Tag: Clinical Data

BellaSeno Reports Positive One-Year Patient Follow-Up Data for Resorbable Breast and Pectus Excavatum Scaffolds

Key milestone for novel, resorbable breast / pectus reconstruction implants

BellaSeno GmbH, an ISO 13485-certified medtech company developing resorbable scaffolds using additive manufacturing technologies, today reported encouraging one-year follow-up data of its breast and pectus excavatum scaffolds.

Both pectus and breast implants demonstrated a very good safety profile, were very well accepted by the surgeons and patients expressed high satisfaction and reported an improvement in quality of life. A significant improvement in pain scores was observed in breast reconstruction patients with prior silicone implants. All patients´ breasts maintained their shape and volume after surgery. Read more…

Company News: InDex Pharmaceuticals to present results from the COLLECT trial at the 10th Congress of the European Crohn’s and Colitis Organisation

InDex Pharmaceuticals today announced that results from COLLECT, a clinical study of the toll-like receptor 9 (TLR9) agonist Kappaproct as an add-on therapy for patients with moderate to severe, chronic active Ulcerative Colitis, will be subject to an oral presentation at the 10th Congress of the European Crohn’s and Colitis Organisation (ECCO). The congress is to be held in Barcelona, Spain on February 18-21, 2015.

In the COLLECT study, 131 patients with moderate to severe Ulcerative Colitis and inadequate response to conventional therapy received either Kappaproct or placebo as an add-on to conventional treatment. The study was conducted at 40 sites in seven European countries.

Despite not meeting the primary endpoint of inducing clinical remission measured at week 12, defined by a clinical activity index (CAI) score of ≤4, Kappaproct showed statistically significant improvement on important secondary endpoints at week 4 and 8, including symptomatic remission (blood in stool, number of stools) and registration remission (clinical remission with concurrent endoscopic remission) as well as rate of colectomy at week 22. Kappaproct was well tolerated and no safety signals compared to the standard of care treatment group were evident. The data strongly support continued development of Kappaproct as a promising and well-tolerated novel therapeutic option for refractory ulcerative colitis patients. The next phase III study is planned to start this year.

The presentation (Oral presentation #15) titled “Multicentre clinical trial with topical administration of the Toll-Like receptor 9 agonist DIMS0150 shows evidence for efficacy in moderate to severe Ulcerative Colitis” will be held by Professor Raja Atreya from the University of Erlangen-Nürnberg on Friday, February 20th, 2015, at 14.20pm CET.

Company News: Anergis Completes Enrolment in the Long-Term Efficacy Trial of Lead Compound AllerT

– Results expected for Q3, 2014 –

Anergis, a company discovering and developing proprietary allergy vaccines, today announced that it has completed the enrolment of 196 subjects in the long-term efficacy trial of its birch pollen allergy vaccine AllerT, and expects to release results in the third quarter of 2014.

The long-term efficacy trial of AllerT is a double-blind, placebo-controlled, field-based clinical trial assessing the persistence of the efficacy of AllerT in post-treatment years.

All 196 patients participated in the field-based Phase IIb trial with AllerT in 2013. They all received a two-month double-blind, randomized treatment with AllerT or a placebo prior to the 2013 birch pollen season, and were then followed for efficacy during the 2013 birch pollen season, i.e. in conditions of natural pollen exposure. Last year’s Phase IIb trial had shown the efficacy of AllerT on allergy symptoms during the first post-treatment birch pollen season, based on combined symptom and medication scores, quality of life and other endpoints.

In the new long-term efficacy trial, the enrolled patients agreed to collect their daily allergy symptoms and allergy medication using electronic diaries, exactly as was done during the previous trial/season. The patients have not received any further investigational treatment since their pre-seasonal two-month treatment in early 2013.

The trial will thus provide efficacy data for AllerT during the second season post-treatment without any intervention since the initial two-month, pre-seasonal treatment. Anergis had already shown that patients from the AllerT Phase IIa trial had a persistent elevation in allergen-specific antibodies (IgG4) until at least the fourth post-treatment season.

Company News: New Clinical Data Demonstrate Strong Synergy between Cancer Vaccine ISA101 and Chemotherapy

–      Data presented at the AACR Annual Meeting 2014

–      Potential new treatment being developed for patients with late-stage cervical cancer

ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, has announced new clinical data on its lead product candidate ISA101. ISA101 is a therapeutic cancer vaccine for the treatment of high-risk, HPV16-induced diseases, such as cervical cancer. The data were presented by principal investigator Prof. Sjoerd van der Burg, Ph.D., at this year’s American Association for Cancer Research (AACR) Annual Meeting in San Diego.

The data demonstrate strong synergy between ISA101 and chemotherapy, offering potential new treatment options for cervical cancer patients scheduled to receive standard chemotherapy with carboplatin / paclitaxel.

Prof. van der Burg and his group evaluated the immunological and clinical responses of patients with advanced cervical carcinoma in a Phase I combination trial. In this pilot trial, patients received ISA101 in combination with standard chemotherapy cycles (carboplatin / paclitaxel). Almost all patients showed a strong immune response to the ISA101 vaccine. Comprehensive immune monitoring confirmed the beneficial effect of myeloid suppressor cell depletion associated with a robust induction of HPV16-specific T-cell responses that were sustained throughout several cycles of chemotherapy.

The observation that depletion of myeloid suppressor cells by a carboplatin/paclitaxel chemotherapy regimen enhances the immune response to ISA101 is in line with prior observations that tumors promote immune tolerance starting early in the disease and that chemotherapy can restore immune competence in cancer patients.

Based on these results ISA has initiated a phase I/II study (CervISA) in October last year testing ISA101 in combination with carboplatin, paclitaxel and pegylated interferon alpha in women with advanced or recurrent cervical cancer.

The presentation titled “Synergistic effects of properly timed HPV16 SLP vaccination during standard carboplatin-paclitaxel chemotherapy in animals and patients with metastatic cervical carcinoma“ was given at the Minisymposium MS.IM02.01 “Immune-based Therapies: Responses, Biomarkers, and Mechanisms” on Monday, April 07, 2014, at 3:20 PM in Room 6CF at the San Diego Convention Center.

The abstract # 2938 is available at the AACR website www.aacr.org.

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