- Announcing the outcomes in the first 100 patients treated with the OsteoCool™ Radiofrequency Ablation System in the OPuS One Clinical Study, Medtronic (NYSE:MDT) says the study reached the primary endpoint.
- Results published in the Journal of Vascular and Interventional Radiology was based on a multicenter study involving 218 patients at 16 centers in the United States, Europe, and Canada, included outcomes out to six months in the first 100 patients.
- With the results indicating the improvement from baseline to three months post-RFA in worst pain score in the past 24 hours in subjects treated for metastatic lesions in only the thoracic and/or lumbar vertebral body(ies), the study achieved the primary endpoint, the company says.
- One in three cancer patients are left with inadequate treatment or undermanaged pain control, and in this instance, OsteoCool™ system can act as an adjunctive treatment, without disrupting other systemic therapies.
- ‘Results showed rapid pain improvement as early as three days and sustained out to six months’, the company notes, adding 'patients in the study also achieved significant improvements in pain interference and quality of life at all visits.’
- https://seekingalpha.com/news/3644387-medtronics-osteocool-procedure-achieves-primary-endpoint-in-multicenter-cancer-study
- The first patient has been dosed in Nektar Therapeutics' (NASDAQ:NKTR) Phase 1/2 trial of NKTR-255 in patients with relapsed or refractory (R/R) head and neck squamous cell carcinoma (HNSCC) or colorectal cancer (CRC) at the START Center for Cancer Care in San Antonio, TX.
- The study is evaluating NKTR-255 plus cetuximab in up to 80 patients.
- NKTR-255 is an investigational IL-15 receptor agonist designed to activate the IL-15 pathway and expand Natural Killer cells and promote the survival and expansion of memory CD8+ T cells without inducing suppressive regulatory T cells.
- Cetuximab is a monoclonal antibody against epidermal growth factor receptor and is approved for the treatment of advanced HNSCC and CRC.
- https://seekingalpha.com/news/3644434-dosing-underway-in-nektar-therapeutics-study-of-nktrminus-255-pluscetuximab-in-head-neck-and
- Zealand Pharma (NASDAQ:ZEAL) down 10% in premarket in reaction to topline data from first Phase 3 trial evaluating dasiglucagon as a treatment of Congenital Hyperinsulinism (CHI), a rare disease in which infants are born with life threatening hypoglycemia (low blood glucose) due to excess insulin secretion.
- The trial showed that dasiglucagon on top of standard of care didn’t significantly reduce rate of hypoglycemia compared to SOC alone when assessed by intermittent self-measured plasma glucose, the primary endpoint of the trial.
- However, hypoglycemia was reduced by 40–50% with dasiglucagon as compared to SOC alone when assessed by blinded continuous glucose monitoring (exploratory analysis)
- Company to engage with regulatory authorities to discuss the results while awaiting the outcome of the second phase 3-trial in younger children with CHI.
- https://seekingalpha.com/news/3644441-zealand-pharma-drops-dasiglucagon-study-fails-to-meet-primary-endpoint
- The FDA has put a partial clinical hold on Regeneron's (REGN -1.4%) odronextamab, a CD20xCD3 bispecific antibody its experimental blood cancer drug trial, over safety concerns. It asked the company to change protocols to reduce the occurrence of an inflammatory response called cytokine release syndrome.
- This will hit enrollment in a Phase 1 monotherapy trial in B-cell non-Hodgkin lymphoma (B-NHL) as well as another mid-stage trial testing the drug in sub-types of B-NHL.
- Though new enrollment will be paused, treatment for enrolled patients will continue if they re-consent.
- Regeneron said it planned to submit the details of a new protocol amendment to FDA, with the goal of resuming enrollment in Q1 of 2021.
- https://seekingalpha.com/news/3644594-regenerons-odronextamab-hit-fda-partial-hold-on-lymphoma-trials
