Thanks for your post and your reference to PolyNovo's RCT for DFU.
I don't see problem with a competitor, nor the fact that they are in Port Melbourne, or that they are now recruiting 5x the amount of patients than CYP in the US:
Randomized Clinical Study Comparing SynPath to Standard of Care in Treatment of Chronic Diabetic Foot Ulcers (DFUs) | Safety, Tolerability and Efficacy of CYP-006TK in Adults With Diabetic Foot Ulcers |
| Study Type: | Interventional (Clinical Trial) | | EstimatedEnrollment: | 138 participants | | Allocation: | Randomized | | Intervention Model: | Parallel Assignment | | Masking: | None (Open Label) | | Primary Purpose: | Treatment | | Official Title: | A Prospective, Multicenter, Open Label, Randomized, Controlled Clinical Study Evaluating the Effect of NovoSorb ® SynPath™ Dermal Matrix Compared to Standard of Care (SOC) In the Treatment of Nonresponsive, Chronic Diabetic Foot Ulcers. | | ActualStudy Start Date: | July 10, 2022 | | EstimatedPrimary Completion Date: | June 1, 2023 | | EstimatedStudy Completion Date: | October 1, 2023 |
| | Study Type: | Interventional (Clinical Trial) | | EstimatedEnrollment: | 30 participants | | Allocation: | Randomized | | Intervention Model: | Parallel Assignment | | Masking: | Single (Outcomes Assessor) | | Primary Purpose: | Treatment | | Official Title: | A Randomised, Controlled, Phase 1 Study to Investigate Safety, Tolerability and Efficacy of CYP-006TK in Adults With Diabetic Foot Ulcers | | ActualStudy Start Date: | January 4, 2022 | | EstimatedPrimary Completion Date: | December 2022 | | EstimatedStudy Completion Date: | December 2022 |
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Primary Outcome Measures:- Percentage of ulcer closed at 12 weeks [ Time Frame: 12 weeks ]
Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart
| Primary Outcome Measures:- Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: 24 weeks ]
- Incidence of changes from baseline in haematology, biochemistry, and urinalysis parameters. [ Time Frame: 24 weeks ]
Results will be summarised by individual and by treatment group using descriptive statistics.
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Secondary Outcome Measures:- Percentage of ulcers that achieved 50% or greater closure rate within 6 weeks [ Time Frame: 6 weeks ]
The percentage of ulcers that achieve 50% or greater closure - Comparison of closure rates for each treatment group [ Time Frame: 12 weeks ]
Comparison of rates of wound closure between Standard of Care and SynPath - Percent Wound Area Reduction(PWAR) over 12 weeks [ Time Frame: 12 Weeks ]
The Change in percentage wound reduction(PWVR) over 12 weeks for each treatment group - Cost of treatment in each treatment group [ Time Frame: 12 weeks ]
Calculation of cost of treatment including number of device applications for each treatment group - Change in reported Pain Levels between each treatment group [ Time Frame: 12 weeks ]
Change in subject reported pain levels using the 0-10 Numerical Pain Scale - The type and number of serious adverse events experienced [ Time Frame: 12 weeks ]
Comparison of the type and number of serious adverse events experience for each treatment group
| Secondary Outcome Measures:- Percentage of area change of study ulcer from baseline to weeks 12 and 24 [ Time Frame: 12 and 24 weeks ]
- Number of days to complete ulcer healing [ Time Frame: 12 and 24 weeks ]
- Number of days to 50% ulcer healing [ Time Frame: 12 and 24 weeks ]
- Percentage change in ulcer volume from baseline to weeks 12 and 24 [ Time Frame: 12 and 24 weeks ]
- Changes from baseline in ulcer pain assessed using a Numeric Rating Scale [ Time Frame: 12 and 24 weeks ]
- Number clinic/home care visits across groups [ Time Frame: 12 and 24 weeks ]
- Differences across groups on ulcer dressing products used [ Time Frame: 12 and 24 weeks ]
- Changes from baseline in Quality of Life assessed using the Cardiff Wound Impact Schedule [ Time Frame: 12 and 24 weeks ]
- Duration of clinic/home care visits across groups [ Time Frame: 12 and 24 weeks ]
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| https://clinicaltrials.gov/ct2/show/NCT05506215 | https://clinicaltrials.gov/ct2/show/NCT05165628?term=cynata&draw=2&rank=2 |
Reality check:Patients should have access to best possible treatment. The only way to determine which one is the best treatment is by conducting clinical trials. Based on the above, we may be able to compare the results not just based on treatment and SOC for each trial separately, but also with each other given the primary and secondary outcome measures.
I see no logic in a statement that suggests to not conduct a trial in an indication such as DFU (or in any indication for that matter) simply because another company is also conducting a clinical trial that could result in a better outcome for patients. Whether they are located in Port Melbourne or in a Garage in Los Altos is even less relevant. I do like the projected timeline of recruiting 138 patients in the US in less than 12 months though (compared to 30 patients in AU in about 9 months). Perhaps a possibility for a P2 trial, if the P1 clinical data warrants it.
The Government funded preclinical data definitely warranted the P1 trial:
https://files.cynata.com/348/18.05.31.Cynatas-MSCs-Effective-in-Model-of-Diabetic-Wounds.pdfAnd in the absence of an IND in the US, AU was a feasibly option to conduct a "dwarfed" P1 trial.
(20min delay)