Starpharma to commence DEP cabazitaxel phase 1/2 trial

Sta Melbou announ clinical tolerabi dose (R types. The tria College Further phase 2 phase 1 DEP® c markete develop and hea this yea DEP® c and foll recently DEP® c enhanc resultin In paral with Sta findings The pha and is a three w (DLTs) safety, RP2D. In phas tumour safety, The ada to phas be mad charact Dr Jack cabazita cabazita survival effect o arpharm urne, Austr nced that it h trial for DEP lity and pha RP2D), and al will be con e London Ho r sites will o 2 part of the 1/2 trial. cabazitaxel ed by Sano pment for a ad and neck ar. cabazitaxel ows DEP® d y progresse cabazitaxel ced efficacy g in signific llel, AstraZe arpharma a s for DEP® d ase 1/2 stud an open-lab weeks at esc and to esta tolerability a se 2, the stu efficacy of tolerability a aptive trial d se 2 and to e de as to whi terise effica kie Fairley, S axel – our s axel has alr l benefits, a of many anti ma to com ralia; 31 Ja has receive P® cabazita armacokine then to det nducted at ospital (UC pen and co e trial gets u is Starpharm fi Aventis to range of ot k. Jevtana® is the secon docetaxel, w ed to phase in preclinica , and in bot cant addition eneca’s first nd has also docetaxel a dy for DEP® bel study. In calating dos ablish the M and PK pro udy will initia DEP® caba and PK of t design emp explore effic ch tumour t cy in specif Starpharma second DEP ready delive as well as e -cancer dru mmence nuary 2018 ed regulatory axel. The ob tics of DEP ermine anti multiple site LH) in the U mmence re underway. A ma’s deterg o treat adva ther cancer ® sales are e nd product f which delive 2. The repr al models in h cases DE nal benefits t DEP® prod o demonstra and DEP® ca ® cabazitaxe phase 1, D ses to deter Maximum To file of DEP® ally enrol up azitaxel in sp he product. ployed enab cacy as ear types to foc fic tumour ty a CEO, com P® product f ered excitin liminating n ugs, includin e DEP® c 8: Starpharm y and ethics bjectives of P® cabazitax -tumour eff es, with Guy UK being th ecruitment a Approximate gent-free ve anced prosta types, inclu estimated to from Starph ered positiv roducible be nclude decr EP® has also for patients duct, AZD04 ated preclin abazitaxel. el will enrol DEP® cabaz rmine if ther olerated Dos ® cabazitaxe p to 20 patie pecific tumo bles Starpha rly as possib cus on and a ypes. mmented: “W from our int g preclinica neutropenia ng Jevtana® cabazita ma (ASX: S s approvals the trial are xel, to define ficacy of the y’s Hospital e first sites as dose esc ely 35 patie ersion of can ate cancer, uding testicu o reach app harma’s DE ve phase 1 c enefits obse eased bone o allowed fo s. 466, has be ical improv patients wi zitaxel will b re are any D se (MTD). T el will help e ents at the R our types, a arma to mov ble. As the any addition We are delig ternal portfo al results sh , which is a ®. axel pha SPL, OTCQ s to commen e to evaluate e a recomm e product in l London an to open for calation prog ents will be e ncer drug, J and is also ular, ovaria proximately EP® platform clinical resu erved for DE e marrow to or a deterge een develop ements con ith advance be administe Dose Limitin The charact establish an RP2D to de and to furthe ve seamles trial progres nal patients ghted to adv olio to the cl howing susta significant ase 1/2 tr X: SPHRY) nce its phas e the safety mended pha select tumo nd Universit r recruitmen gresses and enrolled acr Jevtana®, w o under clini n, breast, b US$500 m m to enter th ults in 2017 EP® doceta oxicity and ent-free form ped under li nsistent with ed solid tum ered once e ng Toxicities terisation of nd characte etermine the er character ssly from ph sses, decis required to vance DEP® linic. DEP® ained effica dose-limitin rial ) today se 1/2 y, ase 2 our ty nt. d the ross the which is ical bladder, illion he clinic, and axel and mulation cence h ours every s f the erise the e anti- rise the ase 1 ions will o further ® acy and ng side “These for our program applica drug pe Dr Fairl About D Starpha version treat ad breast c formula warning hyperse formula DEP® c respect against About Star Starpharma developmen Starpharma and well sui with the Com VivaGel®: S dendrimer. Aspen Phar an antiviral Starpharma DEP® - Den multiple inte DEP® docet developmen and comme Starpharma Media WE Buchan Rebecca W Mob: +61 4 rwilson@bu Forward Lo This docume as “promising provide”, “inte approvals, or may cause a assurance tha there be any particular, ma trial results, i obtain or mai additional fac of these risk s anticipated, b any forward-l benefits for lead interna ms. The gro bility of the erformance ey. DEP® caba arma’s DEP of cancer d dvanced pro cancer, blad ation produc gs in relation ensitivity (e. ation. cabazitaxel t to both lev t the develop rpharma a Holdings Limited nt of dendrimer pr a’s underlying tech ited to pharmaceu mpany developing Starpharma’s portf VivaGel® BV is a rmacare Australia condom which us a has a number of ndrimer Enhance ernal and partnere taxel and DEP® ca nt. Starpharma’s p ercialisation of two a.com | Twitter | n Consulting Wilson 17 382 391 uchanwe.com.au ooking Statements nt contains certain fo g”, “plans”, “anticipat ends”, “is being dev r potential future sa l ctual results to be m at any existing or fut assurance that