HAMLET offers a unique vision for the improvement of cancer-specific therapies.
HAMLET is a tumoricidal protein-lipid complex, formed by two GRAS (generally regarded as safe) molecules present in human milk. The novel therapeutic entity HAMLET is formed when the human milk protein alpha-lactalbumin undergoes a conformational change and binds to oleic acid.
HAMLET kills cancer cells of different origins (>40 different types of cancer cells) and is active in multiple oncology and dermatology indications.
HAMLET does not kill healthy differentiated cells in the laboratory and has not shown toxicity against healthy tissues in animal models or clinical studies. Instead, HAMLET accumulates specifically in tumor tissues in these models.
Remarkably, HAMLET identifies conserved unifying characteristics of cancer cells. HAMLET acts through a broad attack on membrane constituents and multiple intracellular targets with conserved structural motifs. These mechanisms differ from molecules targeted by most traditional monoclonal antibody or small molecule-based therapeutics.
HAMLET has been shown to be safe and effective in man as demonstrated in two proof-of-concept human clinical trials. Convincing therapeutic efficacy was demonstrated in a topical skin papilloma study and in patients with bladder cancer, HAMLET induced rapid shedding of dead tumor cells and a reduction in tumor size after one week. Therapeutic effects have also been demonstrated in several animal cancer models, including glioblastoma, bladder cancer and most recently, colon cancer.
HAMLET addresses serious unmet medical needs in multiple large oncology markets, including colon cancer, bladder cancer, cervix cancer and brain tumors (primary or metastatic) and may qualify for Orphan Disease and Fast Track Status with the FDA.
Intellectual Property includes composition of matter, manufacturing and use patents for HAMLET as well as second-generation HAMLET molecules and manufacturing procedures. Patents have been granted in the US and Europe.
A large scale, GMP certified manufacturing process is in place.
Partnering/Licensing: Oncology is the top therapeutic area for licensing and partnering by pharmaceutical companies. Efficient and suitable strategies for the immediate financing of HAMLET’s development and for future partnering are needed.
Selective and efficient tumor cell removal would present a unique basis for cancer therapy. HAMLET has shown remarkable efficiency and selectivity in several cancer models. We therefore aim to develop HAMLET by producing large quantities under industrial conditions, by extending the clinical trials and by defining HAMLET to fulfill the regulatory and toxicological requirements for a marketable drug.