Spectrum Pharmaceuticals (SPPI) recently announced safety findings from the phase II BELIEF study on belinostat. Spectrum Pharma is developing belinostat (a pan-histone deacetylase (:HDAC) inhibitor) for the treatment of patients suffering from relapsed/refractory peripheral T-cell lymphoma (R/R PTCL).
Results showed that belinostat was safe among R/R PTCL patients including patients who received allogeneic or autologous stem cell transplant previously.
In Dec 2012, the company had announced that the BELIEF study, which was conducted under the US Food and Drug Administration’s Special Protocol Assessment program, met its primary endpoint of beating the objective response rate (:ORR) of at least 20% in R/R PTCL patients.
The company is currently evaluating the efficacy profile of the candidate. Spectrum Pharma expects to submit a New Drug Application (:NDA) for the candidate by mid-2013.
Meanwhile, Spectrum Pharma was recently in the news as the US Patent and Trademark Office (:USPTO) extended the patent covering its lead product Fusilev (levoleucovorin) for injection by more than two years from Dec 31, 2019 to Mar 7, 2022.
Fusilev is approved in combination with chemotherapy with 5-fluorouracil as a palliative treatment for patients suffering from advanced metastatic colorectal cancer. In ex-US territories, the product is marketed by Pfizer Inc. (PFE) and Sanofi (SNY) among others, under various trade names.
Spectrum Pharma carries a Zacks Rank #3 (Hold). Valeant Pharmaceuticals (VRX), carrying a Zacks Rank #1 (Strong Buy), currently appears to be more attractive in the pharma space. Where as Sanofi carries a Zacks Rank #2 (Buy).
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