such anagement’s expecta ncluding additional intain patent or oth e ctors that involve sig s or uncertainties m believed, estimated o ooking statements c r DEP® cab al DEP® pro owing body DEP® platfo and reducin azitaxel P® platform w drug Jevtan ostate cance dder cancer ct has US F n to neutrop .g. anaphyla significantly vel and dura pment of ne d (ASX: SPL, OTC oducts for pharma hnology is built aro utical and medical g a number of prod folio includes wom pproved for marke Pty Ltd for the sa es VivaGel® in the license agreemen ed Product®: Star ed DEP® programs abazitaxel - in clin partnered DEP® pr o novel oncology c LinkedIn A + a s orward-looking state ted”, “will”, “project”, veloped”, “could be” les of product cand i materially different fr ture regulatory filings h product candidate ations regarding the analysis of existing er proprietary intellec nificant risks and un materialize, or shou l or expected. Starph contained in this doc azitaxel are oduct, DEP® of data from orm and the ng toxicity fo was utilised na®. Jevtana er and also r and head Food and Dr penia, which axis) resulti y outperform ation of anti- eutropenia, CQX:SPHRY), loca aceutical, life scien ound dendrimers – uses. Starpharm ducts internally an men’s health produ eting in the EU an les and marketing e lubricant, which nts to market the V pharma’s DEP® d s, including improv ical development rograms include a compounds, with p Arthur Chan +61 2 9237 2805 achan@buchanwe ements, relating to S “believe”, “forecast” ”, “on track”, or simil idates. Such forwar d rom any future resul t s will satisfy the FDA s will be approved b e approval and comm data, and new dat a ctual property protec ncertainties about ou ld underlying assu m arma is providing th cument as a result of e consistent ® docetaxel m our DEP® e compellin or patients, d to create D a® is a leadi under deve and neck c rug Adminis h is a major ing from the med Jevtana -cancer acti which is a ated in Melbourne nce and other app – a type of synthet ma has two core de nd others via comm ucts based on Viva d Australia for bac g of VivaGel® BV i is available in Aus VivaGel® condom rug delivery platfo ved efficacy, safet in patients with so a multiproduct DEP potential to add mo e.com.au Starpharma’s busines ”, “expected”, “estim lar expressions, or b d-looking statement ts, performance or a A’s and other author by any authorities fo mercialization of the a; unexpected regul a ction; competition in ur products, product mptions prove incor r is information as of f new information, fu t with the re and finding ® products il g commerc while exten DEP® cabaz ing oncolog elopment fo cancer. The stration (FDA r dose limiti e polysorba a® in a hum tivity and su serious side Australia, is an A plications. tic nanoscale poly evelopment progra mercial partnersh aGel® (SPL7013, cterial vaginosis (B n Australia and Ne stralia and Canad in other regions, orm has demonstra ty and survival. St olid tumours, and P® licence with As ore. Starpharm Dr Jackie Nigel Baa +61 3 853 investor.re ss, which can be ide ated”, “targeting”, “a by express or impli e ts involve known an achievements expre rities’ requirements r r sale in any marke t product candidates atory actions or del a general; governmen candidates, financia rect, actual results the date of this do c uture events or devel ecent positiv gs in partne lustrates th cial advanta nding paten zitaxel, a de gy agency w or other can current (no A)-mandate ing side effe te 80 deterg man breast c urvival, whils e effect for ASX 300 company ymer that is highly ams: VivaGel® por ips. astodrimer sodium BV). Starpharma h ew Zealand. Starp a under the Lifest including China an ated reproducible tarpharma has two further DEP® prod straZeneca, which ma Fairley, Chief Exe ade, CFO and Com 32 2704 elations@starpha entified by the use of aiming”, “set to”, “pot ed discussions rega r d unknown risks, u n ssed or implied by s regarding any one or t or that they will re a could be affected by ays, or government nt, industry, and ge n al results and busine may vary materiall y cument and does no lopments or otherwis ve phase 1 red DEP® e broad ges of enha nt life”, conc etergent fre which is use cers includi on-dendrime ed ‘black bo ect, and sev rgent used in cancer mod st protecting Jevtana®. and is a world lea y regular in size an rtfolio and DEP® d m), a proprietary has a license agre pharma has also d tyles® Dual Protec nd Japan (Okamo preclinical benefi o internal DEP® pr ducts approaching involves the deve ecutive Officer mpany Secretary rma.com f forward-looking ter tential”, “seeking to” rding potential filing s ncertainties and ot h such statements. Th r more product cand ach any particular lev y, among other thing regulation generally neral public pricing p ess prospects. Shoul y from those descri t assume any obliga se. 2 results ancing cluded e ed to ing er) ox’ ver n its del with g ader in the nd structure drug delivery eement with developed ct™ brand. oto). ts across roducts – g clinical elopment rminology such , “goal”, “could s or marketing her factors that here can be no didates nor can vel of sales. In gs, unexpected y; our ability to pressures; and ld one or more bed herein as ation to update

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