Faron Pharmaceuticals Oy (LON:FARN) (NASDAQFIRSTNORTH:FARON) has been given the green light to broaden the scope of its phase I/II cancer trial after a review of the interim data.
The MATINS study of the immunotherapy Clevegen will now take in seven further strains of the disease besides the two already assessed - colorectal and ovarian.
An assessment of 30 patients looking into the drug’s tolerability, safety and efficacy found that all bar those receiving the lowest levels of the treatment were subject to dose-related immune activation.
As previously flagged, there were two partial responses to Clevegen and seven cases of stable disease. It should be pointed out that Faron’s team was working with people with inoperable tumours.
The data monitoring committee (DMC) overseeing the trial has recommended the second stage be opened to all solid tumour groups on its list of targets.
- ER-positive breast cancer
- Cholangiocarcinoma (bile duct cancer) and gall bladder cancer
- Gastric cancer
- Hepatocellular carcinoma
- Cutaneous melanoma
- Uveal melanoma
- Pancreatic ductal adenocarcinoma
While no dose-limiting toxicity was found, the DMC recommended the dosing for Clevegen should be 1 milligram per kilogram going forward.
“We continue to be highly encouraged by the consistency of the data from the MATINS trial indicating Clevegen's strong immune switch and the low dosing levels required to show these responses, but most importantly its clinical effect on tumour lesions in patients who have exhausted all treatment options,” Faron’s chief executive, Dr Markku Jalkanen said in a statement.
"We will now work with trial sites in the MATINS network across Europe and the US to ensure expansion of the trial beyond the colorectal and ovarian cancer cohorts already recruiting. We look forward to generating further data to assess the durability of effect and efficacy of Clevegen in larger numbers of patients."
Ten patients are expected to be treated in each of the next cohorts and the first colorectal group of the second stage has already been recruited.
Patients in part-one of the MATINS study were assessed at the 60-70-day stage between the third and fourth cycles of treatment.
Faron said patient recruitment for the next stage may be delayed due to restricted resources caused by the coronavirus.