Clinical Trials

* On June 13, 2014, Noxxon Pharma presented updated interim data sets from independent clinical Phase IIa studies of the anti-CXCL12/SDF-1 Spiegelmer® olaptesed pegol (NOX-A12) at the 19th Congress of the European Hematology Association (EHA) in Milan, Italy, from 12-15 June 2014. In afirst study, olaptesed pegol was administered to 28 relapsed chronic lymphocytic leukemia (CLL) patients in combination with bendamustine and rituximab (BR). Olaptesed pegol treatment resulted in an effective and prolonged mobilization of CLL cells into the peripheral blood. This mobilization reflects olaptesed pegol’s ability to block tumor-microenvironment interactions, which is thought to increase tumor cell sensitivity to killing by chemotherapeutic agents. To date, 20 patients have been evaluated for response at the end of therapy, with 4 patients (20%) achieving a complete response (CR) and 13 patients (65%) achieving a partial response, the overall response rate (ORR) was 85%. Compared to historical data, olaptesed pegol compares favorably to BR baseline therapy with regards to overall response rate and shows an increased rate of complete responses. Moreover, the evaluation of baseline characteristics indicated that relapsed / refractory patients were enrolled into the study, which underlines the clinical relevance of the observed effects and warrants further development of this anti-CXCL12 Spiegelmer® in CLL. The title and contributors for the above mentioned poster presentations at EHA are as follows: Abstract P244 - INTERIM RESULTS FROM A PHASE IIA STUDY OF THE ANTI-CXCL12 SPIEGELMER® OLAPTESED PEGOL (NOX-A12) IN COMBINATION WITH BENDAMUSTINE/RITUXIMAB IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA. Michael Steurer, Lydia Scarfò, Marco Montillo, Ann Janssens, Francesca Mauro, Livio Trentin, Josef Thaler, Sonja Burgstaller, Anna Kruschinski, Thomas Dümmler, Kai Riecke, Paolo Ghia, Federico Caligaris-Cappio, Marco Gobbi.

* On December 9, 2013, Noxxon Pharma disclosed interim data from two independent clinical phase IIa studies of the anti-CXCL12/SDF-1 Spiegelmer olaptesed pegol (NOX-A12) at the 55th annual meeting of the American Society of Hematology (ASH) in New Orleans, LA, USA from 7-10 December 2013. In the first study, olaptesed  was administered to relapsed chronic lymphocytic leukemia (CLL) patients in combination with bendamustine and rituximab. In this trial, olaptesed treatment resulted in an effective and prolonged mobilization of CLL cells into the peripheral blood. This mobilization reflects olaptesed’s ability to block tumor-microenvironment interactions, which is thought to increase tumor cell sensitivity to killing by chemotherapeutic agents. In addition, the 100% overall response rate (ORR) and 22% complete response (CR) rate as well as the virtual absence of additional toxicity on top of the treatment with bendamustine and rituximab (BR) observed in this pilot group compares very favorably with historical controls. Provided that this promising clinical picture is maintained in the total sample of 33 patients, Noxxon plans to further develop this novel anti-CXCL12/SDF-1 Spiegelmer.

(presentation and abstract: Anti-CXCL12/SDF-1 Spiegelmer NOX-A12 Alone and In Combination With Bendamustine and Rituximab In Patients With Relapsed Chronic Lymphocytic Leukemia (CLL): Results From A Phase IIa Study. Marco Gobbi, Michael Steurer, Federico Caligaris-Cappio, Marco Montillo, Ann Janssens, Livio Trentin, Thomas Dümmler, Stefan Zöllner, Stefan Zeitler, Kai Riecke, Anna Kruschinski and The SpiegelmerNOX-A12 Abrogates Homing of Human CLL Cells To Bone Marrow and Mobilizes Murine CLL Cells in the E?-TCL1 Transgenic Mouse Model Of CLL. Elisabeth Hinterseer, Tamara Girbl, Evelyn Hutterer, Petra Berghammer, Sylvia Ganghammer, Eveline Sifft, Josefina Pinon Hofbauer, Alexander Egle, Anna Kruschinski, Richard Greil, Tanja Nicole Hartmann).