Thymus cancer drug belinostat undergoes clinical studies: Spectrum Pharma

Belinostat, an experimental drug to be used in combination to treat cancer of the thymus gland, will soon undergo human studies.

Belinostat (PXD 101) is a novel histone deacetylase (HDAC) inhibitor that is being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers.

Belinostat in combination with cisplatin, doxorubicin and cyclophosphamide is being studied as the first line treatment of advanced or recurrent thymic malignancies.

Spectrum Pharmaceuticals, Inc and TopoTarget A/S, announced that the first patient has been dosed in a National Cancer Institute (NCI)-sponsored phase-1/2 trial of  The trial is designed to determine what drug doses can be safely administered together in patients, and to make dose recommendations for future clinical trials.

This trial is among the first to test the feasibility of simultaneously administering a histone deacetylase (HDAC) inhibitor, such as belinostat, with common chemotherapy agents such as cisplatin, doxorubicin, and cyclophosphamide, in the first line treatment of advanced or recurrent thymic malignancies. The study is expected to recruit between 30 and 48 evaluable patients.

“We are pleased that the NCI continues to investigate the use of belinostat in the treatment of various cancers,” said Rajesh C Shrotriya, chairman, chief executive officer, and president of Spectrum Pharmaceuticals.

Belinostat has the potential to be an effective treatment in combination with existing chemotherapeutic agents for the treatment of thymomas, thymic malignancies, and other cancers, Mr Shrotriya said.

Belinostat is currently in registrational trial, under a Special Protocol Assessment (SPA), as a monotherapy for Peripheral T-Cell Lymphoma (PTCL), an indication which has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration (FDA).

The registrational trial is in an open-label, multicenter, single arm efficacy and safety study in patients with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy. The primary endpoint is objective response rate (ORR).

What is thymus cancer?

Thymus cancers are uncommon cancers that start in the thymus. This small organ is located just behind the breast bone in the front part of the mediastinum, the space in the chest between the lungs. The thymus is an important part of the body’s immune system.

During fetal development and childhood, the thymus is involved in the production and maturation of T lymphocytes (also known as T cells), a type of white blood cell. T lymphocytes develop in the thymus and then travel to lymph nodes (bean-sized collections of immune system cells) throughout the body.

There they help the immune system protect the body from viruses, fungus, and other types of infections. The thymus contains different types of cells, each of which can develop into different types of cancer: Epithelial cells give the thymus its structure and shape. They can give rise to thymomas and thymic carcinomas; Lymphocytes make up most of the rest of the thymus.

Whether in the thymus or in other parts of the body, these immunes system cells can develop into cancers called Hodgkin disease and non-Hodgkin lymphomas; and Kulchitsky cells, or neuroendocrine cells, are much less common cells that normally release certain hormones. These cells can give rise to cancers called carcinoid tumors. Thymomas and thymic carcinomas are tumors that start from thymic epithelial cells.

TopoTarget A/S is an international biotech company headquartered in Denmark, dedicated to finding ”Answers for Cancer” and developing improved cancer therapies.

Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in oncology and haematology.