Latest news with #PhaseIItrial
The Australian
9 hours ago
- Health
- The Australian
What the Facts: Argentica Therapeutics
What are strokes? How many people do they impact? And what are the limitations of current treatments? Host Tylah Tully is joined in this episode by Argenica Therapeutics (ASX:AGN) managing director Dr Liz Dallimore, who shares all about the devastating global impact of strokes and the company's innovative approach to treatment. Dallimore explains what happens in the brain during a stroke, why cases are rising worldwide, and the limitations of current treatments. She also explains how Argenica's neuroprotective drug works, which aims to protect brain cells and extend the treatment window for stroke patients; potentially transforming outcomes. With a Phase II trial nearing results, Argenica is positioning itself at the forefront of stroke therapy innovation. This video was developed in collaboration with Argenica Therapeutics, a Stockhead advertiser at the time of publishing. This video does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Yahoo
21-07-2025
- Business
- Yahoo
OKYO reports top-line data from neuropathic corneal pain therapy trial
OKYO Pharma has reported encouraging top-line outcomes from the randomised Phase II trial of urcosimod (previously referred to as OK-101), aimed at treating neuropathic corneal pain (NCP). The double-masked, placebo-controlled trial was carried out at Tufts Medical Center in Boston, US, with Pedram Hamrah as the principal investigator. Its primary endpoint was the change in mean pain scores from baseline to the end of the 12-week treatment period, measured using Visual Analogue Scale (VAS) scores of zero to ten. The company noted that, for the per-protocol population, the 0.05% urcosimod group showed a mean pain score change of 5.5 while the placebo group had a change of 2.75, indicating a 2.75 delta difference between the drug and the placebo after 12 weeks of treatment. In addition, 75% of subjects treated with 0.05% urcosimod achieved an improvement in pain severity of over 80%. The 0.05% therapy showed a marked decrease in pain scores as early as week four, with a mean change of 5.25, compared with 3.0 for the placebo. Although the placebo group also saw improvement, it was notably less than that of the urcosimod group, and 75% of those subjects had only mild NCP pain scores at baseline. In the intent-to-treat subjects, 67% of those in the 0.05% group showed an improvement of more than 50% in pain, versus 33% in the placebo group. The mean decrease in pain severity was 4.2 for the 0.05% therapy group, versus 2.5 for the placebo group. A Cohen-d value of greater than 1.2 indicated a strong treatment impact. Cohen-d is a statistical metric used to evaluate and contrast the effect size of the trial medication with that of the placebo. NCP causes intense pain and sensitivity in the eyes, as well as the face and head. The company noted that the Phase II trial of urcosimod was planned to enrol 48 subjects, but OKYO Pharma closed the trial early in April this year. With 17 subjects having completed the trial, the decision was based on the company's aim to unmask the data for an early readout on the drug's impact. OKYO Pharma CEO Gary Jacob said: 'We are thrilled with these initial top-line results in patients treated with urcosimod from this first in-human Phase II trial. 'In particular, the results strengthen our conviction that this drug may be particularly effective at showing a significant reduction in pain in patients with a greater degree of neuropathic pain.' In 2023, OKYO screened the first subject in its Phase II trial of OK-101 ophthalmic solution to treat dry eye disease (DED). "OKYO reports top-line data from neuropathic corneal pain therapy trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
11-07-2025
- Business
- Yahoo
PDS Biotechnology completes recruitment for stage one of colorectal cancer trial
PDS Biotechnology has completed subject recruitment for stage one of its open-label Phase II trial, evaluating the systemic administration of fused antibody drug conjugate (ADC) PDS01ADC in conjunction with floxuridine given via hepatic artery infusion pump for metastatic colorectal cancer patients. Spearheaded by the National Cancer Institute (NCI)'s surgical oncology section chief Dr Jonathan Hernandez, the single-centre, non-randomised trial includes three cohorts of metastatic colorectal cancer, cholangiocarcinoma, and adrenocortical cancer. Each cohort leverages a Simon two-stage trial design. For the colorectal cancer cohort, the continuation to enrol up to a total of 22 subjects was contingent on at least six out of nine participants showing an objective response by response evaluation criteria in solid tumours (RECIST) v1.1 criteria. The trial has met the pre-set RECIST v1.1 criteria for expansion into stage two. The other two cohorts are still recruiting in stage one. The trial is part of a collaborative research and development agreement with the NCI. PDS Biotechnology noted that the ADC is composed of two interleukin-12 (IL-12) heterodimers. Each of these is fused to the NHS76 antibody, which attaches to single-stranded and double-stranded DNA and targets areas of tumour necrosis, where there is DNA exposure. PDS Biotechnology CEO and president Frank Bedu-Addo said: 'This novel investigational approach to the targeting and use of IL-12 results in little or no systemic exposure to IL-12, and may allow patients to reap the benefits of cytokine therapy without the typical treatment-limiting toxicities. 'We are delighted that the NCI has achieved this milestone and anticipate completion of patient recruitment for the metastatic colorectal cancer cohort of the study by the fourth quarter of 2025.' The company is also commencing a pivotal trial to progress its lead programme in advanced human papillomavirus (HPV)16-positive head and neck squamous cell cancers. Versamune HPV, the company's lead investigational targeted immunotherapy, is under development in conjunction with a standard-of-care immune checkpoint inhibitor and in a triple combo that includes PDS01ADC. "PDS Biotechnology completes recruitment for stage one of colorectal cancer trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
