Brain tumor therapy – a new cancer indication for HAMLET Pharma

Newsletter, 20 March 2018

The prognosis of malignant brain tumors remains dim, even though the development of effective therapies is a priority area both in academia and industry. Ondanks een aggressief behandelingsprotocol bestaande uit operatie, straling en chemotherapie, de mediane overleving is slechts ongeveer 15 maanden. De mislukking van huidige therapies is gedacht aan reflectie van de intrinsieke drug en stralingsweerstand van de tumorcellen, de toxiciteit van de drugs voor normale hersenweefsel, en slechte doping door de bloedstroom via de bloed-hersenbarrière. Videre, de tumorceller er ekstremt invasive, og på tidspunktet for diagnosen, har tumoren spredt over hele hjernen og kan ikke være fuldstændigt fjernet ved kirurgi.

De eigenschappen van HAMLET suggereren dat het mogelijk zou zijn om sommige van de problemen van hersentumatotherapie te overbruggen en moet een voortgang in de richting van klinische studies in bepaalde patientgroepen mogelijk maken. HAMLET shows high tumor specificity, appears to overcome the intrinsic resistance of brain tumor cells, has not shown toxicity for normal brain tissue and can be administered directly to the tumor tissue without having to pass the blood-brain barrier.

Hamlet Pharma’s interest in brain tumor therapy is based on successful preclinical research. Early studies showed that Hamlet effectively kill brain tumor cells in the laboratory, including cells that are the most difficult to treat with conventional methods. Hamlet also works therapeutically against human tumors in an animal model, where tumor cells grow invasively in the rat brain. We observed a marked reduction in tumor volume and an increased survival time in HAMLET treated animals compared to the control group, which received an inactive substance.

A second advantage of HAMLET is the diffusion of the substance throughout the brain. If brain tumor cells are known for their invasive properties and spread to remote areas of the brain, an ideal therapeutic agent should be administered along the migratory routes of the tumor cells. In voorbereiding voor toekomstige klinische studies hebben we daarom de weefselverdeling van infused HAMLET onderzocht. HAMLET was shown to enter the brain tissue and to spread throughout the injected hemisphere. During infusion, no neurological symptoms or side effects were observed.

In conclusion, de resultaten laten zien uitstekende drug penetratie, geen toxiciteit in het omliggende hersenweefsel, verminderde tumorvolume en verlengde overleving van behandelde dieren als vergeleken met de controles.

Hamlet Pharma is currently exploring partnerships to develop Alfa1H-based treatments for new cancer indications, especially in the area of brain tumors. Specifically, new therapeutic technologies will be required to evaluate the safety and efficacy of Alpha1H as an intra-tumoral infusion in patients with recurrent malignant gliomas. In preparation for clinical development, it is important to show that Alfa1H is as effective and non-toxic properties as HAMLET in experimental brain tumor therapy. Due to the successful development of the production and regulatory portfolio of HAMLET for the bladder cancer study, many critical steps have already been initiated.

 

For more information, 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

 

Hamlet Pharma company listed on AktieTorget, is a company engaged in drug development based on a tumoricidal protein-lipid complex, HAMLET, formed by two natural and harmless molecules found in breast milk. The development aims to develop drugs that primarily will be used for the treatment and prevention of cancer. HAMLET effectively kills tumor cells but have also proven to be safe in the proof-of-concept studies done on humans. The substance has demonstrated therapeutic effect on skin papillomas in a placebo-controlled clinical trial and causes shedding of dead cancer cells by injection into the bladder in patients with bladder cancer. Hamlet Pharma intends to initiate a phase II study with Alpha1H in patients with bladder cancer, a difficult and costly cancer form. HAMLET is a registered trademark of Hamlet Pharma.