Onxeo Announces Data Demonstrating High Patient Compliance and Acceptability of Validive® for Treatment of Severe Oral Mucositis — Onxeo offentliggør data, der viser et højt niveau af ordinationsoverholdelse og en god sikkerhedsprofil for Validive® til behandling af svær oral mucositis

Results Presented in Oral ePoster Presentation at ASTRO Annual Meeting 2015

Paris (France), Copenhagen (Denmark) – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, announced compliance and patient acceptability results from a global Phase 2 clinical trial demonstrating daily treatment application of Validive® (Clonidine Lauriad®), a mucoadhesive buccal tablet for the prevention and treatment of chemo-radiation therapy-induced severe oral mucositis (SOM) in patients with head and neck cancer, is well-accepted and well-tolerated by patients, with high compliance, before and throughout chemoradiotherapy treatment.

Results of the study, “Compliance and Patient Acceptability of Clonidine Mucoadhesive Buccal Tablet (Clonidine Lauriad) to Prevent Severe Radiomucositis in Head and Neck Cancer Patients” (Presentation # 1139), were presented by investigator Dr. Jordi Giralt, M.D., Ph.D., Head of the Radiation Oncology Service at Vall d’Hebron University Hospital in Barcelona, Spain, during the ePoster 16 Discussion Session “Head and Neck V” at the 57th American Society for Radiation Oncology (ASTRO) Annual Meeting, being held October 18-21, 2015 in San Antonio, TX.

Judith Greciet, Chief Executive Officer of Onxeo, commented, “These results establish that patient treatment compliance with Validive® is high and consistent between investigator and patient assessment. Compliance is key in the treatment of a lasting condition such as severe oral mucositis, about 5 to 8 weeks, as patients’ acceptability is critical to ensure optimal efficacy.”

The compliance and acceptability portion of the study found the mean overall patient compliance, calculated as the number of tablets taken as an expression for treatment duration in days, to be 95% (95% confidence interval), with median of 98%. The median duration of tablet adherence was 9 hours. Incidence of detachment of the tablet within the 6 hours was 17.1% and replacement of detached tablets with a new tablet was 41.5%. Tablet detachment and replacement rates were higher during the first weeks of the study, suggesting a learning curve. Overall compliance according to the patient diaries was similar in all treatment groups and consistent with the compliance according to the investigator’s evaluation (mean of 89% [95%CI], with median of 98%). Overall mean values, at 95% confidence interval, of comfort, pain-burning and taste according to the daily patient scale from 0 to 10, were respectively 1.36, 1.18 and 1.16 and were not different between treatment groups.

These findings follow efficacy and safety results from the global Phase 2 randomized double-blind, placebo-controlled trial, which were presented at the 2015 ASCO Annual Meeting in May, that confirmed Validive® reduced the incidence and delayed the time to chemo-radiation therapy-induced SOM, with minimal toxicity, compared to placebo in 183 patients with head and neck cancer patients undergoing chemoradiotherapy.

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Resultaterne blev præsenteret på en mundtlig ePoster på 2015-årsmødet i ASTRO

Paris (Frankrig), København (Danmark) – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), et innovativt selskab med speciale i udvikling af lægemidler til behandling af sjældne kræftsygdomme, har offentliggjort resultater vedrørende ordinationsoverholdelse og acceptabilitet fra et globalt klinisk fase II-studie, som viste, at daglig behandling med Validive® (Clonidine Lauriad®), en mucoadhesiv tablet til oral indtagelse der er udviklet til forebyggelse og behandling af svær oral mucositis fremkaldt af radio-kemoterapi hos patienter med hoved-halskræft, er veltolereret af patienterne, som samtidig viste en høj grad af ordinationsoverholdelse før og under hele kemo-strålebehandlingen.

Resultaterne fra studiet, “Compliance and Patient Acceptability of Clonidine Mucoadhesive Buccal Tablet (Clonidine Lauriad) to Prevent Severe Radiomucositis in Head and Neck Cancer Patients” (Præsentation # 1139), blev præsenteret af investigator Dr. Jordi Giralt, MD, PhD, Leder af Radiation Oncology Service på Vall d’Hebron University Hospital i Barcelona, Spanien, under ePoster 16 diskussionssessionen “Head and Neck V” ved det 57. årsmøde i American Society for Radiation Oncology (ASTRO), som afholdes 18.-21. oktober i San Antonio, Texas, USA.

Judith Greciet, Onxeos administrerende direktør, udtaler: “Disse resultater fastslår, at patienterne i høj grad overholder ordinationen af Validive®, og at investigatorens og patienternes egne evalueringer stemmer godt overens. Ordinationsoverholdelse er afgørende i behandlingen af en varig lidelse som svær oral mucositis, omkring 5-8 uger, da patienternes acceptabilitet er afgørende for at sikre optimal behandlingseffekt.”

I studiets del omkring ordinationsoverholdelse og patientsikkerhed sås, at den gennemsnitlige samlede ordinationsoverholdelse beregnet som antallet af tabletter taget som udtryk for behandlingsvarighed, var 95 % (95 % konfidensinterval), med en median på 98 %. Den mediane tid, hvor tabletten sidder fast på slimhinden, var 9 timer. Inden for 6 timer løsrev tabletten sig hos 17,1 % af patienterne , og løsrevne tabletter blev erstattet med nye tabletter i 41,5 % af tilfældene. Løsrivning og erstatning af tabletter sås oftere i de første uger af studiet, så det kunne tyde på, at patienterne blev bedre til at tage medicinen med tiden. Den generelle ordinationsoverholdelse i henhold til patienternes dagbøger var identisk i alle behandlingsgrupperne og stemte overens med overholdelsen ifølge investigatorens evaluering (gennemsnit på 89 % [95 % KI], med en median på 98 %). De samlede gennemsnitsværdier (95 % KI) for komfort, smertefuld svige og smag i henhold til den daglige patientskala fra 0 til 10, var henholdsvis 1,36, 1,18 og 1,16 og var ikke forskellig imellem behandlingsgrupperne.

Disse resultater kommer oven på effekt- og sikkerhedsresultater fra det globale, randomiserede, dobbeltblindede, placebokontrollerede fase II-studie, som blev præsenteret på 2015-årsmødet i ASCO i maj, og som bekræftede, at Validive® reducerede forekomsten og forsinkede tiden til svær oral mucositis fremkaldt af radio-kemoterapi med minimal toksicitet, i sammenligning med placebo hos 183 patienter med hoved-halskræft, som får radio-kemoterapi.

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