SAN DIEGO, CA, USA I December 8, 2014 I Sevion Therapeutics (OTCQB:SVON), a biopharmaceutical company which discovers, develops and acquires next-generation biologics for the treatment of cancer and immunological diseases, today announced the presentation of results from the Company’s Phase 1b/2a clinical trial of SNS01-T for the treatment of multiple myeloma and lymphoma. The results were presented in a poster session titled “Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster III” at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition in San Francisco.
The study, “Mature Results of a Phase 1-2 Open-Label, Dose-Escalation Study of Intravenous SNS01-T in Patients with Relapsed or Refractory B Cell Malignancies,” was an open-label, multiple-dose, dose-escalation study to evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to patients with relapsed or refractory multiple myeloma, mantle cell (MCL) or diffuse large B-cell lymphoma (DLBCL). The primary objective of the study was to evaluate safety and tolerability. Secondary objectives included pharmacokinetics, tumor response markers, and time to relapse or progression.
Of 22 patients treated, 14 patients were evaluable for dose limiting toxicity. Of four dose cohorts tested, the maximum tolerated dose was determined to be the third dose group, at 0.2 mg/Kg. The most frequent adverse events were fatigue, infusion reaction, nausea, thrombocytopenia and chills, with no treatment related deaths. Two dose limited toxicities were observed in the fourth dose group (0.375 mg/Kg), including Grade 4 infusion reaction and Grade 4 neutropenia. Potential treatment effects were observed in cohorts 3 and 4, with a 44% reduction in sum of product of tumor diameter in 1 of 3 lymphoma patients lasting 30 weeks; a 15% and 33% reduction in serum and urine monoclonal proteins (SPEP and UPEP), and a 19% free light chain (FLC) ratio decrease lasting 10 weeks in one of two patients with multiple myeloma enrolled in cohort 3; and a 21-30% UPEP reduction and 0-42% FLC ratio decrease lasting 3 to 6 weeks in 2 of 6 evaluable patients with multiple myeloma in cohort 4.
“Modulation of Factor 5A has the potential to regulate programmed cell death and improve patient outcomes in B-cell Lymphoma and other cancers,” said Ronald Martell, CEO of Sevion. “While we assess a path forward for SNS01-T, we will continue to focus our resources on our novel antibody technologies.”
About Sevion Therapeutics
Sevion Therapeutics is a biopharmaceutical company building and developing a portfolio of innovative therapeutics, from both internal discovery and acquisition, for the treatment of cancer and immunological diseases. The Company’s product candidates are derived from multiple key proprietary technology platforms: cell-based arrayed antibody discovery, ultralong antibody scaffolds and Chimerasome nanocages. Sevion has leveraged these technologies to build a pipeline of innovative product candidates. For more information, please visit SevionTherapeutics.com.
SOURCE: Sevion Therapeutics
Post Views: 94
SAN DIEGO, CA, USA I December 8, 2014 I Sevion Therapeutics (OTCQB:SVON), a biopharmaceutical company which discovers, develops and acquires next-generation biologics for the treatment of cancer and immunological diseases, today announced the presentation of results from the Company’s Phase 1b/2a clinical trial of SNS01-T for the treatment of multiple myeloma and lymphoma. The results were presented in a poster session titled “Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster III” at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition in San Francisco.
The study, “Mature Results of a Phase 1-2 Open-Label, Dose-Escalation Study of Intravenous SNS01-T in Patients with Relapsed or Refractory B Cell Malignancies,” was an open-label, multiple-dose, dose-escalation study to evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to patients with relapsed or refractory multiple myeloma, mantle cell (MCL) or diffuse large B-cell lymphoma (DLBCL). The primary objective of the study was to evaluate safety and tolerability. Secondary objectives included pharmacokinetics, tumor response markers, and time to relapse or progression.
Of 22 patients treated, 14 patients were evaluable for dose limiting toxicity. Of four dose cohorts tested, the maximum tolerated dose was determined to be the third dose group, at 0.2 mg/Kg. The most frequent adverse events were fatigue, infusion reaction, nausea, thrombocytopenia and chills, with no treatment related deaths. Two dose limited toxicities were observed in the fourth dose group (0.375 mg/Kg), including Grade 4 infusion reaction and Grade 4 neutropenia. Potential treatment effects were observed in cohorts 3 and 4, with a 44% reduction in sum of product of tumor diameter in 1 of 3 lymphoma patients lasting 30 weeks; a 15% and 33% reduction in serum and urine monoclonal proteins (SPEP and UPEP), and a 19% free light chain (FLC) ratio decrease lasting 10 weeks in one of two patients with multiple myeloma enrolled in cohort 3; and a 21-30% UPEP reduction and 0-42% FLC ratio decrease lasting 3 to 6 weeks in 2 of 6 evaluable patients with multiple myeloma in cohort 4.
“Modulation of Factor 5A has the potential to regulate programmed cell death and improve patient outcomes in B-cell Lymphoma and other cancers,” said Ronald Martell, CEO of Sevion. “While we assess a path forward for SNS01-T, we will continue to focus our resources on our novel antibody technologies.”
About Sevion Therapeutics
Sevion Therapeutics is a biopharmaceutical company building and developing a portfolio of innovative therapeutics, from both internal discovery and acquisition, for the treatment of cancer and immunological diseases. The Company’s product candidates are derived from multiple key proprietary technology platforms: cell-based arrayed antibody discovery, ultralong antibody scaffolds and Chimerasome nanocages. Sevion has leveraged these technologies to build a pipeline of innovative product candidates. For more information, please visit SevionTherapeutics.com.
SOURCE: Sevion Therapeutics
Post Views: 94
