Therapure Innovations has received approval from the US Food and Drug Administration (FDA) to begin a Phase I clinical trial of TBI 302, a targeted therapeutic for the treatment of liver cancer.
According to the company, TBI 302 is the first drug to emerge from its targeted drug delivery platform, which takes advantage of the natural clearance pathway of haemoglobin predominantly through the liver.
TBI 302 includes a chemotherapy drug floxuridine attached to haemoglobin, which serves as the drug carrier and targeting agent.
The company’s targeted drug delivery approach of TBI 302 is intended to deliver drugs to the liver while sparing other tissues from the toxicity of chemotherapy drug exposure.
Therapure vice-president and chief scientific officer Dr David Bell said: "This technology addresses an area of unmet medical need that may provide a means to specifically deliver an active therapeutic to the site of the cancer and potentially provide a direct benefit to patients.
"Our company has extensive experience working with blood proteins and haemoglobin in particular, so we’re excited to see this innovative product moving into the clinic."
The open-label, multicentre Phase I clinical trial of TBI 302 will evaluate the safety, tolerability and pharmacokinetics of TBI 302 following administration to patients with advanced liver cancer.
Therapure president and chief executive officer Nick Green said: "We’re proud of this major milestone achieved by our Therapure Innovations division.
"Receiving the FDA’s okay to initiate this trial speaks to the great team of skilled researchers, development specialists and manufacturing experts who continue to advance our proprietary pipeline products.
"In a short period of time, this is our second product to advance into clinical trials in a second therapeutic area."
Scientists at Therapure Innovations are developing new protein therapeutics in anaemia, liver cancer and infectious disease using proprietary platform technologies.
The company’s platform technologies also have the potential to improve the pharmacology of existing drugs and therapeutics in other clinical areas.
Image: CT scan showing cholangiocarcinoma. Photo: courtesy of Filip em.