Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company
Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company
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BelinostatSpectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

An HDAC inhibitor

Target Indications

  • Peripheral T-Cell Lymphoma (PTCL)
  • Carcinoma of Unknown Primary (CUP)
  • Non-Small Cell Lung Cancer (NSCLC)
  • Other solid tumors and hematological malignancies

Route of Administration

  • IV
  • Oral

Mode of Action

Belinostat (PXD 101) is an HDAC inhibitor in late stage clinical development with more than 1,000+ patients treated to date. Belinostat is believed to inhibit enzymatic activity of class 1 and class 2 HDACs. Belinostat is also believed to increase in acetylation of both histone and histone proteins, resulting in cell cycle arrest, apoptosis and a decrease in cell proliferation.

Status

Currently in a Pivotal study in PTCL.

In clinical trials, belinostat has shown that it may be well-tolerated which allows for combination with traditional chemotherapy without causing excessive bone marrow toxicity. In pre-clinical studies belinostat has shown to be active against multiple cancers by inhibiting cell proliferation (inhibiting cancer growth) and inducing programed cell death ("apoptosis") in tumor cells (the tumor cells are forced to self-destruct).

Belinostat has been evaluated in a number of Phase 1 and 2 clinical trials in hematological cancers and solid tumors. Data from these trials have provided for the anti-tumor 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 and non-small cell lung cancer (NSCLC).

To date, in clincal trials, belinostat has shown a favorable safety profile at full dose. As such, it is being investigated in high doses not only alone, but also in drug combinations. In preclinical tumor models, belinostat is active in cancer cells that have become resistant to existing chemotherapies. Belinostat could add substantial treatment value to several important drug combinations.

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Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

Market OpportunitiesSpectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

Spectrum Pharmaceuticals - Belinostat for PTCL

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 the NCI, and all trials are born from laboratory data showing the most favorable 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 other HDAC inhibitors. Belinostat has also exhibited a favourable safety profile.

Registrational Strategy

Belinostat is currently being evaluated in multiple indications, including a study for PCTL. The carboplatin/paclitaxel combination represents the standard of care for a number of significant cancer indications, including NSCLC and CUP, and therefore represents future registration opportunities for belinostat as the belinostat/carboplatin/paclitaxel (BelCaP) combination.