TC Biopharm announces MHRA acceptance of amendment for ACHIEVE UK trial

TC BioPharm announced that the Medical and Healthcare Products Regulatory Agency, or MHRA, has officially accepted its proposed amendment to the company’s clinical trial authorization, or CTA. The amendment allows for an increase in dosing size of TCB008. Additionally the amendment allows for patients to be treated as “out patients”, easing the burden on patients and lessening the burden on clinical sites as patients will not need to be monitored overnight after the first five patients are dosed. The ACHIEVE trial is a Phase 2b trial in Acute Myeloid Leukemia testing efficacy for TCBPs lead product TCB-008, or Omnimmune. Bryan Kobel, Chief Executive Officer of TC BioPharm stated, “Management is pleased to receive amendment clearance from the MHRA, this is yet another example of the team executing on plans we have laid out for the investment community. The changes to the protocol will substantially impact both the timing of data in the ACHIEVE trial as well as impacting the proposed FDA trial. Shifting to an out patient procedure means patients in the trial are not forced to spend a night in the hospital, increasing their quality of life in a difficult time, and also allows hospitals to not need to hold a bed for a patient in a time when beds are scarce in the NHS. We believe, after feedback from the clinical sites, that this was a material rate limiting concern in enrolment and are happy we can now provide them relief. Increasing the dose size, in accordance and discussion with our investigators, can increase the positive impact in patients with no safety concerns, furthering our stance that TCB-008 should be used in a myriad of settings at high doses. This step also aligns the dosing levels with the IND, where our second cohort would be receiving this dose, and gives us a window to approach the FDA with data at this level to potentially go immediately to dose level two in our US Phase 1b in relapse/refractory AML.”