TC BioPharm (Holdings) PLC (NASDAQ: TCBP), a clinical-stage biotechnology firm, announced today that the UK's Medical and Healthcare Products Regulatory Agency (MHRA) has approved an amendment to the company's clinical trial authorization. The amendment pertains to the ACHIEVE Phase 2b trial in Acute Myeloid Leukemia (AML) and involves an increase in the dosage of TCB-008, a gamma-delta T cell therapy, as well as a shift from inpatient to outpatient treatment.
The revision authorizes an escalated dose of TCB-008, involving 12x10^7 to 23x10^7 gamma-delta T cells. This increase aligns with the dosing levels of the second cohort in the Investigational New Drug (IND) application and is intended to enhance the therapy's impact on patients without safety concerns.
Furthermore, the trial will now allow patients to be treated on an outpatient basis, which is expected to improve the quality of life for participants by eliminating the need for overnight hospital stays after the initial dosing. This change is also anticipated to alleviate the strain on clinical sites and the National Health Service (NHS) by freeing up hospital beds.
TC BioPharm's CEO, Bryan Kobel, expressed satisfaction with the MHRA's approval, highlighting that the amendment could accelerate the timing of data from the ACHIEVE trial and influence the proposed FDA trial in the United States. Kobel noted that the outpatient treatment could address enrollment challenges by reducing the demand for hospital beds.
The company, known for its development of gamma-delta T cell therapies, is conducting clinical trials with its unmodified gamma-delta T cell product line. TCB-008, also known as Omnimmune®, is being tested in a pivotal trial for the treatment of AML, utilizing the company's proprietary CryoTC technology to provide a frozen product to clinics globally.
This update is based on a press release statement from TC BioPharm.
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