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Spectrum Pharmaceuticals, Orphan Drug Belinostat, And The J.P. Morgan Healthcare Conference

January 10, 2013

       On Wednesday, January 9, 2013, 7:30 AM PST/10:30 AM EST, Spectrum Pharmaceuticals gives a presentation at the J.P. Morgan Healthcare Conference in San Francisco. The presentation is given by Spectrum Pharmaceuticals’ Chairman, CEO & President, Rajesh Shrotriya, MD.

Here are a few highlights from the presentation for orphan drug Belinostat for the treatment of Peripheral T-Cell Lymphoma (PTCL) :

1) Belinostat FDA NDA filing by mid-2013 & FDA decision in 2014

2) PTCL facts :

– Aggressive disease with 6,000 new cases/year in US

– Patients usually cycle through > 3 lines of therapy with drugs yielding 20 – 30% Objective Response Rate (ORR), less than a year Progression Free Survival (PFS)

– Folotyn becoming Standard of Care (SOC); 1st approved PTCL treatment

3) Belinostat facts :

– ORR of at least 20% in most recent trial

– Currently in Pivotal study in PTCL

– Primary efficacy endpoint established under Special Protocol Assessment (SPA)

– At T-Cell Lymphoma Forum, 01/24 – 01/26/13, in San Francisco, will have presentation on complete safety evaluation.

Belinostat receives FDA Orphan Drug Designation (ODD) on September 3, 2009. The development of Belinostat is planned in collaboration with the National Cancer Institute (NCI).

References

Clinicaltrials.gov “Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)”

Spectrum Pharmaceuticals December 21, 2012 Press Release on Belinostat registrational Phase 2 BELIEF trial

Spectrum Pharmaceuticals Pipeline 

T-Cell Lymphoma Forum 01/24 – 01/26/13 Meeting Agenda

– Poster Presentation scheduled for 01/26/13 titled, “Belinostat in Relapsed and/or Refractory Peripheral T Cell Lymphoma (R/R PTCL): Preliminary safety results” to be given by O. O’Connor.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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