Spectrum Pharmaceuticals (NasdaqGM:SPPI), a commercial-stage
biotechnology company with a primary focus in oncology, today announced
that it has entered into a co-development and commercialization
agreement with TopoTarget A/S for Belinostat, a novel histone
deacetylase (HDAC) inhibitor. Belinostat is currently in a
registrational trial, under a Special Protocol Assessment (SPA), as a
monotherapy for relapsed or refractory Peripheral T-Cell Lymphoma
(PTCL), an indication in which it has been granted Orphan Drug and Fast
Track designation by the U.S. Food and Drug Administration (FDA).
Belinostat is also under investigation in a randomized Phase 2 trial, as
a combination therapy with carboplatin and paclitaxel, for cancer of
unknown primary (CUP). Additionally, the NCI is currently conducting
several clinical trials of Belinostat in a variety of hematological and
solid tumors, both as monotherapy as well as combination therapy.
“We believe that this partnership will bring together synergies in our
combined capabilities that will result in significant efficiencies in
Belinostat’s development”
“The addition of Belinostat addresses our key strategic goal of
in-licensing a late-stage anti-cancer compound,” said Rajesh C.
Shrotriya, MD, Chairman, Chief Executive Officer, and President of
Spectrum Pharmaceuticals. “With this collaboration, we have now
completed our strategic initiatives relating to in-licensing of
compounds with near term commercialization opportunities. Belinostat’s
current registrational program is comprehensive and focused in that it
targets key hematological indications such as PTCL and other solid tumor
indications. Belinostat has the potential to be a best-in-class HDAC
inhibitor for both hematological and solid tumors. We look forward to
advancing Belinostat in PTCL and other solid tumor indications, with the
goal of providing cancer patients with more effective treatment options
as quickly and efficiently as possible. With that goal in mind, we
currently expect to file the NDA in PTCL in 2011. TopoTarget has laid a
solid foundation from which we will further develop Belinostat.”