Tag: Clinical Data
Thermosome Reports Encouraging Clinical Data of THE001 in Advanced Soft Tissue Sarcomas
— Heat-triggered release mechanism unequivocally confirmed
— Favorable safety profile with good tolerability
— Signs of encouraging clinical activity in heavily pre-treated patients including meaningful progression-free survival (PFS)
— One participant with previously unresectable disease in DL2 underwent surgery, indicating no vital tumor cells in the target lesion
Munich, Germany – June 24, 2025 – Thermosome GmbH, a clinical-stage drug development company focused on targeted tumor therapies, today announced new, encouraging data from its ongoing Phase I clinical trial evaluating its lead compound THE001 (DPPG2-TSL-DOX) in combination with regional hyperthermia (RHT) for the treatment of soft tissue sarcomas (STS). Read more…
New Clinical Data on BellaSeno’s Novel, Resorbable Breast Implants Presented at The Aesthetic MEET 2025
— Presentation by Prof. Anand Deva highlights 87% breast volume retention and low complication rate in one-year patient follow-up
— Successful vascularization and vessel formation in two-year follow-up
— 3D-printed resorbable scaffold to preserve both volume and shape of autologous fat in the medium to long term
BellaSeno GmbH, an ISO 13485-certified medtech company developing resorbable scaffolds using additive manufacturing technologies, today announced that Prof. Anand Deva presented new clinical data on BellaSeno’s novel, 3D-printed, resorbable breast scaffolds at The Aesthetic MEET 2025 conference in Austin, TX, USA.
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.