics,Inc.(NASDAQ:CYTX)isthatstrokevictimsareoftenolderandmayhavelessviablestemcells.InthecaseofAthersys,theyuseyounghealthydonors.

    BioMedReports

    ScienceDaily

    ForTheStemCellInvestor

    Whoownssharesinthecompany

    2015(2)March

    FeasiblyAFewWeeksAwayARemarkableTreatment...

    January

    BlogArchive

    AthersysStockTwits

    NON_FICTION_1

    $ATHX80/20factors2Rochepartnership,4yearsofDD.Don'tlikethatnorealinsiderbuysinover1.5years,thataccountsfor20%

    stealin_your_thunder

    $ATHXbottomline,Ibelieveinstemcellsandwantthistechnology.PeoplepumpTWTR,FB,AMZN,TSLA!MultiStemcouldsaveyourlovedPoweredby

    NameAthersysOsirisTherapeuticsAlnylamPharmaceuticalsCurisIncVerastemInc

    Copyright2015,Barchart.comInc.

    Barchart.com

    Biotechpage

    WallStreet.com

    EuropeanStemCellNews

    Drugdiscoverynews&events

  • 4/8/2015 TheBiojaxInvestingZone:March2015

    http://webcache.googleusercontent.com/search?q=cache:gWB0KdfQPPMJ:biojaxusa.blogspot.com/2015_03_01_archive.html+&cd=1&hl=en&ct=clnk&gl=ch 3/5

    InthecurrentphaseIItrialanindependentsafetycommitteerevieweddatafrompatientsreceivingMultiStemwithinapproximately1to2daysaftertheyhadexperiencedanischemicstroke.Theyfoundthatbothofthedosesevaluatedweresafeandwelltolerated,andtherefore,recommendedproceedingwithhighdoseadministrationtopatientsfortheremainderofthetrial.ThestudyiscurrentlywrappingupatmultiplecentersthroughouttheUnitedStates.TherearesignsthistrialwentverywelldependingonhowinvestorsviewthebelowvideowithThomasDelvin,MDtheDirectorofErlanger'sSoutheastRegionalStrokeCentertalkingaboutMultiStem.

    StemCellTreatmentatErlangerfromChattanoogaTimesFreePress PRO

    02:39

    It'sadoubleblindstudysoonecan'tbesuretilltheresultsarein,however,investorscandrawtheirownconclusion.Athersyshasinvolved140patientsinthisphaseIIMultiStemstudy.Reallylistentowhat'sbeingsaidinthevideoit'sastrongindicationofjusthowadvancedAthersysreallyisintheraceforanewISstroketherapy.

    Athersys'sPhaseIIstudyisevaluatingtheeffectivenessofMultiStembeingadministered2436hoursfollowingthestroke.Clearly,thiswouldbeasignificantdevelopmentbecausebythetimemanystrokevictimsevengettothehospitalandareproperlydiagnosed,thetimeframeforusingthecurrentlyavailabletreatmentmayhaveelapsed.

    FinancialOutlook

    IschemicstrokeisabigopportunityforAthersysasitrepresentsamajorunmetneedandincludesanannualmarketopportunityofmorethan$15Billion.Further,Athersysmayhaveapotentialstroketherapymonopolyhere.Thisissomethinginvestorsshouldconsiderfactoringin.

    AthersysenjoysaleadinthedevelopmentraceforanischemicstroketreatmentovercompaniessuchasStemCells,Inc.(NASDAQ:STEM)whichisinpreclinicaltrialsforthesameindication.Inthesetrials,StemCellsInc.hasconductedpreliminarystudiesincollaborationwithprofessorsofneurosurgeryattheStanfordUniversitySchoolofMedicine,successfullydemonstratingthatitshumanneuralstemcellsenhancefunctionalrecoveryafterstrokeinrats.ThisiscertainlyanimportantstepforStemCellsandapotentialvaluedriverforthecompany.

    StemCells'marketcapwasalmostexactlythesameasAthersysforawhile,yet,Athersyshasamuchmoreintriguingpipelineaswellasamuchmoreadvancedstrokecandidate.Inaddition,Athersyshasanupcomingcatalystoutsideofstrokeinanorgan(liver)transplanttrialbeingconductedinGermanythatcouldrallythestock.AthersyshasbuiltrelationshipswithsomeverybrightscientistssuchasMarcH.Dahlke,M.D.,Ph.D.

    StemCellsinvestorsmightarguethatStemCellsisanundervalued(especiallyattoday'sstockprice),promising,speculativeinvestmentjustlikeAthersys,however,Athersysoffersbettervaluewhenduediligenceisusedinthedecisionmaking.Somedaythatmaynotbethecase,but,todayStemCellsneedstoadvancefurtheralonginclinicaltrialsbeforethatcasecanbemade.

