(Alliance News) - Faron Pharmaceuticals Oy said Monday it has received approval from the MATINS trial's data monitoring committee to expand the clinical trial of its Clevegen cancer drug.
The MATINS clinical trial is investigating the drug, which targets both metastatic cancers, forms of the disease which spread to new areas of the body, and inoperable tumours, which cannot be removed from the body surgically.
Turku, Finland-based Faron said the data monitoring committee has accepted its proposal that the initial Clevegen dose for part II of the study should be 0.3 milligrams per kilogramme.
A total of ten late-stage colorectal, or bowel, cancer patients are expected to be dosed in this 0.3 milligrams per kilogram cohort, including two patients who had previously received this dose in the earlier part I of the study.
In the first part of the study, patients received Clevegen dosage amounts of 0.1 milligramme per kilogramme, 0.3 milligrams per kilogramme, 1.0 milligrams per kilogramme, 3.0 milligrams per kilogramme or 10 milligrams per kilogramme.
Faron said: "While the dose of 0.3 milligrams per kilogramme has been associated with a clinical response and has produced the strongest immune response, the efficacy of another Part I dose level cohort may be tested separately during Part II following completion and final analysis of Part I."
Faron Chief Executive Officer Markku Jalkanen said: "We continue to be impressed by the potential of Clevegen and are very pleased to have the data monitoring committee support for the commencement of part II of the MATINS trial."
Following the approval of Clevegen as an investigational new drug by the US Food & Drug Administration in November, the company said it is opening new MATINS trials in the US to facilitate its "rapid expansion" beyond existing new sites in Europe.
Faron Pharma shares were trading 4.2% higher in London at 284.00 pence each on Monday.
By Loreta Juodagalvyte; email@example.com
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