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The trial commenced in December 2016. The study is primarily designed to understand the safety profile of Cantrixil in human subjects and to establish a maximum tolerated dose (MTD) for the drug.
In accordance with common practice for phase I studies, patients will initially be administered very low doses of Cantrixil, with doses carefully escalated in subsequent patients under careful monitoring by clinicians according to safety and tolerability criteria. Once the MTD has been established, the study will expand recruitment to additional patients in order to further establish safety and explore signals of clinical efficacy.
Based on the current study progress, Novogen anticipates that it will be able to report the MTD in the first quarter of 2018. Exploratory efficacy data from additional patients is expected to be available later in 2018.
To support continued conduct of the phase I clinical trial in ovarian cancer, Novogen is in the process of engaging a contract manufacturing organisation to produce a second batch of clinical trial material under Good Manufacturing Practice conditions. This material will be used to ensure uninterrupted supply to clinical trial sites as the study progresses.
The patent covering Cantrixil has proceeded to grant in the United States and European Union. Novogen has applied for patent protection in a total of 25 jurisdictions worldwide, and these applications continue to move forward according to each authority’s specific process.
Original Article: Novogen says Cantrixil trial progressing as plannedNEXT ARTICLE
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