(Sharecast News) - Biotechnology company BiVictriX Therapeutics updated the market on the pre-clinical evaluation of BVX001 on Thursday - its first-in-class 'Bi-Cygni' antibody drug conjugate (ADC) developed for the potential treatment of acute myeloid leukaemia (AML).
The AIM-traded firm said that in a stringent pre-clinical model of AML, BVX001 showed a substantial prolongation in survival rates, surpassing that of a currently approved and used AML chemotherapy drug.
It said the data built on previous preclinical efficacy data announced in June and reinforced the therapeutic potential of BVX001.
In the study, BVX001 was evaluated against HiDAC - known as the highest accepted dose of the clinically approved AML chemotherapy drug Cytarabine (Ara C).
BiVictriX noted that Ara C is only administered to patients in excellent health and for limited durations due to its notably high toxicity.
An untreated control group was also included for a comprehensive comparison.
Following a 28-day dosing period and subsequent efficacy evaluation, BVX001 showed a median survival rate of 129 days at a dosage of 10 milligrams and kilograms, dosed twice weekly.
That was notably superior to the 91 days observed in the HiDAC treatment group and drastically better than the 57 days in the untreated control group.
To quantify, BVX001 showed a median survival advantage of 126% compared to the untreated control and a 42% advantage versus HiDAC.
The study was based on a notably challenging AML model, with more cells capable of propelling cancer progression than the more specialised driver cells typically found in AML patients.
"Acute myeloid leukaemia remains a significant unmet medical need, linked to one of the poorest overall survival rates across all cancers," said chief executive officer Tiffany Thorn.
"All currently approved AML therapies are associated with severely toxic side effects, including potentially fatal infections and sepsis, limiting their use to younger, fitter patients."
Thorn said the company was "greatly encouraged" by the preclinical data, demonstrating that BVX001 provides clear survival benefits even in the challenging AML model.
"This data adds further strength to our existing and comprehensive pre-clinical data package, as we accelerate work towards obtaining regulatory approval to support the progression of BVX001 into human trials."
At 0831 BST, shares in BiVictriX Therapeutics were down 3% at 12.12p.
Reporting by Josh White for Sharecast.com.
Bivictrix Thera (BVX)