Cancer Study to Continue at SPPI - Analyst Blog
April 04 2011 - 10:20AM
Zacks
Recently, Spectrum Pharmaceuticals Inc. (SPPI)
announced that it will continue evaluating its cancer candidate
belinostat based on the recommendation of the independent Data
Monitoring Committee (DMC).
Spectrum Pharma is currently studying belinostat for treating
patients suffering from relapsed or refractory peripheral T-Cell
lymphoma (PTCL) in a phase II pivotal trial (BELIEF). Spectrum
Pharma is evaluating belinostat as a monotherapy in the study. The
committee conducted a safety and futility analysis of the interim
data from the study before recommending its continuation until 100
evaluable subjects are enrolled.
Spectrum Pharma is conducting the study under a Special Protocol
Assessment (SPA) with the US Food and Drug Administration (FDA).
Spectrum Pharma intends to seek approval of belinostat from the FDA
in 2011/2012.
We believe that if belinostat is successfully developed and
commercialized for the indication then the top line at Spectrum
Pharma would be boosted significantly since the PTCL market has a
huge unmet need. Allos Therapeutics’ (ALTH)
Folotyn is currently the only FDA approved therapy for treating
patients suffering from relapsed or refractory PTCL.
Apart from the BELIEF study, Spectrum Pharma is also evaluating
belinostat in a mid-stage study (as a combination therapy) for
treating patients suffering from cancer of unknown primary
(CUP).
We note that a key action date (April 29, 2011) is coming up at
Spectrum Pharma later in the month when the FDA is expected to
decide on Fusilev (levoleucovorin) for treating patients suffering
from metastatic colorectal cancer.
We note that Fusilev is already available in the US markets for
rescue in osteosarcoma (a form of bone cancer) patients following
treatment with a high-dose of chemotherapy drug, methotrexate.
Fusilev is also approved to diminish the toxic effects of
methotrexate and counteract the effects of impaired methotrexate
elimination and unintentional excessive dosage of folic acid
antagonists. In ex-US territories, Fusilev is marketed by
Pfizer (PFE), Sanofi-Aventis
(SNY) and Takeda, among others.
Apart from Fusilev, Spectrum Pharma’s other FDA approved product
is Zevalin, meant for treating patients suffering from
non-Hodgkin’s lymphoma (NHL). Moreover, Spectrum Pharma has a deep
pipeline primarily focused on oncology and hematology.
Our Recommendation
Currently, we are Neutral on Spectrum Pharma which is supported
by the Zacks#3 Rank (short-term Hold rating) carried by the
company.
ALLOS THERAPEUT (ALTH): Free Stock Analysis Report
PFIZER INC (PFE): Free Stock Analysis Report
SANOFI-AVENTIS (SNY): Free Stock Analysis Report
SPECTRUM PHARMA (SPPI): Free Stock Analysis Report
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