Lakmustest nå, om alt som ligger til salgs blir kjøpt
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Rart ingen forhåpninger til gode resultater 12 okt?
Hva slags resultater kan en vente seg mener du?
Resultater fra fase III studiet skal presenteres late abstract på konferanse om to dager.
Hvordan vil resultatet presenteres og hva er et godt resultat?
A total of 158 patients were enrolled in this study. The completed statistical analysis results indicate that the study was successful and has achieved the primary research endpoint, which was defined as; the proportion of patients who have at least one tumor found by blue light but not by white light cystoscopy. The results of the study will be submitted to the Chinese National Medical Products Administration (NMPA) for a new drug application (NDA) in the coming months.
"The clinical data of Hexvix further confirms its outstanding clinical performance
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Det har jeg fått med meg. Du savner forhåpninger/forventninger. Hva slags resultater kan vi vente oss da mener du?
Er late-breaking abstract kriteriene de samme for ESMO og SIU siden det sammenlignes?
Er LBA i dette tilfellet pga banebrytende funn, eller pga. timingen for publisering? 
Submit your abstract by March 12, 2023
Late-Breaking Abstracts Deadline: August 30, 2023 @ 11:59 PM
Asieris confirms Hexvix Phase III clinical trial in China meets endpoint: August 11, 2023
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Hvis resultatet er at i alle 158 pasientene fant de en tumor som de ikke fant i WLC må det være et outstandig resultat. Hvis halvparten ikke så bra. Hva tenker dere eller hva er resultatet i andre phase III studier gjort for Hexvix?
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Og det er poenget. Det er ikke som om Hexvix er et nytt produkt. Det er mye forskning bak dette allerede og vi vet at man finner flere tumorer med blått lys. Derfor må man stille seg spørsmål om hvilke forventninger en bør ha for en LBA for Hexvix?
Det her blir veldig spennende. Det er jo konkurransen med hvitt lys som er selve nerven i forhold til videre vekst
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Inclusion Criteria:
- Volunteer to participate in clinical study; thoroughly informed, signed and dated the informed consent form; willing to follow and have the ability to complete all trial procedures.
- Suspicious or confirmed patients with bladder cancer.
- Age 18 or older.
Primary Outcome Measures :
- Proportion of patients with histology-confirmed lesions (Ta, T1, or CIS) who have at least one such lesion found by Hexvix blue light cystoscopy but not by white light cystoscopy. [ Time Frame: 1 day (At time of cystoscopy examination) ]
Previous data on Hexvix
A phase 3 trial of Hexvix (previously Cysview) BLC (NCT02560584) was conducted in the US to compare BLC and WLC with Hexvix in patients with high risk of recurrence.2 Patients included in the study received 100 mg Hexvix intravesical solution before cystoscopy.
Findings showed that 9 of 26 patients who were confirmed to have carcinoma in situ upon operating room examination had disease detected only with BLC (95% CI, 17.2-55.7; P < .0001). Further, BLC identified additional malignant lesions in 29 of the 63 patients with confirmed malignancy. Specificity for BLC and WLC was found to be 9.1%.
In total, 12 adverse events were reported during surveillance, though none were found to be serious.
The authors concluded, “Office based blue light flexible cystoscopy significantly improves the detection of patients with recurrent bladder cancer and it is safe when used for surveillance. Blue light cystoscopy in the operating room significantly improves the detection of carcinoma in situ and detects lesions that are missed with white light cystoscopy.”
Det som blir spennende er å se effekten sammenlignet med data som man har sett fra tidligere studier. Vi ve at det primære endepunktet er nådd, men det er ganske bred formulering. Sitatet til CDO i Asieris gir rom for håp:
“The clinical data of Hexvix further confirms its outstanding clinical performance. We sincerely thank all the researchers and participants for their dedication and efforts in advancing this clinical study. This marks a significant milestone in our company’s comprehensive efforts to create an integrated diagnostic and therapeutic solution in the field of bladder cancer. We will continue to vigorously advance the follow-up work, aiming to achieve commercialization and benefit more bladder cancer patients as soon as possible.”
(Linda Wu, PhD, Chief Development Officer of Asieris,)
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Fant denne fra 2018;
Flexible BLC was approved by the FDA in 2018 for use in the surveillance setting and was demonstrated to improve detection. Results of a phase III prospective multicentre study of blue light flexible cystoscopy (BLFC) in surveillance of intermediate-risk and high-risk NMIBC showed that 20.6% of malignancies were identified only by BLFC. Improved detection rates in the surveillance setting are anticipated to lead to improved clinical outcomes by reducing future recurrences and earlier identification of tumours that are unresponsive to therapy.
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Ble ikke rare reaksonen på nyheten om presentajonen nei. Grunnen til det er kanskje som det nevnes at markedet allerede forventer et godt resultat? Uansett er det jo positivt, og den burde gå litt. Rent teknisk tror det kommer en popp her ganske snart.
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Eller at markedet er noe avventende og ønsker å se at resultatene er gode nok før aksjen går
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Kan det være annerledes nå med forbedret HD ?
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Jeg tror markedet også ønsker å se at all denne forskningen og positive resultater (WLC bs BLC) faktisk kan konverteres til økt omsetning og salg.
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Absolutt. Hittil har det vært helt katastrofe. Men det kan handle om forhold i USA som overhodet ikke er gjeldende i Kina. Hvordan er det med bruk av hvitt lys i Kina forresten ?
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hva om nyhetene inneholder noe nytt innen terapautisk virkning av hexvix?
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Men, det er jo ikke Photocure sin studie, ei heller de som skal presentere ?
Så her kan det jo komme sensasjonelle nyheter, noe som også ligger i begrepet ??
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Ikke helt enig idette, men det gjør ikke så mye, da skulle Asieris sine akjsonærer har fått vite det! Asieris ned ca.40% de siste 12mnd. De er like sulten som oss at skytta snurr.
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