Zacks_Analysts' Blog : Cancer Study to Continue at SPPI - Analyst Blog

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.