An experimental chemotherapy drug that can be taken orally is moving into early phase clinical trials as part of a new partnership between Athenex, Cancer Research UK’s Combinations Alliance and the NIHR Clinical Research Network Industry Alliance, announced today (Thursday).
This unique industry-academic initiative will be run through the Experimental Cancer Medicine Centres (ECMC) and the NIHR Clinical Research Network.
The partnership will enable researchers to investigate Athenex’s innovative experimental drug Oraxol, the first oral formulation of the chemotherapy drug paclitaxel, in combination with other cancer treatments*.
Paclitaxel is very effective at blocking the growth of cancer and is widely used for a range of cancer types, but currently it can only be given intravenously through a drip.
Oral delivery of paclitaxel is made possible by Athenex’s novel orally administered gastrointestinal tract P-glycoprotein pump inhibitor, HM30181A**. It works by blocking the action of a protein on the surface of the gastrointestinal (GI) tract, increasing the amount of chemotherapy that reaches circulation in the bloodstream, to levels where it can have a therapeutic effect on a patient’s tumour.
Being able to take this type of chemotherapy orally opens up the opportunity for patients to have their treatment at home, rather than travelling to hospital regularly, and may reduce treatment delivery costs for health services.
Oraxol was recently awarded PIM (Promising Innovative Medicine) designation by the MHRA. Athenex already has a strong presence in North America and Asia; this partnership is part of a broader plan to move into Europe.
Rudolf Kwan, Athenex’s Chief Medical Officer, said: “Oraxol marks a significant step forward for the development of oral chemotherapies, potentially changing the way a large proportion of cancer patients receive chemotherapy treatment. By working with Cancer Research UK’s Combinations Alliance and NIHR Clinical Research Network, our goal is to develop Oraxol in combinations that would not otherwise be possible, bringing new treatment options to more cancer patients.”
The clinical trials managed by this partnership will be academically sponsored and delivered with additional support and oversight from Cancer Research UK and NIHR Clinical Research Network.
Dr Ian Walker, Cancer Research UK’s director of clinical research, said: “This exciting partnership will enable us to accelerate the development of a treatment that not only has the potential to improve patient outcomes, but also quality of life.
“We look forward to exploring how this drug can be used in combination with other treatments and hope that it can play a part in addressing the urgent need for new treatments for patients with hard to treat and rare cancers.”
Prof Matt Seymour, who leads for cancer research in the NIHR Clinical Research Network, said: “This is a good example of the UK’s unique environment for bringing together academic researchers, industry innovators and the NHS, to join forces and design clinical research trials for more of our patients. I welcome this new alliance. Most anticancer drugs need to be given by injection in hospital, but programmes like this allowing effective drugs to be taken in tablet form at home, could potentially improve our patients’ experience, and may open up opportunities for more sustained treatment, to keep cancers under better control.”
*Expressions of interest for rational combinations in patient populations with unmet medical need are now closed and proposals are under discussion.
**HM30181A is a unique technology that enables oral absorption of a wide range of anticancer drugs, which can currently only be given intravenously due to poor oral absorption (ie: paclitaxel, docetaxel, irinotecan, eribulin, etc.). It is a selective and potent P-glycoprotein (‘P-gp’) inhibitor. Under normal conditions, when paclitaxel is administered orally, the p-glycoprotein pump on surface of the gastrointestinal (GI) tract cells blocks the drug from entering the bloodstream. HM30181A blocks the p-glycoprotein pump, enabling the orally administered paclitaxel to reach blood levels at which it can have a therapeutic effect on a patient’s tumour.