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Belinostat

Peripheral T-Cell Lymphoma
Carcinoma of Unknown Primary (CUP)
Others

IV
Oral

Belinostat (PXD 101) is a novel HDAC inhibitor in late stage clinical development with more than 700+ patients treated to date. Belinostat has shown to be well tolerated which would allow for combination with traditional chemotherapy without causing further bone marrow toxicity. In pre-clinical trials belinostat has shown to be effective against multiple cancers by inhibiting cell proliferation (inhibiting cancer growth) and inducing programed cell death (“apoptosis”) in tumour cells (the tumour cells are forced to self-destruct).

Currently in a Pivotal study in PTCL.
Belinostat has been tested in a number of Phase I/II clinical trials in haematological cancers and solid tumours. Data from these trials has provided proof for the anti-tumour effect of belinostat as monotherapy in peripheral T-cell lymphomas (PTCL) and in combination with other anti-cancer drugs for the treatment of multiple types of cancer including CUP,NCSLC, etc.

The drug has shown a very low toxicity at full dose. As belinostat has limited toxicity in patients, the drug is being investigated in high doses not only alone, but also in drug combinations. In preclinical tumor models, belinostat is active in cancer cells with resistance to existing therapies and belinostat could add substantial treatment value to several important drug combinations.

Continued support from the National Cancer Institute (NCI) has helped build a comprehensive program which has identified the optimal development route for belinostat. The development of belinostat is planned in collaboration with NCI, and all trials are born from laboratory data showing the most favourable methods of use and combinations.

Based on available data so far, Spectrum believes that belinostat has the potential to become the “best in class” HDAC inhibitor. The efficacy of belinostat noted in ongoing clinical trials is likely to be linked to the high blood concentrations of drug achieved using intravenous (“IV”) dosing. This high blood concentration may not be attainable for “oral only” HDAC inhibitors. Belinostat also has shown to exhibits a favourable safety profile compared to other HDAC inhibitors at a similar stage of development.

Registrational program
Belinostat is currently being evaluated in multiple opportunities, including a study for PCT. The belinostat carboplatin/paclitaxel combination represents the standard of care for a number of significant cancer indications, including non-small cell lung cancer (“NSCLC”), cancer of unknown primary (“CUP”), and represents future registration opportunities for belinostat as the BelCaP combination.

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