Isofol Medical: Positive efficacy data from the ISO-CC-005 trial2018-01-11 09:57, Edited at: 2018-01-11 11:06
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Isofol Medical has reported positive efficacy data from the currently ongoing phase I/II trial in colorectal cancer. The results follow from an extended analysis of patients that have been treated for 16 weeks with Modufolin as a first line treatment. The results are, in our view, promising, and gives support for forthcoming studies. Today's news will not result in any changes of our valuation of the company.
A prior analysis of 12 patients after 8 weeks of treatment demonstrated a partial response (PR) in 6 patients and stable disease (SD) in the remaining 6 patients. In the group that was treated with at least 60mg/m2, 5 out of 7 patients had a PR. In the group of patients that also received oxaliplatin, 3 out of 3 patients had a PR.
These results are now strengthened by an extended analysis of 8 patients after 16 weeks of treatment. Results demonstrated continued response in the 5 patients who previously had a PR at week 8. Among the 3 patients who previously showed SD at week 8, continued response could be observed in all patients. None of the patients witnessed of tumour progression after 16 weeks of treatment. The safety profile was in line with prior results.
The ISO-CC-005 trial has included 54 metastatic colorectal cancer (mCRC) patients to date. We believe that the trial will be fully recruited during Q1, slightly later than previousy estimated. Given a successful outcome, the trial will be followed by a pivotal trial in mCRC, set to be initiated around mid-2018.
The reaction on the share has been mildly positive. Continued response after 16 weeks of treatment is positive, but it should be noted that the patient sample is rather small and thar further evaluation is needed. The results do not affect our valuation of the company, but support our belief in a high probability of success for the ongoing trial and advancement to a pivotal trial in 2018. Our fair value range is SEK 18-48 per share, with a base case of SEK 38 per share.
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