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(Alliance News) - Faron Pharmaceuticals Oy on Wednesday said feedback from its Matins study data shows Clevegen may be stronger at lower doses and so Faron will test an even lower dose before moving to the second part of the trial.
Shares in the clinical stage biopharmaceutical firm were up 7.7% at 86.70 pence in London in morning trade.
The phase 1/2 Matins clinical trial is assessing Clevegen's efficacy, safety, and tolerability in metastatic or inoperable solid tumours. So far in part 1, the drug "has had a good tolerability across all dosing levels" - in this case between 0.3 milligram per kilogramme of body weight and 10 milligrams per kilogramme.
All 11 of the study's subjects had immune activation in response to the drug, which is intended to help the patient's immune system fight the cancer. The data monitoring committee noted that lower doses, between 0.3 milligram and 1 milligram per kilogramme of body weight, "may potentially induce a stronger immune response" than doses of 3.0 milligrams per kilogramme and above.
As such, the committee has proposed a new 0.1 milligram per kilogramme test dose, rather than the higher 20 milligram per kilogramme test dose originally considered.
Faron has accepted the recommendation and will expand part 1 of Matins to around 30 patients to find an optimal dose before proceeding to part 2. Once part 1 is over, five patients are to have been treated at each dose level. The expansion will not hinder Faron's US investigative new drug filing.
"We are encouraged by the guidance given by the Matins study [data monitoring committee]. Good safety was the first priority of part I and now we have obtained that status. We are also extremely happy to see that FP-1305 is very active at low doses and that the highest dose may not be the optimal. We believe that we can recruit these extra patients quickly to obtain additional data to select the optimal dose for expansion cohorts. If the optimal dose really is between 0.1-1.0 mg/kg, it provides an unusually high safety margin for stand-alone Clevegen treatment or in combination with other cancer therapies."
By Anna Farley; annafarley@alliancenews.com
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