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US FDA further indicates that one of the four drugs may be eligible for registration via 505(b)(2) Regulatory Pathway
VALLEY FORGE, Pennsylvania, Oct. 30, 2018 /PRNewswire/ — L.E.A.F. Pharmaceuticals LLC (“LEAF”), a global pharmaceutical company focused on developing novel anticancer drugs, today announced that it has received positive feedback following Pre-Investigational New Drug (Pre-IND) interactions with the United States Food and Drug Administration (US FDA) for four of its lead anticancer products, LEAF-1401, LEAF-1701, LEAF-1702 and LEAF-1703. These products are new generation onco-immuno antimetabolites that are designed to disrupt dysregulated serine-glycine 1-carbon metabolism in cancer and the immune system.
The official guidance to LEAF by the US FDA, provides a clear roadmap for filing IND applications, initiating a first-in-human clinical trial and a possible registration path for LEAF-1401, LEAF-1701, LEAF-1702 and LEAF-1703. LEAF’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 LEAF to move all four products simultaneously into the clinic.
“Receiving such a positive and comprehensive US FDA response, less than 15 months after these four novel molecules were first synthesized and formulated, is a testament to the expertise and efficiency of our R&D engine. LEAF is now planning Pre-IND discussions with Rwanda FDA and has plans to subsequently expand availability of these novel drugs to patients across Africa. Four additional novel molecules are expected to be in Pre-IND discussions with US FDA shortly. LEAF is presently seeking suitable partners to accelerate its efforts to make available these novel drugs to cancer patients,” says Founder, President, and CEO of L.E.A.F. Pharmaceuticals, Dr. Clet Niyikiza.
US FDA further indicated that one of LEAF’s four novel molecules may be acceptable for development and registration under 505(b)(2) regulatory pathway. In addition, the Agency also provided guidance on how to establish a “bridge”, between this molecule and the US FDA approved listed drug, for the purpose of fulfilling the 505(b)(2) registration path requirements.
“This new class of molecules is designed to counter tumor mediated metabolic dysregulation associated with cancer and the immune system. The guidance that LEAF received from US FDA brings us one step closer to making available new medicines to physicians and patients in the fight against cancer,” says Dr. Victor Moyo, Global Head of Research and Development and Chief Medical Officer of L.E.A.F. Pharmaceuticals.
Since L.E.A.F. Pharmaceuticals began operations in August 2014, the company has filed over 55 patent applications to protect its intellectual property.
For more information, please visit www.leafpharmaceuticals.com.
About L.E.A.F. Pharmaceuticals
L.E.A.F. Pharmaceuticals is a global pharmaceutical company with a mission to discover, develop and commercialize innovative and safe therapies for cancer. LEAF is committed to Lifting and Empowering All Families (L.E.A.F.) by developing and making accessible new medicines for patients globally, especially the lesser served regions of the world.
Media Contact: Dr. Navreet Dhindsa
Corporate Communications
ndhindsa@leafpharmaceuticals.com
Phone: +1 781 305 4192
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Source: L.E.A.F. Pharmaceuticals LLC
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