WHAT IS AUTISM? · There is no single cause of autism and it is suggested that there are many...

Ahiddendisabilitythatbeginsinchildhoodandcanpersistintoadolescenceandadulthood1,2.Symptomsrangefrommildtosevereandcanresultinsomepeoplehavingseveredisabilitiesandrequirelife-longcareandsupport1,3.Studieshaveshownthat1in160childrenhaveautism1,sohowcanitbetreated?WHATISAUTISM?

Autism spectrum disorder (autism) is a complexdevelopmentaldisorderthataffectsthebrain’snormaldevelopment4.Peoplewithautismoftenhavedifficultyunderstanding others – with the most commonbehaviours being: trouble interacting andcommunicating with others, narrow interests andrepetitivebehaviour4,5.

Causes&SignsThereisnosinglecauseofautismanditissuggestedthattherearemanyfactorsthatincreaseachild’slikelihoodofdevelopingautism,includingenvironmentalandgeneticcontributors1,4.Somechildrenmightdevelopautismduetoanearlybrainovergrowth,whichmeansthatthebrain grows faster than the average brain, resulting in different parts of the brain notcommunicatinginatypicalway4.Signsofautismareusuallyprevalentfromtheageoftwo,when parents begin to see signs such as being unable to get the child’s attention orcommunicatingsimpletasks.Someearlysignsare6:

• Socialchallenges–manyautisticinfantsshowsomeearlysymptomssuchasfailureto respond to theirname, reduced interest inpeopleanddelayed speech.Autisticchildren have difficulties interpreting what others are thinking and feeling, whichresultsindifficultiesplayingsocialgames.

1WHO2017,Autismspectrumdisorders.Availablefrom:http://www.who.int/mediacentre/factsheets/autism-spectrum-disorders/en/.[4September2017].2TheNationalAutisticSociety2017,Autismfactsandhistory.Availablefrom:http://www.autism.org.uk/about/what-is/myths-facts-stats.aspx.[4September2017].3AIHW2017,AutisminAustralia.Availablefrom:http://www.aihw.gov.au/disability/autism-in-australia/.[4September2017].4RaisingChildren2016,Autismspectrumdisorder(ASD):overview.Availablefrom:http://raisingchildren.net.au/articles/autism_spectrum_disorder_overview.html.[31August2017].5RaisingChildren2017,Earlyinterventionforchildrenwithautismspectrumdisorder:gettingstarted.Availablefrom:http://raisingchildren.net.au/articles/autism_spectrum_disorder_choosing_services.html.[31August2017].6AutismSpeaks2017,Symptoms.Availablefrom:https://www.autismspeaks.org/what-autism/symptoms.[18September2017].

• Communication difficulties – some autistic children will have significant language

delaysanddon’tbeginspeakinguntilmuchlater,usingonlysinglewordsorrepeatingphrases. This is due their difficulty combining words into meaningful sentences.Childrenwithautismalsohaveaninabilitytounderstandbodylanguage,toneofvoiceandexpression.

• Repetitivebehaviour–commonrepetitivebehavioursincludehand-flapping,rocking,

jumpingandtwirling,arrangingandrearrangingobjects,andrepeatingsounds,wordsor phrases. People with autism need and demand extreme consistency in theirenvironmentanddailyroutine–slightchangescanbeextremelystressfulandleadtooutbursts.

WHO’SAFFECTED?Studies over the past 50 years have shown that theprevalenceofautismappearstobeincreasingglobally1.It is estimated that more than 21.7 million peopleworldwidearedirectlyaffectedbyautism4.InAustraliaalone,5%(115,400people)havebeendiagnosedwithautism,with1 in100autistic childrenbeingbetweentheagesof5-145.Itiscommonlyidentifiedinchildrenandyoungpeople,with83%ofautismsufferersagedunder 253. Statistics indicate boys being four timesmorelikelytoexperienceautismthangirls5.TREATMENTThereisnosinglecureforautism,howeverithasbeenproventhattherightsupportattherighttimecanmakeadifferencetothelivesofautisticpeople1,2.

