Tag: Phase II

Company News: Anergis Announces Completion of Treatment in AllerT Phase II Dose-Ranging Trial

–      213 patients included in trial of novel ultra-fast allergy immunotherapeutic

Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, today announced treatment completion of its Phase II clinical trial of AllerT, a novel long-peptide immunotherapeutic to treat birch pollen allergies. In the trial, 213 patients were randomized to receive target doses of 10, 25 or 50 µg of AllerT or placebo as 5 subcutaneous injections over 2 months. The last patient was treated at the end of March. No serious adverse events and no grade 3 or 4 allergic reactions were reported. The trial is being conducted in Canada and is still blinded. Results are expected in Q3 of 2015.

Company News: Micromet Initiates Global Phase 2 Trial of Blinatumomab in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia

Micromet, Inc. (NASDAQ: MITI) today announced that it has initiated a phase 2 trial of its lead product candidate blinatumomab (MT103) in adult patients with relapsed or refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.

This phase 2, single-arm study will evaluate the efficacy and safety of blinatumomab in approximately 65 patients with relapsed/refractory Philadelphia-negative B-precursor ALL. Patients will receive blinatumomab daily for 28 days followed by two weeks off blinatumomab over a six week treatment cycle. Patients who achieve a complete remission (CR) or complete response without full recovery of platelets (CRh*) within two cycles of treatment will receive up to three additional cycles of consolidation treatment. The primary endpoint of the study is CR/CRh*. Secondary endpoints include duration of response and overall survival. The study will be conducted at approximately 40 leading cancer centers in the U.S. and EU. The Company currently expects to complete enrollment in this trial by year end 2012.

Additional information regarding this Phase 2 study is available at the U.S. government’s clinical trials database at http://www.clinicaltrials.gov.

Blinatumomab Clinical Experience in Adult R/R ALL

Interim results from a Phase 2 trial presented at the 2011 Meeting of the European Hematology Association show that blinatumomab produced a high CR rate in adult patients with ALL who had relapsed following treatment with standard therapy. 75% of patients (9 of 12) achieved a CR or CRh* following treatment with blinatumomab1. All nine responding patients achieved a complete molecular response, or had no evidence of leukemic cells in their bone marrow, a key prognostic factor for patient survival. Notably, four patients with genetic abnormalities typically associated with poorer outcomes all achieved a CR or CRh*. The most common clinical adverse events were fever, peripheral edema and fatigue. Treatment of two of the twelve patients was interrupted due to fully reversible and manageable central nervous system (CNS) events.

Company News: SuppreMol Starts SM101 Dosing in the Context of SMILE Study

Australian study center treats first systemic lupus erythematosus (SLE) patients –

SuppreMol GmbH today announced the start of dosing in the context of the international SMILE study (SM101 In Lupus Erythematosus). The phase IIa, double-blind clinical trial of SM101, the lead compound of the company, involves patients suffering from Systemic Lupus Erythematosus (SLE).

The first patient was treated last month in Australia. Additional study centers in Belgium, Germany, France, Great Britain, Italy, the Netherlands, Poland, Spain, and the Czech Republic will commence patient treatment in the coming weeks. Over the course of one month, the study participants will receive placebo or two different doses of SM101 weekly.

SM101 is a soluble version of the Fc gamma receptor IIb, which binds to autoantibody/autoantigen complexes and thereby blocks the triggering of Fc receptors on the surface of immune cells.  SM101 has been studied in the context of a clinical phase Ib/IIa trial for the indication of Primary Immune Thrombocytopenia (ITP) since 2010. For this indication, the product is designated as a drug for rare medical conditions (“orphan drug”) in the European Union and in the United States.

Company News: SuppreMol Employs Protagen Biomarkers in SLE Study

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases and allergies, and Protagen AG, a specialist in in-vitro diagnostics and GMP-compliant protein analysis, today announced a collaboration to identify therapy-related biomarkers in patients with Systemic Lupus Erythematosus (SLE).

SuppreMol will use the biomarkers for the rapid identification of autoantibody signatures in the serum of SLE patients enrolled in the current phase IIa study of its lead product SM101. Thereby, the company hopes to identify patients who are most likely to respond favorable to SM101. Since SLE is a disease with very diverse manifestations, the findings may also allow for the classification of patients into subgroups .

Financial details of the collaboration are not disclosed. The cooperation as well as SuppreMol’s phase IIa SLE study are supported by the German Federal Ministry for Education and Research (BMBF) as part of the Leading Edge Cluster m4.

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