L.E.A.F.Pharmaceuticals LLC, a US-based global pharmaceutical company focused on developing novel anticancer drugs, has announced that it has received positive feedback from the US Food and Drug Administration (US FDA) for four of its lead anticancer products.
The four drugs – LEAF-1401, LEAF-1701, LEAF-1702 and LEAF-1703 – are a new generation of drugs designed to treat different kinds of cancer diseases, including liver, lung, breast ovarian, gastrointestinal and head and neck cancers.
L.E.A.F was founded by Rwandan scientist Dr Clet Niyikiza, who is also its President.
According to a statement, the official guidance by the US FDA provides a clear roadmap for filing what is called the Investigational New Drug (IND) applications.
The IND applications are means by which a pharmaceutical company obtains permission to start human clinical trials.
This will initiate a first-in-human clinical trial and a possible registration path for these four drugs.
“L.E.A.F’s proposal to study these four new molecular entities in a single first-in-human Phase 1 clinical trial was acceptable to the US FDA, which effectively enables us to move all four products simultaneously into the clinic,” reads part of the statement.
Speaking during an exclusive interview with The New Times, yesterday, Niyikiza said that receiving such a positive and comprehensive US FDA response, less than 15 months after the four novel molecules were first synthesized and formulated, is testament to the expertise and efficiency of their research and development.
According to him, the clinical trials could take between 2-5 years depending on the strength of the clinical results before they can be registered officially, and that some $100-200 million could be spent to get the job done.
Niyikiza revealed that they plan to conduct clinical trials in different hospitals, including Mass General Hospital in Boston, Institut Gustave Roussy in France and Karolinska in Sweden.
He told The New Times that the laboratory infrastructure and human expertise at L.E.A.F. Pharmaceuticals US facility, where the first research on these drugs was carried out, is planned to be replicated in Rwanda.
“The company plans to start its initial translational clinical research and development operations at the Rwanda Military Hospital this December 2018. This will be followed by a focused basic drug discovery research series of activities, planned to take place in collaboration with the University of Rwanda,” he noted.
With this, Niyikiza’s agenda is to bring the young generation of current and future Rwandan scientists the tools and the environment they need to thrive in the hunt for new treatments and cures against the most deadly diseases in the world.
Since launching its operations in August 2014, L.E.A.F. has filed over 55 patent applications to protect its intellect.