    Themarketcapofthetwocompanieswasaboutthesameforawhile,however,theAthersyssharepricehasrecentlystartedtoclimbheadingtowardstheupcomingischemicstroketrialdatarelease,atrialthatinvolvedalotofplanningandspecialequipmenttohandlefrozenstemcells.Evenwiththatsaid,StemCellshasahistoryofburningmoreperquarterwitha$5millionversusa$4.55millionburnrateforAthersysandStemCellsshareshavebeenindecline.

    StemCellsfacessomestiffcompetitionfromNeuralstem,Inc.(NYSEMKT:CUR)downtheroadsoifyoulikehumanneuralstemcellstakethetimetoresearchbothcompanies.NeitherStemCellsorNeuralstemareseriouscompetitionforAthersysatthistime.OntheflipsideNeuralstemisseriouscompetitionforStemCellsandniceversa.Neuralstemthebetterinvestmentofthetwocurrently.

    Inapastinterview,AthersysCEOGilVanBokkelenwouldnotgiveanexactcostfortheMultiStemtreatmentifitmakesittocommercialization,butsaidthatevenifitcostasmuchas$50,000perpatient,itwouldstillsaveanenormousamountofmoneyindirectandindirecthealthcarecosts.

    "ThecostofstroketreatmentintheU.S.isenormous,"hesaid."It'sinthetensofbillionsofdollarseveryyear,andthatnumberisexpectedtorisedramaticallyoverthenextfewyearswithanagingpopulationwheremoreandmorepeoplearesusceptibletostrokeandheartdisease.

    "It'sahugemarketopportunityandit'salsoanareawhereit'skindofthequintessentialunmetmedicalneedwheremostpatientsgettheequivalentofmedicalhandholding.That'sjustnotsatisfactory."

    IftheabovecommentsbyMr.Bokkelendon'texciteinvestorsmaybethesecommentsbelowandthathemaderecentlywill.KeepinmindMr.Bokkelenisn'tknownforhypingthecompanyratherhe'sknownforbeingpragmatic.Tobehonestthoughhe'sagoodspeakerandassuchagoodsalesman.

    "Thestroketrialcouldbeagamechanger,inalotofways.Unlessyou'vehadafamilymemberorlovedonethathassufferedaseriousstroke,it'sdifficulttounderstandjusthowbiganareaofneeditis.Thereareroughly2millionpeopleayearthatsufferastrokeintheU.S.,EuropeandJapan,andveryfewpatientsactuallygettreatedwithrtPA,theclotdissolvingagentthathastobeadministeredwithin34hoursafterthestroke.Thattimeframeisjusttootight,andmostpatientsdon'tgettothedoctorintime.WeandourcollaboratorshavepublishedworkfrompreclinicalstudiesthatsuggeststhatwecangiveMultiSteminamorepracticaltimeframefollowingastroke,perhapsseveraldays.Ifithelpspatientsrecover,itcouldchangestrokeclinicalcare,andit'salsoanenormouscommercialopportunitywhichissomethingthatgetsourshareholdersveryexcited."

    NewlegislationforregenerativemedicineinJapan\recentpartnering

    RecentlyreformsinJapanesepharmaceuticallegislationdesignedtoacceleratethedevelopmentandcommercializationofregenerativemedicineshascausedsomeexcitementforthoseinvestedinthisfield.Athersys'sfreshpartnershipwithChugaiPharmaceuticalswillenableAthersystopursuethissignificant

  • 4/8/2015 TheBiojaxInvestingZone:March2015

    http://webcache.googleusercontent.com/search?q=cache:gWB0KdfQPPMJ:biojaxusa.blogspot.com/2015_03_01_archive.html+&cd=1&hl=en&ct=clnk&gl=ch 4/5

    opportunityforMultiSteminJapan,andinvestorsshouldanticipatefurtherdevelopmentsonthecommercialfrontin2015.

    AthersyshasbeenlookingtotakeadvantageofrecentlegislationinJapanthat'sfavorabletostemcelltherapyreachingpatientsinanexpeditedfashion.ThepartnershipwithChugaicertainlyshouldbeabletohelpAthersysinthatendeavor.ThemajorityownershipofChugaiisheldbyRocheGroup(ROG.VX)makingthisaveryheavyhittingdealforAthersys.Rochehasamarketcapofover$221billionandAthersyshasapromisingpipelinetheycouldeasilybecomeinterestedin.ForChugaitopartnerwithAthersysinJapanlikelymeansRochegavethegreenlight.IncomparisonPfizerhasamarketcapof$208billion.

