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Company News: Anergis Reports Positive Long-Term Clinical Efficacy of Lead Compound AllerT
– Field-based trial with 196 patients shows significant reductions in seasonal allergy symptoms
– Efficacy of AllerT in both dose groups maintained during the second birch pollen season
Anergis, a company developing proprietary ultra-fast allergy vaccines, today reported positive long-term efficacy results with its lead compound AllerT, a novel birch pollen allergy vaccine.
A total of 196 patients were enrolled in the Phase IIb follow-up, double-blind, placebo-controlled, field-based clinical trial. The trial objective was to evaluate the long-term efficacy of AllerT in patients who had participated last year in the field-based Phase IIb trial with AllerT. Patients evaluated this year either received a placebo, AllerT 50 µg or AllerT 100 µg 18 months before the second birch pollen season. No further investigational treatment was given after the initial randomization.
Subjects who had received AllerT showed persistent, statistically significant (p<0.05) and clinically meaningful (>20% difference from placebo) reductions in the primary (combined symptom and medication score) and main secondary endpoints (quality of life score and nighttime nasal symptoms). The results were remarkably consistent across all clinical endpoints and did not show meaningful differences between Year 1 and Year 2 clinical responses. In addition, the clinical effects of both doses were very similar.
Full results of the trial will be presented at an upcoming scientific conference.
In 2013, Anergis had already shown that patients from the AllerT Phase IIa trial had a long-lasting elevation in allergen-specific antibodies (IgG4) until at least the fourth post-treatment season.
Company News: ISA Pharmaceuticals Appoints Hendrik-Jan Laseur as Member of the Supervisory Board
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced the appointment of Hendrik-Jan Laseur to its Supervisory Board.
Hendrik-Jan Laseur has an outstanding track record in advising foundations, non-governmental organizations and financial institutions. Among others, he currently serves as a Board member of the Center for Public Integrity (Washington, DC, USA), as a member of the Advisory Board of SustainAbility (London, UK) and as a Board member of the Adessium Foundation (Rotterdam, The Netherlands).
Hendrik-Jan Laseur is the founder of Laseur – Lead the Change, an Amsterdam-based strategy advisory firm focused on supporting leaders in achieving lasting social impact of investments and business propositions. Clients include non-governmental organizations, civil society organizations, philanthropic foundations, financial institutions, and the United Nations.
Prior to founding Laseur in 2010, he was Principal Advisor of the Executive Director at UNICEF, where he worked on resource allocation, strategy, finance and funding issues.
From 1992 to 2007, Hendrik-Jan Laseur worked at ABN Amro Bank in a variety of leadership and advisory positions in Tokyo, Frankfurt, London, Amsterdam and Zurich, including roles as personal secretary to the Chairman of the bank, and as a member of the Executive Committee of ABN AMRO Switzerland.
Hendrik-Jan Laseur studied economics in Groningen and Rotterdam and holds an MBA from INSEAD.
Company News: ISA Pharmaceuticals Appoints Ronald Loggers as Chief Executive Officer
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced that the Company has hired Ronald Loggers, the former Chairman of ISA´s Supervisory Board, as Chief Executive Officer.
Previously, Ronald Loggers, M.Sc., MBA, was Managing Director of Multifund B.V., a family-owned investment firm and one of ISA’s major investors. Until June 2013, he served as the Chairman of the Supervisory Board and subsequently assumed the role of Acting CEO of ISA Pharmaceuticals.
From 1998 to 2005, Ronald Loggers worked for private equity firm HAL Investments. During that period, he served on several boards such as the Supervisory Board of Schreiner Luchtvaart Groep B.V., and as Managing Director for the production and logistics facilities of optical retailer Pearle Benelux. From 1993 until 1998, he worked for McKinsey & Company. From 1991 to 1992, he was a manager at the quality control laboratories of Fokker Aircraft’s Ypenburg plant. Ronald Loggers holds an MBA from INSEAD and an M.Sc. in Chemical Engineering from Delft University of Technology.
Company News: InDex Pharmaceuticals announces results from COLLECT, a clinical trial of Kappaproct® in the treatment of moderate to severe Ulcerative Colitis
InDex Pharmaceuticals today reported top-line results from the double blind, placebo-controlled clinical study COLLECT. The aim of the COLLECT study was to investigate the therapeutic potential of the Toll-like receptor 9 agonist Kappaproct as an add-on therapy for patients with moderate to severe, chronic active Ulcerative Colitis.
Patients treated with Kappaproct showed statistically significant improvement on symptomatic remission (blood in stool, number of stools), registration remission (clinical remission with concurrent endoscopic remission) and the rate of colectomy. The rate of clinical remission (Rachmilewitz Index) was high in both the Kappaproct and the control group and no statistically significant difference was observed on this measure. Kappaproct was well tolerated and no safety signals compared to the standard of care treatment group were evident.
In the COLLECT study, 131 patients with moderate to severe Ulcerative Colitis with inadequate response to conventional therapy received either Kappaproct or placebo as an add-on to conventional treatment. Concominant use of TNF-α inhibitors was excluded. The study was conducted at 40 sites in seven European countries.
Kappaproct was administrated as two single rectal doses, given at week 0 and week 4. The primary endpoint was clinical remission (Rachmilewitz/CAI score of ≤4) measured at week 12. There was an unexpectedly high remission rate in the control group and there was no statistically significant difference observed on this measure. Statistically significant effects were demonstrated on the secondary endpoints symptomatic remission (blood in stool = none, number of stools weekly <35) at week 4 and 8, on registration remission (Rachmilewitz/CAI score of ≤4, plus an endoscopic Mayo score of 0 or 1) at week 4 as well as on the rate of colectomy at week 22. The patients were followed for one year from the first dose to evaluate long-term efficacy and safety. More information about the study can be found on clinicaltrials.gov.