HAMLET

Human Alpha-Lactalbumin Made LEthal to Tumor Cells

Clinical Trial In Patients With Bladder Cancer
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July 2018-June 2019
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July 2018-June 2019
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Why clinical trials matter?

The strategic goal of Hamlet Pharma is to develop novel cancer treatments for patients who currently lack therapeutic options. Conducting clinical trials is crucial to reach primary goals such as evaluating the therapeutic window for HAMLET in bladder cancer. We also aim to gain new insights that facilitate the drug development for Alpha1H and the diversification of our activities to include other indications.

The Phase I/II Clinical Trial In Patients With Bladder Cancer

Development Plan Achievements

The discovery of HAMLET defines a new class of cancer drugs with broad effects against cancers of different origin and a high degree of selectivity. Our aim is to prove the efficacy of HAMLET therapy and to develop drugs that kill tumour cells with greater precision than current drugs.

Outcome of the Phase I/II trial in patients with bladder cancer.

Hamlet Pharma Ltd. is making great progress and has just concluded the first part of a clinical trial in patients with bladder cancer. Drug development often takes many years, due to complex development and approval processes. Based on our extensive prior experience, the drug candidate, Alpha1H, has passed a number of important milestones in a relatively short time and with moderate cost.

The results of the clinical trial will be announced shortly.

The HAMLET Story

A research group in Lund, led by Professor Catharina Svanborg discovered in 1995 that a component of human breast milk kills tumor cells without harming mature, healthy cells.

Since the discovery, the research team has successfully worked to characterize the HAMLET structure, its mechanisms and treatment effects in animal models and in patients. HAMLET´s tumor killing abilities have since the discovery been confirmed by several international research groups working on different aspects of HAMLET.

The research results have been published in prestigious journals like The New England Journal of Medicine, GUT, Nature Reviews Gastroenterology and PNAS (Proceedings of the National Academy of Science, USA).

About Hamlet Pharma

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 (more than 40 different types of cancer cells) and is active in multiple oncology and dermatology indications.
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.
A large scale, GMP certified manufacturing process is in place.
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.
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.
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.
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.
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.
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.

News

HAMLET has been featured in a range of articles across the world. See more news

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