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Edison Investment Research is terminating coverage on Genkyotex (GKTX). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant.
Companies: GENTICEL
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Genkyotex has initiated a Phase II investigator-sponsored trial in patients with Type 1 diabetes (T1D) and kidney disease (DKD). Separately, it has announced the positive outcome of a safety review of its Phase II trial with GKT831 in patients with primary biliary cholangitis (PBC) with no adverse events or patient dropouts. Interim data have been pushed back slightly to autumn 2018 from mid-2018 and full data to H119 from end-2018 due to a slow rate of activation of a number of research centres
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As expected, Genkyotex has initiated enrolment in the Phase II trial of GKT831 in patients with primary biliary cholangitis (PBC) in the first clinical trial site in the US. The trial plans to test GKT831 in 102 patients over 24 weeks. Interim data are expected in H118 and full data in H218. Moreover, the company has announced a Phase II investigator-sponsored trial in patients with Type 1 diabetes (T1D) and kidney disease. The trial will start in Australia in H217 and will be entirely funded an
Genkyotex is a Euronext-listed company formed by the merger of Genticel and Genkyotex focused on NOX science and its application in fibrosis and other indications. The lead asset, GKT831, will start a Phase II trial in primary biliary cholangitis (PBC) in Q217, with data expected in 2018. Positive results could justify future development in other large fibrotic diseases including non-alcoholic steatohepatitis (NASH). GKT771 will be Phase I ready in late 2017 and will focus on inflammation and an
Genticel has received a milestone payment of $1.2m from the Serum Institute of India (SIIL). This is the last milestone Genticel will receive associated with the preclinical development of GTL003 in new multivalent vaccines that contain pertussis (whooping cough). SIIL can now finish formal preclinical development before moving to clinical development, which could unlock further milestone payments. Under the collaboration with SIIL, Genticel is entitled to up to $57m development and sales milest
And then worst of all, you never get approval when you say you will. There is nothing that causes investor whiplash more than a sudden announcement of an unsuccessful clinical trial. Whether you are the onedrug wonder on AIM or the multi-drug portfolio NASDAQ darling, the market never takes too kindly to unsavoury news from the FDA on clinical results. But should investors lambast these two scenarios similarly based on poor trial results? The variables are endless but in this example the clear a
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Genticel has announced 18-month data from the Phase II trial of the GTL001 vaccine to treat early-stage human papillomavirus 16 and 18 infections (HPV16/18). In this update, GTL001 showed no statistically significant difference in any subgroup. Safety remains positive. Genticel will present 24-month data in Q117, which will include the full data set and inform next steps. The company continues leveraging its Vaxiclase platform in collaboration with the Serum Institute of India (SIIL) and plans t
Genticel has announced further analysis of its Phase II results on the GTL001 vaccine to treat early-stage human papillomavirus (HPV) 16 and 18 infections. The pre-specified group of patients with normal cytology had a significantly higher viral clearance than those taking placebo (p=0.018). Post-hoc analysis of the combined group of normal and ASCUS patients also shows a statistically significant difference (p=0.0029) between groups. In our view, this indicates that GTL001 could be effective in
Genticel has announced the Phase II results of its GTL001 vaccine to treat early-stage human papillomavirus 16 and 18 (HPV 16 and 18) infections. The primary 12-month endpoint, focused on women with early cervical cellular abnormalities, was not achieved. Positively, in the subgroup of women with normal cytology, a significant clearance rate was seen. Further clearance data after 18 months are expected by Q316 and management expects this to enable Phase III preparations and partnering.
Genticel develops gentle therapeutic vaccines to treat early-stage human papilloma virus infections. The lead vaccine, GTL001, targets high-risk HPV 16 and 18 infections causing c 75% of cervical cancers in North America and the EU. There is no therapeutic vaccine to treat up to 12m women (in these markets). Phase II data, due in H116, could enable a major partnering deal to fund Phase III. A second product, GTL002, based on an improved proprietary platform (Vaxiclase), could enter trials in 201
Research Tree provides access to ongoing research coverage, media content and regulatory news on GENTICEL. We currently have 10 research reports from 2 professional analysts.
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