WntResearch announces early data from Foxy-5 phase 1 study
WntResearch today announces that full data from the 3rd patient out of a total of 6 has been included in the last dose cohort of the Foxy-5 clinical phase 1 study. A full report will be presented after the last patient (6/6) has finalized treatment and the follow up period as per protocol in dose level 8. As finalization of the study report will take some time the company now chooses to present the results as they stand today.
Data obtained so far (including the first 7 dose cohorts and 3 out of 6 patients from cohort 8) demonstrate:
1. No dose limiting toxicities have been observed at any dose, why a continued dose escalation phase 1b study will be initiated as previously announced.
2. A dose related pharmacokinetic profile in patient serum has been observed. This is important for the ability to predict Foxy-5 exposure in the individual patient and points to a relevant dosing schedule.
3. Several of the included patients have continued Foxy-5 treatment following the end of the trial period based on the treating physicians decision. In average they have received 5 weeks additional treatment. These data strongly suggest a lack of late toxicities by Foxy-5.
4. So far too few patients have been analysed with regard to biomarkers to make any firm conclusions.
Nils Brünner, CEO says, “The phase 1 study with FOXY-5 is almost finished and we are very happy to announce that we have not seen any drug-related toxicities. We had of course hoped to be able to close the phase 1 study at the end of May and at this time point present the full set of data. But as the study is conducted on very sick patients, with no other treatment options left, one can never be sure to keep the planned deadlines. We still need final data from 3 more patients on the highest dose before we can close the study and present the final results. Then we will continue our search for the recommended dose of FOXY-5 by initiating the phase 1b study.”
For additional information please contact:
Nils Brünner, CEO
Telephone: + 45 2614 4708
WntResearch AB is a public company on the AktieTorget in Sweden. WntResearch develops the anti-cancer compound Foxy-5 to be used to combat the metastatic process of cancer. WntResearch has one drug candidate in clinical phase 1 – Foxy-5 – as well as one candidate drug in preclinical development – Box-5. The Company is currently focusing mainly on the development of Foxy-5.