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PharmaDrug (CSE: PHRX) yesterday reported that its joint venture, Sairiyo Therapeutics, has begun the process of preparing for its first clinical trial for its PD-001 formulation. Start-up activities for the clinical trial, which will study the drug as a potential treatment for viral infectious diseases, have begun.
Start-up activities in advance of the trial are said to include the manufacturing scale-up of PD-001, as well as the evaluation and final selection of potential clinical sites as well as a clinical research organization to assist in conducing the trial. The phase 1 trial is set to occur in Australia, under approval by the Australian Human Research Ethics Committee.
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The primary objective of the trial is said to be assessing the comparative bioavailability of oral PD-001 to that of oral cepharanthine tablets. Sairiyo’s PD-001 formulation consists of a patented enteric-coated version of cepharanthine, which is expected to improve the bioavailability of the drug. Additional objectives are said to include the evaluation of other comparative safety, tolerability, and pharmacokinetic information of the two formulations.
“We have begun planning for the phase 1 study in Australia. Given cepharanthine’s long history of being a safe and approved drug in Japan for over 70 years, we are fairly confident of its safety profile, but its therapeutic utility is limited due to its low bioavailability. Our patented enteric-coated version of cepharanthine aims to solve the drug’s limitations and we look to have the study confirm PD-001’s higher bioavailability to provide us with important data that we can use for future phase 2 studies in viral infectious diseases,” commented PharmaDrug CEO Robert Steen.
The phase one trial is expected to take place over a 49 day period, including the screening period and a 7-day washout period between doses. Sairiyo expects 15 volunteers will be enrolled in the trial, in an effort to obtain at least 12 volunteers that will complete the study.
Upon successful completion, a phase 2 study will be sought for completion under FDA guidelines, with the aim of studying the use of the drug for a specific viral infectious disease.
PharmaDrug last traded at $0.025 on the CSE.
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