News
Company News: InDex Pharmaceuticals Reports Completion of Patient Recruitment in Phase III Ulcerative Colitis Study (COLLECT) with Kappaproct®
InDex Pharmaceuticals today announced the completion of patient enrollment for its Phase III COLLECT study of Kappaproct. The multinational, randomized, double-blind, placebo-controlled study reached the recruitment goal of 120 patients with treatment-refractory Ulcerative Colitis (UC). InDex is expecting final study results in mid-2014.
The Phase III trial is designed to assess Kappaproct’s efficacy and safety in treatment-refractory UC patients. This cohort consists of chronic active UC patients who have failed all currently available pharmaceutical treatment and whose only remaining treatment option is surgical removal of the colon. This is a rare group of patients with a very high unmet medical need. Kappaproct has an Orphan Drug Designation in Europe.
The study is conducted in seven European countries. The primary endpoint of the study is the induction of clinical remission at week 12. Secondary endpoints, among others, are the rate of and time to colectomy. The patients will be followed for a total of 52 weeks.
Kappaproct is a DNA-based immunomodulatory sequence (DIMS) targeting the toll-like receptor 9 (TLR9). Kappaproct has shown positive effects on key symptoms of UC such as stool frequency, blood in stool and mucosal healing in a previous phase II proof-of-concept study. Kappaproct has also demonstrated a favorable safety and side effect profile in previous clinical trials.
Company News: Prof. Cornelis Melief to Present Novel AMPLIVANT™ Platform at AACR Annual Meeting 2013
ISA Pharmaceuticals B.V., a clinical-stage biopharmaceutical company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced that Prof. Cornelis Melief, M.D., will present details on the novel AMPLIVANTTM platform at this year’s American Association for Cancer Research (AACR) Annual Meeting. AMPLIVANTTM is based on a powerful, proprietary toll-like receptor (TLR) ligand improving immunotherapies.
Presentation title: “Synthetic vaccine for immunotherapy of high risk HPV infections“
Symposium: SY27 “New Cancer Vaccines“
Abstract number: SY27-01
Date: April 9, 2013, at 10:40 a.m.
Location: Room 202 at the Washington Convention Center.
The abstract is available at the AACR website www.aacr.org.
Company News: Merus Further Expands R&D Capacity
– Company Contracts R&D Service Provider FairJourney Biologics –
Merus B.V., a biopharmaceutical company focusing on innovative human antibody therapeutics, today announced that it has significantly expanded its capabilities to generate large collections of distinct, unique bispecific antibodies against target combinations.
Under an agreement signed with R&D service provider FairJourney Biologics, Merus will strengthen its R&D resources for selecting the most promising common light chain antibodies generated by its MeMo® transgenic mouse. These antibodies are then formatted into full-length bispecific IgG antibodies – called Biclonics™ – that can be further tested in high-throughput cell-based assays.
Company News: Curetis AG Strengthens Commercial Team and Expands Distribution Network
– Appointment of Helmut Hilbert as Head of Business Development
– Distribution Agreement with ELITech in Belgium and Luxembourg
Curetis AG today announced the appointment of Helmut Hilbert as Head of Business Development and the expansion of its distribution network into Belgium and Luxembourg by closing a distribution agreement with ELITech BNL (former Lucron Bioproducts), an ELITech Group company.
In order to strengthen its global commercial operations, Curetis has hired Dr. Helmut Hilbert, formerly Associate Director Corporate Business Development at Qiagen, as Head of Business Development. Helmut Hilbert has more than ten years of business and corporate development experience and built a strong track record in licensing, mergers and acquisitions, technology transfer and innovation management. At Qiagen, he was responsible for scouting novel technologies as well as evaluating potential acquisition targets and investment opportunities, including contract negotiation, due diligences and post-merger integration.
Moreover, Curetis has selected ELITech BNL as its Belgian and Luxembourgian distribution partner. ELITech BNL (former Lucron Bioproducts) has a long-standing track record as a distributor of quality diagnostic products and research supplies in the Benelux. Among others, the company supported the market entry of Cepheid into these countries. Acquired by the global in vitro diagnostics distributor ELITech Group in 2010, ELITech BNL is part of an extensive commercial network covering France, Italy, the UK and the rest of the world.