    ThereisareasonEdisonEquityResearchjustraisedtheAthersyspricetargetto$3.75aheadofthedatabeingreleased.Fordetailssee:Edison.

    InvestorsshouldlookintohowEdisoncalculatedit'spricetarget.They'vegivenoddsthatcanbecalculatedouttobeabout$15.40pershareafterdataisreleased.Atleastthat'sthewayitlookswhenyoupluginthelogic\oddsusedindeterminingthelowerpricetargetpriortodatabeingreleased.The$15.40projectedtarget(aftergooddatarelease)isanestimatethatwascalculatedbeforetheraisedpredatapricetargetwasreleasedon3/11/2015meaningthepricetargetcouldnowbehigherafterdataisreleased.

    AthersysInc,recentlyraised$10millionfromthepartnershipdealwithChungai.Theproceedsfromtheofferingwilllikelybeusedtosupporttheongoingandproposedprograms(inJapan)forMultiStem.Athersysstockrecentlytradedupto$3.43edgingclosertowhereittradedonJanuary9th,2014.ThehighpershareonJanuary9th2014was$4.33sothestockisstilldiscountedinsomeinvestorseyes.

    Resultsfromtheischemicstroketrialwillbeasignificanteventthatwillnodoubtreratethestock.ThelackofashareofferinginthefaceofthisrecentsharepriceclimbseemstosuggestthatAthersysmanagementissecureinthecompaniesfuture.ArecentSeekingAlphaarticlesuggestedtheAthersyssharepriceshouldsoar400%fromaboutthe~$3.00markorthatAthersyssharescouldsinktoaboutthe$1area.ThedirectionofthesharepricewillbesubjecttothecomingdatareleasefromtheIStrial.Thatsamearticlemadewhatlookstobean"offthewallcomment"aboutthepotentialforAthersystobecomeagoingconcernifthedataweretofargonetothenoefficacyside.ThatseemsabitextremeconsideringthedepthoftheAthersyspipelinethatincludestechnologiesalreadyinusesuchasMap3technologyandotherprogramsoutsideofMultiStemsuchasthesmallmoleculeprogramortheantiobesitydrugcandidate.TherealfactorthatwasleftoutoftheSeekingAlphaarticlewastheearliermentionedlivertransplanttrialthat'songoinginGermany.Athersysstillhasmorethanoneshotongoalandinvestorswouldbewisetakenote.

    Onamorepositivenote:MultiStemmaygostraightintocommercializationforhumanuseinJapan,ifthecurrentischemicstroketrialconfirmssafetyandefficacytosomedegree.That'sexcitingbecauseJapanistheworld'ssecondlargestmaturehealthcaremarketbehindonlytheUnitedStates.

    TherecentbillinJapanallowstheJapaneseGovernmenttogiveconditionalapprovaltoproductssuchasMultiStemiftheirsafetyisconfirmedinclinicaltrials,asmayoccuroncompletionofPhase2.Thisshouldsubstantiallyreducethetimeandcostofdevelopingstemcelltherapies,withaslittleasoneclinicalstudyrequiredtodemonstratesafetyandmeaningfultherapeuticbenefit,inordertogainprovisionalapprovalandreimbursementinJapan.(Ifthat'sneededatallaheadofusewhilethetrialgoesoninJapan)

    Risks

    MultiStemhadapoorshowingintheulcerativecolitistrial.Thataloneshouldhaveinvestorssiftingthrough,reading,listening,andwatchingforscientificfactstocomparetheIBDtrialtotheIStrial.IfbeingfairtothemselvesandtoAthersysinvestorswillquicklyacknowledgeaonedosecuresallmentalityforahardtotreatgrouplikethosepatientsintheIBDtrialwassetupforfailure,notcompletefailure,learningstilloccurred.Investorsshouldalsonoteitwasn'tAthersyswhoranthetrialitwasPfizer.MakenomistakeAthersysandit'sMultiStemmaystillhaveaplaceintreatingIBD.ThisisahighlyplausibleargumenttomakegivenMesoblastdecidedtocarryonwiththeOsirisTherapeutics,Inc.(OSIR)phaseIIItrialforCrohn'sDisease,also,aformofIBD.Mesoblastusesacellthat'sverysimilartothatusedinAthersys'sMultiStemsoit'sfeasibleAthersysforgesaheadespeciallyonagoodshowingfromMesoblastanditsphaseIIItrialforcrohn'sdisease.

    JasonKolbertManagementDirectoratMaximGroupjustsaidthefollowingwhenactingasamoderatorandinterviewingtheCEOofTXCell,acompanythathasmadeprogressintheareaofcrohn'sdisease."HebelievesMultiStemworksforUC,but,thedosingwasnotdoneright".See:Thelivewebcast

    Whilescientistspointtothevalueofanimalmodels,theyalsoacknowledgethatnoanimalmodelfullyrecapitulateshumanneurologicaldisease.

