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HAMLET Pharma initiates a GLP study to evaluate if intracerebral infusion of the drug candidate Alpha1H has any toxic effects

By December 18, 2019 February 17th, 2020 No Comments

Press Release, Lund December 18, 2019

Hamlet Pharma is on track with its plans to engage in a clinical trial of Alpha1H for the treatment of brain tumors. It is anticipated that Alpha1H will be infused intracerebrally for at least one week in humans in order to evaluate its effects on the disease, either alone or in combination with other drugs. To assess the risk of side effects in clinical studies, it is necessary to first determine whether infusions of Alpha1H cause any adverse effects in animal brain tissue.

The toxicology study will be performed by Adlego Biomedical; a specialist company that has extensive experience in this field and is certified as a GLP (Good Laboratory Practice) provider. Adlego has previously performed toxicology studies of Alpha1H in preparation for the Phase I/II bladder cancer trial and the dose-escalation study, without evidence of any toxic effects.

Severe brain tumors such as glioblastomas are often therapy resistant and recurrence rates remain high, despite surgery, radiation and chemotherapy. Novel, more efficient treatment options are therefore needed. Hamlet Pharma is planning to start clinical studies in brain tumor patients after completion of the necessary preparations including toxicology, approvals from relevant authorities and ethics committees.


For more information, please contact

Catharina Svanborg, Chairman and founder of Hamlet Pharma, +46-709 42 65 49

catharina.svanborg@med.lu.se

Mats Persson, CEO Hamlet Pharma, +46-705 17 67 57

mats.persson@hamletpharma.com

About HAMLET Pharma
HAMLET Pharma, listed on Spotlight, develops drugs based on the unique tumoricidal protein-lipid complex, HAMLET, formed by two natural and harmless molecules found in breast milk. Development focuses primarily on drugs, for the treatment and prevention of cancer. HAMLET kills tumour cells and has proven safe in proof-of-concept studies in animal models. Alpha1H is the synthetic variant of HAMLET, which has enabled development of the agent for clinical trials. Alpha1H kills different types of tumour cells and has demonstrated therapeutic effects on bladder cancer in animal models. Hamlet Pharma has one ongoing Phase I/II clinical trial with Alpha1H in patients with bladder cancer, a costly form of cancer that is difficult to treat, and intends to expand its activities into other types of cancer. The first results from the ongoing clinical Phase I/II study shows no side effects of Alpha1H, indicating that the treatment is safe and well tolerated. Alpha1H also demonstrated clinical efficacy compared with patients who received placebo.

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