29th Apr 2019 09:20
LONDON (Alliance News) - 4d Pharma PLC on Monday reported a positive initial phase of one drug trial and the start of another.
In a phase I/II trial of pembrolizumab, or Keytruda, the first patient has finished cycle one of part A of the study with no dose-limiting toxicity, 4d said.
The trial will include up to 132 patients with cancers such as lung cancer, renal cell carcinoma, bladder cancer, and melanoma, who have failed anti-PD-1 therapy.
Part A is looking at 12 patients, and the main aim is to assess safety and tolerability. 4d, which is carrying out the trial alongside Merck & Co Inc, hopes to finish Part A by the end of 2019.
4d also has started a phase I study of MRx0518 at Imperial College London, trialling it as a therapy in up to 120 patients with a wide variety of solid tumours.
The primary aims are safety and tolerability, with secondary markets including survival.
4d Chief Executive Duncan Payton said: "We are delighted with the clinical progress of our oncology programme. The first patient completing cycle one with no dose-limiting toxicities gives us confidence that we may be able to report on early results of this study this year.
"The commencement of the monotherapy study will significantly strengthen our understanding of the potential of MRx0518 to impact treatment across a range of cancer settings. The novel study design will, for the first time, enable the evaluation of the anti-tumour immunological effects of a live biotherapeutic in treatment-naïve patients who will not be receiving concurrent therapy," Payton continued.
"We see our continued research and focus on the mechanism of action of our Live Biotherapeutic products as crucial to their further clinical development and regulatory approval as we build our oncology franchise."
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