Fina nyheter om att doseskaleringsstudien snart är igång och att man avser köra en kombinationsstudie också i Prag. Titta också på bilderna i nyhetsbrevet! Fascinerande effekt!
The necessary and technically challenging production of substance for higher doses of Alpha1H and the formulation for the dose escalation study are now complete, and the final quality controls are ongoing to ensure compliance with current guidelines. In addition, the clinic in Prague has been initiated and is ready to include patients, as soon as the study medication is released.
Alpha1H shows significant promise as a new and effective cancer drug with low toxicity, and is under active development as a stand-alone drug candidate. In addition, a new pre-clinical discovery shows that Alpha1H improves the therapeutic efficacy of conventional cancer drugs.
These new findings widen the potential to use Alpha1H in bladder cancer and other cancer indications. Combination therapy is widely used in cancer patients, to increase efficacy and reduce the amount of each toxic substance. Hamlet Pharma expects that this approach will broaden the use and reduce the time to market for Alpha1H.
Recently, a preliminary statement from the Czech authority, SUKL, indicated that it will be possible to include combination therapy as one more variable in the ongoing bladder cancer study, in addition to the analysis of Alpha1H alone. A substantial amendment will therefore be submitted shortly for formal approval. This approach would offer a strategic advantage for progression to phase III clinical trials, and ultimately for approval by international pharmaceutical regulatory bodies such as the FDA.