    Animalstudiesthatproducepromisingresultsfordrugsfrequentlyfailinclinicaltrials.Whilethedifferencesbetweenhumanandnonhumanspeciesmayaccountforsomeofthefailures,anewreportbytheInstituteofMedicine(IOM)callsattentiontofaultyexperimentaldesigns,questionablestatisticalanalysis,andthetendencyofjournalstopreferpublishingpositiveresults.InthecaseofAthersys,whilethisisaconcerntheyhavetodatebeenpronetogivingmorethoughttotrialdesignthanmanyothersmallbiotechcompanies.Alsomoreandmorehumanclueshavebecomeavailableforthosewholookthatthistrialwillsucceed.

    CostantinoIadecola,MD,professorofneurologyandneuroscienceatWeillCornellMedicalCollege,notedthatthepathobiologyofstrokecanbereproducedeffectivelyinanimalmodels,althoughthemechanismbywhichtheocclusiondevelopsinhumansmaynotbemimickedexactly.Effortsarebeingmadetomorecloselyalignanimalmodelswithhumanstroke,hesaid.Forexample,treatmentsareincreasinglyadministeredtohypertensive,diabetic,andagedanimalsinanefforttoaccountforstrokeriskfactors.Butunfortunatelymanypharmaceuticalcompanieshaveabandonedthesearchforstroketreatmentsduetothefailureofclinicaltrialstoproduceeffectiveresults.

    TheaboveshouldbodewellforAthersys.Asitspeaksoflimitedcompetitionaswellasanimalmodelsbeingeffectiveforthisapplication.

    WhenitcomestoearlyscientificevidencesuggestinganoutcomeinregardstotheAthersyshumanIStrialinvestorscanfindit.Takealookhere:Stemcellsshowpromiseforstrokeinpilotstudy.It'sthefirstUnitedKingdomstudyofstemcelltreatmentforacutestroketobepublishedandthefirsttrialofitskindinhumans.Here'sanotherpotentiallookintothefuture:InternationalStrokeConferenceOralAbstracts.Additionally,ifinvestorslookbackinthisarticleatthevideocontainingaqualifiedexpertinregardstohowAthersysisdoingfromThomasDelvin,MDtheDirectorofErlanger'sSoutheastRegionalStrokeCentertheyshouldbeexcited!

    Usuallycompetitionisariskfordevelopingbiotechcompanies,however,Cytomedix,Inc.(CMXI)wastheonlyrealcompetitortoAthersysforanischemicstroketreatment.Cytomedix'scoretechnologyusedasingleintracartoidinfusiontotreatischemicstrokebut,theyhavestopfundingfortheirischemicstroketherapyafterlastyear.OnehastobelievethedeliveryrouteCytomedixusedwasalargepartofthefundingstoppage.IntracartoidinfusionisfarlessattractivethanAthersys'sintravenousinfusionandfindingvolunteersmusthavebeentoughincomparison.Cytomedix'streatmenttherapyisalsoadministeredroughlytwoweeksafterexperiencingastroke.Cytomedix'stherapyisclearlynotasconvenientandwholikestowaitfortreatmentletalonegobackfortreatmentthat'suncomfortableandunproven?

    AthersysandCytomedixhadbothbeenassessedbyanalystsasbeingthetwomaincompanieswithapotentialblockbusterstroketreatmentonhand.TodayonlyAthersysisstanding.

    Conclusion

  • 4/8/2015 TheBiojaxInvestingZone:March2015

    http://webcache.googleusercontent.com/search?q=cache:gWB0KdfQPPMJ:biojaxusa.blogspot.com/2015_03_01_archive.html+&cd=1&hl=en&ct=clnk&gl=ch 5/5

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    [email protected]:37PM 2comments:

    TheAthersyspipelinecontinuestogrowandmature,andinvestorsarebeginningtorecognizeandappreciatethepotentialvalueoftheportfolio.IfAthersysstaysfocusedandachieveswhattheyarecapableof,investorsshouldbeconfidentthatonedaysoonAthersyswillberecognizedasagloballeaderintheindustry.

    Disclosure:IamlongATHX.Iwrotethisarticlemyself,anditexpressesmyownopinions.Iamnotreceivingcompensationforit.Ihavenobusinessrelationshipwithanycompanywhosestockismentionedinthisarticle.

    Additionaldisclosure:Scienceisstillevolvingregardingstemcellsandmanyscientificpointsaredebatedincludingsomecontainedinthisarticle.TothebestofmyknowledgeIputforthaccurateinformation

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