Full speed ahead! – Hamlet Pharma adapts the clinical trial program for stand-alone use

Hamlet Pharma develops new drug candidates to treat cancer without causing significant side effects. The drug candidate Alpha1H shows specificity for tumor tissue, where it accumulates and triggers cancer cell death. The anti-tumor effects of Alpha1H have been documented in a placebo-controlled clinical trial of bladder cancer and the effects on the tumor increased with a higher dose of the drug, as demonstrated in a dose-escalation study. There were no drug-related side effects in the treated patients; a very unusual result of cancer therapy.

Hamlet Pharma is now taking one more step towards the design of the Phase III clinical trial protocol. The positive effects on the tumor and  the lack of side effects of the higher dose make it possible to add a second treatment round after the completion of the first round of treatment in the ongoing study. The aim is to optimise the tumor response by introducing repeated treatments; a likely reality in a future clinical scenario. This approach will be tested in a limited number of patients and will not delay the regulatory process.

Preliminary results from the combination study have suggested that Alpha1H is suitable for development as a stand-alone drug candidate. Patients in the combination study, who received Alpha1H in combination with the chemotherapeutic drug epirubicin, showed evidence of side effects, even though a low dose of epirubicin was used. There was no evidence of improved efficacy of the combination treatment compared to Alpha1H alone. For ethical and clinical reasons, Hamlet Pharma has therefore decided not to continue the combination study and instead continue the clinical program with the repeated treatment protocol. These decisions strengthen Hamlet Pharma’s position as a company developing drug candidates with a more beneficial profile than traditional chemotherapeutic drugs.

’’It is essential to balance the benefits of cancer therapy against the risk for side effects. Our advantage is an efficient drug candidate with low toxicity’’, says Catharina Svanborg.