Children with autism can benefit from earlyintervention,whichconsistsofvarioustherapies,interventionsorservices4.Thiscanhaveapositiveimpact on wellbeing and quality of life for apersonwithautismandtheircaregivers1.Medications are also used to treat the coresymptomsofautismandcanhelpsomeautisticpeoplefunctionbetter7.Forexample,medication

7WebMD2017,MedicinesforAutism.Availablefrom:http://www.webmd.com/brain/autism/medications-for-autism.[18September2017].

mighthelpmanagehighenergylevels,inabilitytofocus,depression,orseizures.Medicinesthat are sometimes used to treat behaviors related to autism include selective serotoninreuptakeinhibitors(SSRIs),whichhavebeenfoundtoimprovemood,alleviatedepressionandobsessivecompulsivebehavioursthattypicallypresentthemselveswithautism7.Thesedrugspresent some side effects including weight gain, insomnia and agitation7. Antipsychoticmedicinesarealsousedtoalleviatebehaviouralproblems,thesedrugsalterthechemicalsinthebrain,andhavesideeffectsofweightgain,sleepiness,tremors/shakes7.However,thereisnosinglemedicationthatcuresthecoresymptomsofautism,whichmeansthatautisticchildrenarebeingtreatedforconditionsoftenassociatedwithautisminsteadsuchasanxiety,hyperactivityandaggressionError!Bookmarknotdefined..AstudyreleasedbytheNationalInstituteofMentalHealthshowedthat56%ofchildrenandteenswithautismare taking one ormoremedications, withmany suffering from the side effects of theseprescriptionmedicatonsError!Bookmarknotdefined.It’s due to these side effects and relianceonmultiplemedications, that’s resulting in thesearch for alternative treatments such as medical cannabis. Zelda Therapeutics is onecompanythatislookingtodevelopmedicalcannabisformulationstargetedatautism.ZELDATHERAPEUTICS(ASX:ZLD)ZeldaTherapeutics(Zelda)isanAustralianbasedbio-pharmaceutical company that has secured certainrightastoanextensivesetofhumandatarelatedtomedicalcannabisbasedformulationsandtreatmentprotocols.ThishumandatahasbeengeneratedoverseveralyearsbyaCalifornia-basedgroup,AuntZelda,that has a very high profile within the USA and agrowing international profile based upon its deepknowledge of the scientific rationale for certaincannabis-basedformulationsandprotocolstotreatavarietyofmedicalconditions.Zelda’sinvolvementwithAutismThecompanybeganitsclinicaltrialprogrammeinChile lastyearandasofApril2017,theprogrammeexpandedtoincludeautism.ZeldaisworkingtogetherwithChileannon-profitpatientadvocategroup,FoundationDaya,toleveragetheirclinicalexperiencewithautismpatientswhichhasalreadydemonstratedsolidanecdotalevidenceofpositivequalityoflifeoutcomesusingcannabinoids-basedtherapy.

FoundationDayahasextensiveexperienceoveranumberof years in using medical cannabis to treat patientsdiagnosedwithautism.Zeldawillusethisdataandaccesstopatientstodeveloprobustclinicaltrialsandconductitsresearchunderrigorousandcontrolledclinicalconditions,usingmedicinal cannabis formulations already known tohaveapositiveeffectonsufferersofautism.Furthermore,throughitsrelationshipwithAusCann,ZeldawillleverageAusCann’sChilean joint-ventureDayaCanntosupplyhigh

qualitymedicalcannabisfortheautismtrial.

Subjecttoregulatoryapprovalsbeingobtained,Zeldaexpectsthetrialwillcommenceinthesecondhalfof2017,withtrialprotocolsbeingdeveloped.Thecompanyexpectsthetrialtobeconductedoveraperiodof6-9months.

Recently,ZeldaannouncedthatithassponsoredanobservationautismtrialinChile,whichhasdemonstratedsuccessfulresultsfortreatingthecoresymptomsofautismwithmedicalcannabisextractsthatZeldaisplanningontakingintoclinicaltrials.Agroupof21patents(medianageof9years10months),whohadnotrespondedwilltoconventionalmedicines,weretreatedforatleasta12-weekperiodwithmedicinalcannabisandwereexaminedbyEEG, neuropsychological analysis as well as metabolism and genetic tests. Resultsdemonstrated cannabis extractsweremore effective than conventional autismmedicineswith71.4%of cannabis treatedpatients improving in at least one core symptomare and66.7%ofpatientstreatedshowingsignificantoverallimprovement.

WHAT’SNEXT?

Theexcitingresultsfromtheobservationalstudy,willassistinbuildingZelda’sclinicalautismtrial,fromwhichsuccessfulresultswillallowZeldatoimmediatelycommencetheproductregistrationprocesstosellclinicallyapprovedproductsintheChileanmarket.ThisprovidesaclearpathwaytopotentialrevenuegenerationfromChileandotherSouthAmericanmarketsasearlyas2018.TofollowZelda’sprogressorlearnmore–visitthewebsite:www.zeldatherapeutics.comFollowusonSocialMedia:Facebook:@ZeldaTherapeutics|Twitter:@ZLDTherapeutics|Linkedin:ZeldaTherapeutics